FN Thomson Reuters Web of Science™
VR 1.0
PT J
AU Pogge, A
Slikker, W
AF Pogge, A
Slikker, W
TI Neuroimaging: New approaches for neurotoxicology
SO NEUROTOXICOLOGY
LA English
DT Article; Proceedings Paper
CT 20th International Neurotoxicology Conference
CY NOV 18-21, 2002
CL LITTLE ROCK, AR
DE neuroimaging; neurotoxicology; in vitro NMR; magnetic resonance imaging
(MRI); magnetic resonance imaging microscopy (MRM); positron emission
tomography (PET); apoptosis; risk assessment
ID NMDA RECEPTOR ANTAGONISTS; NONHUMAN-PRIMATES; PET; BRAIN; PERFORMANCE;
MICROSCOPY
AB Over the last 20 years, the impact of imaging on the clinical sciences is unquestionable. It has revolutionized the diagnosis and treatment of disease. Interestingly, the use of imaging in preclinical neurotoxicology has been relatively negligible. This has been in part due to the lack of knowledge or understanding of the capabilities of these powerful technologies. However some of the more immediately applicable imaging approaches could impact the present approach to neurotoxicology. In addition, the recent advent of the development of imagers specifically for application to small animals will provide the opportunity of obtaining information for neurotoxicological risk assessment in a more timely and relevant manner. The ability to visualize changes in structure and function due to neurotoxic insult in a noninvasive manner is a promising direction. Changes in anatomy of soft and hard tissue, metabolism, function and gene expression can now be done in both a preclinical and a clinical setting using such technologies as magnetic resonance imaging (MRI), magnetic resonance imaging microscopy (MRM), and positron emission tomography (PET). This type of information is not readily accessible using conventional preclinical neurotoxicological procedures and usually requires total destruction of the intrinsic structure of the sample of interest. Imaging provides an opportunity to produce much of these data in a nondestructive manner and presents the data in a three-dimensional format. This permits longitudinal studies of the same subject subsequently reducing the number of animals required for studies while providing more information. In addition, as these technologies have been primarily developed for clinical purposes, they provide an outstanding opportunity for cross-species and animal-to-human extrapolation and testing. (C) 2003 Elsevier Inc. All rights reserved.
C1 Natl Ctr Toxicol Res, Div Neurotoxicol, Jefferson, AR 72079 USA.
RP Pogge, A (reprint author), Natl Ctr Toxicol Res, Div Neurotoxicol, 3900 NCTR Rd, Jefferson, AR 72079 USA.
EM apogge@nctr.fda.gov
NR 19
TC 18
Z9 18
U1 0
U2 0
PU ELSEVIER SCIENCE BV
PI AMSTERDAM
PA PO BOX 211, 1000 AE AMSTERDAM, NETHERLANDS
SN 0161-813X
J9 NEUROTOXICOLOGY
JI Neurotoxicology
PD JUN
PY 2004
VL 25
IS 4
BP 525
EP 531
DI 10.1016/j.neuro.2003.10.007
PG 7
WC Neurosciences; Pharmacology & Pharmacy; Toxicology
SC Neurosciences & Neurology; Pharmacology & Pharmacy; Toxicology
GA 830KW
UT WOS:000222121900008
PM 15183007
ER
PT J
AU Bowyer, JF
Harris, AJ
Delongchamp, RR
Jakab, RL
Miller, DB
Little, AR
O'Callaghan, JP
AF Bowyer, JF
Harris, AJ
Delongchamp, RR
Jakab, RL
Miller, DB
Little, AR
O'Callaghan, JP
TI Selective changes in gene expression in cortical regions sensitive to
amphetamine during the Neurodegenerative process
SO NEUROTOXICOLOGY
LA English
DT Article; Proceedings Paper
CT 20th International Neurotoxicology Conference
CY NOV 18-21, 2002
CL LITTLE ROCK, AR
DE amphetamine; gene expression; neurodegeneration
ID METHAMPHETAMINE-INDUCED NEUROTOXICITY; MESSENGER-RNA EXPRESSION;
IMMEDIATE-EARLY GENE; DOPAMINE TRANSPORTER; NEURONAL DEGENERATION; RAT
STRIATUM; MOUSE-BRAIN; SUBSTITUTED AMPHETAMINES; DIFFERENTIAL
REGULATION; INDUCED HYPERTHERMIA
AB Gene expression profiles in several brain regions of adult male rats were evaluated following a D-amphetamine (AMPH) exposure paradigm previously established to produce AMPH neurotoxicity. Escalating doses of AMPH (530 mg/kg) were given over the course of 16 h per day in an 18 degreesC environment for 2 days. This paradigm produces neurotoxicity but eliminates or minimizes the hyperthermia and seizure activity that might influence gene expression in a manner unrelated to the neurotoxic effects of AMPH. The expression of 1185 genes was monitored in the striatum, parietal cortex, piriform cortex and posteriolateral cortical amygdaloid nucleus (PLCo) using cDNA array technology, and potentially significant changes were verified by RT-PCR. Gene expression was determined at time points after AMPH when neurodegeneration was beginning to appear (16 h) or maximal (64 h). Expression was also determined 14 days after AMPH to find long-term changes in gene expression that might be biomarkers of a neurotoxic event. In the parietal cortex there was a two-fold increase in neuropeptide Y precursor protein mRNA whereas nerve growth factor-induced receptor protein I-A and I-B mRNA decreased 50% at 16 h after the end of AMPH exposure. Although these changes in expression were not observed in the PLCo, insulin-like growth factor binding protein I mRNA was increased two-fold in the PLCo at 16 and 64 h after AMPH. Changes in gene expression in the cortical regions were all between 1.2- and 1.5-fold 14 days after AMPH but some of these changes, such as annexin V increases, may be relevant to neurotoxicity. Gene expression was not affected by more than 1.5-fold at the time points in the striatum, although 65% dopamine depletions occurred, but the plasma membrane-associated dopamine transporter and dopamine D2 receptor were decreased about 40% in the substantia nigra at 64 h and 14 days post-AMPH. Thus, the 2-day AMPH treatment produced a few changes in gene expression in the two-fold range at time points 16 h or more after exposure but the majority of expression changes were less than 1.5-fold of control. Nonetheless, some of these lesser fold-changes appeared to be relevant to the neurotoxic process. (C) 2003 Elsevier Inc. All rights reserved.
C1 Natl Ctr Toxicol Res, Div Neurotoxicol, Jefferson, AR 72079 USA.
Natl Ctr Toxicol Res, Div Biometry, Jefferson, AR 72079 USA.
Natl Ctr Toxicol Res, Div Risk Assessment & Genet Toxicol, Jefferson, AR 72079 USA.
NIOSH, Ctr Dis Control & Prevent, Morgantown, WV 26505 USA.
RP Natl Ctr Toxicol Res, Div Neurotoxicol, Jefferson, AR 72079 USA.
EM jbowyer@nctr.fda.gov
RI O'Callaghan, James/O-2958-2013; Little, Roger/O-6191-2014
OI Little, Roger/0000-0001-6831-0177
NR 70
TC 18
Z9 19
U1 0
U2 0
PU ELSEVIER SCIENCE BV
PI AMSTERDAM
PA PO BOX 211, 1000 AE AMSTERDAM, NETHERLANDS
SN 0161-813X
EI 1872-9711
J9 NEUROTOXICOLOGY
JI Neurotoxicology
PD JUN
PY 2004
VL 25
IS 4
BP 555
EP 572
DI 10.1016/j.neuro.2003.08.005
PG 18
WC Neurosciences; Pharmacology & Pharmacy; Toxicology
SC Neurosciences & Neurology; Pharmacology & Pharmacy; Toxicology
GA 830KW
UT WOS:000222121900011
PM 15183010
ER
PT J
AU Slikker, W
AF Slikker, W
TI The fetal programming hypothesis: Possible role in childhood obesity.
SO NEUROTOXICOLOGY
LA English
DT Meeting Abstract
CT 20th International Neurotoxicology Conference
CY NOV 18-21, 2002
CL LITTLE ROCK, AR
C1 US FDA, Natl Ctr Toxicol Res, Jefferson, AR 72079 USA.
NR 0
TC 0
Z9 0
U1 0
U2 1
PU ELSEVIER SCIENCE BV
PI AMSTERDAM
PA PO BOX 211, 1000 AE AMSTERDAM, NETHERLANDS
SN 0161-813X
J9 NEUROTOXICOLOGY
JI Neurotoxicology
PD JUN
PY 2004
VL 25
IS 4
BP 681
EP 681
PG 1
WC Neurosciences; Pharmacology & Pharmacy; Toxicology
SC Neurosciences & Neurology; Pharmacology & Pharmacy; Toxicology
GA 830KW
UT WOS:000222121900062
ER
PT J
AU Xu, ZJ
McCastlain, K
Cawthon, D
Slikker, W
Ali, S
AF Xu, ZJ
McCastlain, K
Cawthon, D
Slikker, W
Ali, S
TI Selective alterations in gene expression using real-time PCR in
MPTP-induced neurtoxicity in mice.
SO NEUROTOXICOLOGY
LA English
DT Meeting Abstract
CT 20th International Neurotoxicology Conference
CY NOV 18-21, 2002
CL LITTLE ROCK, AR
C1 US FDA, Natl Ctr Toxicol Res, Div Neurotoxicol, Neurochem Lab, Jefferson, AR 72079 USA.
NR 0
TC 0
Z9 0
U1 0
U2 0
PU ELSEVIER SCIENCE BV
PI AMSTERDAM
PA PO BOX 211, 1000 AE AMSTERDAM, NETHERLANDS
SN 0161-813X
J9 NEUROTOXICOLOGY
JI Neurotoxicology
PD JUN
PY 2004
VL 25
IS 4
BP 702
EP 702
PG 1
WC Neurosciences; Pharmacology & Pharmacy; Toxicology
SC Neurosciences & Neurology; Pharmacology & Pharmacy; Toxicology
GA 830KW
UT WOS:000222121900114
ER
PT J
AU James, SJ
Slikker, W
Melnyk, S
New, E
Jernigan, S
AF James, SJ
Slikker, W
Melnyk, S
New, E
Jernigan, S
TI Prevention of thimerosal-induced neurotoxicity by glutathione and
cysteine, but not methionine.
SO NEUROTOXICOLOGY
LA English
DT Meeting Abstract
CT 20th International Neurotoxicology Conference
CY NOV 18-21, 2002
CL LITTLE ROCK, AR
DE thimerosal; neurotoxicity; glutathione
C1 Natl Ctr Toxicol Res, Div Biochem Toxicol, Jefferson, AR 72079 USA.
Univ Arkansas Med Sci, Arkansas Childrens Hosp, Res Inst, Little Rock, AR 72205 USA.
NR 0
TC 0
Z9 0
U1 0
U2 0
PU ELSEVIER SCIENCE BV
PI AMSTERDAM
PA PO BOX 211, 1000 AE AMSTERDAM, NETHERLANDS
SN 0161-813X
J9 NEUROTOXICOLOGY
JI Neurotoxicology
PD JUN
PY 2004
VL 25
IS 4
BP 711
EP 711
PG 1
WC Neurosciences; Pharmacology & Pharmacy; Toxicology
SC Neurosciences & Neurology; Pharmacology & Pharmacy; Toxicology
GA 830KW
UT WOS:000222121900135
ER
PT J
AU Yetley, EA
Rader, JI
AF Yetley, EA
Rader, JI
TI Modeling the level of fortification and post-fortification assessments:
US experience
SO NUTRITION REVIEWS
LA English
DT Article; Proceedings Paper
CT Technical Consultations on Recommeded Levels of Folic Acid and Vitamin
B12 Fortification
CY JAN 23-24, 2003
CL Washington, DC
SP Pan Amer Hlth Assoc (PAHO), March Dimes (MOD), Ctr Dis Control Prevention (CDC)
DE fortification; folic acid; post-fortification; assessments; vitamin B-12
ID FOLIC-ACID FORTIFICATION; NEURAL-TUBE DEFECTS; CEREAL-GRAIN PRODUCTS;
FOOD FORTIFICATION; UNITED-STATES; FOLATE FORTIFICATION; PLASMA
HOMOCYSTEINE; SERUM FOLATE
AB Mandatory fortification of enriched cereal-grain products became effective in the United States on January 1, 1998. This fortification was undertaken to assist women of child-bearing age in increasing their intake of folic acid to reduce their risk of having a pregnancy affected by a neural tube birth defect. The process by which the Food and Drug Administration modeled the level of fortification with folic acid illustrates the complex issues and general principles that emerge when fortification of a nation's food supply is evaluated as a means of addressing a public health concern. The effectiveness of fortification for a target population and safety for the much larger general population impose conflicting challenges that must be considered concurrently when making decisions regarding fortification. Recent data show improved folate status and apparent decreases in risk of neural tube birth defects in the U.S. Much about the long-term effects of the fortification program remains unknown and careful monitoring over time will be necessary to ensure that the program functions as intended.
C1 US FDA, Ctr Food Safety & Appl Nutr, College Pk, MD 20740 USA.
RP Yetley, EA (reprint author), US FDA, Ctr Food Safety & Appl Nutr, College Pk, MD 20740 USA.
NR 35
TC 29
Z9 29
U1 1
U2 6
PU INT LIFE SCIENCES INST NORTH AMERICA
PI WASHINGTON
PA ONE THOMAS CIRCLE, N W, 9TH FLOOR, WASHINGTON, DC 20005 USA
SN 0029-6643
J9 NUTR REV
JI Nutr. Rev.
PD JUN
PY 2004
VL 62
IS 6
SU S
BP S50
EP S59
DI 10.1301/nr.2004.jun.S50-S59
PN 2
PG 10
WC Nutrition & Dietetics
SC Nutrition & Dietetics
GA 906AD
UT WOS:000227612000014
PM 15298449
ER
PT J
AU Hutter, JC
Luu, HM
Kim, CS
AF Hutter, JC
Luu, HM
Kim, CS
TI A dynamic simulation of bisphenol A dosimetry in neuroendocrine organs
SO TOXICOLOGY AND INDUSTRIAL HEALTH
LA English
DT Article
DE bisphenol A; neuroendocrine organs; pharmacokinetic modelling
ID TISSUE DISTRIBUTION; RATS; BINDING; DISPOSITION; METABOLISM; ESTROGENS;
EXPOSURE; MCF-7
AB Bisphenol A (BPA) is a known xenoestrogen with similar properties to 17beta-estradiol. BPA and estrogen are hydrophobic compounds, and this affects the pharmacokinetics of both compounds in mammals. In a previous study we measured the distribution of BPA in female F344 rats exposed to oral doses of 0.1, 10 and 100 mg/kg. The results showed distribution to target neuroendocrine organs at all doses tested. Using these results, we developed a pharmacokinetic model to predict the dynamic uptake and excretion of BPA by various routes of exposure (po, iv, sc, ip). The model was able to simulate the entire time course (48 h) following various routes of exposure in rats over the dose ranges tested. The model indicated that the ultimate tissue uptake of BPA was established by the rapid initial transfer of free BPA into tissues. After free BPA enters the systemic circulation, metabolism and excretion reactions cause a relatively short duration and rapid decline. This period is followed by a slower long-term decline characteristic of BPXs biphasic pharmacokinetics. Plasma protein and tissue binding reactions established the long-term half-life of BPA in the body. Route differences in tissue uptake were directly related to the competition between transfer and binding reactions during the absorption phase.
C1 US FDA, Off Sci, Ctr Device & Radiol Hlth, Rockville, MD 20852 USA.
US FDA, Engn Labs, Ctr Device & Radiol Hlth, Rockville, MD 20852 USA.
US FDA, Ctr Food Safety & Appl Nutr, Off Appl Res & Saftey Assessment, Laurel, MD USA.
RP Hutter, JC (reprint author), US FDA, Off Sci, Ctr Device & Radiol Hlth, 12725 Twinbrook Pkwy HFZ-150, Rockville, MD 20852 USA.
EM jch@cdrh.fda.gov
NR 32
TC 4
Z9 4
U1 1
U2 1
PU ARNOLD, HODDER HEADLINE PLC
PI LONDON
PA 338 EUSTON ROAD, LONDON NW1 3BH, ENGLAND
SN 0748-2337
J9 TOXICOL IND HEALTH
JI Toxicol. Ind. Health
PD JUN
PY 2004
VL 20
IS 1-5
BP 29
EP 40
DI 10.1191/0748233704th187oa
PG 12
WC Public, Environmental & Occupational Health; Toxicology
SC Public, Environmental & Occupational Health; Toxicology
GA 904KK
UT WOS:000227496500004
PM 15807406
ER
PT J
AU Kim, CS
Sapienza, PP
Ross, IA
Johnson, W
Luu, HMD
Hutter, JC
AF Kim, CS
Sapienza, PP
Ross, IA
Johnson, W
Luu, HMD
Hutter, JC
TI Distribution of bisphenol A in the neuroendocrine organs of female rats
SO TOXICOLOGY AND INDUSTRIAL HEALTH
LA English
DT Article
DE bisphenol A; neuroendocrine organs; pharmacokinetics
ID TISSUE DISTRIBUTION; DISPOSITION; METABOLISM; FLORIDA; BRAIN
AB The distribution of C-14-bisphenol A (BPA) in plasma and neuroendocrine organs was determined in Fischer 344 female rats following three oral doses (0.1, 10 or 100 mg/kg). Plasma and tissue maximum concentrations (C-max) were reached within 15-30 min of dosing. Plasma areas-under-the-curve (AUC) ranged from 0.06 to 53.9 mug-h/mL. The AUCs of the pituitary gland and uterus/gonads were 16-21% higher than that of plasma. The AUCs of hypothalamus and the rest of the brain were 43.7% and 77% of the plasma AUCs, respectively. In the brain tissue, the exposure increased linearly with the oral dose, as the dose was increased from 0.1 to 10 and 100 mg/kg; the exposure in the brain relative to the plasma increased by factors of 1, 1.19 and 1.24. This indicates that the brain barrier systems do not limit the access of the lipophilic BPA to the brain. The increases of the uterus/gonads relative to the plasma were 1, 1.07 and 1.04. Tissue partitioning was also examined in vitro by the uptake of C-14-BPA. The BPA tissue/blood partition coefficients were as follows: heart, 7.5; liver, 6.1; kidney, 6.4; fat, 3.6; muscle, 2.6; breast, 3.6; ovaries, 9.1; uterus, 5.9; stomach, 5.1; and small intestine, 6.7. The tissue/cerebrospinal fluid partition coefficients were as follows: pituitary gland, 12.8; brain stem, 6.1; cerebellum, 6.4; hippocampus, 7.1; hypothalamus, 6.1; frontal cortex, 4.9; and caudate nucleus, 6.8.
C1 US FDA, Off Appl Res & Saftey Assessment, Ctr Food Safety & Appl Nutr, Laurel, MD 20708 USA.
US FDA, Ctr Devices & Radiol Hlth, Off Sci, Rockville, MD 20857 USA.
US FDA, Ctr Devices & Radiol Hlth, Engn Labs, Rockville, MD 20857 USA.
RP Kim, CS (reprint author), US FDA, Off Appl Res & Saftey Assessment, Ctr Food Safety & Appl Nutr, Laurel, MD 20708 USA.
EM csk@cfsan.fda.gov
NR 18
TC 14
Z9 15
U1 3
U2 6
PU ARNOLD, HODDER HEADLINE PLC
PI LONDON
PA 338 EUSTON ROAD, LONDON NW1 3BH, ENGLAND
SN 0748-2337
J9 TOXICOL IND HEALTH
JI Toxicol. Ind. Health
PD JUN
PY 2004
VL 20
IS 1-5
BP 41
EP 50
DI 10.1191/0748233704th186oa
PG 10
WC Public, Environmental & Occupational Health; Toxicology
SC Public, Environmental & Occupational Health; Toxicology
GA 904KK
UT WOS:000227496500005
PM 15807407
ER
PT J
AU Phelps, R
Robbins, K
Liberti, T
Machuca, A
Leparc, G
Chamberland, M
Kalish, M
Hewlett, I
Folks, T
Lee, LM
McKenna, M
AF Phelps, R
Robbins, K
Liberti, T
Machuca, A
Leparc, G
Chamberland, M
Kalish, M
Hewlett, I
Folks, T
Lee, LM
McKenna, M
TI Window-period human immunodeficiency virus transmission to two
recipients by an adolescent blood donor
SO TRANSFUSION
LA English
DT Article
ID UNITED-STATES; INFECTIOUS-DISEASES; RISK; TRANSFUSION; HIV-1; DONATIONS;
ASSAY; HCV
AB BACKGROUND: Pooled NAT and donor screening have reduced the diagnostic window period for HIV in the blood donor population to approximately 10 to 15 days. This report describes two cases of transfusion-acquired HIV infection and verification of transmission from the donor to the recipients, and attempts to identify how the 18-year-old donor acquired her infection.
STUDY DESIGN AND METHODS: After a repeat donor had a positive HIV test result, two recipients of the donor's previous donation were identified and tested. The donor and recipients were interviewed and blood samples were obtained for HIV DNA sequencing and phylogenetic analysis.
RESULTS: The two recipients had positive HIV test results. Phylogenetic analysis showed a high genetic similarity among the viruses (bootstrap 100%), consistent with transmission from the donor to the recipients. Four of five men with whom the donor had sexual contact during the critical time period when infection most likely occurred were located and tested; results were negative for HIV.
CONCLUSIONS: Pooled NAT of blood donations has not eliminated the window period for HIV identification during seroconversion.
C1 Natl Ctr HIV STD & TB Prevent, Div HIV AIDS Prevent, Atlanta, GA USA.
Natl Ctr HIV STD & TB Prevent, Div AIDS STD & TB Lab Res, Atlanta, GA USA.
Ctr Dis Control, Natl Ctr Infect Dis, Div Viral & Rickettsial Dis, Atlanta, GA 30333 USA.
Ctr Dis Control & Prevent, Atlanta, GA USA.
Florida Dept Hlth, Tallahassee, FL USA.
US FDA, CBER, Mol Biol Lab,Off Blood Res & Review, Div Emerging & Transfus Transmitted Dis, Bethesda, MD USA.
Florida Blood Serv, St Petersburg, FL USA.
RP Phelps, R (reprint author), Ctr Dis Control & Prevent, Natl Ctr HIV STD & TB Prevent, Off Commun, MS E-07, Atlanta, GA 30333 USA.
EM RPhelps@cdc.gov
NR 19
TC 40
Z9 44
U1 0
U2 0
PU BLACKWELL PUBLISHING INC
PI MALDEN
PA 350 MAIN ST, MALDEN, MA 02148 USA
SN 0041-1132
J9 TRANSFUSION
JI Transfusion
PD JUN
PY 2004
VL 44
IS 6
BP 929
EP 933
DI 10.1111/j.1537-2995.2004.03364.x
PG 5
WC Hematology
SC Hematology
GA 826IU
UT WOS:000221823600022
PM 15157262
ER
PT J
AU Ellenberg, SS
George, SL
AF Ellenberg, SS
George, SL
TI Should statisticians reporting to data monitoring committees be
independent of the trial sponsor and leadership?
SO STATISTICS IN MEDICINE
LA English
DT Article
DE clinical trials; data monitoring; interim analysis; conflict of interest
ID CLINICAL-TRIALS; ISSUES
AB It has long been a fundamental principle of clinical trials that interim comparative data should be kept confidential, with such data accessible only to a small number of individuals responsible for its analysis and monitoring. The rationale for keeping investigators and sponsors blinded to interim data has been extensively discussed, but the possible conflicts of interest that could arise for the statistician who performs the analysis of the interim data and presents it to a data monitoring committee has received little attention. We describe these potential conflicts, and the advantages and disadvantages of approaches that might be taken to minimize them. We have invited commentary on this issue from several statisticians with substantial experience in clinical trials and interim data monitoring. Published in 2004 by John Wiley Sons, Ltd.
C1 US FDA, Ctr Biol Evaluat & Res, Rockville, MD 20857 USA.
Duke Univ, Med Ctr, Dept Biostat & Bioinformat, Durham, NC 27706 USA.
RP Ellenberg, SS (reprint author), 1401 Rockville Pike,HFM-210, Rockville, MD 20852 USA.
EM ellenberg@eber.fda.gov
NR 9
TC 14
Z9 16
U1 0
U2 4
PU JOHN WILEY & SONS LTD
PI CHICHESTER
PA THE ATRIUM, SOUTHERN GATE, CHICHESTER PO19 8SQ, W SUSSEX, ENGLAND
SN 0277-6715
J9 STAT MED
JI Stat. Med.
PD MAY 30
PY 2004
VL 23
IS 10
BP 1503
EP 1505
DI 10.1002/sim.1784
PG 3
WC Mathematical & Computational Biology; Public, Environmental &
Occupational Health; Medical Informatics; Medicine, Research &
Experimental; Statistics & Probability
SC Mathematical & Computational Biology; Public, Environmental &
Occupational Health; Medical Informatics; Research & Experimental
Medicine; Mathematics
GA 818GP
UT WOS:000221233900002
PM 15122727
ER
PT J
AU Siegel, JP
O'Neill, RT
Temple, R
Campbell, G
Foulkes, MA
AF Siegel, JP
O'Neill, RT
Temple, R
Campbell, G
Foulkes, MA
TI Independence of the statistician who analyses unblinded data
SO STATISTICS IN MEDICINE
LA English
DT Article
AB This discussion considers arguments for and against separating responsibility for the unblinded interim analysis of a clinical trial from responsibility for trial management and modifications to the ongoing trial. The degree to which one or different statisticians carry out these responsibilities and thus the degree of statistician independence for the two activities can vary, but a sponsor should recognize that giving a single statistician both responsibilities might limit flexibility in managing the trial, particularly with respect to modifying an ongoing trial. Published in 2004 by John Wiley Sons, Ltd.
C1 US FDA, Ctr Biol Evaluat & Res, Rockville, MD 20852 USA.
US FDA, Ctr Drug Evaluat & Res, Rockville, MD 20852 USA.
US FDA, Ctr Devices & Radiol Hlth, Rockville, MD 20852 USA.
RP Foulkes, MA (reprint author), US FDA, Ctr Biol Evaluat & Res, 1401 Rockville Pike,HFM-210, Rockville, MD 20852 USA.
EM foulkes@cber.fda.gov
NR 0
TC 9
Z9 9
U1 0
U2 1
PU JOHN WILEY & SONS LTD
PI CHICHESTER
PA THE ATRIUM, SOUTHERN GATE, CHICHESTER PO19 8SQ, W SUSSEX, ENGLAND
SN 0277-6715
J9 STAT MED
JI Stat. Med.
PD MAY 30
PY 2004
VL 23
IS 10
BP 1527
EP 1529
DI 10.1002/sim.1789
PG 3
WC Mathematical & Computational Biology; Public, Environmental &
Occupational Health; Medical Informatics; Medicine, Research &
Experimental; Statistics & Probability
SC Mathematical & Computational Biology; Public, Environmental &
Occupational Health; Medical Informatics; Research & Experimental
Medicine; Mathematics
GA 818GP
UT WOS:000221233900007
PM 15122732
ER
PT J
AU Hartigan, MD
Crompton, LA
Reynolds, CK
Wray-Cahen, D
Lomax, MA
France, J
AF Hartigan, MD
Crompton, LA
Reynolds, CK
Wray-Cahen, D
Lomax, MA
France, J
TI An integrative model of amino acid metabolism in the liver of the
lactating dairy cow
SO JOURNAL OF THEORETICAL BIOLOGY
LA English
DT Article
DE model; liver; metabolism; amino acid; dairy cow; lactation
ID PARTITIONING LEUCINE UPTAKE; PORTAL-DRAINED VISCERA; ISOTOPE-DILUTION
MODEL; BOVINE MAMMARY-GLAND; VOLATILE FATTY-ACIDS; MESENTERIC VEIN;
SPLANCHNIC METABOLISM; HOLSTEIN COWS; PROTEIN-METABOLISM;
HEPATIC-METABOLISM
AB The objective of this work was to construct a dynamic model of hepatic amino acid metabolism in the lactating dairy cow that could be parameterized using net flow data from in vivo experiments. The model considers 22 amino acids, ammonia, urea, and 13 energetic metabolites, and was parameterized using a steady-state balance model and two in vivo, net flow experiments conducted with mid-lactation dairy cows. Extracellular flows were derived directly from the observed data. An optimization routine was used to derive nine intracellular flows. The resulting dynamic model was found to be stable across a range of inputs suggesting that it can be perturbed and applied to other physiological states. Although nitrogen was generally in balance, leucine was in slight deficit compared to predicted needs for export protein synthesis, suggesting that an alternative source of leucine (e.g. peptides) was utilized. Simulations of varying glucagon concentrations indicated that an additional 5 mol/d of glucose could be synthesized at the reference substrate concentrations and blood flows. The increased glucose production was supported by increased removal from blood of lactate, glutamate, aspartate, alanine, asparagine, and glutamine. As glucose Output increased, ketone body and acetate release increased while CO2 release declined. The pattern of amino acids appearing in hepatic vein blood was affected by changes in amino acid concentration in portal vein blood, portal blood flow rate and glucagon concentration, with methionine and phenylalanine being the most affected of essential amino acids. Experimental evidence is insufficient to determine whether essential amino acids are affected by varying gluconeogenic demands. (C) 2004 Published by Elsevier Ltd.
C1 Univ Guelph, Dept Anim & Poultry Sci, Guelph, ON N1G 2W1, Canada.
Univ London Imperial Coll Sci Technol & Med, Dept Agr Sci, Ashford TN25 5AH, Kent, England.
US FDA, Ctr Devices & Radiol Hlth, OST, DLS,HSB, Laurel, MD 20708 USA.
Ohio State Univ, Ohio Agr Res & Dev Ctr, Dept Anim Sci, Wooster, OH 44691 USA.
Univ Reading, Sch Agr Policy & Dev, Reading RG6 6AR, Berks, England.
Purina Mills LLC, St Louis, MO 63166 USA.
RP France, J (reprint author), Univ Guelph, Dept Anim & Poultry Sci, 50 Gordon St, Guelph, ON N1G 2W1, Canada.
EM jfrance@uoguelph.ca
NR 63
TC 3
Z9 3
U1 0
U2 1
PU ACADEMIC PRESS LTD ELSEVIER SCIENCE LTD
PI LONDON
PA 24-28 OVAL RD, LONDON NW1 7DX, ENGLAND
SN 0022-5193
J9 J THEOR BIOL
JI J. Theor. Biol.
PD MAY 21
PY 2004
VL 228
IS 2
BP 271
EP 289
DI 10.1016/j.jtbi.2004.01.010
PG 19
WC Biology; Mathematical & Computational Biology
SC Life Sciences & Biomedicine - Other Topics; Mathematical & Computational
Biology
GA 817VQ
UT WOS:000221205400011
PM 15094021
ER
PT J
AU Shefcheck, KJ
Musser, SM
AF Shefcheck, KJ
Musser, SM
TI Confirmation of the allergenic peanut protein, Ara h 1, in a model food
matrix using liquid chromatography/tandem mass spectrometry (LC/MS/MS)
SO JOURNAL OF AGRICULTURAL AND FOOD CHEMISTRY
LA English
DT Article
DE allergenicity; analysis; confirmation; LC/MS/MS; peanut; proteins
ID ARA-H-I; ANAPHYLACTIC REACTIONS; ATOPIC-DERMATITIS; IGE BINDING;
PROTEOMICS; CANCER; IDENTIFICATION; BIOMARKERS; DISCOVERY; CHALLENGE
AB Enzymatic digestion of total protein along with liquid chromatography/tandem mass spectrometry (LC/MS/MS) was used to confirm the presence of a major peanut allergen in food. Several peptides obtained from the enzymatic digestion of the most abundant peanut allergen, Ara h 1, were identified as specific peptide biomarkers for peanut protein. Using ice cream as a model food matrix, a method was developed for the detection of the allergen peptide biomarkers. A key component of the method was the use of molecular mass cutoff filters to enrich the Ara h 1 in the protein extracts. By applying the method to ice cream samples containing various levels of peanut protein, levels as low as 10 mg/kg of Ara h 1 could routinely be detected. This method provides an unambiguous means of confirming the presence of the peanut allergen, Ara h 1, in foods and can easily be modified to detect other food allergens.
C1 US FDA, Ctr Food Safety & Nutr, College Pk, MD 20740 USA.
RP Shefcheck, KJ (reprint author), US FDA, Ctr Food Safety & Nutr, College Pk, MD 20740 USA.
EM kshefche@cfsan.fda.gov
NR 31
TC 46
Z9 53
U1 1
U2 17
PU AMER CHEMICAL SOC
PI WASHINGTON
PA 1155 16TH ST, NW, WASHINGTON, DC 20036 USA
SN 0021-8561
J9 J AGR FOOD CHEM
JI J. Agric. Food Chem.
PD MAY 19
PY 2004
VL 52
IS 10
BP 2785
EP 2790
DI 10.1021/jf035129h
PG 6
WC Agriculture, Multidisciplinary; Chemistry, Applied; Food Science &
Technology
SC Agriculture; Chemistry; Food Science & Technology
GA 820WE
UT WOS:000221419500007
PM 15137814
ER
PT J
AU Yu, MYW
Bartosch, B
Zhang, P
Guo, ZP
Renzi, PM
Shen, LM
Granier, C
Feinstone, SM
Cosset, FL
Purcell, RH
AF Yu, MYW
Bartosch, B
Zhang, P
Guo, ZP
Renzi, PM
Shen, LM
Granier, C
Feinstone, SM
Cosset, FL
Purcell, RH
TI Neutralizing antibodies to hepatitis C virus (HCV) in immune globulins
derived from anti-HCV-positive plasma
SO PROCEEDINGS OF THE NATIONAL ACADEMY OF SCIENCES OF THE UNITED STATES OF
AMERICA
LA English
DT Article
ID POST-TRANSFUSION HEPATITIS; HYPERVARIABLE REGION 1; INTRAVENOUS
IMMUNOGLOBULIN; HYPERIMMUNE SERUM; GAMMA-GLOBULIN; INFECTION;
PREVENTION; CHIMPANZEES; FRACTIONATION; PARTICLES
AB The role of humoral immunity in hepatitis C virus (HCV) infections is uncertain. Nevertheless, there is increasing evidence for neutralizing antibodies to HCV in the serum or plasma of chronically infected individuals. Immune globulins prepared by ethanol fractionation of plasma had long been considered safe until a commercial immune globulin product, Gammagard, prepared from plasma from which units containing anti-HCV had been excluded, transmitted HCV to recipients. Studies suggested that the exclusion might have removed neutralizing antibodies from the plasma and hence compromised the safety of the resulting immune globulins. In the present study, by using chimpanzees and a recently validated in vitro system based on neutralization of infectious HCV pseudoparticles, we found broadly reactive neutralizing and protective antibodies in experimental immune globulin preparations made from anti-HCV-positive donations. Neutralizing antibodies were also found in Gammagard lots made from unscreened plasma that did not transmit hepatitis C but not in Gammagard lots, which were prepared from anti-HCV-screened plasma, that did transmit hepatitis C. The results provide an explanation for the mechanism by which the safety of this product was compromised. Immune globulins made from anti-HCV-positive plasma and containing broadly reactive neutralizing antibodies may provide a method of preventing HCV infection.
C1 US FDA, Ctr Biol Evaluat & Res, Div Hematol, Bethesda, MD 20892 USA.
US FDA, Ctr Biol Evaluat & Res, Div Viral Prod, Bethesda, MD 20892 USA.
Ecole Normale Super Lyon, Lab Vectorol Retrovirale & Therapie Genique, Inst Natl Sante & Rech Med, U412, F-69364 Lyon, France.
NIAID, Lab Infect Dis, NIH, Bethesda, MD 20892 USA.
RP Purcell, RH (reprint author), US FDA, Ctr Biol Evaluat & Res, Div Hematol, 29 Lincoln Dr, Bethesda, MD 20892 USA.
EM rpurcell@niaid.nih.gov
NR 35
TC 105
Z9 110
U1 1
U2 2
PU NATL ACAD SCIENCES
PI WASHINGTON
PA 2101 CONSTITUTION AVE NW, WASHINGTON, DC 20418 USA
SN 0027-8424
J9 P NATL ACAD SCI USA
JI Proc. Natl. Acad. Sci. U. S. A.
PD MAY 18
PY 2004
VL 101
IS 20
BP 7705
EP 7710
DI 10.1073/pnas.0402458101
PG 6
WC Multidisciplinary Sciences
SC Science & Technology - Other Topics
GA 822GW
UT WOS:000221528100040
PM 15136748
ER
PT J
AU Casciano, DA
Fuscoe, JC
AF Casciano, DA
Fuscoe, JC
TI Preface to mutation research special issue on toxicogenomics
SO MUTATION RESEARCH-FUNDAMENTAL AND MOLECULAR MECHANISMS OF MUTAGENESIS
LA English
DT Editorial Material
C1 US FDA, Natl Ctr Toxicol Res, Jefferson, AR 72223 USA.
RP Casciano, DA (reprint author), US FDA, Natl Ctr Toxicol Res, HFT-1,3900 NCTR Rd, Jefferson, AR 72223 USA.
EM dcasciano@nctr.fda.gov; jfuscoe@nctr.fda.gov
NR 0
TC 1
Z9 1
U1 0
U2 0
PU ELSEVIER SCIENCE BV
PI AMSTERDAM
PA PO BOX 211, 1000 AE AMSTERDAM, NETHERLANDS
SN 0027-5107
J9 MUTAT RES-FUND MOL M
JI Mutat. Res.-Fundam. Mol. Mech. Mutagen.
PD MAY 15
PY 2004
VL 549
IS 1-2
BP 1
EP 3
DI 10.1016/j.mrfmmm.2004.02.008
PG 3
WC Biotechnology & Applied Microbiology; Genetics & Heredity; Toxicology
SC Biotechnology & Applied Microbiology; Genetics & Heredity; Toxicology
GA 823BB
UT WOS:000221583600001
ER
PT J
AU Akerman, GS
Rosenzweig, BA
Domon, OE
McGarrity, LJ
Blankenship, LR
Tsai, CA
Culp, SJ
MacGregor, JT
Sistare, FD
Chen, JJ
Morris, SM
AF Akerman, GS
Rosenzweig, BA
Domon, OE
McGarrity, LJ
Blankenship, LR
Tsai, CA
Culp, SJ
MacGregor, JT
Sistare, FD
Chen, JJ
Morris, SM
TI Gene expression profiles and genetic damage in benzo(a)pyrene diol
epoxide-exposed TK6 cells
SO MUTATION RESEARCH-FUNDAMENTAL AND MOLECULAR MECHANISMS OF MUTAGENESIS
LA English
DT Article
DE cDNA microarray; benzo(a)pyrene diol epoxide; BPDE; TK6 cells; gene
expression profiles
ID HUMAN LYMPHOBLASTOID-CELLS; S-ADENOSYLMETHIONINE DECARBOXYLASE;
POLYCYCLIC AROMATIC-HYDROCARBONS; KAPPA-B ACTIVATION; HMG-COA REDUCTASE;
DNA-ADDUCTS; POLYAMINE METABOLISM; MUTATION-INDUCTION; RECENT
DISCOVERIES; OXIDATIVE STRESS
AB Microarray analysis is a powerful tool to identify the biological effects of drugs or chemicals on cellular gene expression. In this study, we compare the relationships between traditional measures of genetic toxicology and mutagen-induced alterations in gene expression profiles. TK6 cells were incubated with 0.01, 0.1, or 1.0 muM+/-anti-benzo(a)pyrene-trans-7, 8-dihydrodiol-9,10-epoxide (BPDE) for 4 h and then cultured for an additional 20 h. Aliquots of the exposed cells were removed at 4 and 24 h in order to quantify DNA adduct levels by P-32 post-labeling and measure cell viability by cloning efficiency and flow cytometry. Gene expression profiles were developed by extracting total RNA from the control and exposed cells at 4 and 24 h, labeling with Cy3 or Cy5 and hybridizing to a human 350 gene array. Mutant frequencies in the Thymidine Kinase and Hypoxanthine Phosphoribosyl Transferase genes were also determined. The 10alpha-(deoxyguanosin-N-2-yl)-7alpha,8beta,9beta-trihydroxy-7,8,9, 10-tetrahydrobenzo(a)pyrene (dG-N-2-BPDE) adduct increased as a function of dose and was the only adduct identified. A dose-related decrease in cell viability was evident at 24 h, but not at 4 h. Cell death occurred by apoptosis. At 4 h, analysis of the gene expression profiles revealed that Glutathione Peroxidase and Gadd45 were consistently upregulated (greater than 1.5-fold and significantly (P<0.001) greater than the control in two experiments) in response to 1.0 μM BPDE exposure. Fifteen genes were consistently down-regulated (less than 0.67-fold and significantly (P<0.001) lower than the control in two experiments) at 4 h in cultures exposed to 1.0 muM BPDE. Genes with altered expression at 4 h included genes important in the progression of the cell-cycle and those that inhibit apoptosis. At 24 h post-exposure, 16 genes, involved in cell-cycle control, detoxification, and apoptosis were consistently upregulated; 10 genes were repressed in cultures exposed to the high dose of BPDE. Real-time quantitative PCR confirmed the differential expression of selected genes. These data suggest that changes in gene expression will help to identify effects of drugs and chemicals on molecular pathways in cells, and will provide useful information about the molecular responses associated with DNA damage. Of the endpoints evaluated, DNA adduct formation was the most sensitive indicator of DNA damage. DNA adduct formation was clearly evident at low doses, but the number of genes with significantly altered expression (P<0.001) was minimal. Alterations in gene expression were more robust at doses associated with cellular toxicity and induction of mutations.
C1 US FDA, Div Genet & Reprod Toxicol, Natl Ctr Toxicol Res, Jefferson, AR 72079 USA.
Ctr Drug Evaluat & Res, Div Appl Pharmacol Res, Laurel, MD USA.
US FDA, Div Biochem Toxicol, Natl Ctr Toxicol Res, Jefferson, AR 72079 USA.
US FDA, Div Biometry & Risk Assessment, Natl Ctr Toxicol Res, Jefferson, AR 72079 USA.
US FDA, Environm Hlth & Program Assurance Staff, Natl Ctr Toxicol Res, Jefferson, AR 72079 USA.
US FDA, Washington Operat Off, Natl Ctr Toxicol Res, Rockville, MD 20857 USA.
RP Morris, SM (reprint author), US FDA, Div Genet & Reprod Toxicol, Natl Ctr Toxicol Res, 3900 NCTR Rd, Jefferson, AR 72079 USA.
EM smorris@nctr.fda.gov
OI Tsai, Chen-An/0000-0002-7490-4331
NR 83
TC 53
Z9 56
U1 0
U2 6
PU ELSEVIER SCIENCE BV
PI AMSTERDAM
PA PO BOX 211, 1000 AE AMSTERDAM, NETHERLANDS
SN 0027-5107
J9 MUTAT RES-FUND MOL M
JI Mutat. Res.-Fundam. Mol. Mech. Mutagen.
PD MAY 15
PY 2004
VL 549
IS 1-2
BP 43
EP 64
DI 10.1016/j.mrfmmm.2003.11.013
PG 22
WC Biotechnology & Applied Microbiology; Genetics & Heredity; Toxicology
SC Biotechnology & Applied Microbiology; Genetics & Heredity; Toxicology
GA 823BB
UT WOS:000221583600004
PM 15120962
ER
PT J
AU Harris, AJ
Dial, SL
Casciano, DA
AF Harris, AJ
Dial, SL
Casciano, DA
TI Comparison of basal gene expression profiles and effects of
hepatocarcinogens on gene expression in cultured primary human
hepatocytes and HepG2 cells
SO MUTATION RESEARCH-FUNDAMENTAL AND MOLECULAR MECHANISMS OF MUTAGENESIS
LA English
DT Article
DE filter array; gene expression; HepG2; primary human hepatocytes
ID GROWTH FACTOR-II; ORGANIC CATION TRANSPORTERS; LOOP-HELIX PROTEINS; RAT
HEPATOCYTES; HEPATOMA-CELL; HUMAN-LIVER; CREATINE-TRANSPORTER;
MICROARRAY ANALYSIS; IN-VITRO; HUMAN FIBROBLASTS
AB Toxicogenomics is a relatively new discipline of toxicology. Microarrays and bioinformatics tools are being used successfully to understand the effects of toxicants on in vivo and in vitro model systems, and to gain a better understanding of the relevance of in vitro models commonly used in toxicological studies. In this study, cDNA filter arrays were used to deter-mine the basal expression patterns of human cultured primary hepatocytes from different male donors; compare the gene expression profile of HepG2 to that of primary hepatocytes; and analyze the effects of three genotoxic hepatocarcinogens; aflatoxin B-1 (AFB(1)), 2-acetylaminofluorene (2AAF), and dimethylnitrosamine (DMN), as well as one non-gentoxic hepatotoxin, acetaminophen (APAP) on gene expression in both in vitro systems. Real-time PCR was used to verify differential gene expression for selected genes. Of the approximately 3 1,000 genes screened, 3-6% were expressed in primary hepatocytes cultured on matrigel for 16 h. Of these genes, 867 were expressed in cultured hepatocytes from all donors. HepG2 cells expressed about 98% of the genes detectable in cultured primary hepatocytes, however, 31% of the HepG2 transcriptome was unique to the cell line. A number of these genes are expressed in human liver but expression is apparently lost during culture. There was considerable variability in the response to chemical carcinogen exposure in primary hepatocytes from different donors. The transcription factors, E2F1 and ID1 mRNA were increased three-fold and six-fold (P<0.05, P<0.01), respectively, in AFB(1) treated primary human hepatocytes but were not altered in HepG2. ID1 expression was also increased by dimethylnitrosamine, acetylaminofluorene and acetaminophen in both primary hepatocytes and HepG2. Identification of Genes that are expressed in primary hepatocytes from most donors, as well as those genes with variable expression, will aid in understanding the variability in human reactions to drugs and chemicals. This study suggests that identification of biomarkers of exposure to some chemicals may be possible in the human through microarray analysis, despite the variability in responses. (C) 2004, Published by Elsevier B.V.
C1 US FDA, Ctr Hepatotox, Natl Ctr Toxicol Res, Jefferson, AR 72079 USA.
Natl Ctr Toxicol Res, Off Director, Jefferson, AR 72079 USA.
RP Harris, AJ (reprint author), US FDA, Ctr Hepatotox, Natl Ctr Toxicol Res, 3900 NCTR Dr, Jefferson, AR 72079 USA.
EM aharris@cteh.com
FU NIDDK NIH HHS [N01-DK-9-2310]
NR 75
TC 69
Z9 71
U1 1
U2 8
PU ELSEVIER SCIENCE BV
PI AMSTERDAM
PA PO BOX 211, 1000 AE AMSTERDAM, NETHERLANDS
SN 0027-5107
J9 MUTAT RES-FUND MOL M
JI Mutat. Res.-Fundam. Mol. Mech. Mutagen.
PD MAY 15
PY 2004
VL 549
IS 1-2
BP 79
EP 99
DI 10.1016/j.mrfmmm.2003.11.014
PG 21
WC Biotechnology & Applied Microbiology; Genetics & Heredity; Toxicology
SC Biotechnology & Applied Microbiology; Genetics & Heredity; Toxicology
GA 823BB
UT WOS:000221583600006
PM 15120964
ER
PT J
AU Desai, VG
Moland, CL
Branham, WS
Delongchamp, RR
Fang, H
Duffy, PH
Peterson, CA
Beggs, ML
Fuscoe, JC
AF Desai, VG
Moland, CL
Branham, WS
Delongchamp, RR
Fang, H
Duffy, PH
Peterson, CA
Beggs, ML
Fuscoe, JC
TI Changes in expression level of genes as a function of time of day in the
liver of rats
SO MUTATION RESEARCH-FUNDAMENTAL AND MOLECULAR MECHANISMS OF MUTAGENESIS
LA English
DT Article
DE microarray analysis; circadian rhythm; liver
ID PERIPHERAL CIRCADIAN OSCILLATORS; SUPRACHIASMATIC NUCLEUS; TISSUE
TRANSGLUTAMINASE; CLINICAL IMPLICATIONS; CROSS-LINKING; RECEPTOR; MOUSE;
CELLS; PHARMACOLOGY; TOXICOLOGY
AB Daily, rhythmic variation in various biochemical, physiological, and behavioral events is a fundamental property of biological organization. Here, we report analysis of relative levels of gene expression in the liver of 16 Fischer 344 rats as a function of time of day. Expression levels were determined for 3906 genes using high-density oligonucleotide microarrays. Of the 3906 genes, 1171 (30%) were clearly expressed while 2735 (70%) were not expressed or the expression was too low to distinguish from background levels. The maximum estimated changes observed for most genes (1029, 88%) were less than 1.5-fold. Analysis of variance and the Kruskal-Wallis tests were used to identify 67 genes whose expression was significantly altered as a function of time of day. These significantly altered genes were classified according to their functions and fall into key cellular pathways including drug metabolism, ion transport, signal transduction, DNA binding and regulation of transcription, and immune response. (C) 2004, Elsevier B.V All rights reserved.
C1 US FDA, Ctr Funct Genom, Natl Ctr Toxicol Res, Jefferson, AR 72079 USA.
US FDA, Div Genet & Reprod Toxicol, Natl Ctr Toxicol Res, Jefferson, AR 72079 USA.
US FDA, Div Biometry & Risk Assessment, Natl Ctr Toxicol Res, Jefferson, AR 72079 USA.
Univ Arkansas Med Sci, Cent Arkansas Vet Hlth Care Syst, Little Rock, AR 72205 USA.
RP Desai, VG (reprint author), US FDA, Ctr Funct Genom, Natl Ctr Toxicol Res, Jefferson, AR 72079 USA.
EM vdesai@nctr.fda.gov
NR 52
TC 28
Z9 31
U1 1
U2 1
PU ELSEVIER SCIENCE BV
PI AMSTERDAM
PA PO BOX 211, 1000 AE AMSTERDAM, NETHERLANDS
SN 0027-5107
J9 MUTAT RES-FUND MOL M
JI Mutat. Res.-Fundam. Mol. Mech. Mutagen.
PD MAY 15
PY 2004
VL 549
IS 1-2
BP 115
EP 129
DI 10.1016/j.mrfmmm.2003.11.016
PG 15
WC Biotechnology & Applied Microbiology; Genetics & Heredity; Toxicology
SC Biotechnology & Applied Microbiology; Genetics & Heredity; Toxicology
GA 823BB
UT WOS:000221583600008
PM 15120966
ER
PT J
AU Tong, WD
Harris, S
Cao, XX
Fang, H
Shi, LM
Sun, HM
Fuscoe, J
Harris, A
Hong, HX
Xie, Q
Perkins, R
Casciano, D
AF Tong, WD
Harris, S
Cao, XX
Fang, H
Shi, LM
Sun, HM
Fuscoe, J
Harris, A
Hong, HX
Xie, Q
Perkins, R
Casciano, D
TI Development of public toxicogenomics software for microarray data
management and analysis
SO MUTATION RESEARCH-FUNDAMENTAL AND MOLECULAR MECHANISMS OF MUTAGENESIS
LA English
DT Article
DE toxicogenomics software; DNA microarray; database
ID NORMALIZATION; TOXICOLOGY; BIOLOGY
AB A robust bioinformatics capability is widely acknowledged as central to realizing the promises of toxicogenomics. Successful application of toxicogenomic approaches, such as DNA microarray, inextricably relies on appropriate data management, the ability to extract knowledge from massive amounts of data and the availability of functional information for data interpretation. At the FDA's National Center for Toxicological Research (NCTR), we are developing a public microarray data management and analysis software, called ArrayTrack. ArrayTrack is Minimum Information About a Microarray Experiment (MIAME) supportive for storing both microarray data and experiment parameters associated with a toxicogenomics study. A quality control mechanism is implemented to assure the fidelity of entered expression data. ArrayTrack also provides a rich collection Of functional information about genes, proteins and pathways drawn from various public biological databases for facilitating data interpretation. In addition, several data analysis and visualization tools are available with ArrayTrack, and more tools will be available in the next released version. Importantly, gene expression data, functional information and analysis methods are fully integrated so that the data analysis and interpretation process is simplified and enhanced. ArrayTrack is publicly available online and the prospective user can also request a local installation version by contacting the authors. (C) 2004 Elsevier B.V. All rights reserved.
C1 Natl Ctr Toxicol Res, Ctr Toxicoinformat, Div Biometry & Risk Assessment, Jefferson, AR 72079 USA.
Northrop Grumman Informat Technol, Jefferson, AR 72079 USA.
US FDA, Ctr Funct Genom, Div Reprod & Genet Toxicol, NCTR, Jefferson, AR 72079 USA.
US FDA, Ctr Hepatotox, NCTR, Jefferson, AR 72079 USA.
US FDA, Off Director, NCTR, Jefferson, AR 72079 USA.
RP Tong, WD (reprint author), Natl Ctr Toxicol Res, Ctr Toxicoinformat, Div Biometry & Risk Assessment, 3900 NCTR Rd,HFT-020, Jefferson, AR 72079 USA.
EM wtong@nctr.fda.gov
NR 22
TC 73
Z9 77
U1 0
U2 2
PU ELSEVIER SCIENCE BV
PI AMSTERDAM
PA PO BOX 211, 1000 AE AMSTERDAM, NETHERLANDS
SN 0027-5107
J9 MUTAT RES-FUND MOL M
JI Mutat. Res.-Fundam. Mol. Mech. Mutagen.
PD MAY 15
PY 2004
VL 549
IS 1-2
BP 241
EP 253
DI 10.1016/j.mrfmmm.2003.12.024
PG 13
WC Biotechnology & Applied Microbiology; Genetics & Heredity; Toxicology
SC Biotechnology & Applied Microbiology; Genetics & Heredity; Toxicology
GA 823BB
UT WOS:000221583600016
PM 15120974
ER
PT J
AU Garcia, G
Hicks, R
Skanchy, D
Moorad-Doctor, D
AF Garcia, G
Hicks, R
Skanchy, D
Moorad-Doctor, D
TI The Huperzine A (Hup A) metabolite from the rat
SO FASEB JOURNAL
LA English
DT Meeting Abstract
CT Annual Meeting of the
American-Society-for-Biochemistry-and-Molecular-Biology/8th Congress of
the International-Union-for-Biochemistry-and-Molecular-Biology
CY JUN 12-16, 2004
CL Boston, MA
SP Amer Soc BioChem & Mol Biol, Int Union Biochem & Mol Biol
C1 WRAIR, Div Biochem, Dept Biochem Pharmacol, Silver Spring, MD 20910 USA.
WRAIR, Div Expt Therapeut, Dept Med Chem, Rockville, MD USA.
US FDA, Rockville, MD 20857 USA.
NR 0
TC 0
Z9 0
U1 0
U2 0
PU FEDERATION AMER SOC EXP BIOL
PI BETHESDA
PA 9650 ROCKVILLE PIKE, BETHESDA, MD 20814-3998 USA
SN 0892-6638
J9 FASEB J
JI Faseb J.
PD MAY 14
PY 2004
VL 18
IS 8
SU S
BP C45
EP C45
PG 1
WC Biochemistry & Molecular Biology; Biology; Cell Biology
SC Biochemistry & Molecular Biology; Life Sciences & Biomedicine - Other
Topics; Cell Biology
GA 823UP
UT WOS:000221639100205
ER
PT J
AU Cordoba-Rodriguez, R
Fang, H
Lankford, CSR
Frucht, DM
AF Cordoba-Rodriguez, R
Fang, H
Lankford, CSR
Frucht, DM
TI Anthrax lethal toxin rapidly activates caspase-1/ICE and induces
extracellular release of interleukin (IL)-1 beta and IL-18
SO JOURNAL OF BIOLOGICAL CHEMISTRY
LA English
DT Article
ID BACILLUS-ANTHRACIS; CONVERTING-ENZYME; MICE DEFICIENT; FACTOR CLEAVES;
TNF-ALPHA; MACROPHAGES; APOPTOSIS; KINASE; PHOSPHORYLATION; INACTIVATION
AB Anthrax lethal toxin (LT), a critical virulence factor for Bacillus anthracis, has been demonstrated to cleave and to inactivate mitogen-activated protein kinase kinases (MAPKKs) that propagate prosurvival signals in macrophages (1-5). Whether this action of anthrax LT leads to the production of proinflammatory cytokines by macrophages has been more controversial (6, 7). We now report that anthrax LT treatment leads to the specific extracellular release of interleukin (IL)-1beta and IL-18 by the murine macrophage cell lines, RAW264.7 and J774A.1. Studies of the processing of IL-1beta reveal that the levels of activated/cleaved IL-1beta in RAW264.7 and J774.A1 cells are increased following treatment with anthrax LT. Enhanced processing of IL-1beta directly correlates with increased levels in the activation of its upstream regulator, IL-1beta-converting enzyme/Caspase-1 (ICE). The extracellular release of IL-1beta and IL-18 in response to anthrax LT is ICE-dependent, as an ICE-specific inhibitor blocks this process. These data indicate that ICE, IL-1beta, and IL-18 are downstream effectors of anthrax LT in macrophages, providing the basis for new bioassays for anthrax LT activity and representing potential therapeutic targets.
C1 US FDA, Div Monoclonal Antibodies, Off Biotechnol, Off Pharmaceut Sci,Ctr Drug Evaluat & Res, Bethesda, MD 20892 USA.
RP Frucht, DM (reprint author), US FDA, Div Monoclonal Antibodies, Off Biotechnol, Off Pharmaceut Sci,Ctr Drug Evaluat & Res, Bldg 29B,Rm 3NN22, Bethesda, MD 20892 USA.
EM frucht@cber.fda.gov
NR 23
TC 50
Z9 54
U1 0
U2 0
PU AMER SOC BIOCHEMISTRY MOLECULAR BIOLOGY INC
PI BETHESDA
PA 9650 ROCKVILLE PIKE, BETHESDA, MD 20814-3996 USA
SN 0021-9258
J9 J BIOL CHEM
JI J. Biol. Chem.
PD MAY 14
PY 2004
VL 279
IS 20
BP 20563
EP 20566
DI 10.1074/jbc.C300539200
PG 4
WC Biochemistry & Molecular Biology
SC Biochemistry & Molecular Biology
GA 818VY
UT WOS:000221273800003
PM 15010463
ER
PT J
AU Kleinman, S
Busch, M
Caglioti, S
Stramer, SL
Dodd, R
Strong, DM
Dickey, W
Salvidar, B
Gilchrist, M
Brend, S
Nakhasi, H
Epstein, J
Goodman, J
Chamberland, M
Kuehnert, M
Petersen, L
Crall, N
Marfin, A
Boo, T
Montgomery, S
AF Kleinman, S
Busch, M
Caglioti, S
Stramer, SL
Dodd, R
Strong, DM
Dickey, W
Salvidar, B
Gilchrist, M
Brend, S
Nakhasi, H
Epstein, J
Goodman, J
Chamberland, M
Kuehnert, M
Petersen, L
Crall, N
Marfin, A
Boo, T
Montgomery, S
TI Update: West Nile virus screening of blood donations and
transfusion-associated transmission - United States, 2003 (Reprinted
from MMWR, vol 53, pg 281-284, 2004)
SO JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION
LA English
DT Reprint
C1 Amer Assoc Blood Banks, Victoria, BC, Canada.
Blood Syst Res Inst, San Francisco, CA USA.
Blood Syst Labs, Tempe, AZ USA.
Amer Red Cross, Gaithersburg, MD USA.
Puget Sound Blood Ctr, Seattle, WA 98104 USA.
Belle Bonfils Mem Blood Ctr, Denver, CO USA.
Univ Iowa, Hyg Lab, Iowa City, IA USA.
Iowa Dept Publ Hlth, Des Moines, IA 50319 USA.
US FDA, Ctr Biol Evaluat & Res, Rockville, MD 20857 USA.
CDC, Div Viral & Rickettsial Dis, Atlanta, GA 30333 USA.
CDC, Div Vector Borne Infect Dis, Natl Ctr Infect Dis, Atlanta, GA 30333 USA.
RP Kleinman, S (reprint author), Amer Assoc Blood Banks, Victoria, BC, Canada.
NR 7
TC 0
Z9 0
U1 0
U2 0
PU AMER MEDICAL ASSOC
PI CHICAGO
PA 515 N STATE ST, CHICAGO, IL 60610 USA
SN 0098-7484
J9 JAMA-J AM MED ASSOC
JI JAMA-J. Am. Med. Assoc.
PD MAY 12
PY 2004
VL 291
IS 18
BP 2184
EP +
PG 3
WC Medicine, General & Internal
SC General & Internal Medicine
GA 819GR
UT WOS:000221303500008
ER
PT J
AU Shames, DA
AF Shames, DA
TI Risks of testosterone replacement
SO NEW ENGLAND JOURNAL OF MEDICINE
LA English
DT Letter
C1 US FDA, Rockville, MD 20857 USA.
RP Shames, DA (reprint author), US FDA, Rockville, MD 20857 USA.
NR 4
TC 0
Z9 0
U1 0
U2 0
PU MASSACHUSETTS MEDICAL SOC/NEJM
PI WALTHAM
PA WALTHAM WOODS CENTER, 860 WINTER ST,, WALTHAM, MA 02451-1413 USA
SN 0028-4793
J9 NEW ENGL J MED
JI N. Engl. J. Med.
PD MAY 6
PY 2004
VL 350
IS 19
BP 2004
EP 2004
PG 1
WC Medicine, General & Internal
SC General & Internal Medicine
GA 818AU
UT WOS:000221218800023
PM 15128905
ER
PT J
AU Racoosin, JA
Knudsen, JF
AF Racoosin, JA
Knudsen, JF
TI Safety of newer antiepileptic drugs
SO JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION
LA English
DT Letter
C1 US FDA, Ctr Drug Evaluat & Res, Div Neuropharmacol Drug Prod, Rockville, MD 20857 USA.
RP Racoosin, JA (reprint author), US FDA, Ctr Drug Evaluat & Res, Div Neuropharmacol Drug Prod, Rockville, MD 20857 USA.
EM racoosinj@cder.fda.gov
NR 5
TC 4
Z9 4
U1 0
U2 0
PU AMER MEDICAL ASSOC
PI CHICAGO
PA 515 N STATE ST, CHICAGO, IL 60610 USA
SN 0098-7484
J9 JAMA-J AM MED ASSOC
JI JAMA-J. Am. Med. Assoc.
PD MAY 5
PY 2004
VL 291
IS 17
BP 2074
EP 2074
DI 10.1001/jama.291.17.2074-a
PG 1
WC Medicine, General & Internal
SC General & Internal Medicine
GA 817JR
UT WOS:000221174300012
PM 15126428
ER
PT J
AU Machuca, A
Ding, L
Taffs, R
Lee, SW
Wood, O
Hu, JJ
Hewlett, I
AF Machuca, A
Ding, L
Taffs, R
Lee, SW
Wood, O
Hu, JJ
Hewlett, I
TI HIV type 2 primary isolates induce a lower degree of apoptosis "in
vitro" compared with HIV type 1 primary isolates
SO AIDS RESEARCH AND HUMAN RETROVIRUSES
LA English
DT Article
ID IMMUNODEFICIENCY-VIRUS TYPE-1; T-CELLS; IMMUNE ACTIVATION; DISEASE
PROGRESSION; VIRAL LOAD; INFECTION; SUBTYPES; TAT; PATHOGENICITY;
PATHOGENESIS
AB To determine whether subtypes of HIV-1 and HIV-2 vary in their ability to induce T cell apoptosis in vitro, human peripheral blood mononuclear cells (PBMC) from healthy donors and CEM.NKR-CCR5 cells were infected with a variety of HIV-1 and HIV-2 isolates in vitro. Apoptotic cell levels and chemokine and cytokine production were analyzed. Significant variations in cytopathic effects following in vitro infection with primary isolates of HIV-1 or HIV-2 subtypes were observed in PBMCs. The percent of apoptotic cells from each individual ranged from 2 to 78% after HIV-1 infection and from 0 to 28% after HIV-2 infection (p < 0.01). We did not observe significant differences in the degree of apoptosis induced among cells infected with different HIV-1 group M subtypes or group 0 virus, nor among cells infected with different HIV-2 isolates. However, HIV-2 induced significantly lower degree of apoptosis overall in PBMC and CEM.NKR-CC5 cells when compared with HIV-1 subtypes (p < 0.0001). No significant differences were observed in the production of chemokines, such as RANTES, MIP-1alpha, and MIP-1beta, and cytokines, such as TNF-alpha and TNF-beta when PBMC cultures were infected with different HIV-1 subtype viruses, or HIV-2 isolates. In conclusion, HIV-2 isolates induced significantly lower levels of T cell apoptosis in both PBMC and CEM.NKR-CCR5 cells than HIV-1 isolates. No differences in T cell apoptosis levels were seen between different subtypes of HIV-1 group M or group O isolates. This is consistent with the mild clinical course of infection with HIV-2 that has been reported relative to that observed with HIV-1.
C1 US FDA, Mol Virol Lab, Div Emerging & Transfus Transmitted Dis, Off Blood Review & Res,Ctr Biol Evaluat & Res, Bethesda, MD 20892 USA.
US FDA, Lab Bacterial Parasit & Unconvent Agents, Div Emerging & Transfus Transmitted Dis, Off Blood Review & Res,Ctr Biol Evaluat & Res, Bethesda, MD 20892 USA.
RP Hewlett, I (reprint author), US FDA, Div Emerging & Transfus Transmitted Dis, Ctr Biol Evaluat & Res, HFM 315,1401 Rockville Pike, Rockville, MD 20852 USA.
EM Hewlett@cber.fda.gov
NR 39
TC 9
Z9 10
U1 0
U2 1
PU MARY ANN LIEBERT INC PUBL
PI LARCHMONT
PA 2 MADISON AVENUE, LARCHMONT, NY 10538 USA
SN 0889-2229
J9 AIDS RES HUM RETROV
JI Aids Res. Hum. Retrovir.
PD MAY
PY 2004
VL 20
IS 5
BP 507
EP 512
DI 10.1089/088922204323087750
PG 6
WC Immunology; Infectious Diseases; Virology
SC Immunology; Infectious Diseases; Virology
GA 825MV
UT WOS:000221763500007
PM 15186525
ER
PT J
AU Roy, S
Caillouette, JC
Roy, T
Faden, JS
AF Roy, S
Caillouette, JC
Roy, T
Faden, JS
TI Vaginal pH is similar to follicle-stimulating hormone for menopause
diagnosis
SO AMERICAN JOURNAL OF OBSTETRICS AND GYNECOLOGY
LA English
DT Article
DE vaginal pH value; follicle-stimulating hormone; menopause; estrogen
therapy
ID URINARY-TRACT-INFECTIONS; POSTMENOPAUSAL WOMEN; UROGENITAL SYMPTOMS;
ESTROGEN THERAPY; ESTRIOL; RING; CYTOLOGY; EFFICACY; ATROPHY; HEALTH
AB Objective: This paper is intended to demonstrate whether vaginal pH value is associated with menopausal status and symptoms, to review the sensitivity of follicle-stimulating hormone or vaginal pH to diagnose menopause, to compare these findings to a group of practice patients, and to determine whether vaginal pH could be used in place of follicle-stimulating hormone as an initial screen to determine menopause.
Study design: Sixteen studies regarding vaginal pH and menopausal symptoms before and after estrogen administration were analyzed. Two epidemiologic studies that reported follicle-stimulating hormone or vaginal pH with menopause were reviewed. These findings were compared with similar data from the practice of one of the authors (J.C.C.).
Results: Menopausal women who do not receive estrogen therapy have a weighted average vaginal pH of 6.0, which is reduced significantly to 4.5 with estrogen therapy. To diagnose menopause, follicle-stimulating hormone greater than or equal to 15 or greater than or equal to 20 mIU/mL in the Third National Health and Nutrition Examination Survey had a sensitivity of 65% to 68%. In a study in Costa Rica, where 3 definitions of menopause were used, a pH of > 5.0 had a sensitivity of 64% to 67%. From the practice patients, the 95% confidence interval sensitivities and positive predictive values of vaginal pH and follicle-stimulating hormone to diagnose menopause overlapped, while a pH less than or equal to 4.5 indicated mid follicular phase estradiol levels.
Conclusion: In women without vaginitis and no estrogen therapy, a vaginal pH of > 4.5 indicates menopause, because it demonstrates a similar sensitivity as follicle-stimulating hormone in epidemiologic studies. In the practice patients, the sensitivity of follicle-stimulating hormone was no different than vaginal pH in the diagnosis of menopause. Furthermore, with estrogen therapy, a vaginal pH of less than or equal to 4.5 indicates a mid follicular phase estradiol. (C) 2004 Elsevier Inc. All rights reserved.
C1 Univ So Calif, Keck Sch Med, Womens & Childrens Hosp, Dept Obstet & Gynecol, Los Angeles, CA 90033 USA.
US FDA, Washington, DC 20204 USA.
RP Roy, S (reprint author), Univ So Calif, Keck Sch Med, Womens & Childrens Hosp, Dept Obstet & Gynecol, 1240 N Mission Rd,Rm L1022, Los Angeles, CA 90033 USA.
EM subirro@usc.edu
NR 37
TC 25
Z9 27
U1 0
U2 2
PU MOSBY, INC
PI ST LOUIS
PA 11830 WESTLINE INDUSTRIAL DR, ST LOUIS, MO 63146-3318 USA
SN 0002-9378
J9 AM J OBSTET GYNECOL
JI Am. J. Obstet. Gynecol.
PD MAY
PY 2004
VL 190
IS 5
BP 1272
EP 1277
DI 10.1016/j.ajog.2003.12.015
PG 6
WC Obstetrics & Gynecology
SC Obstetrics & Gynecology
GA 826JJ
UT WOS:000221825100018
PM 15167829
ER
PT J
AU Kanal, E
Borgstede, JP
Barkovich, AJ
Bell, C
Bradley, WG
Etheridge, S
Felmlee, JP
Froelich, JW
Hayden, J
Kaminski, EM
Lester, JW
Scoumis, EA
Zaremba, LA
Zinninger, MD
AF Kanal, E
Borgstede, JP
Barkovich, AJ
Bell, C
Bradley, WG
Etheridge, S
Felmlee, JP
Froelich, JW
Hayden, J
Kaminski, EM
Lester, JW
Scoumis, EA
Zaremba, LA
Zinninger, MD
TI American college of radiology white paper on MR safety: 2004 update and
revisions
SO AMERICAN JOURNAL OF ROENTGENOLOGY
LA English
DT Article
C1 Amer Coll Radiol, Reston, VA USA.
Univ Pittsburgh, Dept Radiol, Magnet Resonance Serv, Pittsburgh, PA 15213 USA.
Penrose St Francis Hlth Syst, Colorado Springs, CO 80907 USA.
Univ Calif San Francisco, Dept Neuroradiol, San Francisco, CA 94143 USA.
NYU, Dept Anesthesiol, Sch Med, New York, NY 10016 USA.
Univ Calif San Diego, Dept Radiol, San Diego, CA 92103 USA.
Hitachi Med Syst Amer Inc, Natl Elect Manufacturers Assoc, Twinsburg, OH 44087 USA.
Mayo Clin, Dept Radiol, Rochester, MN 55902 USA.
Hennepin Cty Med Ctr, Dept Radiol, Minneapolis, MN 55415 USA.
Univ Minnesota, Minneapolis, MN 55415 USA.
Durham Radiol Associates, Durham, NC 27704 USA.
US FDA, Off Device Evaluat, Ctr Devices & Radiol Hlth, Rockville, MD 20850 USA.
RP Kanal, E (reprint author), Amer Coll Radiol, 1891 Preston White Dr, Reston, VA USA.
NR 6
TC 83
Z9 86
U1 2
U2 2
PU AMER ROENTGEN RAY SOC
PI RESTON
PA 1891 PRESTON WHITE DR, SUBSCRIPTION FULFILLMENT, RESTON, VA 22091 USA
SN 0361-803X
J9 AM J ROENTGENOL
JI Am. J. Roentgenol.
PD MAY
PY 2004
VL 182
IS 5
BP 1111
EP 1114
PG 4
WC Radiology, Nuclear Medicine & Medical Imaging
SC Radiology, Nuclear Medicine & Medical Imaging
GA 815DF
UT WOS:000221022300004
PM 15100103
ER
PT J
AU Weininger, S
Shang, AB
Kopotic, RJ
Goldman, JM
Pennello, GA
AF Weininger, S
Shang, AB
Kopotic, RJ
Goldman, JM
Pennello, GA
TI Using the infrared (IR) plethysmogram to assess the effects of motion on
the performance of pulse oximeters
SO ANESTHESIA AND ANALGESIA
LA English
DT Meeting Abstract
CT International Meeting on Medical Simulation
CY JAN 16-18, 2004
CL Albuquerque, NM
C1 US FDA, Ctr Devices & Radiol Hlth, Rockville, MD 20857 USA.
Duke Univ, Dept Anesthesia, Durham, NC 27706 USA.
Imagyn, Irvine, CA USA.
Harvard Univ, Massachusetts Gen Hosp, Sch Med, Dept Anesthesia & Crit Care, Boston, MA 02114 USA.
NR 0
TC 0
Z9 0
U1 0
U2 1
PU LIPPINCOTT WILLIAMS & WILKINS
PI PHILADELPHIA
PA 530 WALNUT ST, PHILADELPHIA, PA 19106-3621 USA
SN 0003-2999
J9 ANESTH ANALG
JI Anesth. Analg.
PD MAY
PY 2004
VL 98
IS 5
SU S
MA A35
BP S16
EP S16
PG 1
WC Anesthesiology
SC Anesthesiology
GA 816PI
UT WOS:000221121400036
ER
PT J
AU Brown, SL
Morrison, AE
AF Brown, SL
Morrison, AE
TI Local anesthetic infusion pump systems adverse events reported to the
Food and Drug Administration
SO ANESTHESIOLOGY
LA English
DT Article
ID WOUND PERFUSION; PAIN-CONTROL; BUPIVACAINE
C1 US FDA, Div Postmarket Surveillance, Off Surveillance & Biometr, Ctr Devices & Radiol Hlth, Rockville, MD 20850 USA.
RP Brown, SL (reprint author), US FDA, Div Postmarket Surveillance, Off Surveillance & Biometr, Ctr Devices & Radiol Hlth, 1350 Piccard Dr,HFZ-541, Rockville, MD 20850 USA.
EM syb@cdrh.fda.gov
NR 8
TC 31
Z9 33
U1 0
U2 0
PU LIPPINCOTT WILLIAMS & WILKINS
PI PHILADELPHIA
PA 530 WALNUT ST, PHILADELPHIA, PA 19106-3621 USA
SN 0003-3022
J9 ANESTHESIOLOGY
JI Anesthesiology
PD MAY
PY 2004
VL 100
IS 5
BP 1305
EP 1306
DI 10.1097/00000542-200405000-00036
PG 2
WC Anesthesiology
SC Anesthesiology
GA 815VS
UT WOS:000221070400034
PM 15114230
ER
PT J
AU Krieg, RC
Fogt, F
Braunschweig, T
Herrmann, PC
Wollscheidt, V
Wellmann, A
AF Krieg, RC
Fogt, F
Braunschweig, T
Herrmann, PC
Wollscheidt, V
Wellmann, A
TI ProteinChip((R)) array analysis of microdissected colorectal carcinoma
and associated tumor stroma shows specific protein bands in the 3.4 to
3.6 kDa range
SO ANTICANCER RESEARCH
LA English
DT Article
DE SELDI; ProteinChip; proteome; protein; array; colorectal cancer;
carcinoma
ID AFFINITY MASS-SPECTROMETRY; PROTEOMIC ANALYSIS; PROSTATE-CANCER;
IDENTIFICATION; BIOCHIP
AB Multiple pathways of carcinogenesis have been associated with colorectal carcinomas, including the adenoma-carcinoma sequence. The non polyposis coli gene has also been implicated in the pathogenesis of these tumors. Identification of the epithelial- mesenchymal interaction may help in understanding the pathways of invasion and may lead to the development of new, non-invasive tools for the diagnosis and prognosis of colon carcinomas. A ProteinChip(R) Array technology (SELDI=Surface Enhanced Laser Desoiption Ionization) has been developed enabling analysis and profiling of complex protein mixtures from a few cells. This study describes the protein analysis of approximately 500-1000 freshly obtained cells from normal and malignant colonic epithelium and its associated stroma by SELDI-TOF-MS (Surface Enhanced Laser Desorption Ionization Time-of-Flight Mass Spectrometry). Pure cell populations of normal and malignant epithelium as well as stroma (without tumor cells) were selected by microdissection from 9 patients. A pattern of 3 peptides of 3.48, 3.55 and 3.6 kDa, which were increased in the colon tumor epithelium and stroma compared to associated normal colon and stroma in all 9 patients, was observed. Coupling microdissection with SELDI represents a powetful tool to identify cell and tumor specific proteins and to understand molecular events underlying the invasive event in colorectal carcinomas. The presence of certain proteins in invasive carcinomas may lead to the development of non invasive biomarkers for the identification or detection of recurrence of colorectal malignancies.
C1 Univ Bonn, Inst Pathol, D-53127 Bonn, Germany.
Rhein Westfal TH Aachen, UK Aachen, D-52074 Aachen, Germany.
Univ Penn, Presbyterian Med Ctr, Philadelphia, PA 19104 USA.
PALM Microlaser Technol AG, D-82347 Bernried, Germany.
NCI, US FDA, Clin Proteom Program, Bethesda, MD 20892 USA.
RP Wellmann, A (reprint author), Univ Bonn, Inst Pathol, Siegmund Freud Str 25, D-53127 Bonn, Germany.
EM axel_wellmann@yahoo.com
NR 14
TC 23
Z9 25
U1 0
U2 0
PU INT INST ANTICANCER RESEARCH
PI ATHENS
PA EDITORIAL OFFICE 1ST KM KAPANDRITIOU-KALAMOU RD KAPANDRITI, PO BOX 22,
ATHENS 19014, GREECE
SN 0250-7005
J9 ANTICANCER RES
JI Anticancer Res.
PD MAY-JUN
PY 2004
VL 24
IS 3A
BP 1791
EP 1796
PG 6
WC Oncology
SC Oncology
GA 839AW
UT WOS:000222756700066
PM 15274357
ER
PT J
AU Huber, AM
Feldman, BM
Rennebohm, RM
Hicks, JE
Lindsley, CB
Perez, MD
Zemel, LS
Wallace, CA
Ballinger, SH
Passo, MH
Reed, AM
Summers, RM
White, PH
Katona, IM
Miller, FW
Lachenbruch, PA
Rider, LG
AF Huber, AM
Feldman, BM
Rennebohm, RM
Hicks, JE
Lindsley, CB
Perez, MD
Zemel, LS
Wallace, CA
Ballinger, SH
Passo, MH
Reed, AM
Summers, RM
White, PH
Katona, IM
Miller, FW
Lachenbruch, PA
Rider, LG
TI Validation and clinical significance of the childhood myositis
assessment scale for assessment of muscle function in the juvenile
idiopathic inflammatory myopathies
SO ARTHRITIS AND RHEUMATISM
LA English
DT Article
ID DISEASE-ACTIVITY; DAMAGE INDEXES; HEALTH-STATUS; CHILDREN;
DERMATOMYOSITIS; RESPONSIVENESS; RELIABILITY
AB Objective. To examine the measurement characteristics of the Childhood Myositis Assessment Scale (CMAS) in children with juvenile idiopathic inflammatory myopathy (juvenile IIM), and to obtain preliminary data on the clinical significance of CMAS scores.
Methods. One hundred eight children with juvenile IIM were evaluated on 2 occasions, 7-9 months apart, using various measures of physical function, strength, and disease activity. Interrater reliability, construct validity, and responsiveness of the CMAS were examined. The minimum clinically important difference (MID) and CMAS scores corresponding to various degrees of physical disability were estimated.
Results. The intraclass correlation coefficient for 26 patients assessed by 2 examiners was 0.89, indicating very good interrater reliability. The CMAS score correlated highly with the Childhood Health Assessment Questionnaire (C-HAQ) score and with findings on manual muscle testing (MMT) (r(s) = -0.73 and 0.73, respectively) and moderately with physician-assessed global disease activity and skin activity, parent-assessed global disease severity, and muscle magnetic resonance imaging (rs = -0.44 to -0.61), thereby demonstrating good construct validity. The standardized response mean was 0.81 (95% confidence interval 0.53, 1.09) in patients with at least 0.8 cm improvement on a 10-cm visual analog scale for physician-assessed global disease activity, indicating strong responsiveness. In bivariate regression models predicting physician-assessed global disease activity, MMT remained significant in models containing the CMAS (P = 0.03) while the C-HAQ did not (P = 0.4). Estimates of the MID ranged from 1.5 to 3.0 points on a 0-52-point scale. CMAS scores corresponding to no, mild, mild-to-moderate, and moderate physical disability, respectively, were 48, 45, 39, and 30.
Conclusion. The CMAS exhibits good reliability, construct validity, and responsiveness, and is therefore a valid instrument for the assessment of physical function, muscle strength, and endurance in children with juvenile IIM. Preliminary data on MID and corresponding levels of disability should aid in the clinical interpretation of CMAS scores when assessing patients with juvenile IIM.
C1 IWK Hlth Ctr, Halifax, NS B3J 3G9, Canada.
Dalhousie Univ, Halifax, NS, Canada.
Hosp Sick Children, Toronto, ON M5G 1X8, Canada.
Univ Toronto, Toronto, ON, Canada.
Ohio State Univ, Columbus, OH 43210 USA.
Columbus Childrens Hosp, Columbus, OH USA.
NIH, Ctr Clin, Bethesda, MD USA.
Univ Kansas, Kansas City, KS USA.
Baylor Coll Med, Houston, TX 77030 USA.
Texas Childrens Hosp, Houston, TX 77030 USA.
Univ Connecticut, Hartford, CT 06112 USA.
Connecticut Childrens Med Ctr, Hartford, CT USA.
Childrens Hosp, Seattle, WA USA.
Univ Washington, Seattle, WA 98195 USA.
James Whitcomb Riley Hosp Children, Indianapolis, IN 46202 USA.
Indiana Univ, Indianapolis, IN 46204 USA.
Childrens Hosp, Cincinnati, OH 45229 USA.
Univ Cincinnati, Cincinnati, OH USA.
Mayo Clin, Rochester, MN USA.
Childrens Natl Med Ctr, Washington, DC 20010 USA.
Uniformed Serv Univ Hlth Sci, Bethesda, MD 20814 USA.
Natl Inst Environm Hlth Sci, NIH, Bethesda, MD USA.
US FDA, Ctr Biol Evaluat & Res, Rockville, MD USA.
RP Huber, AM (reprint author), IWK Hlth Ctr, 5850 Univ Ave, Halifax, NS B3J 3G9, Canada.
EM adam.huber@iwk.nshealth.ca
RI Feldman, Brian/A-8586-2011;
OI Rider, Lisa/0000-0002-6912-2458; Miller, Frederick/0000-0003-2831-9593
NR 21
TC 83
Z9 86
U1 2
U2 3
PU WILEY-LISS
PI NEW YORK
PA DIV JOHN WILEY & SONS INC, 605 THIRD AVE, NEW YORK, NY 10158-0012 USA
SN 0004-3591
J9 ARTHRITIS RHEUM
JI Arthritis Rheum.
PD MAY
PY 2004
VL 50
IS 5
BP 1595
EP 1603
DI 10.1002/art.20179
PG 9
WC Rheumatology
SC Rheumatology
GA 819UI
UT WOS:000221340900028
PM 15146430
ER
PT J
AU Dong, L
Ito, SI
Ishii, KJ
Klinman, DM
AF Dong, L
Ito, SI
Ishii, KJ
Klinman, DM
TI Suppressive oligonucleotides protect against collagen-induced arthritis
in mice
SO ARTHRITIS AND RHEUMATISM
LA English
DT Article
ID INDUCED IMMUNE ACTIVATION; DNA; AUTOIMMUNITY; OLIGODEOXYNUCLEOTIDES;
INHIBITION; MOTIFS; MODEL
AB Objective. To examine whether systemic administration of oligonucleotides (ODNs), known to inhibit the production of proinflammatory cytokines, alters host susceptibility to collagen-induced arthritis (CIA), a murine model of rheumatoid arthritis (RA).
Methods. CIA was induced by injecting DBA/1 mice with type II collagen (CII) in Freund's complete adjuvant, followed 3 weeks later by CH in Freund's incomplete adjuvant. The effect of suppressive ODNs on the incidence and severity of disease was monitored, as were immune correlates of CIA.
Results. Suppressive ODNs administered during the inductive phase of CIA significantly reduced the incidence and severity of arthritis. Treatment with suppressive ODNs significantly decreased serum titers of pathogenic IgG anti-CII autoantibodies and interferon-gamma production by collagen-reactive T cells.
Conclusion. Suppressive ODNs may be of therapeutic value in the treatment of RA, and potentially other autoimmune diseases.
C1 US FDA, CBER, Bethesda, MD 20892 USA.
RP Klinman, DM (reprint author), US FDA, CBER, Bldg 29A,Room 3D10, Bethesda, MD 20892 USA.
EM klinman@cber.fda.gov
RI Ishii, Ken/B-1685-2012
OI Ishii, Ken/0000-0002-6728-3872
NR 14
TC 50
Z9 60
U1 0
U2 0
PU WILEY-LISS
PI NEW YORK
PA DIV JOHN WILEY & SONS INC, 605 THIRD AVE, NEW YORK, NY 10158-0012 USA
SN 0004-3591
J9 ARTHRITIS RHEUM
JI Arthritis Rheum.
PD MAY
PY 2004
VL 50
IS 5
BP 1686
EP 1689
DI 10.1002/art.20263
PG 4
WC Rheumatology
SC Rheumatology
GA 819UI
UT WOS:000221340900038
PM 15146440
ER
PT J
AU Hendry, WJ
Branham, WS
Sheehan, DM
AF Hendry, WJ
Branham, WS
Sheehan, DM
TI Diethylstilbestrol versus estradiol as neonatal disruptors of the
hamster (Mesocricetus auratus) cervix
SO BIOLOGY OF REPRODUCTION
LA English
DT Article
DE cervix; developmental; biology; estradiol; female reproductive tract;
toxicology
ID RECEPTOR NULL MICE; ESTROGEN-RECEPTOR; GENITAL-TRACT;
REPRODUCTIVE-TRACT; ALPHA-FETOPROTEIN; VAGINAL ADENOSIS; SERUM-ALBUMIN;
GUINEA-PIG; EXPOSURE; BINDING
AB The synthetic estrogen diethylstilbestrol (DES) is an established, estrogenic endocrine disruptor (ED). The Syrian golden hamster (Mesocricetus auratus) offers some unique advantages as an experimental system to investigate the perinatal ED action of DES and other estrogenic EDs. Previous analyses regarding the consequences of neonatal administration (100 mug) of DES versus estradiol-17beta (E-2) showed that DES had a more potent disruptive effect on morphogenesis and gene expression in the uterus, oviduct, and ovary as well as in the testis and male accessory organs. The objectives of the present study were to describe the histopathological consequences of the two neonatal treatment regimens in the hamster cervix and to compare them with our previous observations in the hamster uterus. As previously found in the hamster uterus, DES was more potent than E-2 as a neonatal disruptor of the hamster cervix in prepubertal animals and in ovarian-intact adult animals. However, the cervix-versus-uterus scenario diverged in animals that were ovari-ectomized prepubertally and then chronically stimulated with natural estrogen (E-2). We confirmed previous observations that neonatal exposure to DES, but not to E-2 permanently alters estrogen responsiveness in the adult hamster uterus, but neither neonatal treatment regimen affected estrogen responsiveness in the adult hamster cervix. These results suggest that an unidentified ovarian factor influences the extent of neonatal DES-induced disruption of the cervix, but not of the uterus, in hamsters.
C1 Wichita State Univ, Dept Biol Sci, Wichita, KS 67260 USA.
Natl Ctr Toxicol Res, Div Genet & Reprod Toxicol, Jefferson, AR 72079 USA.
Daniel M Sheehan & Associates, Little Rock, AR 72202 USA.
RP Hendry, WJ (reprint author), Wichita State Univ, Dept Biol Sci, 1845 Fairmount, Wichita, KS 67260 USA.
EM william.hendry@wichita.edu
FU NCI NIH HHS [CA60250]; NCRR NIH HHS [P20 RR16475]
NR 44
TC 7
Z9 7
U1 0
U2 1
PU SOC STUDY REPRODUCTION
PI MADISON
PA 1603 MONROE ST, MADISON, WI 53711-2021 USA
SN 0006-3363
J9 BIOL REPROD
JI Biol. Reprod.
PD MAY
PY 2004
VL 70
IS 5
BP 1306
EP 1316
DI 10.1095/biolreprod.103.024992
PG 11
WC Reproductive Biology
SC Reproductive Biology
GA 815ME
UT WOS:000221045600012
PM 14711791
ER
PT J
AU Chera, H
Schaecher, KE
Rocchini, A
Imam, SZ
Sribnick, EA
Ray, SK
Ali, SF
Banik, NL
AF Chera, H
Schaecher, KE
Rocchini, A
Imam, SZ
Sribnick, EA
Ray, SK
Ali, SF
Banik, NL
TI Immunofluorescent labeling of increased calpain expression and neuronal
death in the spinal cord of
1-methyl-4-phenyl-1,2,3,6-tetrahydropyridine-treated mice
SO BRAIN RESEARCH
LA English
DT Article
DE calpain; double immunofluorescent labeling;
1-methyl-4-phenyl-1,2,3,6-tetrahydropyridine neuronal death; Parkinson's
disease; spinal cord
ID PARKINSONS-DISEASE; DOPAMINERGIC-NEURONS; SUBSTANTIA-NIGRA; CELL-DEATH;
APOPTOTIC DEATH; UP-REGULATION; HUMAN BRAIN; DEGENERATION;
VULNERABILITY; DEMYELINATION
AB Parkinson's disease (PD) is a movement disorder characterized by rigidity, tremor, and bradykinesia, originating from degeneration of dopaminergic neurons in the substantia nigra (SN), retrorubral area, and locus ceoruleus (LC). Calpain has been implicated in the pathophysiology of neurodegenerative diseases. Since the spinal cord (SC) and brain are integrally connected and calpain is involved in cell death and mitochondrial dysfunction, we hypothesized that SC neurons are also affected in PD. In order to examine this hypothesis, we examined both brain and SC from mice treated with 1-methyl-4-phenyl-1,2,3,6-tetrahydropyridine (MPTP). To identify cells expressing calpain, double immunofluorescent labeling was performed with antibodies specific for calpain and a cell type (OX-42, GFAP, or NeuN). Combined terminal deoxynucleotidyl transferase-mediated dUTP nick-end labeling (TUNEL) and double immunofluorescent labeling were used to identify death of specific cells in the central nervous system (CNS). There was an increase in calpain expression in microglia, astrocytes, and neurons in the SC of MPTP-treated mice at 1 and 7 days, as compared to controls. TUNEL-positive neurons in the SC and SN showed apoptotic characteristics. These results demonstrated that neuronal death occurred not only in SN but also in the SC of MPTP-treated mice and has provided evidence for a possible calpain-mediated SC neuronal death in MPTP-induced parkinsonism in mice. (C) 2004 Elsevier B.V. All rights reserved.
C1 Med Univ S Carolina, Dept Neurol, Charleston, SC 29425 USA.
Uniformed Serv Univ Hlth Sci, Walter Reed Mem Inst, Dept Microbiol & Immunol, Bethesda, MD 20814 USA.
US FDA, Natl Ctr Toxicol Res, Neurochem Lab, Div Neurotoxicol, Jefferson, AR 72079 USA.
RP Banik, NL (reprint author), Med Univ S Carolina, Dept Neurol, 96 Jonathan Lucas St,POB 250606, Charleston, SC 29425 USA.
EM baniknl@musc.edu
NR 28
TC 16
Z9 16
U1 1
U2 2
PU ELSEVIER SCIENCE BV
PI AMSTERDAM
PA PO BOX 211, 1000 AE AMSTERDAM, NETHERLANDS
SN 0006-8993
J9 BRAIN RES
JI Brain Res.
PD MAY 1
PY 2004
VL 1006
IS 2
BP 150
EP 156
DI 10.1016/j.brainres.2004.01.065
PG 7
WC Neurosciences
SC Neurosciences & Neurology
GA 812EK
UT WOS:000220822600002
ER
PT J
AU Massirer, KB
Hirata, MH
Silva, AEB
Ferraz, MLG
Nguyen, NY
Hirata, RDC
AF Massirer, KB
Hirata, MH
Silva, AEB
Ferraz, MLG
Nguyen, NY
Hirata, RDC
TI Interferon-alpha receptor 1 mRNA expression in peripheral blood
mononuclear cells is associated with response to interferon-alpha
therapy of patients with chronic hepatitis C
SO BRAZILIAN JOURNAL OF MEDICAL AND BIOLOGICAL RESEARCH
LA English
DT Article
DE IFNAR1-mRNA expression; interferon-alpha therapy; chronic hepatitis C;
interferon-alpha receptor; peripheral blood mononuclear cells; reverse
transcription-polymerase chain reaction
ID CHRONIC LIVER-DISEASES; VIRUS
AB Interferon (IFN)-alpha receptor mRNA expression in liver of patients with chronic hepatitis C has been shown to be a response to IFN-alpha therapy. The objective of the present study was to determine whether the expression of mRNA for subunit 1 of the IFN-alpha receptor (IFNAR1) in peripheral blood mononuclear cells (PBMC) is associated with the response to IFN-alpha in patients with chronic hepatitis C. Thirty patients with positive anti-HCV and HCV-RNA, and abnormal levels of alanine aminotransferase in serum were selected and treated with IFN-alpha2b for one year. Those with HBV or HIV infection, or using alcohol. were not included. Thirteen discontinued the treatment and were not evaluated. The IFN-alpha response was monitored on the basis of alanine aminotransferase level and positivity for HCV-RNA in serum. IFNAR1-mRNA expression in PBMC was measured by reverse transcription-polymerase chain reaction before and during the first three months of therapy. The results are reported as IFNAR1-mRNA/beta-actin-mRNA ratio (mean +/- SD). Before treatment, responder patients had significantly higher IFNAR1-mRNA expression in PBMC (0.67 +/- 0.15; N = 5; P < 0.05) compared to non-responders (0.35 +/- 0.17; N = 12) and controls (0.30 +/- 0.16; N = 9). Moreover, IFNAR1-mRNA levels were significantly reduced after 3 months of treatment in responders, whereas there were no differences in IFNAR1 expression in nonresponders during IFN-alpha therapy. Basal IFNAR1-mRNA expression was not correlated with the serum level of alanine and aspartate aminotransferases or the presence of cirrhosis. The present results suggest that IFNAR1-mRNA expression in PBMC is associated with IFN-alpha, response to hepatitis C and may be useful for monitoring therapy in patients with chronic hepatitis C.
C1 Univ Sao Paulo, Fac Ciencias Farmaceut, Dept Anal Clin & Toxicol, Sao Paulo, Brazil.
Univ Fed Sao Paulo, Dept Gastroenterol, Sao Paulo, Brazil.
US FDA, Ctr Biol Evaluat & Res, Bethesda, MD USA.
RP Hirata, MH (reprint author), Av Prof Lineu Prestes 580, BR-05508900 Sao Paulo, Brazil.
EM mdchirta@usp.br
RI Hirata, Rosario/A-7284-2011; Hirata, Mario/C-9718-2013
NR 20
TC 13
Z9 18
U1 0
U2 0
PU ASSOC BRAS DIVULG CIENTIFICA
PI SAO PAULO
PA FACULDADE MEDICINA, SALA 21, 14049 RIBEIRAO PRETO, SAO PAULO, BRAZIL
SN 0100-879X
J9 BRAZ J MED BIOL RES
JI Brazilian J. Med. Biol. Res.
PD MAY
PY 2004
VL 37
IS 5
BP 643
EP 647
DI 10.1590/S0100-879X2004000500003
PG 5
WC Biology; Medicine, Research & Experimental
SC Life Sciences & Biomedicine - Other Topics; Research & Experimental
Medicine
GA 820EK
UT WOS:000221369800003
PM 15107924
ER
PT J
AU Kioi, M
Kawakami, K
Puri, RK
AF Kioi, M
Kawakami, K
Puri, RK
TI Mechanism of action of interleukin-13 antagonist (IL-13E13K) in cells
expressing various types of IL-4R
SO CELLULAR IMMUNOLOGY
LA English
DT Article
DE interleukin-4; interleukin-13; antagonist; receptor; signal transduction
ID COMMON GAMMA-CHAIN; RECEPTOR-ALPHA CHAIN; SIGNAL-TRANSDUCTION;
FUNCTIONAL COMPONENT; BINDING SUBUNIT; CARCINOMA-CELLS; HUMAN BREAST;
T-CELLS; B-CELLS; CLONING
AB As interleukin (IL)-13 and IL-4 play a major role in various diseases including asthma, allergy, and malignancies, it is desirable to generate a molecule that blocks the effects of both cytokines. We previously generated a human IL-13 mutant (IL-13E13K), which is a powerful antagonist of IL-13, blocking the biological activities of IL-13. We now show that IL-13E13K also competitively inhibits signaling and biological activities of IL-4 through type 11 and partially through type III IL-4 receptor (R) system. IL-13E13K completely blocked the IL-4-induced phosphorylation of STAT6 and IL-4-dependent protein synthesis in cells expressing type 11 and partially type Ill IL-4R but not type I IL-4R. Consistent with the inhibition of biological activities, IL-13E13K inhibited IL-4 binding to type 11 IL-4R-expressing cells but not to type I IL-4R-expressing cells. The inhibition efficiency of IL-4 binding by IL-13E13K was relatively lower compared to wtIL-13 even though IL-13E13K bound to IL-13Ralpha1 positive cells with a similar affinity to IL-4Ralpha. These results indicate that Glu 13 in IL- 13 associates with IL-4Ralpha, and mutation to lysine decreases its binding ability to IL-4Ralpha chain. IL-13E13K binds to IL-13Ralpha1, which is shared by both IL-13R and IL-4R systems. Consequently, IL-13E13K inhibits IL-4 binding to these cells and prevents heterodimer formation between IL-13Ralpha1 and IL-4Ra chains. This interference by IL-13E13K blocks the biological activities of not only IL-13 but also partially of IL-4. Thus, IL-13E13K may be a useful agent for the treatment of diseases such as asthma, allergic rhinitis, and cancer, which are dependent on signaling through both IL-4 and IL-13 receptors. Published by Elsevier Inc.
C1 US FDA, Lab Mol Tumor Biol, Div Cellular & Gene Therapies, Ctr Biol Evaluat & Res, Bethesda, MD 20892 USA.
RP Puri, RK (reprint author), US FDA, Lab Mol Tumor Biol, Div Cellular & Gene Therapies, Ctr Biol Evaluat & Res, Bethesda, MD 20892 USA.
EM puri@cber.fda.gov
OI Kioi, Mitomu/0000-0002-7981-3340
NR 38
TC 17
Z9 17
U1 0
U2 1
PU ACADEMIC PRESS INC ELSEVIER SCIENCE
PI SAN DIEGO
PA 525 B ST, STE 1900, SAN DIEGO, CA 92101-4495 USA
SN 0008-8749
J9 CELL IMMUNOL
JI Cell. Immunol.
PD MAY
PY 2004
VL 229
IS 1
BP 41
EP 51
DI 10.1016/j.cellimm.2004.06.005
PG 11
WC Cell Biology; Immunology
SC Cell Biology; Immunology
GA 851SZ
UT WOS:000223707000005
PM 15331327
ER
PT J
AU Xia, QS
Chou, MW
Lin, G
Fu, PP
AF Xia, QS
Chou, MW
Lin, G
Fu, PP
TI Metabolic formation of DHP-derived DNA adducts from a representative
otonecine type pyrrolizidine alkaloid clivorine and the extract of
Ligularia hodgsonnii hook
SO CHEMICAL RESEARCH IN TOXICOLOGY
LA English
DT Article
ID PERFORMANCE LIQUID-CHROMATOGRAPHY; CARCINOGENIC ACTIVITY; MICROSOMAL
METABOLITES; PETASITES-JAPONICUS; HEPATIC-TUMORS; ISLET-CELL; IN-VITRO;
RATS; LASIOCARPINE; RIDDELLIINE
AB Plants that contain pyrrolizidine alkaloids (PAs) are widely distributed, and PAs have been shown to be genotoxic and tumorigenic in experimental animals. Our recent mechanistic studies indicated that riddelhine, a tumorigenic retronecine type PA, induced tumors via a genotoxic mechanism mediated by the formation of a set of eight 6,7-dihydro-7-hydroxy-1-hydroxymethyl-5H-pyrrolizine (DHP)-derived DNA adducts. However, it is not known if this mechanism is general to PAs of other types. In this study, we report that the metabolism of clivorine, a tumorigenic otonecine type PA, by F344 rat liver microsomes results in DHP formation. When incubations were conducted with clivorine in the presence of calf thymus DNA, eight DHP-derived DNA adducts were formed. The Ligularia hodgsonnii Hook plant, an antitussive traditional Chinese medicine, was found to contain otonecine type PAs with clivorine being predominant. DHP and DHP-derived DNA adducts were also obtained when microsomal incubations were conducted with extracts of L. hodgsonnii Hook. This is the first report that DHP-derived DNA adducts are formed from the metabolic activation of otonecine type PA and that these DHP-derived DNA adducts are potential biomarkers of PA exposure and PA-induced tumorigenicity. These results also provide evidence that the principal metabolic activation pathway of clivorine leading to liver genotoxicity and tumorigenicity is (i) formation of the corresponding dehydropyrrolizidine (pyrrolic) derivative through oxidative N-demethylation of the necine base followed by ring closure and dehydration and (ii) binding of the pyrrolic metabolite to DNA leading to the DNA adduct formation and tumor initiation.
C1 Chinese Univ Hong Kong, Dept Pharmacol, Shatin, Hong Kong, Peoples R China.
Natl Ctr Toxicol Res, Div Biochem Toxicol, Jefferson, AR 72079 USA.
RP Fu, PP (reprint author), Chinese Univ Hong Kong, Dept Pharmacol, Shatin, Hong Kong, Peoples R China.
EM linge@cuhk.edu.hk; pfu@nctr.fda.gov
NR 50
TC 40
Z9 42
U1 1
U2 9
PU AMER CHEMICAL SOC
PI WASHINGTON
PA 1155 16TH ST, NW, WASHINGTON, DC 20036 USA
SN 0893-228X
J9 CHEM RES TOXICOL
JI Chem. Res. Toxicol.
PD MAY
PY 2004
VL 17
IS 5
BP 702
EP 708
DI 10.1021/tx030030q
PG 7
WC Chemistry, Medicinal; Chemistry, Multidisciplinary; Toxicology
SC Pharmacology & Pharmacy; Chemistry; Toxicology
GA 822HF
UT WOS:000221529100015
PM 15144228
ER
PT J
AU Spellberg, B
Powers, JH
Brass, EP
Miller, LG
Edwards, JE
AF Spellberg, B
Powers, JH
Brass, EP
Miller, LG
Edwards, JE
TI Trends in antimicrobial drug development: Implications for the future
SO CLINICAL INFECTIOUS DISEASES
LA English
DT Article; Proceedings Paper
CT 43rd Interscience Convention on Antimicrobial Agents and Chemotherapy
CY MAR, 2003
CL San Diego, CA
ID RESISTANT PSEUDOMONAS-AERUGINOSA; UNITED-STATES;
STREPTOCOCCUS-PNEUMONIAE; STAPHYLOCOCCUS-AUREUS; TUBERCULOSIS;
INFECTIONS; PREVALENCE; OUTBREAK
AB The need for new antimicrobial agents is greater than ever because of the emergence of multidrug resistance in common pathogens, the rapid emergence of new infections, and the potential for use of multidrug-resistant agents in bioweapons. Paradoxically, some pharmaceutical companies have indicated that they are curtailing anti-infective research programs. We evaluated the United States Food and Drug Administration (FDA) databases of approved drugs and the research and development programs of the world's largest pharmaceutical and biotechnology companies to document trends in the development of new antimicrobial agents. FDA approval of new antibacterial agents decreased by 56% over the past 20 years ( 1998 - 2002 vs. 1983 - 1987). Projecting future development, new antibacterial agents constitute 6 of 506 drugs disclosed in the developmental programs of the largest pharmaceutical and biotechnology companies. Despite the critical need for new antimicrobial agents, the development of these agents is declining. Solutions encouraging and facilitating the development of new antimicrobial agents are needed.
C1 Univ Calif Los Angeles, Los Angeles Cty Harbor Med Ctr, Res & Educ Inst, Div Infect Dis, Torrance, CA 90502 USA.
Univ Calif Los Angeles, Los Angeles Cty Harbor Med Ctr, Dept Med, Torrance, CA 90509 USA.
Univ Calif Los Angeles, David Geffen Sch Med, Los Angeles, CA USA.
US FDA, Off Drug Evaluat 4, Ctr Drug Evaluat & Res, Rockville, MD 20857 USA.
RP Edwards, JE (reprint author), Univ Calif Los Angeles, Los Angeles Cty Harbor Med Ctr, Res & Educ Inst, Div Infect Dis, 1124 W Carson St, Torrance, CA 90502 USA.
EM edwards@humc.edu
RI a, a/M-9467-2013
FU NIAID NIH HHS [P01 AI37194, R01 AI19990]
NR 77
TC 409
Z9 433
U1 5
U2 60
PU UNIV CHICAGO PRESS
PI CHICAGO
PA 1427 E 60TH ST, CHICAGO, IL 60637-2954 USA
SN 1058-4838
J9 CLIN INFECT DIS
JI Clin. Infect. Dis.
PD MAY 1
PY 2004
VL 38
IS 9
BP 1279
EP 1286
DI 10.1086/420937
PG 8
WC Immunology; Infectious Diseases; Microbiology
SC Immunology; Infectious Diseases; Microbiology
GA 813SG
UT WOS:000220926200014
PM 15127341
ER
PT J
AU Schleinitz, TA
Telford, WG
Perfetto, SP
Caporaso, NE
Stetler-Stevenson, M
Abbasi, F
Zenger, VE
Marti, GE
AF Schleinitz, TA
Telford, WG
Perfetto, SP
Caporaso, NE
Stetler-Stevenson, M
Abbasi, F
Zenger, VE
Marti, GE
TI Multicolor flow cytometry (MCFCM) analysis of precursor states in
chronic lymphocytic leukemia (CLL)
SO CYTOMETRY PART A
LA English
DT Meeting Abstract
CT 22nd Congress of the International-Society-for-Analytical-Cytology
CY MAY 22-27, 2004
CL Montpellier, FRANCE
SP Ins Soc Analyt Cytol
C1 Inst J Paoli I Calmettes, CBER FDA, F-13009 Marseille, France.
NCI, Flow Core Facil, Bethesda, MD 20892 USA.
NIH, Vaccine Res Ctr, Bethesda, MD 20892 USA.
NCI, NIH, Bethesda, MD 20892 USA.
NCI, Pathol Lab, NIH, Bethesda, MD 20892 USA.
US FDA, CBER, Bethesda, MD 20014 USA.
NR 0
TC 0
Z9 0
U1 0
U2 0
PU WILEY-LISS
PI HOBOKEN
PA DIV JOHN WILEY & SONS INC, 111 RIVER ST, HOBOKEN, NJ 07030 USA
SN 0196-4763
J9 CYTOM PART A
JI Cytom. Part A
PD MAY
PY 2004
VL 59A
IS 1
BP 39
EP 39
PG 1
WC Biochemical Research Methods; Cell Biology
SC Biochemistry & Molecular Biology; Cell Biology
GA 819MV
UT WOS:000221319900045
ER
PT J
AU Holleran, JL
Fourcade, J
Egorin, MJ
Eiseman, JL
Parise, RA
Musser, SM
White, KD
Covey, JM
Forrest, GL
Pan, SS
AF Holleran, JL
Fourcade, J
Egorin, MJ
Eiseman, JL
Parise, RA
Musser, SM
White, KD
Covey, JM
Forrest, GL
Pan, SS
TI In vitro metabolism of the phosphatidylinositol 3-kinase inhibitor,
wortmannin, by carbonyl reductase
SO DRUG METABOLISM AND DISPOSITION
LA English
DT Article
ID PHOSPHOINOSITIDE 3-KINASE; ANTICANCER AGENTS; KINASE INHIBITORS;
LIQUID-CHROMATOGRAPHY; SIGNAL-TRANSDUCTION; BINDING PROTEIN; CANCER;
TARGETS; LIPIDS
AB The phosphatidylinositol 3-kinase inhibitor, wortmannin, is extensively used in molecular signaling studies and has been proposed as a potential antineoplastic agent. The failure to detect wortmannin in mouse plasma after i.v. administration prompted in vitro studies of wortmannin metabolism. Wortmannin was incubated with mouse tissue homogenates, homogenate fractions, or purified, recombinant human carbonyl reductase in the presence of specified cofactors and inhibitors. Reaction products were characterized and quantified with liquid chromatography (LC)/mass spectrometry. Reaction rates were characterized using Michaelis-Menten kinetics. Wortmannin was metabolized to a material 2 atomic mass units greater than wortmannin. Liver homogenate had the highest metabolic activity. Some metabolism occurred in kidney and lung homogenates. Very little metabolism occurred in brain or red blood cell homogenates. Liver S9 fraction and cytosol metabolized wortmannin in the presence of NADPH and, to a much lesser extent, in the presence of NADH. Microsomal metabolism of wortmannin was minimal. Purified, recombinant human carbonyl reductase metabolized wortmannin. Quercetin, a carbonyl reductase inhibitor, greatly decreased wortmannin metabolism by S9, cytosol, and carbonyl reductase. The K-M for wortmannin metabolism by purified, recombinant human carbonyl reductase was 119+/-9 muM, and the V-max was 58+/-9 nmol/min/mg of protein. LC-tandem mass spectrometry spectra indicated that carbonyl reductase metabolized wortmannin to 17-OH-wortmannin. Wortmannin reduction by carbonyl reductase may partly explain why wortmannin is not detected in plasma after being administered to mice. Metabolism of wortmannin to 17-OH-wortmannin has mechanistic, and possibly toxicologic, implications because 17-OH-wortmannin is 10-fold more potent an inhibitor of phosphatidylinositol 3-kinase than is wortmannin.
C1 Univ Pittsburgh, Inst Canc, Mol Therapeut Drug Discovery Program, Pittsburgh, PA 15213 USA.
Univ Pittsburgh, Sch Med, Dept Med, Div Hematol Oncol, Pittsburgh, PA USA.
Univ Pittsburgh, Sch Med, Dept Pharmacol, Pittsburgh, PA 15261 USA.
US FDA, Instrumentat & Biophys Branch, Ctr Food Safety & Appl Nutr, College Pk, MD USA.
NCI, Toxicol & Pharmacol Branch, DTP, Bethesda, MD 20892 USA.
City Hope Natl Med Ctr, Beckman Res Inst, Duarte, CA 91010 USA.
RP Egorin, MJ (reprint author), Univ Pittsburgh, Inst Canc, Mol Therapeut Drug Discovery Program, Room G27E,Hillman Res Pavil,5117 Ctr Ave, Pittsburgh, PA 15213 USA.
EM egorinmj@msx.upmc.edu
FU NCI NIH HHS [2P30 CA 47904, N01 CM 07106]
NR 38
TC 11
Z9 11
U1 2
U2 4
PU AMER SOC PHARMACOLOGY EXPERIMENTAL THERAPEUTICS
PI BETHESDA
PA 9650 ROCKVILLE PIKE, BETHESDA, MD 20814-3998 USA
SN 0090-9556
J9 DRUG METAB DISPOS
JI Drug Metab. Dispos.
PD MAY 1
PY 2004
VL 32
IS 5
BP 490
EP 496
DI 10.1124/dmd.32.5.490
PG 7
WC Pharmacology & Pharmacy
SC Pharmacology & Pharmacy
GA 814BZ
UT WOS:000220951500004
PM 15100170
ER
PT J
AU Komoroski, BJ
Zhang, SM
Cai, HB
Hutzler, JM
Frye, R
Tracy, TS
Strom, SC
Lehmann, T
Ang, CYW
Cui, YY
Venkataramanan, R
AF Komoroski, BJ
Zhang, SM
Cai, HB
Hutzler, JM
Frye, R
Tracy, TS
Strom, SC
Lehmann, T
Ang, CYW
Cui, YY
Venkataramanan, R
TI Induction and inhibition of cytochromes P450 by the St. John's wort
constituent hyperforin in human hepatocyte cultures
SO DRUG METABOLISM AND DISPOSITION
LA English
DT Article
ID GENE INDUCTION; DEPRESSION; METABOLISM; HYPERICUM; ENZYMES; LIVER
AB St. John's wort extract (SJW) (Hypericum perforatum L.) is among the most commonly used herbal medications in the United States. The predominance of clinical reports indicates that SJW increases the activity of cytochrome P450 3A4 (CYP3A4) enzyme and reduces plasma concentrations of certain drugs. Although the inductive effect of SJW on CYP3A4 is clear, other reports indicate that SJW constituents may have, to a small degree, some enzyme inhibitory effects. Therefore, we sought to study the induction and inhibition effects of the constituents of SJW on CYP3A4 in the human hepatocyte model. Moreover, most research has focused on the induction of CYP3A4 by SJW with little attention paid to other prominent drug-metabolizing enzymes such as CYP1A2, CYP2C9, and CYP2D6. To examine the effects of SJW on CYP1A2, CYP2C9, CYP2D6, as well as CYP3A4, hepatocytes were exposed to hyperforin and hypericin, the primary constituents of SJW extract. Hepatocytes treated with hypericin or hyperforin were exposed to probe substrates to determine enzyme activity and protein and RNA harvested. Hyperforin treatment resulted in significant increases in mRNA, protein, and activity of CYP3A4 and CYP2C9, but had no effect on CYP1A2 or CYP2D6. Acute administration of hyperforin at 5 and 10 muM 1 h before and along with probe substrate inhibited CYP3A4 activity. Hypericin had no effect on any of the enzymes tested. These results demonstrate that with chronic exposure, the inductive effect of SJW on drug-metabolizing enzymes predominates, and human hepatocyte cultures are a versatile in vitro tool for screening the effect of herbal products on cytochrome P450 enzymes.
C1 Univ Pittsburgh, Sch Pharm, Dept Pharmaceut Sci, Pittsburgh, PA 15261 USA.
Univ Pittsburgh, Sch Med, Dept Pathol, Pittsburgh, PA 15261 USA.
W Virginia Univ, Sch Pharm, Morgantown, WV 26506 USA.
US FDA, Natl Ctr Toxicol Res, Div Chem, Jefferson, AR 72079 USA.
RP Venkataramanan, R (reprint author), Univ Pittsburgh, Sch Pharm, Dept Pharmaceut Sci, 718 Salk Hall, Pittsburgh, PA 15261 USA.
EM rv@pitt.edu
RI Strom, Stephen/A-6501-2008;
OI Frye, Reginald/0000-0002-1841-1401
FU NIDDK NIH HHS [N01 DK 92310]
NR 25
TC 109
Z9 112
U1 0
U2 8
PU AMER SOC PHARMACOLOGY EXPERIMENTAL THERAPEUTICS
PI BETHESDA
PA 9650 ROCKVILLE PIKE, BETHESDA, MD 20814-3998 USA
SN 0090-9556
J9 DRUG METAB DISPOS
JI Drug Metab. Dispos.
PD MAY 1
PY 2004
VL 32
IS 5
BP 512
EP 518
DI 10.1124/dmd.32.5.512
PG 7
WC Pharmacology & Pharmacy
SC Pharmacology & Pharmacy
GA 814BZ
UT WOS:000220951500007
PM 15100173
ER
PT J
AU Zhou, M
Lucas, DA
Chan, KC
Issaq, HJ
Petricoin, EF
Liotta, LA
Veenstra, TD
Conrads, TR
AF Zhou, M
Lucas, DA
Chan, KC
Issaq, HJ
Petricoin, EF
Liotta, LA
Veenstra, TD
Conrads, TR
TI An investigation into the human serum "interactome"
SO ELECTROPHORESIS
LA English
DT Article; Proceedings Paper
CT 14th Annual Frederick Conference on Capillary Electrophoresis/Proteomics
CY NOV 03-04, 2003
CL NCI, Frederick, MD
HO NCI
DE albumin; biomarker; human serum; proteome; surface-enhanced laser
desorption/ionization
ID PROSTATE-SPECIFIC ANTIGEN; HUMAN PLASMA PROTEOME; PANCREATIC-CANCER;
OVARIAN-CANCER; DOWN-SYNDROME; EXPRESSION; IDENTIFICATION; PATTERNS;
PROTEINS; BINDING
AB The protein content of human serum is composed of a millieu of proteins from almost every type of cell and tissue within the body. The serum proteome has been shown to contain information that directly reflects pathophysiological states and represents an invaluable source of diagnostic information for a variety of different diseases. Unfortunately, the dynamic range of protein abundance, ranging from much greater than mg/mL level to much less than pg/mL level, renders complete characterization of this proteome nearly impossible with current analytical methods. To study low-abundance proteins, which have potential value for clinical diagnosis, the high-abundant species, such as immunoglobulins and albumin, are generally eliminated as the first step in many analytical protocols. This step, however, is hypothesized to concomitantly remove proteins/peptides associated with the high-abundant proteins targeted for depletion. In this study, immunoprecipitation was combined with microcapillary reversed-phase liquid chromatography (muRPLC) coupled on-line with tandem mass spectrometry (MS/MS) to investigate the low-molecular-weight proteins/peptides that associate with the most abundant species in serum. By this targeted isolation of select highly abundant serum proteins, the associated proteins/peptides can be enriched and effectively identified by muRPLC-MS/MS. Among the 210 proteins identified, 73% and 67% were not found in previous studies of the low-molecular-weight or whole-serum proteome, respectively.
C1 SAIC Frederick Inc, Natl Canc Inst, Lab Proteom & Analyt Technol, Frederick, MD 21702 USA.
US FDA, Ctr Biol Evaluat & Res, Natl Canc Inst, Clin Proteom Program, Bethesda, MD 20014 USA.
NCI, Ctr Canc Res, Pathol Lab, Bethesda, MD 20892 USA.
RP Conrads, TR (reprint author), SAIC Frederick Inc, Natl Canc Inst, Lab Proteom & Analyt Technol, POB B, Frederick, MD 21702 USA.
EM Conrads@ncifcrf.gov
FU NCI NIH HHS [N01-CO-12400]
NR 48
TC 222
Z9 229
U1 2
U2 17
PU WILEY-V C H VERLAG GMBH
PI WEINHEIM
PA PO BOX 10 11 61, D-69451 WEINHEIM, GERMANY
SN 0173-0835
J9 ELECTROPHORESIS
JI Electrophoresis
PD MAY
PY 2004
VL 25
IS 9
SI SI
BP 1289
EP 1298
DI 10.1002/elps.200405866
PG 10
WC Biochemical Research Methods; Chemistry, Analytical
SC Biochemistry & Molecular Biology; Chemistry
GA 825DB
UT WOS:000221735100016
PM 15174051
ER
PT J
AU Rabatsky-Ehr, T
Whichard, J
Rossiter, S
Holland, B
Stamey, K
Headrick, ML
Barrett, TJ
Angulo, FJ
AF Rabatsky-Ehr, T
Whichard, J
Rossiter, S
Holland, B
Stamey, K
Headrick, ML
Barrett, TJ
Angulo, FJ
CA NARMS Working Grp
TI Multidrug-resistant strains of Salmonella enterica typhimurium, United
States, 1997-1998
SO EMERGING INFECTIOUS DISEASES
LA English
DT Article
ID SEROTYPE TYPHIMURIUM; DT104; INFECTIONS; EMERGENCE; SPECTRUM; HUMANS;
GENES
AB To evaluate multidrug-resistant strains of Salmonella enterica serotype Typhimurium, including definitive type 104 (DT104) in the United States, we reviewed data from the National Antimicrobial Resistance Monitoring System (NARMS). In 1997 to 1998, 703 (25%) of 2,767 serotyped Salmonella isolates received at NARMS were S. Typhimurium; antimicrobial susceptibility testing and phage typing were completed for 697. Fifty-eight percent (402) were resistant to greater than or equal to1 antimicrobial agent. Three multidrug-resistant (greater than or equal to5 drugs) strains accounted for (74%) 296 of all resistant isolates. Ceftriaxone resistance was present in 8 (3%), and nalidixic acid resistance in 4 (1%), of these multidrug-resistant strains. By phage typing, 259 (37%) of S. Typhimurium isolates were DT104, 209 (30%) were of undefined type and 103 (15%) were untypable. Fifty percent (202) of resistant (greater than or equal to1 drug) isolates were DT104. Multidrug-resistant S. Typhimurium isolates, particularly DT104, account for a substantial proportion of S. Typhimurium isolates; ceftriaxone resistance is exhibited by some of these strains.
C1 Yale Univ, Sch Med, New Haven, CT USA.
Ctr Dis Control & Prevent, Atlanta, GA USA.
US FDA, Bethesda, MD 20014 USA.
RP Rabatsky-Ehr, T (reprint author), Dept Publ Hlth Epidemiol & Emerging Infect, 401 Capital Ave,MS Epi 11,POB 340308, Hartford, CT USA.
EM Therese.Rabatsky-Ehr@po.state.ct.us
FU ODCDC CDC HHS [U50/CCU111188-07]
NR 21
TC 25
Z9 28
U1 0
U2 1
PU CENTER DISEASE CONTROL
PI ATLANTA
PA ATLANTA, GA 30333 USA
SN 1080-6040
J9 EMERG INFECT DIS
JI Emerg. Infect. Dis
PD MAY
PY 2004
VL 10
IS 5
BP 795
EP 801
PG 7
WC Immunology; Infectious Diseases
SC Immunology; Infectious Diseases
GA 818GL
UT WOS:000221233500005
PM 15200811
ER
PT J
AU Olsen, SJ
Ying, M
Davis, MF
Deasy, M
Holland, B
Iampietro, L
Baysinger, CM
Sassano, F
Polk, LD
Gormley, B
Hung, MJ
Pilot, K
Orsini, M
Van Duyne, S
Rankin, S
Genese, C
Bresnitz, EA
Smucker, J
Moll, M
Sobel, J
AF Olsen, SJ
Ying, M
Davis, MF
Deasy, M
Holland, B
Iampietro, L
Baysinger, CM
Sassano, F
Polk, LD
Gormley, B
Hung, MJ
Pilot, K
Orsini, M
Van Duyne, S
Rankin, S
Genese, C
Bresnitz, EA
Smucker, J
Moll, M
Sobel, J
TI Multidrug-resistant Salmonella Typhimurium infection from milk
contaminated after pasteurization
SO EMERGING INFECTIOUS DISEASES
LA English
DT Article
ID OUTBREAK
AB An outbreak of multidrug-resistant Salmonella enterica serotype Typhimurium infections occurred in Pennsylvania and New Jersey. A case-control study implicated pasteurized milk from a dairy, and an inspection indicated the potential for contamination after pasteurization. Dairy cattle are the likely reservoir, and milk may be an important vehicle of Salmonella transmission to humans.
C1 Ctr Dis Control & Prevent, Atlanta, GA USA.
Penn Dept Hlth, Harrisburg, PA 17108 USA.
Montgomery Cty Dept Hlth, Norristown, PA USA.
Bucks Cty Dept Hlth, Doylestown, PA USA.
Gloucester Cty Hlth Dept, Turnersville, NJ USA.
New Jersey State Dept Hlth & Senior Serv, Trenton, NJ USA.
Univ Penn, Philadelphia, PA 19104 USA.
US FDA, Washington, DC 20204 USA.
RP Olsen, SJ (reprint author), Ctr Dis Control & Prod, Int Emerging Infect Program, Amer Embassy, APO, AP 96546 USA.
EM sco2@cdc.gov
OI Davis, Meghan/0000-0002-3475-4578
NR 15
TC 45
Z9 47
U1 0
U2 4
PU CENTER DISEASE CONTROL
PI ATLANTA
PA ATLANTA, GA 30333 USA
SN 1080-6040
J9 EMERG INFECT DIS
JI Emerg. Infect. Dis
PD MAY
PY 2004
VL 10
IS 5
BP 932
EP 935
PG 4
WC Immunology; Infectious Diseases
SC Immunology; Infectious Diseases
GA 818GL
UT WOS:000221233500029
PM 15200835
ER
PT J
AU Kim, YH
Pak, K
Pothuluri, JV
Cerniglia, CE
AF Kim, YH
Pak, K
Pothuluri, JV
Cerniglia, CE
TI Mineralization of erythromycin A in aquaculture sediments
SO FEMS MICROBIOLOGY LETTERS
LA English
DT Article
DE desorption; erythromycin A; erythromycin esterase; microcosm;
mineralization
ID AROMATIC-COMPOUNDS; BIODEGRADATION; DEGRADATION; DECOMPOSITION;
ADSORPTION; KINETICS; CLAY
AB Mineralization of erythromycin A was studied using two differently C-14-labeled erythromycins A, which were added to aqua-culture sediment samples obtained from the two salmon hatchery sites in Washington state. The added erythromycin A did not significantly alter the numbers of the total viable colonies and erythromycin-resistant bacteria. Erythromycin-resistant Pseudomonas species contained a constitutive erythromycin esterase activity contributing to the inactivation of biologically active erythromycin A in aquatic and sediment environments. The initial rate of mineralization of erythromycin A appeared to be governed by the rate of release of soil-sorbed erythromycin A. After a prolonged lag time, the S-curves of erythromycin A mineralization were observed probably because of the increase in the Population density metabolizing it. This study suggests that erythromycin A is partially or completely mineralized by the sediment microbial populations. (C) 2004 Federation of European Microbiological Societies. Published by Elsevier B.V.. All rights reserved.
C1 US FDA, Natl Ctr Toxicol Res, Div Microbiol, Jefferson, AR 72079 USA.
RP Cerniglia, CE (reprint author), US FDA, Natl Ctr Toxicol Res, Div Microbiol, 3900 NCTR Rd, Jefferson, AR 72079 USA.
EM ccerniglia@uctr.fda.gov
NR 26
TC 19
Z9 20
U1 3
U2 11
PU ELSEVIER SCIENCE BV
PI AMSTERDAM
PA PO BOX 211, 1000 AE AMSTERDAM, NETHERLANDS
SN 0378-1097
J9 FEMS MICROBIOL LETT
JI FEMS Microbiol. Lett.
PD MAY 1
PY 2004
VL 234
IS 1
BP 169
EP 175
DI 10.1016/j.femsle.2004.03.027
PG 7
WC Microbiology
SC Microbiology
GA 818AP
UT WOS:000221218300024
PM 15109736
ER
PT J
AU Il Kim, P
Chung, KC
AF Il Kim, P
Chung, KC
TI Production of an antifungal protein for control of Colletotrichum
lagenarium by Bacillus amyloliquefaciens MET0908
SO FEMS MICROBIOLOGY LETTERS
LA English
DT Article
DE Colletotrichum lagenarium; watermelon anthracnose; Bacillus
amyloliquefaciens; antifungal agent; beta-glucanase
ID BIOLOGICAL-CONTROL; TRICHODERMA-HARZIANUM; FUSARIUM-SOLANI; BIOCONTROL;
MECHANISM; AGENT; MOLD
AB A plant pathogenic fungus, Colletotrichum lagenarium, causing watermelon anthracnose, was isolated from naturally infected leaves, stems, and fruits of watermelon. A bacterial strain, MET0908, showing a potent antifungal activity against C lagenarium, was isolated from soil. An antifungal protein was purified by 30% ammonium sulfate saturation and concentrated using Centricon 10, DEAE-Sepharose(TM) Fast Flow column and Sephacryl S-100 gel filtration chromatography. The molecular weight of the purified protein was estimated as 40 kDa by SIDS-PAGE. The purified protein was stable at 80degreesC for 20 min and exhibited a broad spectrum of antifungal activity against various plant pathogenic fungi. Confocal microscopy image analysis and scanning electron microscopy showed that the protein acted on the cell wall of C. lagenarium. The purified antifungal protein exhibited beta-1,3-glucanase activity. The N-terminal amino acid sequence of the purified protein was determined as Ser-Lys-Ile-x-Ile-Asn-Ile-Asn-Ile-x-Gln-Ala-Pro-Ala-Pro-x-Ala. A search of the sequence with NCBI BLAST showed no significant homology with any known proteins, suggesting that the purified protein may be novel. (C) 2004 Federation of European Microbiological Societies. Published by Elsevier B.V. All rights reserved.
C1 Chonnam Natl Univ, Dept Genet Engn, Kwangju, South Korea.
Chonnam Natl Univ, Biotechnol Res Inst, Kwangju, South Korea.
Food & Drug Adm, Natl Ctr Toxicol Res, Div Microbiol, Jefferson, AR USA.
RP Chonnam Natl Univ, Dept Genet Engn, Kwangju, South Korea.
EM pkim@nctr.fda.gov; chungkc@chon-nam.ac.kr
NR 30
TC 2
Z9 3
U1 0
U2 4
PU OXFORD UNIV PRESS
PI OXFORD
PA GREAT CLARENDON ST, OXFORD OX2 6DP, ENGLAND
SN 0378-1097
EI 1574-6968
J9 FEMS MICROBIOL LETT
JI FEMS Microbiol. Lett.
PD MAY 1
PY 2004
VL 234
IS 1
BP 177
EP 183
DI 10.1016/j.femsle.2004.03.032
PG 7
WC Microbiology
SC Microbiology
GA 818AP
UT WOS:000221218300025
ER
PT J
AU Cisneros, FJ
AF Cisneros, FJ
TI DNA methylation and male infertility
SO FRONTIERS IN BIOSCIENCE
LA English
DT Review
DE infertility; epigenetics; DNA methylation; gene expression;
spermatogenesis; male reproductive organ development; review
ID FEMALE SEX REVERSAL; X-CHROMOSOME INACTIVATION; TESTIS-DETERMINING
REGION; EMBRYONIC STEM-CELLS; DE-NOVO METHYLATION; ACID-DEFINED DIETS;
MALE GERM-CELLS; Y-CHROMOSOME; MAMMALIAN DEVELOPMENT; GONADAL
DEVELOPMENT
AB Male infertility is one of the biggest concerns of today's health care community. In the US and other developed countries, approximately 70% of infertility among couples is attributed to male reproductive failure. Alterations in reproductive organ development and sperm production have been listed as the major causes of this phenomenon. Sex determination and differentiation, X chromosome inactivation, gene imprinting and normal germ cell development are important biological processes that, in turn, control mammalian reproduction. Specific patterns of gene expression and repression are important in such processes. The strong correlation between DNA methylation, a major epigenetic modification of the genome, and gene expression patterns is well documented. The effects of DNA methylation on the expression of genes affecting male reproductive organ development, spermatogenesis, and male sexual behavior have been reported, suggesting that alterations in DNA methylation could induce abnormal male sexual development and reproductive performance. Inheritance of epigenetic processes and changes in DNA methylation patterns induced by certain diets have been demonstrated in recent years. However, the effects of DNA methylation on male fertility have not been well studied. Since inherited altered DNA methylation patterns could be a cause of increased susceptibility to xenobiotics or abnormal phenotype in future generations, multigenerational studies oriented to determine the effects of xenobiotics affecting DNA methylation in male fertility are recommended.
C1 US FDA, Natl Ctr Toxicol Res, Jefferson, AR 72079 USA.
RP Cisneros, FJ (reprint author), US FDA, Natl Ctr Toxicol Res, 3900 NCTR Dr, Jefferson, AR 72079 USA.
EM fcisneros@nctr.fda.gov
NR 184
TC 23
Z9 26
U1 0
U2 6
PU FRONTIERS IN BIOSCIENCE INC
PI MANHASSET
PA C/O NORTH SHORE UNIV HOSPITAL, BIOMEDICAL RESEARCH CENTER, 350 COMMUNITY
DR, MANHASSET, NY 11030 USA
SN 1093-9946
J9 FRONT BIOSCI
JI Front. Biosci.
PD MAY
PY 2004
VL 9
BP 1189
EP 1200
DI 10.2741/1332
PG 12
WC Biochemistry & Molecular Biology; Cell Biology
SC Biochemistry & Molecular Biology; Cell Biology
GA 779ZA
UT WOS:000189333700012
PM 14977536
ER
PT J
AU Pitts, P
AF Pitts, P
TI FDA decision making
SO HEALTH AFFAIRS
LA English
DT Letter
C1 US FDA, Rockville, MD 20857 USA.
RP Pitts, P (reprint author), US FDA, Rockville, MD 20857 USA.
NR 0
TC 0
Z9 0
U1 0
U2 0
PU PROJECT HOPE
PI BETHESDA
PA 7500 OLD GEORGETOWN RD, STE 600, BETHESDA, MD 20814-6133 USA
SN 0278-2715
J9 HEALTH AFFAIR
JI Health Aff.
PD MAY-JUN
PY 2004
VL 23
IS 3
BP 287
EP 287
DI 10.1377/hlthaff.23.3.287
PG 1
WC Health Care Sciences & Services; Health Policy & Services
SC Health Care Sciences & Services
GA 818HX
UT WOS:000221237300038
PM 15160828
ER
PT J
AU Rochon, G
Caron, A
Toussaint-Hacquard, M
Alayash, AI
Gentils, M
Labrude, P
Stoltz, JF
Menu, P
AF Rochon, G
Caron, A
Toussaint-Hacquard, M
Alayash, AI
Gentils, M
Labrude, P
Stoltz, JF
Menu, P
TI Hemodilution with stoma-free hemoglobin at physiologically maintained
viscosity delays the onset of vasoconstriction
SO HYPERTENSION
LA English
DT Article
DE hemoglobin; vascular resistance; viscosity
ID NITRIC-OXIDE; BLOOD-VISCOSITY; RENAL HEMODYNAMICS; RAT; SUBSTITUTES;
VOLUME; OXYGENATION; CONSUMPTION; HEMORRHAGE; RABBITS
AB Solutions of modified cell-free hemoglobin, prepared from outdated red blood cells, have been developed during the past decade to circumvent the increasing need for allogeneic blood. Despite improvements in the safety and efficacy of these solutions, undesirable effects such as an increase in vascular tone leading to hypertension have not been fully resolved, which might hinder their clinical usefulness. To discriminate between the pharmacological and rheological effects of cell-free hemoglobin, we compared the effects of blood/cell-free hemoglobin mixtures of high versus low viscosity on hemodynamics and vascular hindrance, an index of vascular tone, which was normalized for blood viscosity. Anesthetized rats were subjected to 50% exchange transfusion with ( 1) high-viscosity solutions: whole blood (n = 5) or red blood cells mixed with cell-free hemoglobin (Hb-Hv group, n = 5); ( 2) low-viscosity solutions: cell-free hemoglobin (Hb-Lv group, n = 5) or human albumin ( n = 5). Two hours after hemodilution, vascular hindrance remained unchanged in animals transfused with whole blood and albumin. Hb-Lv induced an immediate and sustained increase in vascular hindrance (208%). Conversely, in Hb-Hv animals, the vascular hindrance increase was delayed and smaller (27% to 147%), whereas peripheral resistance increased gradually (94% after 2 hours). Our results demonstrate the beneficial effects of cell-free hemoglobin in the presence of the animals' own red blood cells in maintaining physiological viscosity and limiting vasoconstriction because of the pharmacological properties of cell-free hemoglobin.
C1 Univ Henri Poincare, Sch Pharm, Dept Hematol & Physiol, Nancy, France.
US FDA, Lab Biochem & Vasc Biol, Ctr Biol Evaluat & Res, Bethesda, MD 20014 USA.
Fac Med, Lab Mech Engn Cells & Tissue, Nancy, France.
RP Menu, P (reprint author), Fac Pharm Nancy, Lab Hematol & Physiol, 5 Rue Albert Lebrun, F-54001 Nancy, France.
EM menu@pharma.uhp-nancy.fr
NR 28
TC 12
Z9 13
U1 0
U2 0
PU LIPPINCOTT WILLIAMS & WILKINS
PI PHILADELPHIA
PA 530 WALNUT ST, PHILADELPHIA, PA 19106-3621 USA
SN 0194-911X
J9 HYPERTENSION
JI Hypertension
PD MAY
PY 2004
VL 43
IS 5
BP 1110
EP 1115
DI 10.1161/01.HYP.0000123075.48420.e8
PG 6
WC Peripheral Vascular Disease
SC Cardiovascular System & Cardiology
GA 816ME
UT WOS:000221113200037
PM 15051666
ER
PT J
AU Pickering, AK
Merkel, TJ
AF Pickering, AK
Merkel, TJ
TI Macrophages release tumor necrosis factor alpha and interleukin-12 in
response to intracellular Bacillus anthracis spores
SO INFECTION AND IMMUNITY
LA English
DT Article
ID EXPERIMENTAL INHALATION ANTHRAX; LETHAL TOXIN; ALVEOLAR MACROPHAGES;
TNF-ALPHA; GERMINATION; PATHOGENESIS; PATHOLOGY; CELLS; MICE
AB Herein we report that infection of a murine macrophage cell line with Bacillus anthracis results in the production of tumor necrosis factor alpha and interleukin-12 (IL-12). When infected with B. anthracis spores in combination with lipopolysaccharide, macrophages release increased amounts of IL-12. We found no evidence of inhibition of cytokine responses in macrophages infected with B. anthracis spores.
C1 US FDA, CBE, DBPAP, Lab Resp & Special Pathogens, Bethesda, MD 20892 USA.
RP Merkel, TJ (reprint author), US FDA, CBE, DBPAP, Lab Resp & Special Pathogens, Bldg 29, Room 418,29 Lincoln Dr, Bethesda, MD 20892 USA.
EM merkel@cber.fda.gov
NR 27
TC 34
Z9 35
U1 0
U2 0
PU AMER SOC MICROBIOLOGY
PI WASHINGTON
PA 1752 N ST NW, WASHINGTON, DC 20036-2904 USA
SN 0019-9567
J9 INFECT IMMUN
JI Infect. Immun.
PD MAY
PY 2004
VL 72
IS 5
BP 3069
EP 3072
DI 10.1128/IAI.72.5.3069-3072.2004
PG 4
WC Immunology; Infectious Diseases
SC Immunology; Infectious Diseases
GA 816OV
UT WOS:000221120100074
PM 15102824
ER
PT J
AU Gallagher, G
Eskdale, J
Jordan, W
Peat, J
Campbell, J
Boniotto, M
Lennon, GP
Dickensheets, H
Donnelly, RP
AF Gallagher, G
Eskdale, J
Jordan, W
Peat, J
Campbell, J
Boniotto, M
Lennon, GP
Dickensheets, H
Donnelly, RP
TI Human interleukin-19 and its receptor: a potential role in the induction
of Th2 responses
SO INTERNATIONAL IMMUNOPHARMACOLOGY
LA English
DT Review
DE interleukin-19; Th-2 response; induction
ID SYSTEMIC-LUPUS-ERYTHEMATOSUS; EARLY-ONSET PERIODONTITIS;
T-REGULATORY-CELLS; GENE-EXPRESSION; IL-10 LOCUS; IN-VIVO; TRANSCRIPTION
FACTOR; INDUCIBLE FACTOR; DENDRITIC CELLS; IL-TIF
AB Interleukin-19 (IL-19) is a newly discovered member of the IL-10 family of ligands whose function is presently undefined. We recently described its cloning and initial characterization and in so doing, noted that the induction of IL-19 by LPS in human monocytes was down-regulated by interferon-gamma (IFN-gamma) and up-regulated by IL-4. This preliminary observation led us to speculate that IL-19 may play a role in the Th1/Th2 system and we examined this hypothesis further. Our results suggested that IL-19 is able to influence the maturation of human T-cells. CD4+ T-cells resulting from SEB stimulation in the presence of IL-19 contained a higher proportion of IL-4 producing cells than those developing in the absence of IL-19. This observation was complimented by the observation that fewer IFN-gamma cells accrued in the presence of IL-19, thereby suggesting that IL-19 altered the balance of Th1/Th2 cells in favour of Th2. Furthermore, in whole PBMC cultures, IL-19 up-regulated IL-4 and down-regulated IFNgamma in a dose-dependent manner. These results are presented here in review format, in the context of an overall discussion of IL-19 and its receptor. (C) 2004 Published by Elsevier B.V.
C1 Univ Med & Dent New Jersey, Dept Oral Biol, Newark, NJ 07103 USA.
Univ Glasgow, Dept Med, Glasgow, Lanark, Scotland.
US FDA, Div Therapeut Prot, Ctr Biol Evaluat & Res, Bethesda, MD 20892 USA.
Univ Glasgow, Dept Surg, Glasgow, Lanark, Scotland.
RP Gallagher, G (reprint author), Univ Med & Dent New Jersey, Dept Oral Biol, Room C-636,MSB,185 S Orange Ave, Newark, NJ 07103 USA.
EM gallaggr@umdnj.edu
RI Boniotto, Michele/F-1857-2010
OI Boniotto, Michele/0000-0002-9548-2254
NR 64
TC 80
Z9 84
U1 0
U2 1
PU ELSEVIER SCIENCE BV
PI AMSTERDAM
PA PO BOX 211, 1000 AE AMSTERDAM, NETHERLANDS
SN 1567-5769
EI 1878-1705
J9 INT IMMUNOPHARMACOL
JI Int. Immunopharmacol.
PD MAY
PY 2004
VL 4
IS 5
BP 615
EP 626
DI 10.1016/j.intimp.2004.01.005
PG 12
WC Immunology; Pharmacology & Pharmacy
SC Immunology; Pharmacology & Pharmacy
GA 820FY
UT WOS:000221374000005
PM 15120647
ER
PT J
AU Lard-Whiteford, SL
Matecka, D
O'Rear, JJ
Yuen, IS
Litterst, C
Reichelderfer, P
AF Lard-Whiteford, SL
Matecka, D
O'Rear, JJ
Yuen, IS
Litterst, C
Reichelderfer, P
CA The International Working Grp on M
TI Recommendations for the nonclinical development of topical microbicides
for prevention of HIV transmission: An update
SO JAIDS-JOURNAL OF ACQUIRED IMMUNE DEFICIENCY SYNDROMES
LA English
DT Article
DE HIV; topical microbicides; antimicrobial activities; toxicological and
chemical testing
ID IMMUNODEFICIENCY-VIRUS TYPE-1; SODIUM DODECYL-SULFATE; SPERMICIDE
BENZALKONIUM CHLORIDE; GENITAL HERPES INFECTION; CELL-ASSOCIATED HIV-1;
IN-VITRO; VAGINAL MICROBICIDES; CHLAMYDIA-TRACHOMATIS; LAURYL SULFATE;
BACTERIAL VAGINOSIS
AB The development of methods to prevent HIV infection is critical to curbing the rising epidemic. Topical microbicides represent a potential new strategy for reduction of HIV transmission. The purpose of this article is to update and expand upon the nonclinical recommendations of a previously published document on the development of microbicides prepared by the International Working Group on Microbicides. The nonclinical studies discussed here represent general concepts and regulatory considerations that are pertinent to the development of topical microbicides for prevention or reduction of HIV transmission. Essential early steps in product development include the determination of antiviral activity, cytotoxicity, mechanism of action, pathways to resistance, and cross-resistance to approved drugs. Other parameters to consider include activity against vaginal microflora and pathogens that cause sexually transmitted diseases. Before and during clinical trials, nonclinical data on toxicology and pharmacokinetics should be obtained. Finally, product quality issues, including microbicide formulation characteristics, interaction with other products, and stability, should be addressed.
C1 US FDA, Ctr Drug Evaluat & Res, Div Antiviral Drug Prod, Rockville, MD 20857 USA.
US FDA, Ctr Biol Evaluat & Res, Rockville, MD 20857 USA.
NIAID, NIH, Bethesda, MD 20892 USA.
NICHHD, NIH, Bethesda, MD 20892 USA.
RP Yuen, IS (reprint author), US FDA, Ctr Drug Evaluat & Res, Div Antiviral Drug Prod, HFD-530,5600 Fisheries Lane, Rockville, MD 20857 USA.
EM yueni@cder.fda.gov
NR 80
TC 64
Z9 73
U1 1
U2 7
PU LIPPINCOTT WILLIAMS & WILKINS
PI PHILADELPHIA
PA 530 WALNUT ST, PHILADELPHIA, PA 19106-3621 USA
SN 1525-4135
J9 JAIDS-J ACQ IMM DEF
JI JAIDS
PD MAY 1
PY 2004
VL 36
IS 1
BP 541
EP 552
DI 10.1097/00126334-200405010-00001
PG 12
WC Immunology; Infectious Diseases
SC Immunology; Infectious Diseases
GA 817KX
UT WOS:000221177500001
PM 15097296
ER
PT J
AU Howell, MD
Tomazic, VJ
Leakakos, T
Truscott, W
Meade, BJ
AF Howell, MD
Tomazic, VJ
Leakakos, T
Truscott, W
Meade, BJ
TI Immunomodulatory effect of endotoxin on the development of latex allergy
SO JOURNAL OF ALLERGY AND CLINICAL IMMUNOLOGY
LA English
DT Article
DE latex; endotoxin; mouse model; IgE; airway hyperreactivity
ID CYTOKINE GENE-EXPRESSION; HEALTH-CARE WORKERS; INTERFERON-GAMMA;
BRONCHIAL HYPERRESPONSIVENESS; LIPOPOLYSACCHARIDE EXPOSURE; AIRWAY
HYPERREACTIVITY; BACTERIAL-ENDOTOXIN; MOUSE LUNG; IFN-GAMMA; MICE
AB Background: Although numerous studies have been conducted delineating the clinical manifestations of latex allergy and characterizing the protein allergens, little is known regarding the natural history of the disease.
Objective: These studies were undertaken to investigate the immunomodulatory role of inhaled endotoxin on the development of latex-specific IgE-mediated responses to natural rubber latex (NRL) proteins by using a mouse model.
Methods: Female BALB/c mice were exposed to 25 mug of NRL proteins with or without increasing concentrations of endotoxin (50-25,000 EU) through the respiratory tract. Serum antibody levels were evaluated biweekly during the study. After sensitization, mice were challenged with methacholine or NRL proteins, and airway hyperreactivity (AHR) was evaluated with whole-body plethysmography. After NRL challenge, lungs were excised for histopathology, and lung-associated lymph nodes were removed for cytokine mRNA evaluation.
Results: When compared with mice exposed to latex alone, mice exposed to latex and endotoxin demonstrated up to 50% lower levels of latex-specific IgE and decreased latex-specific AHR and mucin production. Conversely, these same animals demonstrated increased levels of latex-specific serum IgG2a and IgA antibodies and an increase in IFN-gamma and IL-12 mRNA levels in the draining lymph node cells. Concurrent exposure to LPS with nonammoniated latex resulted in increased alveolitis and nonspecific AHR on respiratory challenge with methacholine.
Conclusion: Coexposure with LPS and allergen decreased latex-specific IgE but augmented nonspecific AHR. These studies demonstrate that endotoxin associated with NRL gloves can modulate the development of allergic responses to NRL proteins.
C1 NIOSH, Agr & Immunotoxicol Grp, Morgantown, WV 26505 USA.
US FDA, Ctr Devices & Radiol Hlth, Rockville, MD 20857 USA.
FeRX Inc, Preclin Dev, San Diego, CA USA.
Kimberly Clark Inc, Sci Affairs & Clin Educ, Roswell, GA USA.
RP Meade, BJ (reprint author), MS 4020,1095 Willowdale Rd, Morgantown, WV 26505 USA.
FU NIEHS NIH HHS [Y1 ES 000102]
NR 46
TC 11
Z9 11
U1 0
U2 2
PU MOSBY, INC
PI ST LOUIS
PA 11830 WESTLINE INDUSTRIAL DR, ST LOUIS, MO 63146-3318 USA
SN 0091-6749
J9 J ALLERGY CLIN IMMUN
JI J. Allergy Clin. Immunol.
PD MAY
PY 2004
VL 113
IS 5
BP 916
EP 924
DI 10.1016/j.jaci.2004.02.017
PG 9
WC Allergy; Immunology
SC Allergy; Immunology
GA 818UC
UT WOS:000221269000015
PM 15131575
ER
PT J
AU Ross, IA
Sapienza, PP
Hanes, DE
Johnson, W
Kim, CS
AF Ross, IA
Sapienza, PP
Hanes, DE
Johnson, W
Kim, CS
TI Determination of the rat tissue partitioning of endotoxin in vitro for
physiologically-based pharmacokinetic (PBPK) modeling
SO JOURNAL OF APPLIED TOXICOLOGY
LA English
DT Article; Proceedings Paper
CT 41st Annual Meeting of the Society-of-Toxicology
CY MAR 24-29, 2001
CL SAN FRANCISCO, CA
SP Soc Toxicol
DE partition coefficients; endotoxin; PBPK modeling
ID 2,4-DICHLOROPHENOXYACETIC ACID DOSIMETRY; CEREBROSPINAL FLUID; RABBIT
BRAIN; TRANSPORT; BACTERIAL; GLYCINE; RISK
AB The biosynthetically double-labeled lipopolysaccharide (LPS), containing H-3-labeled on the fatty acyl-chains and C-14-labeled on the glucosamine of Salmonella enterica serotype typhimurium, was isolated from bacteria grown in proteose peptone-beef extract (PPBE) medium in the presence of labeled precursors; 133 muCi/ml of [2-H-3] acetate sodium salt and 0.167 muCi/ml of N-acetyl[D-1-C-14]glucosamine. The LPS was extracted from the bacteria with 90% phenol/chloroform/petroleum ether, purified and stored in 0.1% (v/v) triethylamine/10 mM Tris HCl at -70 degreesC. Tissue slices and portions of the meninges were prepared and incubated in artificial cerebrospinal fluid (CSF) or Krebs phosphate buffer (Krebs) containing 150 ng/ml LPS with [H-3] LPS (0.004 muCi/ml, sp. act. 28 muCi/mg LPS). The tissues were incubated under 95% oxygen/5% carbon dioxide at 37 degreesC with constant agitation until steady-state uptake was reached (60 min). At the end of the incubation period, tissues were processed for radioactivity measurement. The rat tissue partitioning of LPS in artificial CSF for brain and Krebs for other organs was measured by using the ratio of tissue to medium at the steady state in vitro. The following results were obtained from the study: Heart, 0.15; liver, 0.19; spleen, 0.12; kidney, 0.18; stomach, 0.17; small intestine, 0.18; brain stem, 0.10; cerebellum, 0.11; meninges, 0.77; hippocampus, 0.12; hypothalamus, 0.12; frontal cortex, 0.09 and caudate nucleus, 0.10. This information, along with plasma or blood/buffer partition coefficients, is a requisite for constructing a physiologically-based pharmacokinetic (PBPK) model of endotoxins for quantitative risk assessment. Copyright (C) 2004 John Wiley Sons, Ltd.
C1 US FDA, Ctr Food Safety & Appl Nutr, Off Appl Res & Safety Assessment, Laurel, MD 20708 USA.
RP Kim, CS (reprint author), US FDA, Ctr Food Safety & Appl Nutr, Off Appl Res & Safety Assessment, HFS25, Laurel, MD 20708 USA.
NR 19
TC 5
Z9 5
U1 2
U2 3
PU JOHN WILEY & SONS LTD
PI CHICHESTER
PA THE ATRIUM, SOUTHERN GATE, CHICHESTER PO19 8SQ, W SUSSEX, ENGLAND
SN 0260-437X
J9 J APPL TOXICOL
JI J. Appl. Toxicol.
PD MAY-JUN
PY 2004
VL 24
IS 3
BP 177
EP 181
DI 10.1002/jat.956
PG 5
WC Toxicology
SC Toxicology
GA 826DL
UT WOS:000221809400002
PM 15211610
ER
PT J
AU Hilbert, SL
Boerboom, LE
Livesey, SA
Ferrans, VJ
AF Hilbert, SL
Boerboom, LE
Livesey, SA
Ferrans, VJ
TI Explant pathology study of decellularized carotid artery vascular grafts
SO JOURNAL OF BIOMEDICAL MATERIALS RESEARCH PART A
LA English
DT Article
DE pathology; decellularized; small-diameter vascular graft
ID VEIN BYPASS GRAFTS; SAPHENOUS-VEIN; GASTROEPIPLOIC ARTERY;
REVASCULARIZATION; POLYTETRAFLUOROETHYLENE; ASSIST
AB The purpose of this study was to evaluate the morphologic findings in small-diameter freeze-dried decellularized carotid artery grafts implanted in goats as carotid artery interposition grafts for 6-7 months. Unimplanted decellularized carotid artery grafts did not contain intact cells; however, remnants of smooth muscle cells were present in the media. The extracellular matrix was well preserved. All decellularized grafts were patent at explant, without significant dimensional changes or aneurysm formation. Their luminal surfaces were lined by a thin neointima, consisting of myofibroblasts, collagen, and a discontinuous layer of endothelial cells. Histologic evidence of calcification within the explants was not observed; however, electron microscopy showed calcification of minute remnants of cell membranes. Inflammatory cells were not present in the graft wall. Host cell migration was greatest in the adventitia along the length of the graft. Migration of host cells into the media was more apparent close to the anastomoses, forming cellular nests rich in extracellular proteoglycans, whereas cell migration into areas subjacent to the lumen was minimal. Ingrowth of host blood vessels was not observed. These results demonstrate satisfactory structural and morphologic features of a decellularized carotid artery small-diameter graft implanted for up to 7 months. (C) 2004 Wiley Periodicals, Inc.
C1 US FDA, Off Sci & Technol HFZ150, Ctr Devices & Radiol Hlth, Rockville, MD 20850 USA.
LifeCell Corp, Branchburg, NJ USA.
NHLBI, NIH, Bethesda, MD 20892 USA.
RP Hilbert, SL (reprint author), US FDA, Off Sci & Technol HFZ150, Ctr Devices & Radiol Hlth, 9200 Corp Blvd, Rockville, MD 20850 USA.
EM sxh@cdrh.fda.gov
NR 17
TC 16
Z9 23
U1 1
U2 5
PU WILEY-LISS
PI NEW YORK
PA DIV JOHN WILEY & SONS INC, 605 THIRD AVE, NEW YORK, NY 10158-0012 USA
SN 0021-9304
J9 J BIOMED MATER RES A
JI J. Biomed. Mater. Res. Part A
PD MAY 1
PY 2004
VL 69A
IS 2
BP 197
EP 204
DI 10.1002/jbm.a.10135
PG 8
WC Engineering, Biomedical; Materials Science, Biomaterials
SC Engineering; Materials Science
GA 812ST
UT WOS:000220859900001
PM 15057992
ER
PT J
AU Guan, EN
Wang, J
Norcross, MA
AF Guan, EN
Wang, J
Norcross, MA
TI Amino-terminal processing of MIP-1 beta/CCL4 by
CD26/dipeptidyl-peptidase IV
SO JOURNAL OF CELLULAR BIOCHEMISTRY
LA English
DT Article
DE mip-1 beta; CD26/DPPIV; HIV-1 Tat
ID DIPEPTIDYL-PEPTIDASE-IV; T-CELL-ACTIVATION; CD26 EXPRESSION; RECEPTOR
SPECIFICITY; CHEMOKINE RECEPTORS; ADENOSINE-DEAMINASE;
HUMAN-LYMPHOCYTES; BETA-CHEMOKINES; FACTOR 1-ALPHA; HIV-1 TAT
AB CD26 is a membrane-bound ectopeptidase with dipeptidyl peptidase IV (DPPIV) activity that has diverse functional properties in T cell physiology and in regulation of bioactive peptides. We have previously reported that activated human peripheral lymphocytes (PBL) secrete an amino-terminal truncated form of macrophage inflammatory protein (MIP)-1 beta/(3-69) with novel functional specificity for CCR1, 2, and 5. In this report, we show that the full length MIP-1 beta is processed by CD26/DPPIV to the truncated form and that cleavage can be blocked by DPPIV inhibitory peptides derived from HIV Tat(1-9) or the thromboxane A2 receptor, TAX2-R(1-9). Addition of Tat(] -9) or TAX2-R(l -9) peptides to PBL cultures partially blocks endogenous MIP-1 beta processing. The kinetics of conversion of MIP-1 beta from intact to MIP-1 beta(3-69) in activated PBLs correlates with cell surface expression of CD26. Our results suggest that NH2-terminal processing of MIP-1 beta and possibly other chemokines may depend on the balance between CD26/DPPIV enzymatic activity and cellular and viral proteins that modulate enzyme function. (C) 2004 Wiley-Liss, Inc.
C1 US FDA, Ctr Drug Evaluat & Res, Div Therapeut Prot, NIH, Bethesda, MD 20892 USA.
RP Guan, EN (reprint author), US FDA, Ctr Drug Evaluat & Res, Div Therapeut Prot, NIH, Bldg 29B,Room 4E12,HFM 535,8800 Rockville Pike, Bethesda, MD 20892 USA.
EM guan@cber.fda.gov; norcross@cber.fda.gov
NR 40
TC 24
Z9 24
U1 0
U2 1
PU WILEY-LISS
PI NEW YORK
PA DIV JOHN WILEY & SONS INC, 605 THIRD AVE, NEW YORK, NY 10158-0012 USA
SN 0730-2312
J9 J CELL BIOCHEM
JI J. Cell. Biochem.
PD MAY 1
PY 2004
VL 92
IS 1
BP 53
EP 64
DI 10.1002/jcb.20041
PG 12
WC Biochemistry & Molecular Biology; Cell Biology
SC Biochemistry & Molecular Biology; Cell Biology
GA 818IT
UT WOS:000221239500006
PM 15095403
ER
PT J
AU Beger, RD
Young, JF
Fang, H
AF Beger, RD
Young, JF
Fang, H
TI Discriminant function analyses of liver-specific carcinogens
SO JOURNAL OF CHEMICAL INFORMATION AND COMPUTER SCIENCES
LA English
DT Article
ID BINDING; RECEPTOR; SPECTRA; MODELS; NMR
AB The ability to predict organ-specific carcinogenicity would aid FDA reviewers in evaluating new chemical applications. A NCTR liver cancer database (NCTRlcdb) containing 999 compounds has been developed with three sets of descriptors. The NCTRlcdb has Cerius2, Molconn-Z, and C-13 NMR descriptors for each compound. Each compound in the database was assigned a liver cancer or a nonliver cancer classification. Compounds within the NCTRlcdb were evaluated for liver-specific carcinogenicity using partial least squares principal component discriminant function (PLS-DF) modeling. PLS-DF models based on estimated a priori classification probabilities of 0.29 for liver cancer and 0.71 for noncancer yielded an overall predictability of 70.6% which was comprised of a liver cancer sensitivity of 18.8% and a noncancer specificity of 90.8%. PLS-DF models based on equal a priori classification probabilities, 0.50 for liver cancer and 0.5 for noncancer, yielded an overall predictability of 61.0% which was comprised of a liver cancer sensitivity of 50.5% and a noncancer specificity of 65.3%.
C1 US FDA, Natl Ctr Toxicol Res, Div Chem, Jefferson, AR 72079 USA.
US FDA, Natl Ctr Toxicol Res, Div Biometry & Risk Assessment, Jefferson, AR 72079 USA.
Logicon ROW Sci, Jefferson, AR 72079 USA.
RP Beger, RD (reprint author), US FDA, Natl Ctr Toxicol Res, Div Chem, Jefferson, AR 72079 USA.
EM rbeger@nctr.fda.gov
NR 11
TC 4
Z9 4
U1 0
U2 0
PU AMER CHEMICAL SOC
PI WASHINGTON
PA 1155 16TH ST, NW, WASHINGTON, DC 20036 USA
SN 0095-2338
J9 J CHEM INF COMP SCI
JI J. Chem. Inf. Comput. Sci.
PD MAY-JUN
PY 2004
VL 44
IS 3
BP 1107
EP 1110
DI 10.1021/ci0342829
PG 4
WC Chemistry, Multidisciplinary; Computer Science, Information Systems;
Computer Science, Interdisciplinary Applications
SC Chemistry; Computer Science
GA 823JQ
UT WOS:000221608000037
PM 15154779
ER
PT J
AU Sergeev, N
Volokhov, D
Chizhikov, V
Rasooly, A
AF Sergeev, N
Volokhov, D
Chizhikov, V
Rasooly, A
TI Simultaneous analysis of multiple Staphylococcal enterotoxin genes by an
oligonucleotide microarray assay
SO JOURNAL OF CLINICAL MICROBIOLOGY
LA English
DT Article
ID SHOCK-SYNDROME TOXIN-1; ATOPIC-DERMATITIS; PATHOGENICITY ISLANDS;
RHEUMATOID-ARTHRITIS; EXFOLIATIVE TOXINS; COMMON ANTIBODIES; AUREUS;
SUPERANTIGENS; PCR; DETERMINANTS
AB Staphylococcal enterotoxins (SEs) are a family of 17 major serological types of heat-stable enterotoxins that are one of the leading causes of gastroenteritis resulting from consumption of contaminated food. SEs are considered potential bioweapons. Many Staphylococcus aureus isolates contain multiple SEs. Because of the large number of SEs, serological typing and PCR typing are laborious and time-consuming. Furthermore, serological typing may not always be practical because of antigenic similarities among enterotoxins. We report on a microarray-based one-tube assay for the simultaneous detection and identification (genetic typing) of multiple enterotoxin (ent) genes. The proposed typing method is based on PCR amplification of the target region of the ent genes with degenerate primers, followed by characterization of the PCR products by microchip hybridization with oligonucleotide probes specific for each ent gene. We verified the performance of this method by using several other techniques, including PCR amplification with gene-specific primers, followed by gel electrophoresis or microarray hybridization, and sequencing of the enterotoxin genes. The assay was evaluated by analysis of previously characterized staphylococcal isolates containing 16 ent genes. The microarray assay revealed that some of these isolates contained additional previously undetected ent genes. The use of degenerate primers allows the simultaneous amplification and identification of as many as nine different ent genes in one S. aureus strain. The results of this study demonstrate the usefulness of the oligonucleotide microarray assay for the analysis of multitoxigenic strains, which are common among S. aureus strains, and for the analysis of microbial pathogens in general.
C1 US FDA, Ctr Food Safety & Appl Nutr, College Pk, MD USA.
US FDA, Ctr Biol Evaluat & Res, College Pk, MD USA.
RP Rasooly, A (reprint author), NCI, NIH, EPN, 6130 Execut Blvd,Room 6035A, Rockville, MD 20852 USA.
EM rasoolya@mail.nih.gov
NR 42
TC 65
Z9 75
U1 1
U2 4
PU AMER SOC MICROBIOLOGY
PI WASHINGTON
PA 1752 N ST NW, WASHINGTON, DC 20036-2904 USA
SN 0095-1137
J9 J CLIN MICROBIOL
JI J. Clin. Microbiol.
PD MAY
PY 2004
VL 42
IS 5
BP 2134
EP 2143
DI 10.1128/JCM.42.5.2134-2143.2004
PG 10
WC Microbiology
SC Microbiology
GA 820XU
UT WOS:000221424100041
PM 15131181
ER
PT J
AU Jakubzick, C
Choi, ES
Kunkel, SL
Evanoff, H
Martinez, FJ
Puri, RK
Flaherty, KR
Toews, GB
Colby, TV
Kazerooni, EA
Gross, BH
Travis, WD
Hogaboam, CM
AF Jakubzick, C
Choi, ES
Kunkel, SL
Evanoff, H
Martinez, FJ
Puri, RK
Flaherty, KR
Toews, GB
Colby, TV
Kazerooni, EA
Gross, BH
Travis, WD
Hogaboam, CM
TI Augmented pulmonary IL-4 and IL-13 receptor subunit expression in
idiopathic interstitial pneumonia
SO JOURNAL OF CLINICAL PATHOLOGY
LA English
DT Article
ID CRYPTOGENIC FIBROSING ALVEOLITIS; MONOCYTE CHEMOATTRACTANT PROTEIN-1;
HUMAN LUNG FIBROBLASTS; GROWTH-FACTOR; SIGNAL-TRANSDUCTION; CYTOKINE
PROFILES; CELL-TYPES; INTERLEUKIN-13; DISEASE; CLASSIFICATION
AB Background: Some idiopathic interstitial pneumonias (IIPs) are characterised by fibroproliferation and deposition of extracellular matrix. Because efficacious treatment options are limited, research has been directed towards understanding the cytokine networks that may affect fibroblast activation and, hence, the progression of certain IIPs.
Aims: To examine the expression of interleukin 4 (IL-4), IL-13, and their corresponding receptor subunits in the various forms of IIP and normal patient groups.
Methods: Molecular and immunohistochemical analysis of IL-4, interferon gamma (IFNgamma), IL-13, IL-4 receptor (IL-R), and IL-13 receptor subunits in surgical lung biopsies (SLBs) from 39 patients (21 usual interstitial pneumonia (UIP), six non-specific interstitial pneumonia (NSIP), eight respiratory bronchiolitic interstitial lung disease (RBILD), and five normal controls).
Results: Molecular analysis demonstrated that IL-13Ralpha2, IL-13Ralpha1, and IL-4Ralpha were present in a greater proportion of upper and lower lobe biopsies from patients with UIP than patients with NSIP and RBILD. Immunohistochemical analysis of patients with UIP, NSIP, and RBILD revealed interstitial staining for all three receptor subunits, whereas such staining was only seen in mononuclear cells present in normal SLBs. Fibroblastic foci in patients with UIP strongly stained for IL-4Ralpha and IL-13Ralpha2. Localised expression of IL-4Ralpha was also seen in SLBs from patients with NSIP but not in other groups.
Conclusion: Some histological subtypes of IIP are associated with increased pulmonary expression of receptor subunits responsive to IL-4 and IL-13. These findings may be of particular importance in understanding the pathogenesis of IIP and, more importantly, may provide important novel therapeutic targets.
C1 Univ Michigan, Sch Med, Dept Pathol, Ann Arbor, MI 48109 USA.
Univ Michigan, Sch Med, Dept Med, Div Pulm & Crit Care Med, Ann Arbor, MI 48104 USA.
Univ Michigan, Sch Med, Dept Radiol, Ann Arbor, MI 48104 USA.
US FDA, Lab Mol Tumor Biol, Div Cellular & Gene Therapies, Ctr Biol Evaluat & Res, Rockville, MD 20852 USA.
Mayo Clin, Scottsdale, AZ 85259 USA.
Armed Forces Inst Pathol, Washington, DC 20306 USA.
RP Hogaboam, CM (reprint author), Univ Michigan, Sch Med, Dept Pathol, Room 5214,Med Sci 1,1301 Catherine Rd, Ann Arbor, MI 48109 USA.
EM Hogaboam@med.umich.edu
RI hogaboam, cory /M-3578-2014
FU NIAID NIH HHS [T32 AI007413]
NR 53
TC 33
Z9 35
U1 0
U2 1
PU B M J PUBLISHING GROUP
PI LONDON
PA BRITISH MED ASSOC HOUSE, TAVISTOCK SQUARE, LONDON WC1H 9JR, ENGLAND
SN 0021-9746
J9 J CLIN PATHOL
JI J. Clin. Pathol.
PD MAY 1
PY 2004
VL 57
IS 5
BP 477
EP 486
DI 10.1136/jcp.2003.012799
PG 10
WC Pathology
SC Pathology
GA 815WS
UT WOS:000221073000006
PM 15113854
ER
PT J
AU Seo, KH
Valentin-Bon, IE
Brackett, RE
Holt, PS
AF Seo, KH
Valentin-Bon, IE
Brackett, RE
Holt, PS
TI Rapid, specific detection of Salmonella enteritidis in pooled eggs by
real-time PCR
SO JOURNAL OF FOOD PROTECTION
LA English
DT Article
ID POLYMERASE-CHAIN-REACTION; ENTERICA SEROTYPE ENTERITIDIS;
QUANTIFICATION; PLASMIDS; SHELL; GENE
AB An assay was developed for the specific detection of Salmonella Enteritidis in eggs with the use of an application of the fluorogenic 5' nuclease assay (TaqMan). In this assay, a segment of the gene sefA specific to Salmonella group D strains such as Salmonella Enteritidis was used. The amplification of the target gene products was monitored in real-time by incorporating a fluorescent dye-labeled gene-specific probe in the PCR reaction. This method correctly detected and distinguished Salmonella Enteritidis from nearly 50 of non-group D Salmonella and other non-Salmonella strains. Detection of the sefA gene was linear for DNA extracted from approximately 10(2) to 10(9) CFU/ml in phosphate-buffered saline and 10(3) to 10(8) CFU/ml in raw egg. In two trials, when applied to detection of Salmonella Enteritidis in homogenized egg pools and compared with conventional culture methods, the newly developed PCR method yielded a 100% correlation with results obtained by a conventional culture method. However, the PCR method required only 2 days, compared to the 5 days required by the culture method. The sensitivity of this assay was approximately less than 1 CFU/600 g of egg pool. The real-time PCR assay proved to be a rapid, highly sensitive test for detection and quantification of low concentrations of Salmonella Enteritidis in egg samples.
C1 US FDA, CFSAN, OPDFB, College Pk, MD 20740 USA.
USDA ARS, SE Poultry Res Lab, Athens, GA 30605 USA.
RP Seo, KH (reprint author), US FDA, CFSAN, OPDFB, 5100 Paint Branch Pkwy, College Pk, MD 20740 USA.
EM kseo@cfsan.fda.gov
NR 23
TC 43
Z9 46
U1 0
U2 3
PU INT ASSOC FOOD PROTECTION
PI DES MOINES
PA 6200 AURORA AVE SUITE 200W, DES MOINES, IA 50322-2863 USA
SN 0362-028X
J9 J FOOD PROTECT
JI J. Food Prot.
PD MAY
PY 2004
VL 67
IS 5
BP 864
EP 869
PG 6
WC Biotechnology & Applied Microbiology; Food Science & Technology
SC Biotechnology & Applied Microbiology; Food Science & Technology
GA 820FU
UT WOS:000221373600001
PM 15151219
ER
PT J
AU Hammack, TS
Valentin-Bon, IE
Jacobson, AP
Andrews, WH
AF Hammack, TS
Valentin-Bon, IE
Jacobson, AP
Andrews, WH
TI Relative effectiveness of the Bacteriological Analytical Manual method
for the recovery of Salmonella from whole cantaloupes and cantaloupe
rinses with selected preenrichment media and rapid methods
SO JOURNAL OF FOOD PROTECTION
LA English
DT Article
ID BOARD SURFACES; MICROORGANISMS; PRODUCE
AB Soak and rinse methods were compared for the recovery of Salmonella from whole cantaloupes. Cantaloupes were surface inoculated with Salmonella cell suspensions and stored for 4 days at 2 to 6degreesC. Cantaloupes were placed in sterile plastic bags with a nonselective preenrichment broth at a 1:1.5 cantaloupe weight-to-broth volume ratio. The cantaloupe broths were shaken for 5 min at 100 rpm after which 25-ml aliquots (rinse) were removed from the bags. The 25-ml rinses were preenriched in 225-ml portions of the same uninoculated broth type at 35degreesC for 24 h (rinse method). The remaining cantaloupe broths were incubated at 35degreesC for 24 h (soak method). The preenrichment broths used were buffered peptone water (BPW), modified BPW, lactose (LAC) broth, and Universal Preenrichment (UP) broth. The Bacteriological Analytical Manual Salmonella culture method was compared with the following rapid methods: the TECRA Unique Salmonella method, the VIDAS ICS/SLM method, and the VIDAS SLM method. The soak method detected significantly more Salmonella-positive cantaloupes (P < 0.05) than did the rinse method: 367 Salmonella-positive cantaloupes of 540 test cantaloupes by the soak method and 24 Salmonella-positive cantaloupes of 540 test cantaloupes by the rinse method. Overall, BPW, LAC, and UP broths were equivalent for the recovery of Salmonella from cantaloupes. Both the VIDAS ICS/SLM and TECRA Unique Salmonella methods detected significantly fewer Salmonella-positive cantaloupes than did the culture method: the VIDAS ICS/SLM method detected 23 of 50 Salmonella-positive cantaloupes (60 tested) and the TECRA Unique Salmonella method detected 16 of 29 Salmonella-positive cantaloupes (60 tested). The VIDAS SLM and culture methods were equivalent: both methods detected 37 of 37 Salmonella-positive cantaloupes (60 tested).
C1 US FDA, Ctr Food Safety & Appl Nutr, Div Microbiol Studies, College Pk, MD 20740 USA.
RP Hammack, TS (reprint author), US FDA, Ctr Food Safety & Appl Nutr, Div Microbiol Studies, College Pk, MD 20740 USA.
EM Thomas.Hammack@fda.hhs.gov
NR 24
TC 12
Z9 12
U1 0
U2 2
PU INT ASSOC FOOD PROTECTION
PI DES MOINES
PA 6200 AURORA AVE SUITE 200W, DES MOINES, IA 50322-2863 USA
SN 0362-028X
J9 J FOOD PROTECT
JI J. Food Prot.
PD MAY
PY 2004
VL 67
IS 5
BP 870
EP 877
PG 8
WC Biotechnology & Applied Microbiology; Food Science & Technology
SC Biotechnology & Applied Microbiology; Food Science & Technology
GA 820FU
UT WOS:000221373600002
PM 15151220
ER
PT J
AU Lampel, KA
Dyer, D
Kornegay, L
Orlandi, PA
AF Lampel, KA
Dyer, D
Kornegay, L
Orlandi, PA
TI Detection of Bacillus spores using PCR and FTA filters
SO JOURNAL OF FOOD PROTECTION
LA English
DT Article
ID TEMPLATE PREPARATION; ANTHRACIS; SUBTILIS
AB Emphasis has been placed on developing and implementing rapid detection systems for microbial pathogens. We have explored the utility of expanding FTA filter technology for the preparation of template DNA for PCR from bacterial spores. Isolated spores from several Bacillus spp., B. subtilis, B. cereus, and B. megaterium, were applied to FIFA filters, and specific DNA products were amplified by PCR. Spore preparations were examined microscopically to ensure that the presence of vegetative cells, if any, did not yield misleading results. PCR primers SRM86 and SRM87 targeted a conserved region of bacterial rRNA genes, whereas primers Bsub5F and Bsub3R amplified a product from a conserved sequence of the B. subtilis rRNA gene. With the use of the latter set of primers for nested PCR, the sensitivity of the PCR-based assay was increased. Overall, 53 spores could be detected after the first round of PCR, and the sensitivity was increased to five spores by nested PCR. FTA filters are an excellent platform to remove PCR inhibitors and have universal applications for environmental, clinical, and food samples.
C1 US FDA, Ctr Food Safety & Appl Nutr, Laurel, MD 20708 USA.
RP Lampel, KA (reprint author), US FDA, Ctr Food Safety & Appl Nutr, Laurel, MD 20708 USA.
EM klampel@cfsan.fda.gov
NR 13
TC 11
Z9 13
U1 0
U2 4
PU INT ASSOC FOOD PROTECTION
PI DES MOINES
PA 6200 AURORA AVE SUITE 200W, DES MOINES, IA 50322-2863 USA
SN 0362-028X
J9 J FOOD PROTECT
JI J. Food Prot.
PD MAY
PY 2004
VL 67
IS 5
BP 1036
EP 1038
PG 3
WC Biotechnology & Applied Microbiology; Food Science & Technology
SC Biotechnology & Applied Microbiology; Food Science & Technology
GA 820FU
UT WOS:000221373600029
PM 15151247
ER
PT J
AU Stewart, SFC
Herman, BA
Nell, DM
Retta, SM
AF Stewart, SFC
Herman, BA
Nell, DM
Retta, SM
TI Effects of valve characteristics on the accuracy of the Bernoulli
equation: A survey of data submitted to the USFDA
SO JOURNAL OF HEART VALVE DISEASE
LA English
DT Article; Proceedings Paper
CT 2nd Biennial Meeting of the Society-for-Heart-Valve-Disease
CY JUN 28-JUL 01, 2003
CL PARIS, FRANCE
SP Soc Heart Valve Dis
ID PRESSURE-GRADIENT MEASUREMENT; DOPPLER ULTRASOUND; PROSTHETIC VALVES;
AORTIC-STENOSIS; STARR-EDWARDS; INVITRO; RECOVERY; HANCOCK; ERRORS; SIZE
AB Background and aim of the study: In 1988, valve manufacturers petitioned the U. S. Food & Drug Administration (FDA) to replace catheter with Doppler ultrasound measurements of pressure gradient (DeltaP) in clinical studies. Manufacturers agreed to submit bench data validating the Bernoulli equation used to calculate DeltaP: DeltaP = K(V-d(2) - V-p(2)), where K = constant, V-d = distal Doppler velocity, and V-p = proximal Doppler velocity. Previous studies suggest that K may vary from the idealized 4.0, which could lead to incorrect valve assessment and clinical errors.
Methods: Variation in K-values in marketing application data submitted to the FDA was assessed. Pulse duplicator data included four bileaflet valves, two stented bioprostheses, and seven stentless bioprostheses, sized from 19 to 33 mm. Effects of valve type, valve size, blood-mimicking fluid used, and distal pressure tap position (DPTP) were evaluated via an analysis of variance. *
Results: K-values varied from 2.50 to 7.40 (n = 90). K was found to be dependent on valve type (p <0.0001), blood-mimicking fluid (p <0.0001) and DPTP (p <0.0001), but not valve size. At DPTP 30 mm, K = 3.43 +/- 0.56, 5.15 +/- 0.81, and 4.81 +/- 1.02, for bileaflet, stented and stentless valves, respectively. K averaged 10% less using the 100-mm DPTP, due to pressure recovery. Variations due to blood-mimicking fluid were likely related to the fluid density.
Conclusion: Variations due to DPTP and fluid used are consistent with physical mechanisms of pressure recovery and fluid density. Results from previous studies have suggested that effects of valve type on K are also real. The magnitude of these effects appeared to be 25%. Extrapolation to patients is difficult, but clinicians should be aware that Doppler measurements may vary by similar amounts. Doppler pressure gradients should be interpreted qualitatively and moderated by other diagnostic measures of valve performance.
C1 US FDA, Off Sci & Engn Labs, Rockville, MD 20850 USA.
US FDA, Ctr Devices & Radiol Hlth, Off Device Evaluat, Rockville, MD 20850 USA.
RP Stewart, SFC (reprint author), US FDA, Off Sci & Engn Labs, 9200 Corp Blvd,HFZ-132, Rockville, MD 20850 USA.
EM sxs@cdrh.fda.gov
NR 16
TC 1
Z9 1
U1 0
U2 1
PU I C R PUBLISHERS
PI NORTHWOOD
PA CRISPIN HOUSE, 12/A SOUTH APPROACH, MOOR PARK, NORTHWOOD HA6 2ET,
ENGLAND
SN 0966-8519
J9 J HEART VALVE DIS
JI J. Heart Valve Dis.
PD MAY
PY 2004
VL 13
IS 3
BP 461
EP 466
PG 6
WC Cardiac & Cardiovascular Systems
SC Cardiovascular System & Cardiology
GA 824PN
UT WOS:000221698600026
PM 15222294
ER
PT J
AU Tomazic-Jezic, VJ
Lucas, AD
Sanchez, BA
AF Tomazic-Jezic, VJ
Lucas, AD
Sanchez, BA
TI Binding and measuring natural rubber latex proteins on glove powder
SO JOURNAL OF IMMUNOASSAY & IMMUNOCHEMISTRY
LA English
DT Article
DE natural rubber latex; latex proteins; glove powder; immunoassay; latex
allergy
ID AIRBORNE LATEX; CORNSTARCH; ALLERGENS; QUANTIFICATION; AEROALLERGENS;
RISK
AB Cornstarch used as a donning powder on natural rubber latex (NRL) gloves adsorbs NRL proteins. During glove use, powder-carried proteins can be aerosolized and can cause allergic reactions in NRL sensitized individuals. The amount of NRL proteins bound to glove powder and its relative relationship to the total amount of proteins on the glove has not been studied, due to the difficulty in measuring proteins on powder. Using the ELISA inhibition assay for NRL proteins [Standard test method for the immunological measurement of antigenic protein in natural rubber and its products. In: The Annual Book of ASTM Standards; ASTM: West Conshohocken, PA, 2000; ASTM D 64-0] we have investigated possible protocol modifications in order to include measurement of proteins bound to glove powder, as well as the water-extractable glove proteins. Possible interference of the starch itself was evaluated by adding clean cornstarch to the assay. No significant interference was observed with powder concentrations below 5 mg/mL. We analyzed 19 extracts of powdered surgical and examination gloves before and after removal of the particulate component. Comparison of NRL glove extracts with, and without, the cornstarch powder fraction indicated significant variations in the ratios of powder-bound protein and corresponding water-extractable protein. The ratios did not appear to correlate with either the total protein on the glove, the glove weight, or the total amount of powder on the glove. However, when virgin glove powders were exposed to NRL proteins, binding was proportional to the protein concentration in the suspension. Temperature in the range from 4degreesC to 37degreesC, did not affect binding intensity, while a higher pH resulted in a higher level of protein associated with, or bound to, the starch. The major differences in the propensity for NRL protein binding were observed among different glove powders.
The data indicate that the amount of protein that binds to glove powder does not depend only on the initial protein levels in the raw NRL. More likely, other physical or chemical factors introduced during the manufacturing process, as well as the properties of the donning powder itself, may influence protein binding. Moreover, we demonstrated that the ELISA inhibition assay could be successfully modified for quantitation of proteins adsorbed on the glove powder, together with water-extractable proteins.
C1 US FDA, Ctr Devices & Radiol Hlth, Div Life Sci, Rockville, MD 20852 USA.
RP Tomazic-Jezic, VJ (reprint author), US FDA, Ctr Devices & Radiol Hlth, Div Life Sci, HFZ-112,12709 Twinbrook Pkwy, Rockville, MD 20852 USA.
NR 25
TC 2
Z9 2
U1 1
U2 5
PU MARCEL DEKKER INC
PI NEW YORK
PA 270 MADISON AVE, NEW YORK, NY 10016 USA
SN 1532-1819
J9 J IMMUNOASS IMMUNOCH
JI J. Immunoass. Immunoch.
PD MAY
PY 2004
VL 25
IS 2
BP 109
EP 123
DI 10.1081/IAS-120030521
PG 15
WC Biochemical Research Methods; Immunology; Medical Laboratory Technology
SC Biochemistry & Molecular Biology; Immunology; Medical Laboratory
Technology
GA 818VG
UT WOS:000221272000001
PM 15162915
ER
PT J
AU Kucuk, O
Sarkar, F
Sakr, W
Wood, D
Cher, M
Abrams, J
Doerge, DD
Pollak, MM
Djuric, Z
Majumdar, A
AF Kucuk, O
Sarkar, F
Sakr, W
Wood, D
Cher, M
Abrams, J
Doerge, DD
Pollak, MM
Djuric, Z
Majumdar, A
TI Clinical trial of soy isoflavone supplementation before radical
prostatectomy in patients with localized prostate cancer.
SO JOURNAL OF NUTRITION
LA English
DT Meeting Abstract
CT 5th International Symposium on the Role of Soy in Preventing and
Treating Chronic Disease
CY SEP 21-24, 2003
CL Orlando, FL
C1 Karmanos Canc Inst, Detroit, MI USA.
Wayne State Univ, Detroit, MI USA.
Univ Michigan, Ann Arbor, MI 48109 USA.
US FDA, Natl Ctr Toxicol Res, Rockville, MD 20857 USA.
McGill Univ, Montreal, PQ H3A 2T5, Canada.
RI Djuric, Zora/H-5147-2013
OI Djuric, Zora/0000-0002-8886-8853
NR 0
TC 0
Z9 0
U1 0
U2 1
PU AMER INST NUTRITION
PI BETHESDA
PA 9650 ROCKVILLE PIKE, BETHESDA, MD 20814 USA
SN 0022-3166
J9 J NUTR
JI J. Nutr.
PD MAY
PY 2004
VL 134
IS 5
BP 1258S
EP 1258S
PG 1
WC Nutrition & Dietetics
SC Nutrition & Dietetics
GA 820XK
UT WOS:000221423000108
ER
PT J
AU Vaishampayan, UV
Forman, JJ
Hussain, M
Cher, M
Pontes, E
Fontana, J
Alluri, KC
Doerge, D
Sarkar, F
Kucuk, O
AF Vaishampayan, UV
Forman, JJ
Hussain, M
Cher, M
Pontes, E
Fontana, J
Alluri, KC
Doerge, D
Sarkar, F
Kucuk, O
TI Soy isoflavones and lycopene in the treatment of hormone-sensitive and
hormone-refractory prostate cancer.
SO JOURNAL OF NUTRITION
LA English
DT Meeting Abstract
CT 5th International Symposium on the Role of Soy in Preventing and
Treating Chronic Disease
CY SEP 21-24, 2003
CL Orlando, FL
C1 Karmanos Canc Inst, Detroit, MI USA.
Wayne State Univ, Detroit, MI USA.
Univ Michigan, Ann Arbor, MI 48109 USA.
US FDA, Natl Ctr Toxicol Res, Rockville, MD 20857 USA.
NR 0
TC 0
Z9 0
U1 0
U2 2
PU AMER INST NUTRITION
PI BETHESDA
PA 9650 ROCKVILLE PIKE, BETHESDA, MD 20814 USA
SN 0022-3166
J9 J NUTR
JI J. Nutr.
PD MAY
PY 2004
VL 134
IS 5
BP 1258S
EP 1258S
PG 1
WC Nutrition & Dietetics
SC Nutrition & Dietetics
GA 820XK
UT WOS:000221423000110
ER
PT J
AU Miller, FR
Tait, LR
Doerge, D
Sarkar, F
Kucuk, O
AF Miller, FR
Tait, LR
Doerge, D
Sarkar, F
Kucuk, O
TI Genistein and tamoxifen interaction in MCF10DCIS.corn xenograft model
for chemoprevention.
SO JOURNAL OF NUTRITION
LA English
DT Meeting Abstract
CT 5th International Symposium on the Role of Soy in Preventing and
Treating Chronic Disease
CY SEP 21-24, 2003
CL Orlando, FL
C1 US FDA, Natl Ctr Toxicol Res, Rockville, MD 20857 USA.
Wayne State Univ, Detroit, MI USA.
Karmanos Canc Inst, Detroit, MI USA.
NR 1
TC 0
Z9 0
U1 0
U2 0
PU AMER INST NUTRITION
PI BETHESDA
PA 9650 ROCKVILLE PIKE, BETHESDA, MD 20814 USA
SN 0022-3166
J9 J NUTR
JI J. Nutr.
PD MAY
PY 2004
VL 134
IS 5
BP 1261S
EP 1261S
PG 1
WC Nutrition & Dietetics
SC Nutrition & Dietetics
GA 820XK
UT WOS:000221423000117
ER
PT J
AU Kucuk, O
Sarkar, F
Adsay, V
Newman, L
Bouwman, D
Djuric, Z
Doerge, D
Parchment, R
Banerjee, M
Majumdar, A
AF Kucuk, O
Sarkar, F
Adsay, V
Newman, L
Bouwman, D
Djuric, Z
Doerge, D
Parchment, R
Banerjee, M
Majumdar, A
TI Clinical trial of soy Isoflavones before breast cancer surgery.
SO JOURNAL OF NUTRITION
LA English
DT Meeting Abstract
CT 5th International Symposium on the Role of Soy in Preventing and
Treating Chronic Disease
CY SEP 21-24, 2003
CL Orlando, FL
C1 Univ Michigan, Ann Arbor, MI 48109 USA.
Wayne State Univ, Detroit, MI USA.
Karmanos Canc Inst, Detroit, MI USA.
US FDA, Natl Ctr Toxicol Res, Rockville, MD 20857 USA.
RI Djuric, Zora/H-5147-2013
OI Djuric, Zora/0000-0002-8886-8853
NR 0
TC 2
Z9 2
U1 0
U2 4
PU AMER INST NUTRITION
PI BETHESDA
PA 9650 ROCKVILLE PIKE, BETHESDA, MD 20814 USA
SN 0022-3166
J9 J NUTR
JI J. Nutr.
PD MAY
PY 2004
VL 134
IS 5
BP 1262S
EP 1262S
PG 1
WC Nutrition & Dietetics
SC Nutrition & Dietetics
GA 820XK
UT WOS:000221423000122
ER
PT J
AU Kodali, U
Kucuk, O
Jaszewski, R
Levi, E
Doerge, D
Sarkar, F
Majumdar, APN
AF Kodali, U
Kucuk, O
Jaszewski, R
Levi, E
Doerge, D
Sarkar, F
Majumdar, APN
TI Genistein and EGFR related protein (ERRP) potentiate each other in
gastric, colon and prostate cancer cells.
SO JOURNAL OF NUTRITION
LA English
DT Meeting Abstract
CT 5th International Symposium on the Role of Soy in Preventing and
Treating Chronic Disease
CY SEP 21-24, 2003
CL Orlando, FL
C1 US FDA, Natl Ctr Toxicol Res, Rockville, MD 20857 USA.
Wayne State Univ, Detroit, MI USA.
Karmanos Canc Inst, Detroit, MI USA.
NR 0
TC 0
Z9 0
U1 0
U2 2
PU AMER INST NUTRITION
PI BETHESDA
PA 9650 ROCKVILLE PIKE, BETHESDA, MD 20814 USA
SN 0022-3166
J9 J NUTR
JI J. Nutr.
PD MAY
PY 2004
VL 134
IS 5
BP 1263S
EP 1264S
PG 2
WC Nutrition & Dietetics
SC Nutrition & Dietetics
GA 820XK
UT WOS:000221423000126
ER
PT J
AU Mohammad, R
Al-Katib, A
Aboukameel, A
Ibrahim, D
Doerge, D
Sarkar, F
Kucuk, O
AF Mohammad, R
Al-Katib, A
Aboukameel, A
Ibrahim, D
Doerge, D
Sarkar, F
Kucuk, O
TI Genistein sensitizes resistant diffuse large cell lymphoma cells to
chemotherapy.
SO JOURNAL OF NUTRITION
LA English
DT Meeting Abstract
CT 5th International Symposium on the Role of Soy in Preventing and
Treating Chronic Disease
CY SEP 21-24, 2003
CL Orlando, FL
C1 Karmanos Canc Inst, Detroit, MI USA.
Wayne State Univ, Detroit, MI USA.
US FDA, Natl Ctr Toxicol Res, Rockville, MD USA.
NR 0
TC 0
Z9 0
U1 0
U2 0
PU AMER INST NUTRITION
PI BETHESDA
PA 9650 ROCKVILLE PIKE, BETHESDA, MD 20814 USA
SN 0022-3166
J9 J NUTR
JI J. Nutr.
PD MAY
PY 2004
VL 134
IS 5
BP 1264S
EP 1264S
PG 1
WC Nutrition & Dietetics
SC Nutrition & Dietetics
GA 820XK
UT WOS:000221423000128
ER
PT J
AU Parchment, RE
Sarkar, F
Kassab, J
Ellis, KL
Doerge, D
Kucuk, O
AF Parchment, RE
Sarkar, F
Kassab, J
Ellis, KL
Doerge, D
Kucuk, O
TI Genistein does not sensitize human bone marrow to XK469 toxicity at
concentrations that sensitize BxPC3 pancreatic cancer to XK469
chemotherapy.
SO JOURNAL OF NUTRITION
LA English
DT Meeting Abstract
CT 5th International Symposium on the Role of Soy in Preventing and
Treating Chronic Disease
CY SEP 21-24, 2003
CL Orlando, FL
C1 Karmanos Canc Inst, Detroit, MI USA.
Wayne State Univ, Detroit, MI USA.
US FDA, Natl Ctr Toxicol Res, Rockville, MD 20857 USA.
NR 1
TC 0
Z9 0
U1 0
U2 0
PU AMER INST NUTRITION
PI BETHESDA
PA 9650 ROCKVILLE PIKE, BETHESDA, MD 20814 USA
SN 0022-3166
J9 J NUTR
JI J. Nutr.
PD MAY
PY 2004
VL 134
IS 5
BP 1264S
EP 1264S
PG 1
WC Nutrition & Dietetics
SC Nutrition & Dietetics
GA 820XK
UT WOS:000221423000127
ER
PT J
AU Sahin, K
Onderci, M
Gursu, MF
Sahin, N
Doerge, D
Sarkar, F
Kucuk, O
AF Sahin, K
Onderci, M
Gursu, MF
Sahin, N
Doerge, D
Sarkar, F
Kucuk, O
TI Genistein supplementation alleviates the deterioration in performance
and antioxidant status of Japanese quail associated with heat stress.
SO JOURNAL OF NUTRITION
LA English
DT Meeting Abstract
CT 5th International Symposium on the Role of Soy in Preventing and
Treating Chronic Disease
CY SEP 21-24, 2003
CL Orlando, FL
C1 Firat Univ, Elazig, Turkey.
Karmanos Canc Inst, Detroit, MI USA.
Wayne State Univ, Detroit, MI USA.
US FDA, Natl Ctr Toxicol Res, Rockville, MD USA.
RI Sahin, Kazim/D-5625-2009; Sahin, Nurhan/D-5626-2009
NR 0
TC 0
Z9 0
U1 0
U2 4
PU AMER INST NUTRITION
PI BETHESDA
PA 9650 ROCKVILLE PIKE, BETHESDA, MD 20814 USA
SN 0022-3166
J9 J NUTR
JI J. Nutr.
PD MAY
PY 2004
VL 134
IS 5
BP 1266S
EP 1267S
PG 2
WC Nutrition & Dietetics
SC Nutrition & Dietetics
GA 820XK
UT WOS:000221423000136
ER
PT J
AU Thomas, LC
Kerr, LN
Andersen, PC
Carter, EJ
McIlvain, LD
AF Thomas, LC
Kerr, LN
Andersen, PC
Carter, EJ
McIlvain, LD
TI Water testing natural rubber latex condoms: A comparison of surveillance
test methods
SO JOURNAL OF TESTING AND EVALUATION
LA English
DT Article
DE condoms; water test methods; holes; natural rubber latex
ID TRANSMISSION
AB Manufacturers, consumers, and regulators use various water test methods to test the integrity of the barrier offered by natural rubber latex condoms. The purpose of this study is to analyze three alternative water test methods and determine which is the best method for detecting holes in condoms. Three types of holes (laser, acupuncture, and 28 gage insulin needles), approximating defects that occur in condoms, were placed in condoms and then into equal size test sets for testing by six laboratories for the purpose of evaluating the three alternative methods: the ASTM method, the ISO/FDA method, and the CSI/FHI method. Each method shares a hang portion for 1 min, and then uses a different form of manipulation; either elevate (ASTM), roll (ISO/FDA), or squeeze (CSI/FHI). The interlaboratory study data indicate the CSI/FHI is the most sensitive method for locating holes in condoms, becoming more sensitive as the defect approaches the closed end.
C1 Custom Serv Int Inc, Las Vegas, NV 89118 USA.
US FDA, Winchester Engn & Analyt Ctr, Winchester, MA 01890 USA.
Church & Dwight Co Inc, Princeton, NJ 08543 USA.
Family Hlth Int, Prod Qual & Compliance Dept, Res Triangle Pk, NC 27713 USA.
Ansell Healthcare Inc, Dothan, AL 36303 USA.
RP Thomas, LC (reprint author), Custom Serv Int Inc, 3111 W Post Rd, Las Vegas, NV 89118 USA.
NR 13
TC 0
Z9 0
U1 0
U2 1
PU AMER SOC TESTING MATERIALS
PI W CONSHOHOCKEN
PA 100 BARR HARBOR DR, W CONSHOHOCKEN, PA 19428-2959 USA
SN 0090-3973
J9 J TEST EVAL
JI J. Test. Eval.
PD MAY
PY 2004
VL 32
IS 3
BP 202
EP 216
PG 15
WC Materials Science, Characterization & Testing
SC Materials Science
GA 839TD
UT WOS:000222806900005
ER
PT J
AU Holm, GH
Zhang, CS
Gorry, PR
Peden, K
Schols, D
De Clercq, E
Gabuzda, D
AF Holm, GH
Zhang, CS
Gorry, PR
Peden, K
Schols, D
De Clercq, E
Gabuzda, D
TI Apoptosis of bystander T cells induced by human immunodeficiency virus
type 1 with increased envelope/receptor affinity and coreceptor binding
site exposure
SO JOURNAL OF VIROLOGY
LA English
DT Article
ID CHEMOKINE RECEPTOR CXCR4; HUMAN LYMPHOID-TISSUE; EXPRESS FAS LIGAND; CD4
CROSS-LINKING; IN-VIVO; ENVELOPE GLYCOPROTEINS; MEMBRANE-FUSION;
INFECTED INDIVIDUALS; CLINICAL PROGRESSION; DEPENDENT APOPTOSIS
AB Apoptosis of uninfected bystander CD4(+) T cells contributes to T-cell depletion during human immunodeficiency virus type 1 (HIV-1) pathogenesis. The viral and host mechanisms that lead to bystander apoptosis are not well understood. To investigate properties of the viral envelope glycoproteins (Env proteins) that influence the ability of HIV-1 to induce bystander apoptosis, we used molecularly cloned viruses that differ only in specific amino acids in Env. The ability of these strains to induce bystander apoptosis was tested in herpesvirus saimiri-immortalized primary CD4(+) T cells (CD4/HVS), which resemble activated primary T cells. Changes in Env that increase affinity for CD4 or CCR5 or increase coreceptor binding site exposure enhanced the capacity of HIV-1 to induce bystander apoptosis following viral infection or exposure to nonreplicating virions. Apoptosis induced by HIV-1 virions was inhibited by CD4, CXCR4, and CCR5 antibodies or by the CXCR4 inhibitor AMD3100, but not the fusion inhibitor T20. HIV-1 virions with mutant Envs that bind CXCR4 but are defective for CD4 binding or membrane fusion induced apoptosis, whereas CXCR4 binding-defective mutants did not. These results demonstrate that HIV-1 virions induce apoptosis through a CXCR4- or CCR5-dependent pathway that does not require Env/CD4 signaling or membrane fusion and suggest that HIV-1 variants with increased envelope/receptor affinity or coreceptor binding site exposure may promote T-cell depletion in vivo by accelerating bystander cell death.
C1 Dana Farber Canc Inst, Dept Canc Immunol & AIDS, Boston, MA 02115 USA.
Harvard Univ, Sch Med, Dept Pathol, Boston, MA 02115 USA.
Harvard Univ, Sch Med, Dept Neurol, Boston, MA 02115 USA.
US FDA, Ctr Biol Evaluat & Res, Lab Retrovirus Res, Bethesda, MD 20892 USA.
Katholieke Univ Leuven, Rega Inst Med Res, Lab Expt Chemotherapy, Louvain, Belgium.
RP Gabuzda, D (reprint author), Dana Farber Canc Inst, Dept Canc Immunol & AIDS, JFB 816,44 Binney St, Boston, MA 02115 USA.
EM dana_gabuzda@dfci.harvard.edu
RI Holm, Geoffrey/C-3188-2009
FU NIAID NIH HHS [P30 AI028691, AI28691]; NINDS NIH HHS [NS35734, R01
NS035734]
NR 82
TC 48
Z9 49
U1 0
U2 3
PU AMER SOC MICROBIOLOGY
PI WASHINGTON
PA 1752 N ST NW, WASHINGTON, DC 20036-2904 USA
SN 0022-538X
J9 J VIROL
JI J. Virol.
PD MAY
PY 2004
VL 78
IS 9
BP 4541
EP 4551
DI 10.1128/JVI.78.9.4541-4551.2004
PG 11
WC Virology
SC Virology
GA 813AO
UT WOS:000220880200017
PM 15078935
ER
PT J
AU Mohan, KVK
Muller, J
Som, I
Atreya, CD
AF Mohan, KVK
Muller, J
Som, I
Atreya, CD
TI The N- and C-terminal regions of rotavirus NSP5 are the critical
determinants for the formation of viroplasm-like structures independent
of NSP2 (vol 77, pg 12184, 2003)
SO JOURNAL OF VIROLOGY
LA English
DT Correction
C1 US FDA, Ctr Biol Evaluat & Res, Div Viral Prod, Lab Pediat & Resp Viral Dis,Sect Viral Pathogenes, Bethesda, MD 20892 USA.
US FDA, Ctr Biol Evaluat & Res, Div Viral Prod, Lab Vector Borne Viral Dis, Bethesda, MD 20892 USA.
RP Atreya, CD (reprint author), US FDA, Ctr Biol Evaluat & Res, Div Viral Prod, Lab Pediat & Resp Viral Dis,Sect Viral Pathogenes, Bethesda, MD 20892 USA.
NR 1
TC 0
Z9 0
U1 0
U2 0
PU AMER SOC MICROBIOLOGY
PI WASHINGTON
PA 1752 N ST NW, WASHINGTON, DC 20036-2904 USA
SN 0022-538X
J9 J VIROL
JI J. Virol.
PD MAY
PY 2004
VL 78
IS 9
BP 4951
EP 4951
DI 10.1128/JVI.78.9.4951.2004
PG 1
WC Virology
SC Virology
GA 813AO
UT WOS:000220880200064
ER
PT J
AU Budge, PJ
Li, YQ
Beeler, JA
Graham, BS
AF Budge, PJ
Li, YQ
Beeler, JA
Graham, BS
TI RhoA-derived peptide dimers share mechanistic properties with other
polyanionic inhibitors of respiratory syncytial virus (RSV), including
disruption of viral attachment and dependence on RSV G
SO JOURNAL OF VIROLOGY
LA English
DT Article
ID REPLICATION IN-VITRO; DEXTRAN SULFATE; FUSION PROTEIN; ANTIVIRAL
ACTIVITY; HEPARAN-SULFATE; F-GLYCOPROTEIN; INFECTION; TYPE-1; CELLS;
BINDING
AB Large polyanionic molecules, such as sulfated polysaccharides (including soluble heparin and dextran sulfate), synthetic polyanionic polymers, and negatively charged proteins, have been shown to broadly inhibit several enveloped viruses. We recently reported the antiviral activity of a peptide derived from amino acids 77 to 95 of a potential binding partner of respiratory syncytial virus F protein (RSV F), the GTPase RhoA. A subsequent study with a truncated peptide (amino acids 80 to 94) revealed that optimal antiviral activity required dimerization via intermolecular disulfide bonds. We report here that the net negative charge of this peptide is also a determining factor for its antiviral activity and that it, like other polyanions, inhibits virus attachment. In a flow cytometry-based binding assay, peptide 80-94, heparin, and dextran sulfate inhibited the attachment of virus to cells at 4degreesC at the same effective concentrations at which they prevent viral infectivity. Interestingly, time-of-addition experiments revealed that peptide 80-94 and soluble heparin were also able to inhibit the infectivity of a virus that had been prebound to cells at 4degreesC, as had previously been shown for dextran sulfate, suggesting a potential role for postattachment effects of polyanions on RSV entry. Neutralization experiments with recombinant viruses showed that the antiviral activities of peptide 80-94 and dextran sulfate were diminished in the absence of the RSV attachment glycoprotein (G). Taken together, these data indicate that the antiviral activity of RhoA-derived peptides is functionally similar to that of other polyanions, is dependent on RSV G, and does not specifically relate to a protein-protein interaction between F and RhoA.
C1 NIAID, Vaccine Res Ctr, NIH, Viral Pathogenesis Lab, Bethesda, MD 20892 USA.
Vanderbilt Univ, Med Ctr, Dept Microbiol & Immunol, Nashville, TN 37232 USA.
US FDA, Ctr Biol Evaluat & Res, Lab Pediat & Resp Virus Dis, Bethesda, MD 20892 USA.
RP Graham, BS (reprint author), NIAID, Vaccine Res Ctr, NIH, Viral Pathogenesis Lab, MSC 3017,Bldg 40,Room 2502,40 Convent Dr, Bethesda, MD 20892 USA.
EM bgraham@nih.gov
NR 53
TC 12
Z9 14
U1 0
U2 3
PU AMER SOC MICROBIOLOGY
PI WASHINGTON
PA 1752 N ST NW, WASHINGTON, DC 20036-2904 USA
SN 0022-538X
J9 J VIROL
JI J. Virol.
PD MAY
PY 2004
VL 78
IS 10
BP 5015
EP 5022
DI 10.1128/JVI.78.10.5015-5022.2004
PG 8
WC Virology
SC Virology
GA 817YF
UT WOS:000221212100008
PM 15113882
ER
PT J
AU Brown, SL
Todd, JF
Do Luu, HM
AF Brown, SL
Todd, JF
Do Luu, HM
TI Breast implant adverse events during mammography: Reports to the food
and drug administration
SO JOURNAL OF WOMENS HEALTH
LA English
DT Article
ID AUGMENTATION MAMMAPLASTY; RUPTURE; CANCER; WOMEN; PREVALENCE; DIAGNOSIS
AB Objective: To characterize reports of adverse events occurring during mammography to women with breast implants submitted to the Food and Drug Administration (FDA).
Methods: We searched the adverse events database for any report on silicone gel breast implants or saline breast implants that included the word "mammography" or "mammogram" in the text. We also searched adverse event reports for mammographic equipment that included the term "breast implant" in the text.
Results: We retrieved 714 adverse event reports using this strategy. Sixty-six of these reports detailed an adverse event that occurred during mammography or described breast implant interference with mammography. The majority of these reports, 41 of 66 (62.1%), described breast implant rupture during mammography. Other adverse events reported included mammographic compression crushing implants, pain during mammography attributed to implants, inability to perform mammography because of capsular contracture or fear of implant rupture, and delayed detection of cancer attributed to implants.
Conclusions: It is important that women considering breast implants be informed of these potential risks and that clinicians, radiologists, and mammographic technicians keep them in mind when imaging women with implants.
C1 US FDA, Ctr Devices & Radiol Hlth, Off Surveillance & Biometr, Div Postmarket Surveillance, Rockville, MD 20850 USA.
US FDA, Ctr Devices & Radiol Hlth, Off Surveillance & Biometr, Div Mech & Mat Sci, Rockville, MD 20850 USA.
RP Brown, SL (reprint author), US FDA, Ctr Devices & Radiol Hlth, Off Surveillance & Biometr, Div Postmarket Surveillance, 1350 Piccard Dr,HFZ 541, Rockville, MD 20850 USA.
EM syb@cdrh.fda.gov
NR 32
TC 13
Z9 14
U1 0
U2 1
PU MARY ANN LIEBERT INC PUBL
PI LARCHMONT
PA 2 MADISON AVENUE, LARCHMONT, NY 10538 USA
SN 1540-9996
J9 J WOMENS HEALTH
JI J. Womens Health
PD MAY
PY 2004
VL 13
IS 4
BP 371
EP 378
DI 10.1089/154099904323087042
PG 8
WC Public, Environmental & Occupational Health; Medicine, General &
Internal; Obstetrics & Gynecology; Women's Studies
SC Public, Environmental & Occupational Health; General & Internal
Medicine; Obstetrics & Gynecology; Women's Studies
GA 825NC
UT WOS:000221764200003
PM 15195650
ER
PT J
AU Vila, MR
Kaplan, GG
Feigelstock, D
Nadal, M
Morote, J
Porta, R
Bellmunt, J
Meseguer, A
AF Vila, MR
Kaplan, GG
Feigelstock, D
Nadal, M
Morote, J
Porta, R
Bellmunt, J
Meseguer, A
TI Hepatitis A virus receptor blocks cell differentiation and is
overexpressed in clear cell renal cell carcinoma
SO KIDNEY INTERNATIONAL
LA English
DT Article; Proceedings Paper
CT Symposium on Immunology in Renal Disease
CY JUN 02-05, 2003
CL Berlin, GERMANY
SP Int Soc Nephrol
DE ccRCC; differentiation; hhavcr-1; kidney tumors; proximal tubule cells;
RAP-PCR; tumor markers
ID POLYMERASE-CHAIN-REACTION; KIDNEY INJURY MOLECULE-1; SCATTER-FACTOR;
CANCER-CELLS; RNA; IDENTIFICATION; ADHESION; GENE; CHROMOSOME-3;
EXPRESSION
AB Background. The molecular mechanisms underlying tumorigenesis and progression of clear cell renal cell carcinoma (ccRCC) are not well understood. We aimed to identify new molecular markers to provide insight into these processes.
Methods. This work reports on the identification of human hepatitis A virus cellular receptor 1 (hHAVcr-1) as a differentially expressed gene in ccRCC using RNA-based arbitrarily primed polymerase chain reaction (RAP-PCR). Results were further confirmed by Northern and Western blot assays. Carcinoma 769-P and normal HK-2 cells derived from proximal tubule epithelial cells. grown under different culture conditions, were used to understand the putative role of hHAVcr-1 in renal malignancy hHAVcr-1 stable transfected clones and dipeptidyl peptidase IV (DPPIV) assays allowed assessing its involvement in cell differentiation.
Results. The hHAVcr-1 is overexpressed in eight out of 13 ccRCC and its expression neglected in benign oncocytomas. In culture, hhavcr-1 is dramatically overexpressed in normal and tumor cell lines that, having acquired the fully differentiated phenotype, are induced to de-differentiate by means of phorbol ester phorbol 12-myristate-13-acetate (PMA) treatment. Similarly differentiation prevention by addition of PMA to confluent cells also increases hhavcr-1 expression. hHAVcr-1 stable transfected 769-P cells proved that hhavcr-1 itself blocks differentiation. Since hhavcr-1 is expressed at higher levels in tumor cells. we used an African green monkey cell model to show that immunotoxins directed against the monkey homologue of hhavcr-1 could kill kidney cells.
Conclusion. Our results showed that hHAVcr-1 blocks differentiation of proximal tubule epithelial cells and that it could be used as a target for therapy of kidney carcinomas.
C1 Hosp Univ Vall Hebron, Ctr Invest Bioquim & Biol Mol, Barcelona 08035, Spain.
Hosp Univ Vall Hebron, Serv Oncol, Barcelona, Spain.
Hosp Univ Vall Hebron, Serv Urol, Barcelona, Spain.
Hosp Duran i Reynals, Inst Recerca Oncol, Barcelona, Spain.
US FDA, Lab Hepatitis & Related Emerging Agents, CBER, Bethesda, MD 20014 USA.
RP Meseguer, A (reprint author), Hosp Univ Vall Hebron, Ctr Invest Bioquim & Biol Mol, Pg Vall Hebron 119-129, Barcelona 08035, Spain.
EM ameseguer@vhebron.net
RI Meseguer Navarro, Anna/M-2222-2014
OI Meseguer Navarro, Anna/0000-0003-3833-2249
NR 42
TC 21
Z9 22
U1 0
U2 3
PU BLACKWELL PUBLISHING INC
PI MALDEN
PA 350 MAIN ST, MALDEN, MA 02148 USA
SN 0085-2538
J9 KIDNEY INT
JI Kidney Int.
PD MAY
PY 2004
VL 65
IS 5
BP 1761
EP 1773
DI 10.1111/j.1523-1755.2004.00601.x
PG 13
WC Urology & Nephrology
SC Urology & Nephrology
GA 815CR
UT WOS:000221020900035
PM 15086915
ER
PT J
AU Cieslak, TJ
Pavlin, JA
Noah, DL
Dire, DJ
Stanek, SA
Kortepeter, MG
Jarrett, DG
Pastel, RH
Darling, RG
Jacocks, JM
Hurst, CG
Richards, BA
Eitzen, EM
AF Cieslak, TJ
Pavlin, JA
Noah, DL
Dire, DJ
Stanek, SA
Kortepeter, MG
Jarrett, DG
Pastel, RH
Darling, RG
Jacocks, JM
Hurst, CG
Richards, BA
Eitzen, EM
TI Military medical education: Nuclear, biological, and chemical medical
defense training as a model for planners
SO MILITARY MEDICINE
LA English
DT Article
ID STUDENTS
C1 San Antonio Mil Pediat Ctr, San Antonio, TX USA.
Walter Reed Army Inst Res, Silver Spring, MD USA.
Bolling AFB, Off AF Surg Gen, Washington, DC USA.
USA, Med Grp 5, Birmingham, AL USA.
USA, Med Res Inst Infect Dis, Ft Detrick, MD 21702 USA.
Armed Forces Radiobiol Res Inst, Bethesda, MD USA.
USA, Med Res Inst Chem Def, Aberdeen Proving Ground, MD 21010 USA.
US FDA, Ctr Devices & Radiol Hlth, Gaithersburg, MD USA.
US Dept HHS, Washington, DC 20201 USA.
RP Cieslak, TJ (reprint author), Brooke Army Med Ctr, Dept Pediat, Ft Sam Houston, TX 78234 USA.
EM Ted.Cieslak@amedd.army.mil
NR 10
TC 1
Z9 2
U1 0
U2 0
PU ASSN MILITARY SURG US
PI BETHESDA
PA 9320 OLD GEORGETOWN RD, BETHESDA, MD 20814 USA
SN 0026-4075
J9 MIL MED
JI Milit. Med.
PD MAY
PY 2004
VL 169
IS 5
BP 337
EP 341
PG 5
WC Medicine, General & Internal
SC General & Internal Medicine
GA 019IU
UT WOS:000235829600003
PM 15185995
ER
PT J
AU Ravichandran, V
Vasquez, GB
Srivastava, S
Verma, M
Petricoin, E
Lubell, J
Sriram, RD
Barker, PE
Gilliland, GL
AF Ravichandran, V
Vasquez, GB
Srivastava, S
Verma, M
Petricoin, E
Lubell, J
Sriram, RD
Barker, PE
Gilliland, GL
TI Data standards for proteomics: mitochondrial two-dimensional
polyacrylamide gel electrophoresis data as a model system
SO MITOCHONDRION
LA English
DT Article
DE 2D gel electrophoresis; data standards; interoperability; proteomics;
data uniformity
ID PROTEIN IDENTIFICATION
AB Proteomics has emerged as a major discipline that led to a re-examination of the need for consensus and a nationally sanctioned set of proteomics technology standards. Such standards for databases and data reporting may be applied to two-dimensional polyacrylamide gel electrophoresis (2D PAGE) technology as a pilot project for assessing global and national needs in proteomics, and the role of the National Institute of Standards and Technology (NIST) and other similar standards and measurement organizations. The experience of harmonizing the heterogeneous data included in the Protein Data Bank (PDB) provides a paradigm for technology in an area where significant heterogeneity in technical detail and data storage has evolved. Here we propose an approach toward standardizing mitochondrial 2D PAGE data in support of a globally relevant proteomics consensus. (C) 2004 Elsevier B.V. and Mitochondria Research Society. All rights reserved.
C1 Natl Inst Stand & Technol, Div Biotechnol, Gaithersburg, MD 20899 USA.
Natl Inst Stand & Technol, Mfg Syst Integrat Div, Gaithersburg, MD 20899 USA.
Natl Canc Inst, Div Canc Prevent, Rockville, MD 20852 USA.
US FDA, Ctr Biol Evaluat & Res, Div Therapeut Prod, Off Therapeut Res & Review, Bethesda, MD 20892 USA.
RP Ravichandran, V (reprint author), Univ Maryland, Ctr Adv Res Biotechnol, 9600 Gudelsky Dr, Rockville, MD 20850 USA.
EM vravi@nist.gov
NR 12
TC 2
Z9 2
U1 0
U2 0
PU ELSEVIER SCI LTD
PI OXFORD
PA THE BOULEVARD, LANGFORD LANE, KIDLINGTON, OXFORD OX5 1GB, OXON, ENGLAND
SN 1567-7249
J9 MITOCHONDRION
JI Mitochondrion
PD MAY
PY 2004
VL 3
IS 6
BP 327
EP 336
DI 10.1016/j.mito.2004.02.006
PG 10
WC Cell Biology; Genetics & Heredity
SC Cell Biology; Genetics & Heredity
GA 823TE
UT WOS:000221635300002
PM 16120364
ER
PT J
AU Bernstein, RM
Mills, FC
Mitchell, M
Max, EE
AF Bernstein, RM
Mills, FC
Mitchell, M
Max, EE
TI Complex mechanisms for inhibition of immunoglobulin gene expression in a
germinal center B cell line
SO MOLECULAR IMMUNOLOGY
LA English
DT Article
DE B lymphocytes; human; antibodies; cytokines; gene regulation
ID NF-KAPPA-B; DNA-BINDING; TRANSCRIPTION FACTORS; SYNERGISTIC ACTIVATION;
PROTEIN COMPLEXES; ENHANCER FUNCTION; CD40 RECEPTOR; CROSS-LINKING;
IN-VITRO; OCA-B
AB CD40 ligation and IL-4 stimulation are critical Th2 cell-derived signals that act on germinal center B cells to stimulate immunoglobulin isotype switching. In addition to this well-known effect, these same Th2 signals have also been reported to inhibit ongoing immunoglobulin synthesis in germinal center B cells. To study the mechanism of this inhibition, we have investigated which immunoglobulin gene regulatory regions might be affected by IL-4 and CD40 Ligand (CD40L). CL-01 cells, a human B cell line of germinal center phenotype, were transiently transfected with luciferase reporter constructs containing various light and heavy chain enhancers and promoters; the cells were then incubated with or without CD40L and IL-4 and then assayed for luciferase expression. We find that the intronic enhancer of the kappa light chain (but not the heavy chain) is upregulated by CD40 ligation, but that VH and Vkappa promoters and the 3' enhancers of both the kappa and heavy chain loci are inhibited by CD40 ligation and the Th2 cytokines IL-4 and IL-10. The inhibitory response of the 3'alpha enhancer can be observed with a 130 by core fragment of the enhancer, and remains unaffected by mutations in several motifs known or suspected to contribute to enhancer function. The ultimate effects of cytokines and CD40 ligation on immunoglobulin gene transcription therefore represent a complex integration of positive and negative stimuli acting on enhancers and promoters. Published by Elsevier Ltd.
C1 US FDA, Ctr Biol Evaluat & Res, Off Therapeut Res & Review, Bethesda, MD 20892 USA.
RP Max, EE (reprint author), US FDA, Ctr Biol Evaluat & Res, Off Therapeut Res & Review, HFM-541, Bethesda, MD 20892 USA.
EM max@cber.fda.gov
NR 34
TC 3
Z9 3
U1 0
U2 0
PU PERGAMON-ELSEVIER SCIENCE LTD
PI OXFORD
PA THE BOULEVARD, LANGFORD LANE, KIDLINGTON, OXFORD OX5 1GB, ENGLAND
SN 0161-5890
J9 MOL IMMUNOL
JI Mol. Immunol.
PD MAY
PY 2004
VL 41
IS 1
BP 63
EP 72
DI 10.1016/j.molimm.2004.01.005
PG 10
WC Biochemistry & Molecular Biology; Immunology
SC Biochemistry & Molecular Biology; Immunology
GA 826EO
UT WOS:000221812300007
PM 15140576
ER
PT J
AU Delogu, G
Pusceddu, C
Bua, A
Fadda, G
Brennan, MJ
Zanetti, S
AF Delogu, G
Pusceddu, C
Bua, A
Fadda, G
Brennan, MJ
Zanetti, S
TI Rv1818c-encoded PE_PGRS protein of Mycobacterium tuberculosis is surface
exposed and influences bacterial cell structure
SO MOLECULAR MICROBIOLOGY
LA English
DT Article
ID ESCHERICHIA-COLI; COLONY MORPHOLOGY; GENOME SEQUENCE; BOVIS BCG;
LOCALIZATION; ANTIGENS; FAMILY; GENE; EXPRESSION; VIRULENCE
AB Identification of the novel PE multigene family was an unexpected finding of the genomic sequencing of Mycobacterium tuberculosis. Presently, the biological role of the PE and PE_PGRS proteins encoded by this unique family of mycobacterial genes remains unknown. In this report, a representative PE_PGRS gene (Rv1818c/PE_PGRS33) was selected to investigate the role of these proteins. Cell fractionation studies and fluorescence analysis of recombinant strains of Mycobacterium smegmatis and M. tuberculosis expressing green fluorescent protein (GFP)-tagged proteins indicated that the Rv1818c gene product localized in the mycobacterial cell wall, mostly at the bacterial cell poles, where it is exposed to the extracellular milieu. Further analysis of this PE_PGRS protein showed that the PE domain is necessary for subcellular localization. In addition, the PGRS domain, but not PE, affects bacterial shape and colony morphology when Rv1818c is overexpressed in M. smegmatis and M. tuberculosis. Taken together, the results indicate that PE_PGRS and PE proteins can be associated with the mycobacterial cell wall and influence cellular structure as well as the formation of mycobacterial colonies. Regulated expression of PE genes could have implications for the survival and pathogenesis of mycobacteria within the human host and in other environmental niches.
C1 Univ Sassari, Dept Biomed Sci, I-07100 Sassari, Italy.
Univ Sacred Heart, Inst Microbiol, I-00168 Rome, Italy.
US FDA, Ctr Biol Evaluat & Res, Lab Mycobacteriol Dis & Cellular Immunol, Bethesda, MD USA.
RP Delogu, G (reprint author), Univ Cattolica Sacro Cuore, Ist Microbiol, Largo F Vito, I-00168 Rome, Italy.
EM gdelogu@rm.unicatt.it
RI Delogu, Giovanni/I-3701-2012; Fadda, Giovanni/K-6224-2012
OI Delogu, Giovanni/0000-0003-0182-8267;
NR 35
TC 117
Z9 123
U1 0
U2 2
PU BLACKWELL PUBLISHING LTD
PI OXFORD
PA 9600 GARSINGTON RD, OXFORD OX4 2DG, OXON, ENGLAND
SN 0950-382X
J9 MOL MICROBIOL
JI Mol. Microbiol.
PD MAY
PY 2004
VL 52
IS 3
BP 725
EP 733
DI 10.1111/j.1365-2958.2004.04007.x
PG 9
WC Biochemistry & Molecular Biology; Microbiology
SC Biochemistry & Molecular Biology; Microbiology
GA 813YC
UT WOS:000220941400011
PM 15101979
ER
PT J
AU Smith, JS
Tian, R
Lozier, JN
Byrnes, AP
AF Smith, JS
Tian, R
Lozier, JN
Byrnes, AP
TI Severe pulmonary pathology after intravenous administration of
adenovirus vectors in cirrhotic rats
SO MOLECULAR THERAPY
LA English
DT Meeting Abstract
CT 7th Annual Meeting of the American-Society-of-Gene-Therapy
CY JUN 02-06, 2004
CL Minneapolis, MN
SP Amer Soc Gene Therapy
C1 US FDA, Div Cellular & Gene Therapies, CBER, Bethesda, MD 20014 USA.
US FDA, Div Hematol, CBER, Bethesda, MD 20014 USA.
RI Byrnes, Andrew/D-2808-2013
OI Byrnes, Andrew/0000-0003-1135-2629
NR 0
TC 0
Z9 0
U1 0
U2 0
PU ACADEMIC PRESS INC ELSEVIER SCIENCE
PI SAN DIEGO
PA 525 B ST, STE 1900, SAN DIEGO, CA 92101-4495 USA
SN 1525-0016
J9 MOL THER
JI Mol. Ther.
PD MAY
PY 2004
VL 9
SU 1
MA 464
BP S176
EP S176
PG 1
WC Biotechnology & Applied Microbiology; Genetics & Heredity; Medicine,
Research & Experimental
SC Biotechnology & Applied Microbiology; Genetics & Heredity; Research &
Experimental Medicine
GA 833DM
UT WOS:000222316600465
ER
PT J
AU Chelonis, JJ
Flake, RA
Baldwin, RL
Blake, DJ
Paule, MG
AF Chelonis, JJ
Flake, RA
Baldwin, RL
Blake, DJ
Paule, MG
TI Developmental aspects of timing behavior in children
SO NEUROTOXICOLOGY AND TERATOLOGY
LA English
DT Article
DE timing; time production; temporal response differentiation; age; sex;
intelligence; children
ID DEFICIT HYPERACTIVITY DISORDER; OPERANT TEST BATTERY; TIME-ESTIMATION;
INTERNAL CLOCK; YOUNG-CHILDREN; TEMPORAL DISCRIMINATION; REINFORCEMENT
HISTORY; RESPONSE DURATION; DRL PERFORMANCE; SEX DIFFERENCES
AB This research examined the association of age, sex, and intelligence on the performance of a time production (temporal response differentiation, TRD) task. Variations of this task have been used extensively with both animals and humans to study factors that affect aspects of timing ability. The participants in this study (720 children, ages 5 to 13 years) were required to hold down a response lever for at least 10 s, but no more than 14 s, to receive a nickel. Older children made more correct lever holds and exhibited less variability in the duration of their lever holds than did the younger children. Boys and girls performed similarly on this task, whereas children with higher IQs made more correct lever holds. Young children with below average IQs exhibited increased variability in lever hold duration compared with young children with average and above average IQs. The results of this study illustrate that both age and intelligence influence timing ability. The use of this timing task in children, which also has been widely used in animal models, provides unique opportunities for interspecies comparisons. (C) 2004 Elsevier Inc. All rights reserved.
C1 Univ Arkansas, Dept Psychol, Little Rock, AR 72204 USA.
Univ Arkansas Med Sci, Arkansas Childrens Hosp, Little Rock, AR 72205 USA.
Natl Ctr Toxicol Res, Jefferson, AR 72079 USA.
RP Chelonis, JJ (reprint author), Univ Arkansas, Dept Psychol, 2801 S Univ Ave, Little Rock, AR 72204 USA.
EM JJChelonis@UALR.edu
NR 85
TC 21
Z9 21
U1 3
U2 6
PU PERGAMON-ELSEVIER SCIENCE LTD
PI OXFORD
PA THE BOULEVARD, LANGFORD LANE, KIDLINGTON, OXFORD OX5 1GB, ENGLAND
SN 0892-0362
J9 NEUROTOXICOL TERATOL
JI Neurotoxicol. Teratol.
PD MAY-JUN
PY 2004
VL 26
IS 3
BP 461
EP 476
DI 10.1016/j.ntt.2004.01.004
PG 16
WC Neurosciences; Toxicology
SC Neurosciences & Neurology; Toxicology
GA 820DH
UT WOS:000221366500012
PM 15113607
ER
PT J
AU Gardner, S
Schultz, DG
AF Gardner, S
Schultz, DG
TI Complications associated with global endometrial ablation: The utility
of the MAUDE database
SO OBSTETRICS AND GYNECOLOGY
LA English
DT Letter
C1 US FDA, Off Surveillance & Biometr, Ctr Devices & Radiol Hlth, Rockville, MD 20857 USA.
US FDA, Off Device Evaluat, Ctr Devices & Radiol Hlth, Rockville, MD USA.
RP Gardner, S (reprint author), US FDA, Off Surveillance & Biometr, Ctr Devices & Radiol Hlth, Rockville, MD 20857 USA.
NR 1
TC 1
Z9 1
U1 0
U2 0
PU LIPPINCOTT WILLIAMS & WILKINS
PI PHILADELPHIA
PA 530 WALNUT ST, PHILADELPHIA, PA 19106-3621 USA
SN 0029-7844
J9 OBSTET GYNECOL
JI Obstet. Gynecol.
PD MAY
PY 2004
VL 103
IS 5
BP 995
EP 996
DI 10.1097/01.AOG.0000125669.32200.be
PN 1
PG 2
WC Obstetrics & Gynecology
SC Obstetrics & Gynecology
GA 875IR
UT WOS:000225414200026
PM 15121577
ER
PT J
AU Kovalchuk, I
Abramov, V
Pogribny, I
Kovalchuk, O
AF Kovalchuk, I
Abramov, V
Pogribny, I
Kovalchuk, O
TI Molecular aspects of plant adaptation to life in the Chernobyl zone
SO PLANT PHYSIOLOGY
LA English
DT Article
ID INTRACHROMOSOMAL HOMOLOGOUS RECOMBINATION; RADIOACTIVE CONTAMINATION;
TRANSGENIC PLANTS; PINUS-SILVESTRIS; POST-CHERNOBYL; MUTATION-RATE;
WHOLE PLANTS; DNA; REPAIR; GERMLINE
AB With each passing year since the Chernobyl accident of 1986, more questions arise about the potential for organisms to adapt to radiation exposure. Often this is thought to be attributed to somatic and germline mutation rates in various organisms. We analyzed the adaptability of native Arabidopsis plants collected from areas with different levels of contamination around the Chernobyl nuclear power plant from 1986 to 1992. Notably, progeny of Chernobyl plants resisted higher concentrations of the mutagens Rose Bengal and methyl methane sulfonate. We analyzed the possible molecular mechanisms of their resistance to mutagens and found a more than 10-fold lower frequency of extra chromosomal homologous recombination, significant differences in the expression of radical scavenging (CAT1 and FSD3) and DNA-repair (RAD1 and RAD51-like) genes upon exposure to mutagens (Rose Bengal and x-rays), and a higher level of global genome methylation. This data suggests that adaptation to ionizing radiation is a complex process involving epigenetic regulation of gene expression and genome stabilization that improves plants' resistance to environmental mutagens.
C1 Univ Lethbridge, Dept Biol Sci, Lethbridge, AB T1K 3M4, Canada.
Russian Acad Sci, NI Vavilov Gen Genet Res Inst, Moscow 117809, Russia.
Natl Ctr Toxicol Res, Div Biochem Toxicol, Jefferson, AR 72079 USA.
RP Kovalchuk, I (reprint author), Univ Lethbridge, Dept Biol Sci, Lethbridge, AB T1K 3M4, Canada.
EM olga.kovalchuk@uleth.ca
NR 35
TC 78
Z9 86
U1 3
U2 36
PU AMER SOC PLANT BIOLOGISTS
PI ROCKVILLE
PA 15501 MONONA DRIVE, ROCKVILLE, MD 20855 USA
SN 0032-0889
J9 PLANT PHYSIOL
JI Plant Physiol.
PD MAY
PY 2004
VL 135
IS 1
BP 357
EP 363
DI 10.1104/pp.104.040477
PG 7
WC Plant Sciences
SC Plant Sciences
GA 820WQ
UT WOS:000221420800037
PM 15133154
ER
PT J
AU Badano, A
AF Badano, A
TI AAPM/RSNA tutorial on equipment selection: PACS equipment overview -
Display systems
SO RADIOGRAPHICS
LA English
DT Article
DE cathode ray tubes; computers; images, display; images, quality
ID LIQUID-CRYSTAL DISPLAYS; VEILING GLARE; MONOCHROME; LUMINANCE;
CROSSTALK; MONITOR; DEVICES
AB Display systems are key components of the digital radiology department. Current display systems for medical imaging are based on cathode-ray tubes (CRTs) or active-matrix liquid crystal displays (AMLCDs). The CRT is a cathodoluminescent display: Light is generated by exciting a luminescent material with energetic electrons. AMLCDs are light-modulating devices that form the image in the screen by controlling the transparency of individual display pixels. Many image quality aspects of CRTs are determined by the way the pixel luminance is generated in the cathodoluminescent screen. The resolution properties of AMLCDs are much better than those of CRTs. In CRT devices, phosphor granularity and raster scanning patterns are the main components of spatial noise. In AMLCDs, the most notable feature of the noise characteristic is the subpixel structure of complex pixel designs used in medical displays. The small-spot contrast of CRTs is dominated mainly by veiling glare and reflections of ambient illumination. In addition to display reflectance, the contrast of medical AMLCDs is affected by crosstalk and by variations of the luminance at off-normal viewing angles.
C1 Off Sci & Technol, Ctr Devices & Radiol Hlth, US FDA, Rockville, MD 20857 USA.
RP Badano, A (reprint author), Off Sci & Technol, Ctr Devices & Radiol Hlth, US FDA, 12720 Twinbrook Pkwy, Rockville, MD 20857 USA.
EM agb@cdrh.fda.gov
OI badano, aldo/0000-0003-3712-6670
NR 37
TC 25
Z9 25
U1 4
U2 5
PU RADIOLOGICAL SOC NORTH AMERICA
PI OAK BROOK
PA 820 JORIE BLVD, OAK BROOK, IL 60523 USA
SN 0271-5333
J9 RADIOGRAPHICS
JI Radiographics
PD MAY-JUN
PY 2004
VL 24
IS 3
BP 879
EP 889
DI 10.1148/rg.243035133
PG 11
WC Radiology, Nuclear Medicine & Medical Imaging
SC Radiology, Nuclear Medicine & Medical Imaging
GA 819CB
UT WOS:000221289700020
PM 15143237
ER
PT J
AU Chang, I
Mikityansky, I
Wray-Cahen, D
Pritchard, W
Karanian, JW
Wood, BJ
AF Chang, I
Mikityansky, I
Wray-Cahen, D
Pritchard, W
Karanian, JW
Wood, BJ
TI Effects of perfusion on radiofrequency ablation in Swine kidneys
SO RADIOLOGY
LA English
DT Article
DE animals; experimental study; kidney, interventional procedures; kidney,
perfusion; radiofrequency (RF) ablation
ID RENAL-CELL CARCINOMA; NEPHRON SPARING SURGERY; PORCINE MODEL; IN-VIVO;
VASCULAR OCCLUSION; THERMAL ABLATION; LESION SIZE; BLOOD-FLOW;
FOLLOW-UP; EXPERIENCE
AB PURPOSE: To evaluate the effect of vascular occlusion on the size of radiofrequency (RF) ablation lesions and to evaluate embolization as an occlusion method.
MATERIALS AND METHODS: The kidneys of six swine were surgically exposed. Fifteen RF ablation lesions were created in nine kidneys by using a 2-cm-tip single-needle ablation probe in varying conditions: Seven lesions were created with normal blood flow and eight were created with blood flow obstructed by means of vascular clamping (n = 5) or renal artery embolization (n = 3). The temperature, applied voltage, current, and impedance were recorded during RF ablation. Tissue-cooling curves acquired for 2 minutes immediately after the ablation were compared by using regression analysis. Lesions were bisected, and their maximum diameters were measured and compared by using analysis of variance.
RESULTS: The mean diameter of ablation lesions created when blood flow was obstructed was 60% greater than that of lesions created when blood flow was normal (1.38 cm +/- 0.05 [standard error of mean] vs 0.86 cm +/- 0.07, P < .001). The two methods of flow obstruction yielded lesions of similar mean sizes: 1.40 cm 0.06 with vascular clamping and 1.33 cm +/- 0.07 with embolization. The temperature at the probe tip when lesions were ablated with normal blood flow decreased more rapidly than did the temperature when lesions were ablated after flow obstruction (P <.001). but no significant differences in tissue-cooling curves between the two flow obstruction methods were observed.
CONCLUSION: Obstruction of renal blood flow before and during RF ablation resulted in larger thermal lesions with potentially less variation in size compared with the lesions created with normal nonobstructed blood flow. Selective arterial embolization of the kidney vessels may be a useful adjunct to RF ablation of kidney tumors.
C1 US FDA, Ctr Devices & Radiol Hlth, Off Sci & Technol, Rockville, MD 20852 USA.
NIH, Dept Diagnost Radiol, Special Procedures Div, Warren Grant Magnuson Clin Ctr, Bethesda, MD 20892 USA.
RP Chang, I (reprint author), US FDA, Ctr Devices & Radiol Hlth, Off Sci & Technol, 12725 Twinbrook Pkwy,HFZ-133, Rockville, MD 20852 USA.
EM iac@cdrh.fda.gov
FU Intramural NIH HHS [Z99 CL999999]
NR 34
TC 50
Z9 54
U1 0
U2 1
PU RADIOLOGICAL SOC NORTH AMERICA
PI OAK BROOK
PA 820 JORIE BLVD, OAK BROOK, IL 60523 USA
SN 0033-8419
J9 RADIOLOGY
JI Radiology
PD MAY
PY 2004
VL 231
IS 2
BP 500
EP 505
DI 10.1148/radiol.2312021248
PG 6
WC Radiology, Nuclear Medicine & Medical Imaging
SC Radiology, Nuclear Medicine & Medical Imaging
GA 817CH
UT WOS:000221155100029
PM 15128994
ER
PT J
AU Duncan, R
AF Duncan, R
TI DNA microarray analysis of protozoan parasite gene expression: outcomes
correlate with mechanisms of regulation
SO TRENDS IN PARASITOLOGY
LA English
DT Article
ID PLASMODIUM-FALCIPARUM; TOXOPLASMA-GONDII; GENOMIC ORGANIZATION;
TRYPANOSOMA-BRUCEI; CDNA MICROARRAY; LEISHMANIA; PATTERNS;
TRANSCRIPTION; PROTEINS; MALARIA
AB DNA microarray analysis has been successfully applied to most of the protozoan parasites that cause human disease, but has not made equal progress in all cases. The results for kinetoplastid parasites (Leishmania and Trypanosoma) are primarily at the stage of validation and new gene discovery. By contrast, the results for apicomplexan parasites (Plasmodium and Toxoplasma) have advanced to the analysis of coordinate regulation of clusters of genes. This difference in progress relates to the more complete genome sequence identified for the apicomplexans and, more significantly, to the differences in the regulation of gene expression between these two groups.
C1 US FDA, Ctr Biol Evaluat & Res, Div Emerging & Transfus Transmitted Dis, Rockville, MD 20852 USA.
RP Duncan, R (reprint author), US FDA, Ctr Biol Evaluat & Res, Div Emerging & Transfus Transmitted Dis, 1401 Rockville Pk, Rockville, MD 20852 USA.
EM duncan@cber.fda.gov
RI Duncan, Robert/I-8168-2015
OI Duncan, Robert/0000-0001-8409-2501
NR 32
TC 21
Z9 22
U1 0
U2 1
PU ELSEVIER SCI LTD
PI OXFORD
PA THE BOULEVARD, LANGFORD LANE, KIDLINGTON, OXFORD OX5 1GB, OXON, ENGLAND
SN 1471-4922
J9 TRENDS PARASITOL
JI Trends Parasitol.
PD MAY
PY 2004
VL 20
IS 5
BP 211
EP 215
DI 10.1016/j.pt.2004.02.008
PG 5
WC Parasitology
SC Parasitology
GA 820NH
UT WOS:000221396000007
PM 15105020
ER
PT J
AU Mendelsohn, AB
Governale, LA
AF Mendelsohn, AB
Governale, LA
TI The impact of the System to Manage Accutane-Related Teratogenicity (TM)
(SMART (TM)) risk management program on isotretinoin prescribing trends
SO VALUE IN HEALTH
LA English
DT Meeting Abstract
C1 US FDA, Rockville, MD 20857 USA.
CDC, Rockville, MD USA.
NR 0
TC 0
Z9 0
U1 0
U2 0
PU BLACKWELL PUBLISHING INC
PI MALDEN
PA 350 MAIN ST, MALDEN, MA 02148 USA
SN 1098-3015
J9 VALUE HEALTH
JI Value Health
PD MAY-JUN
PY 2004
VL 7
IS 3
BP 263
EP 263
DI 10.1016/S1098-3015(10)62198-5
PG 1
WC Economics; Health Care Sciences & Services; Health Policy & Services
SC Business & Economics; Health Care Sciences & Services
GA 819ZW
UT WOS:000221356600137
ER
PT J
AU Morrato, E
Staffa, J
AF Morrato, E
Staffa, J
TI Analysis of longitudinal claims data to examine first and second-line
use of pemoline (Cylert (R))
SO VALUE IN HEALTH
LA English
DT Meeting Abstract
C1 Johns Hopkins Univ, Bloomberg Sch Publ Hlth, Baltimore, MD 21218 USA.
US FDA, Rockville, MD 20857 USA.
NR 0
TC 0
Z9 0
U1 0
U2 0
PU BLACKWELL PUBLISHING INC
PI MALDEN
PA 350 MAIN ST, MALDEN, MA 02148 USA
SN 1098-3015
J9 VALUE HEALTH
JI Value Health
PD MAY-JUN
PY 2004
VL 7
IS 3
BP 282
EP 282
DI 10.1016/S1098-3015(10)62254-1
PG 1
WC Economics; Health Care Sciences & Services; Health Policy & Services
SC Business & Economics; Health Care Sciences & Services
GA 819ZW
UT WOS:000221356600193
ER
PT J
AU Bright, R
Mermel, L
Richards, C
Yoder, D
AF Bright, R
Mermel, L
Richards, C
Yoder, D
TI Mechanical and allergic adverse events related to central vascular
catheters: Epidemiology in the Medicare hospitalized surgical
population, 2002
SO VALUE IN HEALTH
LA English
DT Meeting Abstract
C1 US FDA, Rockville, MD 20857 USA.
Brown Med Sch, Providence, RI USA.
Rhode Isl Hosp, Providence, RI USA.
Ctr Dis Control & Prevent, Atlanta, GA USA.
RI Bright, Roselie/D-2240-2016
NR 0
TC 0
Z9 0
U1 0
U2 0
PU BLACKWELL PUBLISHING INC
PI MALDEN
PA 350 MAIN ST, MALDEN, MA 02148 USA
SN 1098-3015
J9 VALUE HEALTH
JI Value Health
PD MAY-JUN
PY 2004
VL 7
IS 3
BP 331
EP 332
DI 10.1016/S1098-3015(10)62411-4
PG 2
WC Economics; Health Care Sciences & Services; Health Policy & Services
SC Business & Economics; Health Care Sciences & Services
GA 819ZW
UT WOS:000221356600350
ER
PT J
AU Bright, R
Cope, J
AF Bright, R
Cope, J
TI Tampon-related toxic shock syndrome (TSS) continues to peak among
adolescent girls: A nationwide hospital study
SO VALUE IN HEALTH
LA English
DT Meeting Abstract
C1 US FDA, Rockville, MD 20857 USA.
RI Bright, Roselie/D-2240-2016
NR 0
TC 0
Z9 0
U1 0
U2 1
PU BLACKWELL PUBLISHING INC
PI MALDEN
PA 350 MAIN ST, MALDEN, MA 02148 USA
SN 1098-3015
J9 VALUE HEALTH
JI Value Health
PD MAY-JUN
PY 2004
VL 7
IS 3
BP 352
EP 352
DI 10.1016/S1098-3015(10)62474-6
PG 1
WC Economics; Health Care Sciences & Services; Health Policy & Services
SC Business & Economics; Health Care Sciences & Services
GA 819ZW
UT WOS:000221356600413
ER
PT J
AU Drum, B
AF Drum, B
TI FDA regulation of labeling and promotional claims in therapeutic color
vision devices: A tutorial
SO VISUAL NEUROSCIENCE
LA English
DT Article; Proceedings Paper
CT 17th Biennial Symposium of the International-Colour-Vision-Society
CY JUL, 2003
CL Seattle, WA
SP Int Colour Vision Soc
DE color-vision aid; color vision deficiency; colored prescription lens;
reading discomfort aid; FDA device evaluation
AB The Food and Drug Administration (FDA) is responsible for determining whether medical device manufacturers have provided reasonable assurance, based on valid scientific evidence, that new devices are safe and effective for their intended use before they are introduced into the U.S. market. Most existing color vision devices pose so little risk that their manufacturers are not required to submit a premarket notification [510(k)] to FDA prior to market. However, even low-risk devices may not be acceptable if they are marketed on the basis of misleading or excessive claims. Although most color vision devices are diagnostic, two types that are therapeutic rather than diagnostic are colored lenses intended to improve deficient color vision and colored lenses intended to improve reading performance. Both of these devices have presented special regulatory challenges to FDA because the intended uses and effectiveness claims initially proposed by the manufacturers were not Supported by valid scientific evidence. fro each instance. however, FDA worked with the manufacturer to restrict labeling and promotional claims in ways that were consistent with the available device performance data and that allowed for the legal marketing of the device.
C1 US FDA, CDRH, ODE, DOED, Rockville, MD 20850 USA.
RP Drum, B (reprint author), US FDA, CDRH, ODE, DOED, HFZ-460,9200 Corp Blvd, Rockville, MD 20850 USA.
EM bad@cdrh.fda.gov
NR 3
TC 2
Z9 2
U1 0
U2 1
PU CAMBRIDGE UNIV PRESS
PI NEW YORK
PA 40 WEST 20TH ST, NEW YORK, NY 10011-4211 USA
SN 0952-5238
J9 VISUAL NEUROSCI
JI Visual Neurosci.
PD MAY-JUN
PY 2004
VL 21
IS 3
BP 461
EP 463
DI 10.1017/S0952523804213256
PG 3
WC Neurosciences; Ophthalmology
SC Neurosciences & Neurology; Ophthalmology
GA 863FU
UT WOS:000224547200044
PM 15518230
ER
PT J
AU Verthelyi, D
Wang, VW
Lifson, JD
Klinman, DM
AF Verthelyi, D
Wang, VW
Lifson, JD
Klinman, DM
TI CpG oligodeoxynucleotides improve the response to hepatitis B
immunization in healthy and SIV-infected rhesus macaques
SO AIDS
LA English
DT Article
DE CpG oligodeoxynucleotides; hepatitis B vaccine; rhesus macaques; SIV
ID PLASMACYTOID DENDRITIC CELLS; VIRUS-INFECTION; HIV-1 INFECTION;
BACTERIAL-DNA; VACCINE; MOTIFS; INDIVIDUALS; ACTIVATION; MONOCYTES;
ADJUVANTS
AB Objective: The development of an immunogenic vaccine against hepatitis B virus (HBV) is particularly important for HIV-infected patients since shared epidemiological risks result in HIV-infected subjects having a high incidence of HBV, and coinfection with HBV increases the occurrence of hepatotoxicity with aritiretroviral therapy. Although HBV vaccination is recommended to all HIV-positive patients, its efficacy in these patients is reduced.
Methods: Healthy (n = 15) and SIV-infected (n = 17) rhesus macaques were immunized with Engerix B alone or combined with type D or type K CpG ODN. SIV plasma RNA levels were determined by a real time reverse transcriptase polymerase chain reaction and antibody titers to HBV surface antigen (HbsAg) were measured by enzyme-linked immunosorbent assay every 2 weeks.
Results: In healthy macaques, adding D or K ODN to Engerix B accelerated and boosted the titer of the anti-HbsAg response. In SIV-infected macaques, Engerix B alone elicited no detectable antibody response but a significant response was seen when it was combined with K or D ODN. The antibody titer induced by vaccinating HIV-infected macaques was inversely correlated with their initial viral load, with animals having > 10(7) copies/ml being unable to mount a significant response. No adverse events or changes in SIV viral load were evident during the study.
Conclusions: These findings support the development of clinical studies to assess the use of CpG ODN as an adjuvant for HBV vaccination in healthy and immunocompromised HIV-infected subjects. (C) 2004 Lippinecott Williams Wilkins.
C1 US FDA, Ctr Biol Evaluat & Res, Div Therapeut Prot, Bethesda, MD 20892 USA.
US FDA, Ctr Biol Evaluat & Res, Sect Retroviral Immunol, Bethesda, MD 20892 USA.
NCI, AIDS Vaccine Program, SAIC Frederick, Frederick, MD 21701 USA.
RP Verthelyi, D (reprint author), US FDA, Ctr Biol Evaluat & Res, Div Therapeut Prot, Bldg 29A Rm 3B19,8800 Rockville Pike, Bethesda, MD 20892 USA.
FU NCI NIH HHS [N01-CO-12400]
NR 33
TC 35
Z9 39
U1 0
U2 3
PU LIPPINCOTT WILLIAMS & WILKINS
PI PHILADELPHIA
PA 530 WALNUT ST, PHILADELPHIA, PA 19106-3621 USA
SN 0269-9370
J9 AIDS
JI Aids
PD APR 30
PY 2004
VL 18
IS 7
BP 1003
EP 1008
DI 10.1097/01.aids.0000111474.61782.d1
PG 6
WC Immunology; Infectious Diseases; Virology
SC Immunology; Infectious Diseases; Virology
GA 821OG
UT WOS:000221470100008
PM 15096802
ER
PT J
AU Yue, HF
Strauss, KI
Borenstein, MR
Barbe, MF
Rossi, LJ
Jansen, SA
AF Yue, HF
Strauss, KI
Borenstein, MR
Barbe, MF
Rossi, LJ
Jansen, SA
TI Determination of bioactive eicosanoids in brain tissue by a sensitive
reversed-phase liquid chromatographic method with fluorescence detection
SO JOURNAL OF CHROMATOGRAPHY B-ANALYTICAL TECHNOLOGIES IN THE BIOMEDICAL
AND LIFE SCIENCES
LA English
DT Article
DE eicosanoids
ID ARACHIDONIC-ACID; CARBOXYLIC-ACIDS; P-450 METABOLITES; CYTOCHROME-P-450;
EPOXYGENASE; DERIVATIZATION; ULTRAVIOLET; INJURY
AB Arachidonic acid (AA) is metabolized to prostaglandins (PGs) via cyclooxygenases (COX) catalysis, and to epoxyeicosatrienoic acids (EETs), dihydroxyeicosatrienoic acids (DiHETrEs), and hydroxyeicosatetraenoic acids (HETEs) via cytochrome P450 (CYP450) enzymes. A reliable and robust fluorescence based HPLC method for these eicosanoids was developed. A new selective reverse-phase solid phase extraction (SPE) procedure was developed for PG, DiHETrEs, HETE, and EETs of interest from rat cortical brain tissue. The eicosanoids were derivatized with 2-(2,3-naphthalimino)ethyl-trifluoromethanesulphonate (NE-OTf), followed by separation and quantification at high sensitivity using reverse-phase HPLC with fluorescent detection, and further identified via LC/MS. The derivatization was studied and optimized to obtain reproducible reactions. Various PGs, DiHETrEs, HETEs, EETs, and AA were sensitively detected and baseline resolved simultaneously. LC/MS under positive electrospray ionization selected ion monitoring (SIM) mode was developed to further identify the peaks of these eicosanoids in cortical brain tissue. The method was applied in the traumatic brain injured rat brain. (C) 2004 Elsevier B.V. All rights reserved.
C1 Temple Univ, Dept Chem, Philadelphia, PA 19122 USA.
Univ Cincinnati, Coll Med, Dept Neurosurg, Cincinnati, OH 45267 USA.
Temple Univ, Sch Pharm, Philadelphia, PA 19140 USA.
Temple Univ, Dept Phys Therapy, Philadelphia, PA 19140 USA.
Temple Univ, Dept Anat & Cell Biol, Philadelphia, PA 19140 USA.
US FDA, Philadelphia, PA 19106 USA.
RP Jansen, SA (reprint author), Temple Univ, Dept Chem, 1901 N 13th St, Philadelphia, PA 19122 USA.
EM suebee@unix.temple.edu
FU NINDS NIH HHS [R01 NS038654-03]
NR 26
TC 35
Z9 38
U1 0
U2 5
PU ELSEVIER SCIENCE BV
PI AMSTERDAM
PA PO BOX 211, 1000 AE AMSTERDAM, NETHERLANDS
SN 1570-0232
J9 J CHROMATOGR B
JI J. Chromatogr. B
PD APR 25
PY 2004
VL 803
IS 2
BP 267
EP 277
DI 10.1016/j.jchromb.2003.12.027
PG 11
WC Biochemical Research Methods; Chemistry, Analytical
SC Biochemistry & Molecular Biology; Chemistry
GA 809MG
UT WOS:000220640200012
PM 15063335
ER
PT J
AU Werler, M
McCloskey, C
Edmonds, LD
Olney, R
Honein, MA
Reefhuis, J
AF Werler, M
McCloskey, C
Edmonds, LD
Olney, R
Honein, MA
Reefhuis, J
CA CDCP
TI Evaluation of an association between loratadine and hypospadias - United
States, 1997-2001 (Reprinted from MMWR, vol 53, pg 219-221, 2004)
SO JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION
LA English
DT Reprint
ID BIRTH-DEFECTS PREVENTION; PREGNANCY
C1 Boston Univ, Sch Publ Hlth, Slone Epidemiol Ctr, Boston, MA 02215 USA.
US FDA, Ctr Drug Evaluat & Res, Rockville, MD 20857 USA.
NCBDDD, Div Birth Defects & Dev Disabil, Atlanta, GA USA.
CDC, Atlanta, GA USA.
RP Werler, M (reprint author), Boston Univ, Sch Publ Hlth, Slone Epidemiol Ctr, Boston, MA 02215 USA.
RI Reefhuis, Jennita/E-1793-2011
OI Reefhuis, Jennita/0000-0002-4747-4831
NR 10
TC 2
Z9 2
U1 3
U2 3
PU AMER MEDICAL ASSOC
PI CHICAGO
PA 515 N STATE ST, CHICAGO, IL 60610 USA
SN 0098-7484
J9 JAMA-J AM MED ASSOC
JI JAMA-J. Am. Med. Assoc.
PD APR 21
PY 2004
VL 291
IS 15
BP 1828
EP 1830
PG 3
WC Medicine, General & Internal
SC General & Internal Medicine
GA 812XC
UT WOS:000220871200010
ER
PT J
AU Xu, B
Bhattacharjee, A
Roy, B
Feldman, GM
Cathcart, MK
AF Xu, B
Bhattacharjee, A
Roy, B
Feldman, GM
Cathcart, MK
TI Role of protein kinase C isoforms in the regulation of
interleukin-13-induced 15-lipoxygenase gene expression in human
monocytes
SO JOURNAL OF BIOLOGICAL CHEMISTRY
LA English
DT Article
ID HUMAN ATHEROSCLEROTIC PLAQUES; STAT1 SERINE PHOSPHORYLATION; CENTRIFUGAL
ELUTRIATION CCE; SUPEROXIDE ANION PRODUCTION; MONONUCLEAR CELL SUBSETS;
POLAR STEROL ESTERS; TYROSINE PHOSPHORYLATION; ENRICHED FRACTIONS;
ENDOTHELIAL-CELLS; HUMAN ATHEROMA
AB We reported previously that interleukin-13 (IL-13) induces tyrosine phosphorylation/activation of Jak2 and Tyk2 kinases and Stats 1, 3, 5, and 6 in primary human monocytes. We recently revealed that p38 MAPK-mediated serine phosphorylation of both Stat1 and Stat3 is required for the induction of 15-lipoxygenase (15-LO) expression by IL-13. In this study, we present data indicating that another serine/threonine kinase, PKCdelta, is also required for IL-13-induced 15-LO expression. PKCdelta, a member of the novel protein kinase C (PKC) subclass, was rapidly phosphorylated and activated upon exposure to IL-13. Treatment of cells with rottlerin, a PKCdelta inhibitor, blocked IL-13-induced 15-LO mRNA and protein expression, whereas Go6976, an inhibitor of the conventional PKC subclass, had no inhibitory effects. Down-regulation of cellular PKCdelta protein levels by PKCdelta-specific antisense oligodeoxyribonucleotides also inhibited 15-LO expression markedly. IL-13-induced 15-LO expression resulted in significant inhibition of synthesis of the potent chemotactic factor leukotriene B-4, and that process was reversed by rottlerin, presumably through the blockage of PKCdelta-dependent 15-LO expression. Furthermore, our data demonstrate that IL-13-mediated activation of PKCdelta and p38 MAPK are independent pathways, because inhibition of one kinase activity had no effect on the other, suggesting that the two pathways act in parallel to regulate the downstream targets necessary for 15-LO expression. Inhibition of PKCdelta activation by rottlerin also markedly attenuated IL-13-induced Stat3 DNA binding activity. Our findings indicate that PKCdelta plays an important role in regulating IL-13-induced 15-LO expression in human monocytes and subsequently modulates the inflammatory responses mediated by 15-LO products.
C1 Cleveland Clin Fdn, Dept Cell Biol, Lerner Res Inst, Cleveland, OH 44195 USA.
US FDA, Ctr Biol Evaluat & Res, Div Monoclonal Antibodies, Off Therapeut Res & Review, Bethesda, MD 20892 USA.
RP Cathcart, MK (reprint author), Cleveland Clin Fdn, Dept Cell Biol, Lerner Res Inst, 9500 Euclid Ave, Cleveland, OH 44195 USA.
EM cathcam@ccf.org
FU NHLBI NIH HHS [HL51068]
NR 45
TC 22
Z9 24
U1 0
U2 0
PU AMER SOC BIOCHEMISTRY MOLECULAR BIOLOGY INC
PI BETHESDA
PA 9650 ROCKVILLE PIKE, BETHESDA, MD 20814-3996 USA
SN 0021-9258
J9 J BIOL CHEM
JI J. Biol. Chem.
PD APR 16
PY 2004
VL 279
IS 16
BP 15954
EP 15960
DI 10.1074/jbc.M400413200
PG 7
WC Biochemistry & Molecular Biology
SC Biochemistry & Molecular Biology
GA 811BR
UT WOS:000220747900032
PM 14757756
ER
PT J
AU Morel, F
Rauch, C
Petit, E
Piton, A
Theret, N
Coles, B
Guillouzo, A
AF Morel, F
Rauch, C
Petit, E
Piton, A
Theret, N
Coles, B
Guillouzo, A
TI Gene and protein characterization of the human glutathione S-transferase
Kappa and evidence for a peroxisomal localization*
SO JOURNAL OF BIOLOGICAL CHEMISTRY
LA English
DT Article
ID 2-HYDROXYCHROMENE-2-CARBOXYLATE ISOMERASE; CHROMOSOMAL LOCALIZATION;
GENOMIC ORGANIZATION; PEROXIDASE ACTIVITY; METABOLISM; SEQUENCE;
CLUSTER; BINDING; ENZYME; ALPHA
AB Kappa class glutathione S-transferase (GST) cDNA sequences have been identified in rat, mouse, and human. In the present study, we determined the structure and chromosomal location of the human GST Kappa 1 (hGSTK1) gene, characterized the protein, and demonstrated its subcellular localization. The human gene spans similar to5 kb, has 8 exons, and maps onto chromosome 7q34. The 5'-flanking region lacks TATA or CCAAT boxes, but there is an initiator element overlapping the transcription start site. hGSTK1 amino acid sequence showed homology to bacterial 2-hydroxychromene-2-carboxylate isomerase, an enzyme involved in naphthalene degradation pathway. hGSTK1 mRNA was expressed in all of the organs examined. Subcellular fractionation of HepG2 cells showed that the protein was located in peroxisomes and mitochondria and was not detectable in cytoplasm. The peroxisomal localization was confirmed by transfection of HepG2 cells with a plasmid coding a green fluorescent protein fused in-frame to the N terminus of hGSTK1. The C terminus of hGSTK1 was essential for localization of the protein to peroxisomes, and the C-terminal sequence Ala-Arg-Leu represents a peroxisome targeting signal. This is the first time that a human GST has been found in peroxisomes, suggesting a new function for this family of enzymes.
C1 Univ Rennes 1, INSERM, U456, F-35043 Rennes, France.
Natl Ctr Toxicol Res, Div Mol Epidemiol, Jefferson, AR 72079 USA.
RP Morel, F (reprint author), Univ Rennes 1, INSERM, U456, 2 Ave Prof Leon Bernard, F-35043 Rennes, France.
EM Fabrice.Morel@rennes.inserm.fr
RI Theret, Nathalie/I-2871-2015;
OI Piton, Amelie/0000-0003-0408-7468
NR 38
TC 75
Z9 78
U1 1
U2 2
PU AMER SOC BIOCHEMISTRY MOLECULAR BIOLOGY INC
PI BETHESDA
PA 9650 ROCKVILLE PIKE, BETHESDA, MD 20814-3996 USA
SN 0021-9258
J9 J BIOL CHEM
JI J. Biol. Chem.
PD APR 16
PY 2004
VL 279
IS 16
BP 16246
EP 16253
DI 10.1074/jbc.M313357200
PG 8
WC Biochemistry & Molecular Biology
SC Biochemistry & Molecular Biology
GA 811BR
UT WOS:000220747900068
PM 14742434
ER
PT J
AU Bhattacharya, B
Miura, T
Brandenberger, R
Mejido, J
Luo, YQ
Yang, AX
Joshi, BH
Ginis, I
Thies, RS
Amit, M
Lyons, I
Condie, BG
Itskovitz-Eldor, J
Rao, MS
Puri, RK
AF Bhattacharya, B
Miura, T
Brandenberger, R
Mejido, J
Luo, YQ
Yang, AX
Joshi, BH
Ginis, I
Thies, RS
Amit, M
Lyons, I
Condie, BG
Itskovitz-Eldor, J
Rao, MS
Puri, RK
TI Gene expression in human embryonic stem cell lines: unique molecular
signature
SO BLOOD
LA English
DT Article
ID ZINC-FINGER PROTEIN; IN-VITRO; DIFFERENTIATION; MICROARRAY;
PLURIPOTENCY; NEURONS; PRECURSORS; PROGRAMS; CLONING; NANOG
AB Human embryonic stem (huES) cells have the ability to differentiate into a variety of cell lineages and potentially provide a source of differentiated cells for many therapeutic uses. However, little is known about the mechanism of differentiation of huES cells and factors regulating cell development. We have used high-quality microarrays containing 16 659 seventy-base pair oligonucleotides to examine gene expression in 6 of the 11 available huES cell lines. Expression was compared against pooled RNA from multiple tissues (universal RNA) and genes enriched in huES cells were identified. All 6 cell lines expressed multiple markers of the undifferentiated state and shared significant homology in gene expression (overall similarity coefficient > 0.85). A common subset of 92 genes was identified that included Nanog, GTCM-1, connexin 43 (GJA1), oct-4, and TDGF1 (cripto). Gene expression was confirmed by a variety of techniques including comparison with databases, reverse transcriptase-polymerase chain reaction, focused cDNA microarrays, and immunocytochemistry. Comparison with published "sternness" genes revealed a limited overlap, suggesting little similarity with other stem cell populations. Several novel ES cell-specific expressed sequence tags were identified and mapped to the human genome. These results represent the first detailed characterization of undifferentiated huES cells and provide a unique set of markers to profile and better understand the biology of huES cells.
C1 NIH, Lab Mol Tumor Biol, Div Cellular & Gene Therapies, Ctr Biol Evaluat & Res,Food & Drug Adm, Bethesda, MD 20892 USA.
NIA, Neurosci Lab, Baltimore, MD 21224 USA.
Geron Corp, Menlo Pk, CA USA.
BresaGen Inc, Athens, GA USA.
Univ Georgia, Dept Genet, Athens, GA 30602 USA.
Rambam Med Ctr, Dept Obstet & Gynecol, IL-31096 Haifa, Israel.
Fac Med, Haifa, Israel.
RP Puri, RK (reprint author), NIH, Lab Mol Tumor Biol, Div Cellular & Gene Therapies, Ctr Biol Evaluat & Res,Food & Drug Adm, Bldg 29B,Rm 2NN22,29 Lincoln Dr, Bethesda, MD 20892 USA.
EM raomah@grc.nia.nih.gov
FU NIAMS NIH HHS [PAR-02-023]
NR 42
TC 284
Z9 304
U1 1
U2 8
PU AMER SOC HEMATOLOGY
PI WASHINGTON
PA 1900 M STREET. NW SUITE 200, WASHINGTON, DC 20036 USA
SN 0006-4971
J9 BLOOD
JI Blood
PD APR 15
PY 2004
VL 103
IS 8
BP 2956
EP 2964
DI 10.1182/blood-2003-09-3314
PG 9
WC Hematology
SC Hematology
GA 830ZU
UT WOS:000222163500025
PM 15070671
ER
PT J
AU Twaddle, NC
McDaniel, LP
da Costa, GG
Churchwell, MI
Belanda, FA
Doerge, DR
AF Twaddle, NC
McDaniel, LP
da Costa, GG
Churchwell, MI
Belanda, FA
Doerge, DR
TI Determination of acrylamide and glycidamide serum toxicokinetics in
B6C3F(1) mice using LC-ES/MS/MS
SO CANCER LETTERS
LA English
DT Article
DE acrylamide; glycidamide; mass spectrometry; toxicokinetics
ID HEMOGLOBIN ADDUCTS; MASS-SPECTROMETRY; MAILLARD REACTION; RAT;
METABOLISM; MOUSE; INTRAPERITONEAL; ACRYLONITRILE; EXPOSURE; WORKERS
AB Acrylamide (AA) is a well-studied industrial toxicant; however, recent findings of AA at ppm levels in cooked starchy foods have refocused attention on the potential for neurotoxicity, germ cell mutagenicity, and carcinogenicity from AA. Oxidative metabolism of AA to glycidamide (GA) in experimental animals has previously been linked with many toxic effects of AA exposure. We report a new sensitive and selective analytical method, based on LC with electrospray tandem mass spectrometry, for the quantification of AA and GA in serum and its application to a preliminary toxicokinetic evaluation of AA and GA in adult 1360171 mice following oral administration of AA. (C) 2004 Elsevier Ireland Ltd. All rights reserved.
C1 Natl Ctr Toxicol Res, Div Biochem Toxicol, Jefferson, AR 72079 USA.
Univ Tecn Lisboa, Ctr Quim Estrutural, Inst Super Tecn, P-1049001 Lisbon, Portugal.
RP Doerge, DR (reprint author), Natl Ctr Toxicol Res, Div Biochem Toxicol, 3900 NCTR Rd, Jefferson, AR 72079 USA.
EM ddoerge@nctr.fda.gov
NR 30
TC 47
Z9 47
U1 0
U2 7
PU ELSEVIER IRELAND LTD
PI CLARE
PA ELSEVIER HOUSE, BROOKVALE PLAZA, EAST PARK SHANNON, CO, CLARE, 00000,
IRELAND
SN 0304-3835
J9 CANCER LETT
JI Cancer Lett.
PD APR 15
PY 2004
VL 207
IS 1
BP 9
EP 17
DI 10.1016/j.canlet.2003.10.017
PG 9
WC Oncology
SC Oncology
GA 813UI
UT WOS:000220931600002
PM 15050729
ER
PT J
AU Chou, MW
Yan, J
Nichols, J
Xia, QS
Beland, FA
Chan, PC
Fu, PP
AF Chou, MW
Yan, J
Nichols, J
Xia, QS
Beland, FA
Chan, PC
Fu, PP
TI Correlation of DNA adduct formation and riddelliine-induced liver
tumorigenesis in F344 rats and B6C3F(1) mice (vol 193, pg 119, 2003)
SO CANCER LETTERS
LA English
DT Correction
ID CARCINOGENIC ACTIVITY; PYRROLIZIDINE ALKALOIDS; CELL SPECIFICITY;
HEPATIC-TUMORS; IN-VIVO; 2-ACETYLAMINOFLUORENE; HEPATOCYTES; INDUCTION;
REPAIR; HONEY
AB The Publisher regrets that in the original printing of the above-mentioned paper, the citations to the references were missing on pages 119, 122 and 123 of the printed paper. The missing references are now included in the following article.
C1 Natl Ctr Toxicol Res, Div Biochem Toxicol, Jefferson, AR 72079 USA.
Natl Inst Environm Hlth Res, Res Triangle Pk, NC 22709 USA.
RP Chou, MW (reprint author), Natl Ctr Toxicol Res, Div Biochem Toxicol, Jefferson, AR 72079 USA.
EM mchou@nctr.fda.gov
NR 24
TC 1
Z9 1
U1 1
U2 3
PU ELSEVIER SCI IRELAND LTD
PI CLARE
PA CUSTOMER RELATIONS MANAGER, BAY 15, SHANNON INDUSTRIAL ESTATE CO, CLARE,
IRELAND
SN 0304-3835
J9 CANCER LETT
JI Cancer Lett.
PD APR 15
PY 2004
VL 207
IS 1
BP 117
EP +
DI 10.1016/j.canlet.2003.11.004
PG 8
WC Oncology
SC Oncology
GA 813UI
UT WOS:000220931600014
ER
PT J
AU Fleischer, R
Boxwell, D
Sherman, KE
AF Fleischer, R
Boxwell, D
Sherman, KE
TI Nucleoside analogues and mitochondrial toxicity
SO CLINICAL INFECTIOUS DISEASES
LA English
DT Article
ID RIBAVIRIN
AB An evaluation of the US Food and Drug Administration's Adverse Event Reporting System identified that patients coinfected with human immunodeficiency virus and chronic hepatitis C virus who were treated with a regimen of ribavirin and didanosine, with or without stavudine, were at increased risk for events associated with mitochondrial toxicity, including fatal hepatic failure, peripheral neuropathy, pancreatitis, and symptomatic hyperlactatemia/ lactic acidosis. In response, the US product labels for didanosine and ribavirin have been revised to caution clinicians against coadministration of these drugs.
C1 US FDA, Div Antiviral Drug Prod, Ctr Drug Evaluat & Res, Rockville, MD 20857 USA.
US FDA, Off Drug Safety, Ctr Drug Evaluat & Res, Rockville, MD 20857 USA.
Univ Cincinnati, Coll Med, Dept Internal Med, Div Digest Dis, Cincinnati, OH 45221 USA.
RP Fleischer, R (reprint author), US FDA, Div Antiviral Drug Prod, Ctr Drug Evaluat & Res, HFD-530, Rockville, MD 20857 USA.
EM fleischerr@cder.fda.gov
NR 5
TC 57
Z9 58
U1 0
U2 1
PU UNIV CHICAGO PRESS
PI CHICAGO
PA 1427 E 60TH ST, CHICAGO, IL 60637-2954 USA
SN 1058-4838
J9 CLIN INFECT DIS
JI Clin. Infect. Dis.
PD APR 15
PY 2004
VL 38
IS 8
BP E79
EP E80
DI 10.1086/383151
PG 2
WC Immunology; Infectious Diseases; Microbiology
SC Immunology; Infectious Diseases; Microbiology
GA 810WU
UT WOS:000220735200034
PM 15095236
ER
PT J
AU Doublet, B
Carattoli, A
Whichard, JM
White, DG
Baucheron, S
Chaslus-Dancla, E
Cloeckaert, A
AF Doublet, B
Carattoli, A
Whichard, JM
White, DG
Baucheron, S
Chaslus-Dancla, E
Cloeckaert, A
TI Plasmid-mediated florfenicol and ceftriaxone resistance encoded by the
floR and bla(CMY-2) genes in Salmonella enterica serovars Typhimurium
and Newport isolated in the United States
SO FEMS MICROBIOLOGY LETTERS
LA English
DT Article
DE Salmonella; multidrug resistance; phenicols; cephalosporins; plasmid;
conjugation
ID ESCHERICHIA-COLI; BETA-LACTAMASE; STRAINS; ANIMALS; IDENTIFICATION;
SEQUENCE; CMY-2
AB Multidrug resistance plasmids carrying the bla(CMY-2) gene have been identified in Salmonella enterica serovars Typhimurium and Newport from the United States. This gene confers decreased susceptibility to ceftriaxone, and is most often found in strains with concomitant resistance to ampicillin, chloramphenicol, streptomycin, sulfamethoxazole and tetracycline. The bla(CMY-2)-carrying plasmids studied here were shown to also carry the florfenicol resistance gene, floR, on a genetic structure previously identified in Escherichia coli plasmids in Europe. These data indicate that the use of different antimicrobial agents, including phenicols, may serve to maintain multidrug resistance plasmids on which extended-spectrum cephalosporin resistance determinants co-exist with other resistance genes in Salmonella. (C) 2004 Published by Elsevier B.V. on behalf of the Federation of European Microbiological Societies.
C1 INRA, Unite Bioagresseurs, F-37380 Nouzilly, France.
Ist Super Sanita, Batteriol & Micol Med Lab, I-00161 Rome, Italy.
CDCP, Natl Ctr Infect Dis, Div Bacterial & Mycot Dis, Foodborne & Diarrheal Dis Branch, Atlanta, GA 30333 USA.
US FDA, Ctr Vet Med, Laurel, MD 20708 USA.
RP Cloeckaert, A (reprint author), INRA, Unite Bioagresseurs, F-37380 Nouzilly, France.
EM cloeckae@tours.inra.fr
NR 20
TC 27
Z9 30
U1 1
U2 6
PU ELSEVIER SCIENCE BV
PI AMSTERDAM
PA PO BOX 211, 1000 AE AMSTERDAM, NETHERLANDS
SN 0378-1097
J9 FEMS MICROBIOL LETT
JI FEMS Microbiol. Lett.
PD APR 15
PY 2004
VL 233
IS 2
BP 301
EP 305
DI 10.1016/j.femsle.2004.02.023
PG 5
WC Microbiology
SC Microbiology
GA 812BQ
UT WOS:000220815400017
PM 15063500
ER
PT J
AU Baylor, MS
Johann-Liang, R
AF Baylor, MS
Johann-Liang, R
TI Hepatotoxicity associated with nevirapine use
SO JAIDS-JOURNAL OF ACQUIRED IMMUNE DEFICIENCY SYNDROMES
LA English
DT Letter
C1 US FDA, Div Antiviral Drug Prod, Rockville, MD 20857 USA.
RP Baylor, MS (reprint author), US FDA, Div Antiviral Drug Prod, Rockville, MD 20857 USA.
NR 9
TC 70
Z9 77
U1 0
U2 0
PU LIPPINCOTT WILLIAMS & WILKINS
PI PHILADELPHIA
PA 530 WALNUT ST, PHILADELPHIA, PA 19106-3621 USA
SN 1525-4135
J9 JAIDS-J ACQ IMM DEF
JI JAIDS
PD APR 15
PY 2004
VL 35
IS 5
BP 538
EP 539
DI 10.1097/00126334-200404150-00014
PG 2
WC Immunology; Infectious Diseases
SC Immunology; Infectious Diseases
GA 809JC
UT WOS:000220632000014
PM 15021321
ER
PT J
AU Pogribny, IP
James, SJ
Jernigan, S
Pogribna, M
AF Pogribny, IP
James, SJ
Jernigan, S
Pogribna, M
TI Genomic hypomethylation is specific for preneoplastic liver in
folate/methyl deficient rats and does not occur in non-target tissues
SO MUTATION RESEARCH-FUNDAMENTAL AND MOLECULAR MECHANISMS OF MUTAGENESIS
LA English
DT Article
DE DNA hypomethylation; DNA methyltransferase; rat folate/methyl deficiency
ID PERICENTROMERIC SATELLITE REGIONS; HUMAN HEPATOCELLULAR-CARCINOMA;
CPG-BINDING PROTEINS; DNA-METHYLTRANSFERASE; METHYLATION PATTERNS; HUMAN
HEPATOCARCINOGENESIS; MESSENGER-RNA; CANCER-CELLS; P53 GENE; EXPRESSION
AB Chronic dietary insufficiency of the lipotropic nutrients choline and methionine is hepatocarcinogenic in male rats and certain mouse strains. Despite the fact that DNA hypomethylation is a hallmark of most cancer genomes, the tissue-specific consequences of this alternation with respect to tumorigenesis remain to be determined. In the present study, the folate/methyl deficient model of multistage hepatocarcinogenesis was used to evaluate in vivo alterations in DNA methylation in the liver, the carcinogenesis target tissue, and in non-target tissues, including pancreas, spleen, kidney, and thymus, of male F344 rats. By utilizing the HpaII/MspI-based cytosine extension assay, we demonstrated that the percent of CpG sites that lost methyl groups on both strands progressively increased in liver tissue after 9, 18, and 36 weeks of folate/methyl deficiency. The endogenous activity of DNA methyltransferase in liver of rats fed with folate/methyl deficient diet for the 36-week period Gradually increased with time. In contrast, non-target tissues displayed no changes in DNA methylation level or activity of DNA methyltransferase. The failure of DNA methyltransferase to restore and maintain DNA methylation patterns in preneoplastic liver tissue may lead to the establishment of tumor-specific DNA methylation and DNA methyltransferase profiles that are not expressed in normal liver. These results provide additional information about alterations in DNA methylation during early preneoplastic stages of carcinogenesis. They also demonstrate that DNA hypomethylation is localized to tissue that undergoes carcinogenesis, and is not altered in non-target tissues. (C) 2004 Elsevier B.V. All rights reserved.
C1 US FDA, Natl Ctr Toxicol Res, Div Biochem Toxicol, Jefferson, AR 72079 USA.
Univ Arkansas Med Sci, Dept Pediat, Little Rock, AR 72205 USA.
RP Pogribny, IP (reprint author), US FDA, Natl Ctr Toxicol Res, Div Biochem Toxicol, 3900 NCTR Rd, Jefferson, AR 72079 USA.
EM ipogribny@nctr.fda.gov
NR 31
TC 81
Z9 83
U1 0
U2 1
PU ELSEVIER SCIENCE BV
PI AMSTERDAM
PA PO BOX 211, 1000 AE AMSTERDAM, NETHERLANDS
SN 0027-5107
J9 MUTAT RES-FUND MOL M
JI Mutat. Res.-Fundam. Mol. Mech. Mutagen.
PD APR 14
PY 2004
VL 548
IS 1-2
BP 53
EP 59
DI 10.1016/j.mrfmmm.2003.12.014
PG 7
WC Biotechnology & Applied Microbiology; Genetics & Heredity; Toxicology
SC Biotechnology & Applied Microbiology; Genetics & Heredity; Toxicology
GA 814BA
UT WOS:000220949000007
PM 15063136
ER
PT J
AU Kovalchuk, O
Burke, P
Besplug, J
Slovack, M
Filkowski, J
Pogribny, I
AF Kovalchuk, O
Burke, P
Besplug, J
Slovack, M
Filkowski, J
Pogribny, I
TI Methylation changes in muscle and liver tissues of male and female mice
exposed to acute and chronic low-dose X-ray-irradiation
SO MUTATION RESEARCH-FUNDAMENTAL AND MOLECULAR MECHANISMS OF MUTAGENESIS
LA English
DT Article
DE ionizing radiation; low doses; global genome methylation; promoter
methylation; gene expression; p16(INK alpha); MGMT
ID INDUCED GENOMIC INSTABILITY; IONIZING-RADIATION; DNA METHYLATION;
PROMOTER HYPERMETHYLATION; CHERNOBYL ACCIDENT; TUMOR-SUPPRESSOR;
MOUSE-TISSUES; MUTATION-RATE; CPG ISLANDS; GENE
AB The biological and genetic effects of chronic low-dose radiation (LDR) exposure and its relationship to carcinogenesis have received a lot of attention in the recent years. For example, radiation-induced genome instability, which is thought to be a precursor of tumorogenesis, was shown to have a transgenerational nature. This indicates a possible involvement of epigenetic mechanisms in LDR-induced genome instability. Genomic DNA methylation is one of the most important epigenetic mechanisms. Existing data on radiation effects on DNA methylation patterns is limited, and no one has specifically studied the effects of the LDR. We report the first study of the effects of whole-body LDR exposure on global genome methylation in muscle and liver tissues of male and female mice. In parallel, we evaluated changes in promoter methylation and expression of the tumor suppressor gene p16(INKa) and DNA repair gene O-6-methylguanine-DNA methyltransferase (MGMT).
We observed different patterns of radiation-induced global genome DNA methylation in the liver and muscle of exposed males and females. We also found sex and tissue-specific differences in p16(INKa) promoter methylation upon LDR exposure. In male liver tissue, p16(INKa) promoter methylation was more pronounced than in female tissue. In contrast, no significant radiation-induced changes in p16(INKa) promoter methylation were noted in the muscle tissue of exposed males and females. Radiation also did not significantly affect methylation status of MGMT promoter. We also observed substantial sex differences in acute and chronic radiation-induced expression of p16(INKa) and MGMT genes. Another important outcome of our study was the fact that chronic low-dose radiation exposure proved to be a more potent inducer of epigenetic effects than the acute exposure. This supports previous findings that chronic exposure leads to greater genome destabilization than acute exposure. (C) 2004 Elsevier B.V. All rights reserved.
C1 Univ Lethbridge, Dept Biol Sci, Lethbridge, AB T1K 3M4, Canada.
Natl Ctr Toxicol Res, Div Biochem Toxicol, Jefferson, AR 72079 USA.
RP Kovalchuk, O (reprint author), Univ Lethbridge, Dept Biol Sci, 4401 Univ Dr, Lethbridge, AB T1K 3M4, Canada.
EM olga.kovalchuk@uleth.ca
NR 40
TC 58
Z9 70
U1 1
U2 7
PU ELSEVIER SCIENCE BV
PI AMSTERDAM
PA PO BOX 211, 1000 AE AMSTERDAM, NETHERLANDS
SN 0027-5107
J9 MUTAT RES-FUND MOL M
JI Mutat. Res.-Fundam. Mol. Mech. Mutagen.
PD APR 14
PY 2004
VL 548
IS 1-2
BP 75
EP 84
DI 10.1016/j.mrfmmm.2003.12.01
PG 10
WC Biotechnology & Applied Microbiology; Genetics & Heredity; Toxicology
SC Biotechnology & Applied Microbiology; Genetics & Heredity; Toxicology
GA 814BA
UT WOS:000220949000009
PM 15063138
ER
PT J
AU Auch, CJ
Saha, RN
Sheikh, FG
Liu, XJ
Jacobs, BL
Pahan, K
AF Auch, CJ
Saha, RN
Sheikh, FG
Liu, XJ
Jacobs, BL
Pahan, K
TI Role of protein kinase R in double-stranded RNA-induced expression of
nitric oxide synthase in human astroglia
SO FEBS LETTERS
LA English
DT Article
DE double-stranded RNA; human astroglia; inducible nitric oxide synthase;
nuclear factor-kappa B; CCAAT/enhancer-binding protein beta
ID CENTRAL-NERVOUS-SYSTEM; HUMAN CORONAVIRUS OC43; NF-KAPPA-B; HUMAN
ASTROCYTES; ACTIVATION; INDUCTION; INFECTION; GENE; PKR; INHIBITION
AB Environmental factor(s), such as viral infection, has been implicated as one of the triggering events leading to neuro-inflammation in multiple sclerosis. This study underlines the importance of double-stranded RNA (dsRNA), the active component of a viral infection, in inducing the expression of inducible nitric oxide synthase (iNOS) in human astroglia. DsRNA in the form of synthetic polyinosinic-polycytidylic acid (poly IC) induced expression of iNOS and iNOS promoter-driven luciferase activity through activation of nuclear factor (NF)-kappaB and CCAAT/enhancer-binding proteinbeta (C/EBPbeta). In addition, we show that inhibitors of protein kinase R attenuated iNOS by suppressing the activation of NF-kappaB but not C/EBPbeta. In contrast, knock down of p38 mitogen-activated protein kinase (MAPK) attenuated iNOS by suppressing the activation of C/EBPbeta but not NF-kappaB. This study delineates a novel role of dsRNA in inducing the expression of iNOS through dsRNA-activated protein kinase (PKR)-mediated activation of NF-kappaB and p38-mediated activation of C/EBPbeta in human astroglia that may participate in virus-induced neurological abnormalities. (C) 2004 Published by Elsevier B.V. on behalf of the Federation of European Biochemical Societies.
C1 Univ Nebraska, Med Ctr, Dept Oral Biol, Lincoln, NE 68583 USA.
US FDA, Div Therapeut Prot, Bethesda, MD 20892 USA.
Arizona State Univ, Dept Microbiol, Tempe, AZ 85287 USA.
RP Pahan, K (reprint author), Univ Nebraska, Med Ctr, Dept Oral Biol, 40th & Holdrege, Lincoln, NE 68583 USA.
EM kpahan@unmc.edu
RI Saha, Ramendra/C-7000-2014
OI Saha, Ramendra/0000-0002-5494-2584
FU NINDS NIH HHS [R01 NS039940-03, NS39940, R01 NS039940]
NR 28
TC 33
Z9 33
U1 0
U2 2
PU ELSEVIER SCIENCE BV
PI AMSTERDAM
PA PO BOX 211, 1000 AE AMSTERDAM, NETHERLANDS
SN 0014-5793
J9 FEBS LETT
JI FEBS Lett.
PD APR 9
PY 2004
VL 563
IS 1-3
BP 223
EP 228
DI 10.1016/S0014-5793(04)00302-3
PG 6
WC Biochemistry & Molecular Biology; Biophysics; Cell Biology
SC Biochemistry & Molecular Biology; Biophysics; Cell Biology
GA 811LK
UT WOS:000220773200042
PM 15063753
ER
PT J
AU Hasan, RK
Wulfkuhle, JD
Liotta, LA
Petricoin, EF
AF Hasan, RK
Wulfkuhle, JD
Liotta, LA
Petricoin, EF
TI Molecular technologies for personalized cancer management
SO JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION
LA English
DT Article
ID PHASE PROTEIN MICROARRAYS; BREAST-CANCER; OVARIAN-CANCER; CHEMOTHERAPY;
SURVIVAL; PROGRESSION; MUTATIONS; DNA
C1 Johns Hopkins Univ, Sch Med, Baltimore, MD 21205 USA.
NCI, Bethesda, MD 20892 USA.
US FDA, Bethesda, MD 20014 USA.
RP Hasan, RK (reprint author), Johns Hopkins Univ, Sch Med, Baltimore, MD 21205 USA.
NR 20
TC 3
Z9 3
U1 0
U2 2
PU AMER MEDICAL ASSOC
PI CHICAGO
PA 515 N STATE ST, CHICAGO, IL 60610 USA
SN 0098-7484
J9 JAMA-J AM MED ASSOC
JI JAMA-J. Am. Med. Assoc.
PD APR 7
PY 2004
VL 291
IS 13
BP 1644
EP 1645
DI 10.1001/jama.291.13.1644
PG 2
WC Medicine, General & Internal
SC General & Internal Medicine
GA 809PQ
UT WOS:000220649000033
PM 15069056
ER
PT J
AU Andrzejewski, D
Roach, JAG
Gay, ML
Musser, SM
AF Andrzejewski, D
Roach, JAG
Gay, ML
Musser, SM
TI Analysis of coffee for the presence of acrylamide by LC-MS/MS
SO JOURNAL OF AGRICULTURAL AND FOOD CHEMISTRY
LA English
DT Article
DE acrylamide; LC-MS/MS; coffee; FDA
ID MASS-SPECTROMETRY; MAILLARD REACTION; HEATED FOODS; CHROMATOGRAPHY
AB A variety of popular instant, ground, and brewed coffees were analyzed using a modified liquid chromatography-tandem mass spectrometry (LC-MS/MS) method specifically developed for the determination of acrylamide in foods. Coffee test portions were spiked with C-13(3)-labeled acrylamide as an internal standard prior to their extraction and cleanup. Ground coffees (1 g) and instant coffees (0.5 g) were extracted by shaking with 9 mL of water for 20 min. Brewed coffee test portions (9 mL) were taken through the cleanup procedure without further dilution with extraction solvent. Coffee test portions were cleaned up by passing 1.5 mL first through an Oasis HLB (hydrophilic/lipophilic copolymer sorbent) solid phase extraction (SPE) cartridge and then a Bond Elut-Accucat (cation and anion exchange sorbent) SPE cartridge. The cleaned up extracts were analyzed by positive ion electrospray LC-MS/MS. The MS/MS data was used to detect, confirm, and quantitate acrylamide. The limit of quantitation of the method was 10 ng/g for ground and instant coffees and 1.0 ng/mL for brewed coffee. The levels of acrylamide ranged from 45 to 374 ng/g in unbrewed coffee grounds, from 172 to 539 ng/g in instant coffee crystals, and from 6 to 16 ng/mL in brewed coffee.
C1 US FDA, Ctr Food Safety & Appl Nutr, Instrumentat & Biophys Branch, College Pk, MD 20740 USA.
RP Andrzejewski, D (reprint author), US FDA, Ctr Food Safety & Appl Nutr, Instrumentat & Biophys Branch, HFS-717,5100 Paint Branch Pkwy, College Pk, MD 20740 USA.
EM dandrzej@cfsan.fda.gov
NR 18
TC 100
Z9 104
U1 1
U2 30
PU AMER CHEMICAL SOC
PI WASHINGTON
PA 1155 16TH ST, NW, WASHINGTON, DC 20036 USA
SN 0021-8561
J9 J AGR FOOD CHEM
JI J. Agric. Food Chem.
PD APR 7
PY 2004
VL 52
IS 7
BP 1996
EP 2002
DI 10.1021/jf0349634
PG 7
WC Agriculture, Multidisciplinary; Chemistry, Applied; Food Science &
Technology
SC Agriculture; Chemistry; Food Science & Technology
GA 809KZ
UT WOS:000220636900033
PM 15053542
ER
PT J
AU Padayatty, SJ
Sun, H
Wang, YH
Riordan, HD
Hewitt, SM
Katz, A
Wesley, RA
Levine, M
AF Padayatty, SJ
Sun, H
Wang, YH
Riordan, HD
Hewitt, SM
Katz, A
Wesley, RA
Levine, M
TI Vitamin C pharmacokinetics: Implications for oral and intravenous use
SO ANNALS OF INTERNAL MEDICINE
LA English
DT Article
ID RECOMMENDED DIETARY ALLOWANCE; ASCORBIC-ACID; DISEASE PREVENTION;
ADVANCED CANCER; CYTOTOXICITY; VOLUNTEERS; TRIAL
AB Background: Vitamin C at high concentrations is toxic to cancer cells in vitro. Early clinical studies of vitamin C in patients with terminal cancer suggested clinical benefit, but 2 double-blind, placebo-controlled trials showed none. However, these studies used different routes of administration.
Objective: To determine whether plasma vitamin C concentrations vary substantially with the route of administration.
Design: Dose concentratior. studies and pharmacokinetic modeling.
Setting: Academic medical center. Participants: 17 healthy hospitalized volunteers.
Measurements: Vitamin C plasma and urine concentrations were measured after administration of oral and intravenous doses at a dose range of 0.015 to 1.25 g, and plasma concentrations were calculated for a dose range of 1 to 100 g.
Results: Peak plasma vitamin C concentrations were higher after administration of intravenous doses than after administration of oral doses (P < 0.001), and the difference increased according to dose. Vitamin C at a dose of 1.25 g administered orally produced mean ( +/- SD) peak plasma concentrations of 134.8 +/- 20.6 mumol/L compared with 885 +/- 201.2 mumol/L for intravenous administration. For the maximum tolerated oral dose of 3 g every 4 hours, pharmacokinetic modeling predicted peak plasma vitamin C concentrations of 220 mumol/L and 13 400 mumol/L for a 50-g intravenous dose. Peak predicted urine concentrations of vitamin C from intravenous administration were 140-fold higher than those from maximum oral doses.
Limitations: Patient data are not available to confirm pharmacokinetic modeling at high doses and in patients with cancer.
Conclusions: oral vitamin C produces plasma concentrations that are tightly controlled. Only intravenous administration of vitamin C produces high plasma and urine concentrations that might have antitumor activity. Because efficacy of vitamin C treatment cannot be judged from clinical trials that use only oral dosing, the role of vitamin C in cancer treatment should be re-evaluated.
C1 NIH, Mol & Clin Nutr Sect, Bethesda, MD 20892 USA.
NCI, NIDDKD, Bethesda, MD 20892 USA.
NIH, Clin Ctr, Bethesda, MD 20892 USA.
Food & Drug Adm, Rockville, MD USA.
Biocommun Res Inst, Wichita, KS USA.
RP Levine, M (reprint author), NIH, Mol & Clin Nutr Sect, Bldg 10,Room 4D52-MSC 1372, Bethesda, MD 20892 USA.
RI Padayatty, Sebastian/A-8581-2012;
OI Padayatty, Sebastian/0000-0001-8758-3170; Hewitt,
Stephen/0000-0001-8283-1788
FU NIDDK NIH HHS [Z01 DK 54506]
NR 20
TC 245
Z9 255
U1 4
U2 20
PU AMER COLL PHYSICIANS
PI PHILADELPHIA
PA INDEPENDENCE MALL WEST 6TH AND RACE ST, PHILADELPHIA, PA 19106-1572 USA
SN 0003-4819
J9 ANN INTERN MED
JI Ann. Intern. Med.
PD APR 6
PY 2004
VL 140
IS 7
BP 533
EP 537
PG 5
WC Medicine, General & Internal
SC General & Internal Medicine
GA 808OE
UT WOS:000220577600005
PM 15068981
ER
PT J
AU Powers, JH
Higgins, KM
AF Powers, JH
Higgins, KM
TI Itraconazole versus fluconazole for antifungal prophylaxis
SO ANNALS OF INTERNAL MEDICINE
LA English
DT Letter
C1 US FDA, Rockville, MD 20850 USA.
RP Powers, JH (reprint author), US FDA, Rockville, MD 20850 USA.
NR 3
TC 4
Z9 4
U1 0
U2 0
PU AMER COLL PHYSICIANS
PI PHILADELPHIA
PA INDEPENDENCE MALL WEST 6TH AND RACE ST, PHILADELPHIA, PA 19106-1572 USA
SN 0003-4819
J9 ANN INTERN MED
JI Ann. Intern. Med.
PD APR 6
PY 2004
VL 140
IS 7
BP 580
EP 580
PG 1
WC Medicine, General & Internal
SC General & Internal Medicine
GA 808OE
UT WOS:000220577600017
PM 15068992
ER
PT J
AU Cieslak, J
Grajkowski, A
Livengood, V
Beaucage, SL
AF Cieslak, J
Grajkowski, A
Livengood, V
Beaucage, SL
TI Thermolytic 4-methylthio-1-butyl group for phosphate/thiophosphate
protection in solid-phase synthesis of DNA oligonucleotides
SO JOURNAL OF ORGANIC CHEMISTRY
LA English
DT Article
ID SULFUR-TRANSFER REAGENT; 3H-1,2-BENZODITHIOL-3-ONE 1,1-DIOXIDE;
OLIGODEOXYRIBONUCLEOTIDE SYNTHESIS; PHOSPHATE PROTECTION; OXIDATION;
PHOSPHITES; CHEMISTRY
AB The thermolabile 4-methylthio-1-butyl phosphate/thiophosphate protecting group for DNA oligonucleotides has been investigated for its potential application to a "heat-driven" process for either oligonucleotide synthesis on diagnostic microarrays or, oppositely, to the large-scale preparation of therapeutic oligonucleotides. The preparation of phosphoramidites 10a-d is straightforward, and the incorporation of these amidites into oligonucleotides via solid-phase techniques proceeds as efficiently as that achieved with 2-cyanoethyl deoxyribonucleoside phosphoramidites. The versatility of the 4-methylthio-1-butyl phosphate/thiophosphate protecting group is exemplified by its facile removal from oligonucleotides upon heating for 30 min at 55 degreesC in an aqueous buffer under neutral conditions or within 2 h at 55 degreesC in concentrated NH4OH. The deprotection reaction occurs through an intramolecular cyclodeesterification mechanism leading to the formation of sulfonium salt 18. When mixed with deoxyribonucleosides and N-protected 2'-deoxyribonucleosides or with a model phosphorothioate diester under conditions approximating those of large-scale (>50 mmol) oligonucleotide deprotection reactions, the salt 18 did not significantly alter DNA nucleobases or desulfurize the phosphorothioate diester model to an appreciable extent.
C1 US FDA, Div Therapeut Prot, Ctr Drug Evaluat & Res, Bethesda, MD 20892 USA.
NIDDK, Bioorgan Chem Lab, NIH, Bethesda, MD 20892 USA.
RP Beaucage, SL (reprint author), US FDA, Div Therapeut Prot, Ctr Drug Evaluat & Res, 8800 Rockville Pike, Bethesda, MD 20892 USA.
EM beaucage@cber.fda.gov
NR 28
TC 16
Z9 16
U1 0
U2 5
PU AMER CHEMICAL SOC
PI WASHINGTON
PA 1155 16TH ST, NW, WASHINGTON, DC 20036 USA
SN 0022-3263
J9 J ORG CHEM
JI J. Org. Chem.
PD APR 2
PY 2004
VL 69
IS 7
BP 2509
EP 2515
DI 10.1021/jo035861f
PG 7
WC Chemistry, Organic
SC Chemistry
GA 807MS
UT WOS:000220506200040
PM 15049652
ER
PT J
AU Dodd, LE
Wagner, RF
Armato, SG
McNitt-Gray, MF
Beiden, S
Chan, HP
Gur, D
McLennan, G
Metz, CE
Petrick, N
Sahiner, B
Sayre, J
AF Dodd, LE
Wagner, RF
Armato, SG
McNitt-Gray, MF
Beiden, S
Chan, HP
Gur, D
McLennan, G
Metz, CE
Petrick, N
Sahiner, B
Sayre, J
CA Lung Image Database Consortium Res
TI Assessment methodologies and statistical issues for computer-aided
diagnosis of lung nodules in computed tomography: Contemporary research
topics relevant to the lung image database consortium
SO ACADEMIC RADIOLOGY
LA English
DT Article
DE computer-aided diagnosis (CAD); database development; lung cancer; lung
nodule; MRMC; ROC
ID OPERATING CHARACTERISTIC ANALYSIS; OF-VARIANCE MODELS; FINITE-SAMPLE
SIZE; OBSERVER-PERFORMANCE; ROC ANALYSIS; CONDITIONAL DEPENDENCE;
MULTIPLE-ABNORMALITIES; REGRESSION METHODOLOGY; DISEASE VERIFICATION;
SELECTION BIAS
AB Cancer of the lung and bronchus is the leading fatal malignancy in the United States. Five-year survival is low, but treatment of early stage disease considerably improves chances of survival. Advances in multidetector-row computed tomography technology provide detection of smaller lung nodules and offer a potentially effective screening tool. The large number of images per exam, however, requires considerable radiologist time for interpretation and is an impediment to clinical throughput. Thus, computer-aided diagnosis (CAD) methods are needed to assist radiologists with their decision making. To promote the development of CAD methods, the National Cancer Institute formed the Lung Image Database Consortium (LIDC). The LIDC is charged with developing the consensus and standards necessary to create an image database of multidetector-row computed tomography lung images as a resource for CAD researchers. To develop such a prospective database, its potential uses must be anticipated. The ultimate applications will influence the information that must be included along with the images, the relevant measures of algorithm performance, and the number of required images. In this article we outline assessment methodologies and statistical issues as they relate to several potential uses of the LIDC database. We review methods for performance assessment and discuss issues of defining "truth" as well as the complications that arise when truth information is not available. We also discuss issues about sizing and populating a database. (C) AUR, 2004.
C1 NCI, Biometr Res Branch, Div Canc Treatment & Diag, Bethesda, MD 20892 USA.
US FDA, Ctr Devices & Radiol Hlth, Rockville, MD 20857 USA.
Univ Chicago, Dept Radiol, Chicago, IL 60637 USA.
Univ Calif Los Angeles, Dept Radiol, David Geffen Sch Med, Los Angeles, CA 90024 USA.
Univ Michigan, Dept Radiol, Ann Arbor, MI 48109 USA.
Univ Pittsburgh, Dept Radiol, Pittsburgh, PA 15260 USA.
Univ Iowa, Dept Med, Iowa City, IA 52242 USA.
Univ Calif Los Angeles, Dept Biostat, Sch Publ Hlth, Los Angeles, CA 90024 USA.
Univ Calif Los Angeles, Dept Radiol, Sch Publ Hlth, Los Angeles, CA 90024 USA.
Univ Calif Los Angeles, Dept Radiol, Sch Med, Los Angeles, CA 90024 USA.
Univ Calif Los Angeles, Dept Biostat, Sch Med, Los Angeles, CA 90024 USA.
RP NCI, Biometr Res Branch, Div Canc Treatment & Diag, 6130 Execut Blvd,MSC 7434, Bethesda, MD 20892 USA.
EM doddl@mail.nih.gov
FU NCI NIH HHS [U01CA091103, U01CA091099, U01CA091090, U01CA091100,
U01CA091085]
NR 85
TC 51
Z9 52
U1 0
U2 4
PU ELSEVIER SCIENCE INC
PI NEW YORK
PA 360 PARK AVE SOUTH, NEW YORK, NY 10010-1710 USA
SN 1076-6332
EI 1878-4046
J9 ACAD RADIOL
JI Acad. Radiol.
PD APR
PY 2004
VL 11
IS 4
BP 462
EP 475
DI 10.1016/S1076-6332(03)00814-6
PG 14
WC Radiology, Nuclear Medicine & Medical Imaging
SC Radiology, Nuclear Medicine & Medical Imaging
GA 807HC
UT WOS:000220491600011
PM 15109018
ER
PT J
AU Haylock, PJ
AF Haylock, PJ
TI Nurses against tobacco
SO AMERICAN JOURNAL OF NURSING
LA English
DT Editorial Material
C1 Univ Texas, Med Branch, Sch Nursing, Galveston, TX 77550 USA.
US FDA, Oncol Drugs Advisory Committee, Rockville, MD 20857 USA.
RP Haylock, PJ (reprint author), Univ Texas, Med Branch, Sch Nursing, Galveston, TX 77550 USA.
EM pjhaylock@indian-creek.net
NR 0
TC 0
Z9 0
U1 0
U2 0
PU LIPPINCOTT WILLIAMS & WILKINS
PI PHILADELPHIA
PA 530 WALNUT ST, PHILADELPHIA, PA 19106-3621 USA
SN 0002-936X
J9 AM J NURS
JI Am. J. Nurs.
PD APR
PY 2004
VL 104
IS 4
BP 13
EP 13
PG 1
WC Nursing
SC Nursing
GA 812ZY
UT WOS:000220878600002
PM 15171109
ER
PT J
AU Cantril, CA
Haylock, PJ
AF Cantril, CA
Haylock, PJ
TI Tumor lysis syndrome - Prevention and early defection are crucial in
caring for patients with cancer
SO AMERICAN JOURNAL OF NURSING
LA English
DT Article
ID LYMPHOMA
C1 Montana State Univ, Sch Nursing, Bozeman, MT 59717 USA.
Univ Texas, Med Branch, Sch Nursing, Galveston, TX 77550 USA.
US FDA, Oncol Drugs Advisory Committee, Rockville, MD 20857 USA.
NR 9
TC 2
Z9 2
U1 0
U2 0
PU LIPPINCOTT WILLIAMS & WILKINS
PI PHILADELPHIA
PA 530 WALNUT ST, PHILADELPHIA, PA 19106-3621 USA
SN 0002-936X
J9 AM J NURS
JI Am. J. Nurs.
PD APR
PY 2004
VL 104
IS 4
BP 49
EP 52
PG 4
WC Nursing
SC Nursing
GA 812ZY
UT WOS:000220878600024
PM 15171115
ER
PT J
AU Lachenbruch, PA
Rosenberg, AS
Bonvini, E
Cavaille-Coll, MW
Colvin, RB
AF Lachenbruch, PA
Rosenberg, AS
Bonvini, E
Cavaille-Coll, MW
Colvin, RB
TI Biomarkers and surrogate endpoints in renal transplantation: Present
status and considerations for clinical trial design
SO AMERICAN JOURNAL OF TRANSPLANTATION
LA English
DT Review
DE allograft rejection; predictive variables; surrogate endpoints
ID CHRONIC ALLOGRAFT-REJECTION; KIDNEY-TRANSPLANTATION; QUANTITATIVE
DETECTION; HUMORAL REJECTION; MESSENGER-RNA; EXPRESSION; CLASSIFICATION;
BIOPSIES; REPRODUCIBILITY; CAPILLARIES
AB Of major importance in clinical trials is the ability to predict individual patient outcome or endpoints using biomarkers, also known as variables or predictors, in as safe, efficient, and accurate a manner as possible. This review addresses the concepts and possible strategies for use of predictor and surrogate biomarkers in the design of clinical trials in renal transplantation. The statistical concepts apply equally well to other organ grafts.
C1 US FDA, Ctr Biol Evaluat & Res, Off Therapeut Res & Review, Div Therapeut Prot, Bethesda, MD 20892 USA.
US FDA, Ctr Biol Evaluat & Res, Off Therapeut Res & Review, Div Monoclonal Antibodies, Bethesda, MD 20892 USA.
US FDA, Ctr Biol Evaluat & Res, Off Biostat & Epidemiol, Div Biostat, Bethesda, MD 20892 USA.
US FDA, Ctr Drug Evaluat & Res, Off New Drugs, Div Special Pathogen & Immunol Drug Prod, Rockville, MD USA.
Massachusetts Gen Hosp, Dept Pathol, Boston, MA 02114 USA.
Harvard Univ, Sch Med, Boston, MA 02114 USA.
RP Rosenberg, AS (reprint author), US FDA, Ctr Biol Evaluat & Res, Off Therapeut Res & Review, Div Therapeut Prot, Bethesda, MD 20892 USA.
EM rosenberg@cber.fda.gov
NR 31
TC 49
Z9 50
U1 0
U2 2
PU BLACKWELL MUNKSGAARD
PI COPENHAGEN
PA 35 NORRE SOGADE, PO BOX 2148, DK-1016 COPENHAGEN, DENMARK
SN 1600-6135
J9 AM J TRANSPLANT
JI Am. J. Transplant.
PD APR
PY 2004
VL 4
IS 4
BP 451
EP 457
DI 10.1111/j.1600-6143.2004.00386.x
PG 7
WC Surgery; Transplantation
SC Surgery; Transplantation
GA 810YZ
UT WOS:000220740900001
PM 15023136
ER
PT J
AU Jiang, J
Chan, TC
Temenak, JJ
Dasch, GA
Ching, WM
Richards, AL
AF Jiang, J
Chan, TC
Temenak, JJ
Dasch, GA
Ching, WM
Richards, AL
TI Development of a quantitative real-time polymerase chain reaction assay
specific for Orientia tsutsugamushi
SO AMERICAN JOURNAL OF TROPICAL MEDICINE AND HYGIENE
LA English
DT Article
ID LINKED IMMUNOSORBENT ASSAYS; PROTEIN ANTIGEN R56; SCRUB TYPHUS;
RICKETTSIA-TSUTSUGAMUSHI; FLOW ASSAY; ANTIBODIES; DIAGNOSIS;
AMPLIFICATION; EXPRESSION; CHIGGERS
AB Two specific and sensitive polymerase chain reaction (PCR) assays were developed to detect and quantitate Orientia tsutsugamushi, the agent of scrub typhus, using a portion of the 47-kD outer membrane protein antigen/ high temperature requirement A gene as the target. A selected 47-kD protein gene primer pair amplified a 118-basepair fragment from all 26 strains of O. tsutsugamushi evaluated, but it did not produce amplicons when 17 Rickettsia and 18 less-related bacterial nucleic acid extracts were tested. Similar agent specificity for the real-time PCR assay, which used the same primers and a 31-basepair fluorescent probe, was demonstrated. This sensitive and quantitative assay determination of the content of O. tsutsugamushi nucleic acid used a plasmid containing the entire 47-kD gene from the Kato strain as a standard. Enumeration of the copies of O. tsutsugamushi DNA extracted from infected tissues from mice and monkeys following experimental infection with Orientia showed 27-5,552 copies/muL of mouse blood, 14,448-86,012 copies/muL of mouse liver/spleen homogenate, and 3-21 copies/muL of monkey blood.
C1 USN, Rickettsial Dis Dept, Med Res Ctr, Silver Spring, MD 20910 USA.
US FDA, Div Vaccines & Related Prod Applicat, Rockville, MD 20857 USA.
Ctr Dis Control & Prevent, Div Viral & Rickettsial Dis, Atlanta, GA USA.
Uniformed Serv Univ Hlth Sci, Dept Prevent Med & Biometr, Bethesda, MD 20814 USA.
RP Jiang, J (reprint author), USN, Rickettsial Dis Dept, Med Res Ctr, 503 Robert Grant Ave, Silver Spring, MD 20910 USA.
EM JiangJ@nmrc.navy.mil; ChanC@nmrc.navy.mil
NR 44
TC 97
Z9 105
U1 0
U2 6
PU AMER SOC TROP MED & HYGIENE
PI MCLEAN
PA 8000 WESTPARK DR, STE 130, MCLEAN, VA 22101 USA
SN 0002-9637
J9 AM J TROP MED HYG
JI Am. J. Trop. Med. Hyg.
PD APR
PY 2004
VL 70
IS 4
BP 351
EP 356
PG 6
WC Public, Environmental & Occupational Health; Tropical Medicine
SC Public, Environmental & Occupational Health; Tropical Medicine
GA 814RI
UT WOS:000220991400003
PM 15100446
ER
PT J
AU Xing, Y
He, ZM
Warnock, JN
Hilbert, SL
Yoganathan, AP
AF Xing, Y
He, ZM
Warnock, JN
Hilbert, SL
Yoganathan, AP
TI Effects of constant static pressure on the biological properties of
porcine aortic valve leaflets
SO ANNALS OF BIOMEDICAL ENGINEERING
LA English
DT Article
DE aortic valve leaflets; collagen synthesis; tissue engineering
ID EXTRACELLULAR-MATRIX SYNTHESIS; SMOOTH-MUSCLE CELLS; HUMAN HEART-VALVES;
INTERSTITIAL-CELLS; HYDROSTATIC-PRESSURE; HYPERTENSIVE RATS;
ENDOTHELIAL-CELLS; MESSENGER-RNA; EXPRESSION; METABOLISM
AB An understanding of how mechanical forces impact cells within valve leaflets would greatly benefit the development of a tissue-engineered heart valve. In this study, the effect of constant ambient pressure on the biological properties of heart valve leaflets was evaluated using a custom-designed pressure system. Native porcine aortic valve leaflets were exposed to static pressures of 100, 140, or 170 mmHg for 48 h. Collagen synthesis, DNA synthesis, sulfated glycoaminoglycan (sGAG) synthesis, alpha-SMC actin expression, and extracellular matrix (ECM) structure were examined. Results showed that elevated pressure caused an increase in collagen synthesis. This increase was not statistically significant at 100 mmHg, but at 140 mmHg and 170 mmHg collagen synthesis increased by 37.5 and 90%, respectively. No significant difference in DNA or sGAG synthesis was observed at elevated pressures, with the exception that DNA synthesis at 100 mmHg decreased. A notable decline in a-SMC actin was observed over the course of the experiments although no significant difference was observed between the pressure and control groups. It was concluded that elevated pressure caused a proportional increase in collagen synthesis of porcine aortic valve leaflets, but was unable to preserve alpha-SMC actin immunoreactive cells.
C1 Georgia Inst Technol, Wallace H Coulter Sch Biomed Engn, Atlanta, GA 30332 USA.
Georgia Inst Technol, Bioengn Program, Sch Chem Engn, Atlanta, GA 30332 USA.
Georgia Inst Technol, George W Woodruff Sch Mech Engn, Atlanta, GA 30332 USA.
CDRH, Rockville, MD USA.
RP Yoganathan, AP (reprint author), Georgia Inst Technol, Wallace H Coulter Sch Biomed Engn, 315 Ferst DR,Suite 1121, Atlanta, GA 30332 USA.
EM ajit.yoganathan@bme.gatech.edu
NR 23
TC 31
Z9 31
U1 0
U2 2
PU KLUWER ACADEMIC PUBL
PI DORDRECHT
PA VAN GODEWIJCKSTRAAT 30, 3311 GZ DORDRECHT, NETHERLANDS
SN 0090-6964
J9 ANN BIOMED ENG
JI Ann. Biomed. Eng.
PD APR
PY 2004
VL 32
IS 4
BP 555
EP 562
DI 10.1023/B:ABME.0000019175.12013.8f
PG 8
WC Engineering, Biomedical
SC Engineering
GA 835FC
UT WOS:000222465200006
PM 15117029
ER
PT J
AU Lu, JH
Dveksler, G
Kaplan, GG
AF Lu, JH
Dveksler, G
Kaplan, GG
TI Rescue of Hepatitis A virus from cDNA-transfected but not virion
RNA-transfected mouse Ltk-cells
SO ARCHIVES OF VIROLOGY
LA English
DT Article
ID COMPLETE NUCLEOTIDE-SEQUENCE; CAP-INDEPENDENT TRANSLATION; MONKEY
KIDNEY-CELLS; WILD-TYPE VIRUS; CULTURE; ADAPTATION; MUTATIONS; GROWTH;
REPLICATION; IDENTIFICATION
AB Hepatitis A virus (HAV) has stringent replication requirements and a restricted host-range. Mouse Ltk-cells do not support growth of HAV upon infection or transfection of virion RNA. However, low levels of HAV were rescued from Ltk- cells transiently transfected with its infectious cDNA. Ltk- stable transfectants that expressed HAV antigens and produced infectious HAV were selected and termed Ltk-pJH15 cells. After a few serial passages, HAV became undetectable in the Ltk-pJH15 cells. Multiple rounds of single cell cloning of HAV antigen positive Ltk-pJH15 cells resulted in the isolation of clone E8 that produced higher levels of HAV for at least 5 passages. HAV produced in E8 cells was similar to the parental virus as shown by infectivity assays. Luciferase assays using a bi-cistronic construct containing the HAV 5' noncoding region showed similar levels of HAV IRES-dependent translation in Ltk- and Ltk-pJH15 cells, which suggested that HAV IRES-dependent translation was not a limiting factor for HAV growth in these cells. The availability of the Ltk-pHJ15 cells will allow the identification of cellular factors required for HAV growth, which could lead to the development of a mouse model to study pathogenesis of HAV.
C1 US FDA, Ctr Biol Evaluat & Res, Hepatatis Lab, Bethesda, MD USA.
Uniformed Serv Univ Hlth Sci, Dept Pathol, Bethesda, MD 20814 USA.
RP Kaplan, GG (reprint author), 8800 Rockville Pike,Bldg 29-NIH,Rm 225,HFM-325, Bethesda, MD 20892 USA.
EM gk@helix.nih.gov
NR 27
TC 3
Z9 3
U1 0
U2 0
PU SPRINGER-VERLAG WIEN
PI VIENNA
PA SACHSENPLATZ 4-6, PO BOX 89, A-1201 VIENNA, AUSTRIA
SN 0304-8608
J9 ARCH VIROL
JI Arch. Virol.
PD APR
PY 2004
VL 149
IS 4
BP 759
EP 772
DI 10.1007/s00705-003-0226-2
PG 14
WC Virology
SC Virology
GA 812NN
UT WOS:000220846300007
PM 15045562
ER
PT J
AU Atreya, CD
Kulkarni, S
Mohan, KVK
AF Atreya, CD
Kulkarni, S
Mohan, KVK
TI Rubella virus P90 associates with the cytokinesis regulatory protein
Citron-K kinase and the viral infection and constitutive expression of
P90 protein both induce cell cycle arrest following S phase in cell
culture
SO ARCHIVES OF VIROLOGY
LA English
DT Article
ID VIRUS-INDUCED APOPTOSIS; BINDING PROTEIN; RUBELLA; RHO; IDENTIFICATION;
REPLICATION; INTERACTS; TARGET; RB
AB In utero infection of developing fetus by Rubella virus (RV) causes cell division inhibition of critical precursor cells in organogenesis, CNS-associated birth defects and induction of apoptosis in cell culture. The underlying mechanisms of RV-induced congenital abnormalities are not known. Here, we identified a novel interaction between RV replicase P90 protein and a cytokinesis-regulatory protein, the Citron-K kinase (CK), in a yeast two-hybrid cDNA library screen. Aberrations in cytokinesis and subsequent apoptosis do occur in specific cell types when the CK gene is knocked out or, its regulatory function is perturbed. Our analysis found that full-length P90 binds CK and in RV-infected cells P90 colocalizes with CK in the cytoplasm. Furthermore, during RN infection as well as cellular expression of P90 alone, we identified a discrete subpopulation of cells containing 4N DNA content, indicating that these cells are arrested in the cell cycle following S phase, suggesting that cellular expression of viral P90 during RV infection perturbs cytokinesis. Previous reports by others established that RV infection leads to apoptosis in cell culture. These observations together taken to the fetal organogenesis level, favor the idea that RV P90, by binding to cellular CK, invokes cell cycle aberrations resulting in the cell-and organ-specific growth inhibition and programmed cell death during RV infection in utero, which commonly is referred to as RV-induced teratogenesis.
C1 US FDA, Ctr Biol Evaluat & Res, Sect Viral Pathogenesis & Adverse React, Lab Pediat & Resp Viral Dis, Bethesda, MD 20892 USA.
RP Atreya, CD (reprint author), US FDA, Ctr Biol Evaluat & Res, Sect Viral Pathogenesis & Adverse React, Lab Pediat & Resp Viral Dis, HFM-460,Bldg 29A,2C-11,NIH Campus,8800 Rockville, Bethesda, MD 20892 USA.
EM Atreya@cber.fda.gov
NR 31
TC 11
Z9 11
U1 1
U2 3
PU SPRINGER-VERLAG WIEN
PI VIENNA
PA SACHSENPLATZ 4-6, PO BOX 89, A-1201 VIENNA, AUSTRIA
SN 0304-8608
J9 ARCH VIROL
JI Arch. Virol.
PD APR
PY 2004
VL 149
IS 4
BP 779
EP 789
DI 10.1007/s00705-003-0267-6
PG 11
WC Virology
SC Virology
GA 812NN
UT WOS:000220846300009
PM 15045564
ER
PT J
AU Sung, KD
Stern, NJ
Hiett, KL
AF Sung, KD
Stern, NJ
Hiett, KL
TI Relationship of messenger RNA reverse transcriptase-polymerase chain
reaction signal to Campylobacter spp. viability
SO AVIAN DISEASES
LA English
DT Article
DE Campylobacter; detection in production; poultry
ID NON-CULTURABLE CAMPYLOBACTER; ESCHERICHIA-COLI; VIBRIO-CHOLERAE;
SALMONELLA-ENTERITIDIS; UNITED-STATES; JEJUNI CELLS; RT-PCR; RECOVERY;
AMPLIFICATION; ENVIRONMENT
AB Discriminating viable from dead cells is of importance in the development of bacterial detection methods. A positive reverse transcriptase-polymerase chain reaction (RTPCR) amplification signal was tested as a potential predictor of chick colonization. Some researchers have suggested that the presence of messenger RNA (mRNA) may not correlate with cell viability. Chicken colonization by cells that have positive mRNA signal but that are noncultivable would provide a correlation in cell viability and persistence of mRNA. The role of a viable but noncultivable (VBNC) form of Campylobacter spp. for colonization of poultry could be verified by such an mRNA signal. The levels of four strains of Campylobacter spp., previously isolated from poultry feces, declined progressively over time, and loss of cultivability occurred after 6 to 7 wk incubation in phosphate-buffered saline (PBS) at 4 C. Cold-stored, noncultivable and heat-inactivated (60 C for 10 min) Campylobacter spp. produced inconsistent amplified products from RT-PCR assay, depending on the target transcripts and strains used, although all fresh cultures showed mRNA signals. For the most part, signals of mRNA species from VBNC and heat-killed Campylobacter spp. AH-1, AH-2, and CH-3 persisted. RT-PCR amplification of transcripts originating from the tkt and cmp genes and a 256-base pair amplicon (from a previously described putative haem-copper oxidase) provided consistent signals, whereas transcripts from the M gene did not. Presumed VBNC and heat-inactivated Campylobacter spp., which produced positive mRNA signal but was not cultivable by conventional culture-based methods, did not establish colonization in the intestine of chicks 7 days after challenge. These results lead us to question the correlation between mRNA durability with cell viability as well as the significance of the VBNC cells in environmental transmission of Campylobacter spp.
C1 Russell Res Ctr, Poultry Microbiol Safety Res Unit, Athens, GA 30604 USA.
Natl Ctr Toxicol Res, Div Microbiol, Jefferson, AR 72079 USA.
Univ Georgia, Dept Food Sci & Technol, Athens, GA 30606 USA.
RP Stern, NJ (reprint author), Russell Res Ctr, Poultry Microbiol Safety Res Unit, Athens, GA 30604 USA.
NR 33
TC 7
Z9 7
U1 2
U2 5
PU AMER ASSOC AVIAN PATHOLOGISTS
PI ATHENS
PA 953 COLLEGE STATION RD, ATHENS, GA 30602-4875 USA
SN 0005-2086
J9 AVIAN DIS
JI Avian Dis.
PD APR-JUN
PY 2004
VL 48
IS 2
BP 254
EP 262
DI 10.1637/7062
PG 9
WC Veterinary Sciences
SC Veterinary Sciences
GA 937IF
UT WOS:000229917100004
PM 15283412
ER
PT J
AU Acheson, DWK
Luccioli, S
AF Acheson, DWK
Luccioli, S
TI Mucosal immune responses
SO BEST PRACTICE & RESEARCH IN CLINICAL GASTROENTEROLOGY
LA English
DT Article
DE mucosal immunity; intestinal epithelial cells; food-borne pathogens;
gut-associated lymphoid tissue; follicle associated epithelia
ID INTESTINAL EPITHELIAL-CELLS; NF-KAPPA-B; HELICOBACTER-PYLORI; BACTERIAL
TRANSLOCATION; LYMPHOCYTE-ACTIVATION; T-CELLS; LISTERIA-MONOCYTOGENES;
ENTAMOEBA-HISTOLYTICA; GIARDIA-LAMBLIA; BRUGIA-MALAYI
AB The host gastrointestinal tract is exposed to countless numbers of foreign antigens and has embedded a unique and complex network of immunological and non-immunological mechanisms, often termed the gastrointestinal 'mucosal barrier', to protect the host from potentially harmful pathogens while at the same time 'tolerating' other resident microbes to allow absorption and utilization of nutrients. Of the many important roles of this barrier, it is the distinct responsibility of the mucosal immune system to sample and discriminate between harmful and beneficial antigens and to prevent entry of food-borne pathogens through the gastrointestinal (GI) tract. This system comprises an immunological network termed the gut-associated lymphoid tissue (GALT) that consists of unique arrangements of B cells, T cells and phagocytes which sample luminal antigens through specialized epithelia termed the follicle associated epithelia (FAE) and orchestrate co-ordinated molecular responses between immune cells and other components of the mucosal barrier. Certain pathogens have developed ways to bypass and/or withstand defence by the mucosal immune system to establish disease in the host. Some 'opportunistic' pathogens (such as Clostridium difficile) take advantage of host or other factors (diet, stress, antibiotic use) which may alter or weaken the response of the immune system. Other pathogens have developed mechanisms for invading gastrointestinal epithelium and evading phagocytosis/destruction by immune system defences. Once cellular invasion occurs, host responses are activated to limit local mucosal damage and repel the foreign influence. Some pathogens (Shigella spp, parasites and viruses) primarily establish localized disease while others (Salmonella, Yersinia, Listeria) use the lymphatic system to enter organs or the bloodstream and cause more systemic illness. In some cases, pathogens (Helicobacter pylori and Salmonella typhi) colonize the GI tract or associated lymphoid structures for extended periods of time and these persistent pathogens may also be potential triggers for other chronic or inflammatory diseases, including inflammatory bowel disease and malignancies. The ability of certain pathogens to avoid or withstand the host's immune assault and/or utilize these host responses to their own advantage (i.e. enhance further colonization) will dictate the pathogen's success in promoting illness and furthering its own survival.
C1 US FDA, CFSAN, DHSS, College Pk, MD 20740 USA.
RP Acheson, DWK (reprint author), US FDA, CFSAN, DHSS, 5100 Paint Branch Pkwy,Mail Code HFS 6,Room 2B-00, College Pk, MD 20740 USA.
EM david.acheson@cfsan.fda.gov
NR 90
TC 53
Z9 69
U1 2
U2 7
PU BAILLIERE TINDALL
PI LONDON
PA 24-28 OVAL RD, LONDON NW1 7DX, ENGLAND
SN 1521-6918
J9 BEST PRACT RES CL GA
JI Best Pract. Res. Clin. Gastroenterol.
PD APR
PY 2004
VL 18
IS 2
BP 387
EP 404
DI 10.1053/ybega.2004.449
PG 18
WC Gastroenterology & Hepatology
SC Gastroenterology & Hepatology
GA 816NR
UT WOS:000221117100013
PM 15123077
ER
PT J
AU Owen, MP
Kiernan, JA
AF Owen, MP
Kiernan, JA
TI The M'Fadyean reaction: a stain for anthrax bacilli
SO BIOTECHNIC & HISTOCHEMISTRY
LA English
DT Editorial Material
C1 FDA Pacific Reg Lab NW, Bothell, WA 98021 USA.
Univ Western Ontario, Dept Anat & Cell Biol, London, ON N6A 5C1, Canada.
RP Owen, MP (reprint author), FDA Pacific Reg Lab NW, 22201 23rd Dr SE, Bothell, WA 98021 USA.
EM michael.owen@fda.gov; kiernan@uwo.ca
OI Kiernan, John/0000-0002-3324-1092
NR 6
TC 2
Z9 2
U1 0
U2 0
PU B I O S SCIENTIFIC PUBLISHERS LTD
PI OXFORD
PA 9 NEWTEC PLACE, MAGDALEN RD, OXFORD OX4 1RE, ENGLAND
SN 1052-0295
J9 BIOTECH HISTOCHEM
JI Biotech. Histochem.
PD APR
PY 2004
VL 79
IS 2
BP 107
EP 108
PG 2
WC Biotechnology & Applied Microbiology; Cell Biology
SC Biotechnology & Applied Microbiology; Cell Biology
GA 865YR
UT WOS:000224740600010
PM 15513713
ER
PT J
AU Goel, V
Shuren, J
Sheesley, L
Grafman, J
AF Goel, V
Shuren, J
Sheesley, L
Grafman, J
TI Asymmetrical involvement of frontal lobes in social reasoning
SO BRAIN
LA English
DT Article
DE reasoning; frontal lobes; Wason selection task; social knowledge
ID WASON SELECTION TASK; HUMAN PREFRONTAL CORTEX; BRAIN; EXPERIENCE; MINDS;
LOGIC
AB The frontal lobes are widely implicated in logical reasoning. Recent neuroimaging studies suggest that frontal lobe involvement in reasoning is asymmetric (L>R) and increases with the presence of familiar, meaningful content in the reasoning situation. However, neuroimaging data can only provide sufficiency criteria. To determine the necessity of prefrontal involvement in logical reasoning, we tested 19 patients with focal frontal lobe lesions and 19 age- and education-matched normal controls on the Wason Card Selection Task, while manipulating social knowledge. Patients and controls performed equivalently on the arbitrary rule condition. Normal controls showed the expected improvement in the social knowledge conditions, but frontal lobe patients failed to show this facilitation in performance. Furthermore, left hemisphere patients were more affected than right hemisphere patients, suggesting that frontal lobe involvement in reasoning is asymmetric (L>R) and necessary for reasoning about social situations.
C1 York Univ, Dept Psychol, Toronto, ON M3J 1P3, Canada.
NINDS, Cognit Neurosci Sect, NIH, Bethesda, MD 20892 USA.
US FDA, Off Policy, Rockville, MD 20857 USA.
RP Goel, V (reprint author), York Univ, Dept Psychol, Toronto, ON M3J 1P3, Canada.
EM vgoel@yorku.ca
OI Grafman, Jordan H./0000-0001-8645-4457
NR 39
TC 28
Z9 32
U1 4
U2 7
PU OXFORD UNIV PRESS
PI OXFORD
PA GREAT CLARENDON ST, OXFORD OX2 6DP, ENGLAND
SN 0006-8950
J9 BRAIN
JI Brain
PD APR
PY 2004
VL 127
BP 783
EP 790
DI 10.1093/brain/awh086
PN 4
PG 8
WC Clinical Neurology; Neurosciences
SC Neurosciences & Neurology
GA 807ET
UT WOS:000220485500012
PM 14976069
ER
PT J
AU Kim, DH
Kadlubar, FF
Teitel, CH
Guengerich, FP
AF Kim, DH
Kadlubar, FF
Teitel, CH
Guengerich, FP
TI Formation and reduction of aryl and heterocyclic nitroso compounds and
significance in the flux of hydroxylamines
SO CHEMICAL RESEARCH IN TOXICOLOGY
LA English
DT Article
ID HUMAN CYTOCHROME-P450 1A2; HUMAN LIVER-MICROSOMES; AROMATIC-AMINES;
METABOLIC-ACTIVATION; CARCINOGENIC ARYLAMINES; SALMONELLA-TYPHIMURIUM;
N-ACETYLTRANSFERASE; ENZYMATIC REDUCTION; HUMAN HEPATOCYTES;
ESCHERICHIA-COLI
AB Cytochrome P450 (P450) 1A2 and NADPH-P450 reductase (NPR) catalyzed the oxidation of 2-amino-3-methylimidazo[4,5-f]quinoline (IQ), with consumption of NADPH. The oxidation rate of NADPH by P450 1A2/NPR increased with time in the presence of IQ until depletion of NADPH. This unusual autocatalytic pattern of NADPH oxidation could be rationalized by formation of a nitroso derivative (IQ-N=O) and the subsequent reduction of the hydroxylamine, (IQ-NHOH) and IQ-N=O, which would consume more NADPH. The formation of IQ-NHOH and IQ-N=O from IQ was confirmed using HPLC/MS. Reduction of IQ-NHOH and IQ-N=O was NPR-dependent but did not require P450. Autocatalytic NADPH oxidation was also observed in the oxidation of other heterocyclic and arylamines. However, the N-hydroxyl and nitroso oxidation products of 2-aminofluorene and 4-aminobiphenyl were reduced nonenzymatically by NADPH, and NPR did not catalyze the reactions. We simulated the enzymatic kinetic model for possible pathways for IQ metabolism, which included the formation of IQ-N=O, using some. kinetic parameters obtained from the experimental results. In the kinetic model, we could reproduce the similar curvature for NADPH oxidation and the formation of IQ-N=O, and the reduction of IQ-NHOH and IQ-N=O is required to explain the observed results for NADPH oxidation. Our results support a role for nitroso derivatives of HAAS in the unusual autocatalytic NADPH oxidation and may have relevance in terms of possible toxicities of the nitroso derivatives. Both IQ-NHOH and IQ-N=O were mutagenic in a bacterial tester system devoid of P450 and NPR; the mutagenicity of both was decreased by expression of NPR, consistent with the reduction of these compounds observed with purified NPR.
C1 Vanderbilt Univ, Sch Med, Dept Biochem, Nashville, TN 37232 USA.
Vanderbilt Univ, Sch Med, Ctr Mol Toxicol, Nashville, TN 37232 USA.
Natl Ctr Toxicol Res, Div Mol Epidemiol, Jefferson, AR 72079 USA.
RP Guengerich, FP (reprint author), Vanderbilt Univ, Sch Med, Dept Biochem, 221 Kirkland Hall, Nashville, TN 37232 USA.
EM f.guengerich@vanderbilt.edu
FU NCI NIH HHS [R01 CA90426]; NIEHS NIH HHS [P30 ES00267]
NR 62
TC 24
Z9 24
U1 1
U2 4
PU AMER CHEMICAL SOC
PI WASHINGTON
PA 1155 16TH ST, NW, WASHINGTON, DC 20036 USA
SN 0893-228X
J9 CHEM RES TOXICOL
JI Chem. Res. Toxicol.
PD APR
PY 2004
VL 17
IS 4
BP 529
EP 536
DI 10.1021/tx034267y
PG 8
WC Chemistry, Medicinal; Chemistry, Multidisciplinary; Toxicology
SC Pharmacology & Pharmacy; Chemistry; Toxicology
GA 814JQ
UT WOS:000220971400009
PM 15089095
ER
PT J
AU Brinker, A
Johnston, M
AF Brinker, A
Johnston, M
TI Acute pulmonary injury in association with amiodarone
SO CHEST
LA English
DT Letter
ID TOXICITY
C1 US FDA, CDER, Off Drug Safety, Rockville, MD 20857 USA.
RP Brinker, A (reprint author), US FDA, CDER, Off Drug Safety, 15B-08 HFD-430,5600 Fishers Ln, Rockville, MD 20857 USA.
EM brinkera@cder.fda.gov
NR 5
TC 9
Z9 10
U1 0
U2 0
PU AMER COLL CHEST PHYSICIANS
PI NORTHBROOK
PA 3300 DUNDEE ROAD, NORTHBROOK, IL 60062-2348 USA
SN 0012-3692
J9 CHEST
JI Chest
PD APR
PY 2004
VL 125
IS 4
BP 1591
EP 1592
DI 10.1378/chest.125.4.1591-a
PG 2
WC Critical Care Medicine; Respiratory System
SC General & Internal Medicine; Respiratory System
GA 825YB
UT WOS:000221793700071
PM 15078784
ER
PT J
AU Davis, RD
Gilman, JW
Sutto, TW
Callahan, JH
Trulove, PC
De Long, H
AF Davis, RD
Gilman, JW
Sutto, TW
Callahan, JH
Trulove, PC
De Long, H
TI Improved thermal stability of organically modified layered silicates
SO CLAYS AND CLAY MINERALS
LA English
DT Article
DE alkyl ammonium; montmorillonite; nanocomposites; organic modifier
degradation; organoclay; synthetic mica
ID CLAY NANOCOMPOSITES; MONTMORILLONITE; DISPERSION; QUALITY
AB Bromide-containing impurities were found to decrease the thermal stability of quaternary alkyl ammonium-modified layered silicates. Improved purification procedures completely removed bromide and led to a 20degreesC to >100degreesC increase in organic modified layered silicate thermal stability. Using mass spectrometry and thermal and electrochemical analysis, N,N-dimethyl-N,N-dioctadecyl quaternary ammonium-modified montmorillonite and fluorinated synthetic mica were found to degrade primarily through elimination and nucleophilic attack by these anions. The nature of residual bromides was identified and quantified, and the efficiency of removing these anions was found to be solvent dependent; sequential extraction, first ethanol then tetrahydrofuran, gave the best results. This exhaustive extraction method represents a viable alternative to the use of expensive, more thermally stable oniumion treatments for layered silicates.
C1 Natl Inst Stand & Technol, Bldg & Fire Res Labs, Gaithersburg, MD 20899 USA.
USN Acad, Washington, DC 20375 USA.
Naval Res Lab, Washington, DC 20375 USA.
US FDA, CFSAN, Instrumentat & Biophys Branch, College Pk, MD 20740 USA.
USAF, Off Sci Res, Arlington, VA 22203 USA.
RP Davis, RD (reprint author), Natl Inst Stand & Technol, Bldg & Fire Res Labs, Gaithersburg, MD 20899 USA.
EM rick.davis@nist.gov
NR 11
TC 56
Z9 57
U1 2
U2 12
PU CLAY MINERALS SOC
PI CHANTILLY
PA 3635 CONCORDE PKWY, STE 500, CHANTILLY, VA 20151-1125 USA
SN 0009-8604
J9 CLAY CLAY MINER
JI Clay Clay Min.
PD APR
PY 2004
VL 52
IS 2
BP 171
EP 179
DI 10.1346/CCMN.2004.0520203
PG 9
WC Chemistry, Physical; Geosciences, Multidisciplinary; Mineralogy; Soil
Science
SC Chemistry; Geology; Mineralogy; Agriculture
GA 813LZ
UT WOS:000220909900003
ER
PT J
AU Linnet, K
Kondratovich, M
AF Linnet, K
Kondratovich, M
TI Partly nonparametric approach for determining the limit of detection
SO CLINICAL CHEMISTRY
LA English
DT Article
AB Background: According to recent International Organization for Standardization (ISO) standards, the limit of detection (LoD) of an assay should be estimated taking both type I (alpha) and II (beta) errors into account. The suggested procedure, however, supposes gaussian distributions of both blank and sample measurements and a linear calibration curve. In clinical chemistry, asymmetric, nongaussian blank distributions are common, and the calibration curve may be nonlinear. We present a partly nonparametric procedure that takes these aspects into account.
Methods: Using theoretical distribution models and simulation studies, we developed a LoD estimation, procedure suitable for the field of clinical chemistry that is partly based on nonparametric statistics.
Results: For sample size n, the nonparametrically determined 95th percentile of the blank measurements {obtained as the value of the [n(95/100) + 0.5]th ordered observation} defines the limit for results significantly exceeding zero [limit of, blank (LoB)]. The LoD is the lowest value that is likely to yield a result exceeding the LoB. LoD is estimated as: LoB + c(beta) x SDS, where SDS is the analytical SD of a sample with a low concentration; C-beta = z(1-beta)/[1 - 1/(4 x f)]; z(1-beta) is the standard normal deviate; and f is the number of degrees of freedom for estimation of SDS. c(beta) is approximately equal to 1.65 for a type II error of 5%. Approaches and needed tabular values for calculation of confidence limits are presented as well as sample size. Worked examples are given to illustrate estimation and verification of the limit of detection. Simulation results are used to document performance.
Conclusion: The proposed procedure appears useful for application in the field of clinical chemistry and promotes a standardized approach for estimating LoDs of clinical chemistry assays. (C) 2004 American Association for Clinical Chemistry.
C1 Psychiat Univ Hosp, Lab Clin Biochem, DK-8240 Risskov, Denmark.
US FDA, Div Biostat, Rockville, MD 20857 USA.
RP Linnet, K (reprint author), Psychiat Univ Hosp, Lab Clin Biochem, Skovagervej 2, DK-8240 Risskov, Denmark.
EM linnet@post7.tele.dk
OI Linnet, Kristian/0000-0001-6974-5535
NR 26
TC 45
Z9 45
U1 0
U2 4
PU AMER ASSOC CLINICAL CHEMISTRY
PI WASHINGTON
PA 2101 L STREET NW, SUITE 202, WASHINGTON, DC 20037-1526 USA
SN 0009-9147
J9 CLIN CHEM
JI Clin. Chem.
PD APR
PY 2004
VL 50
IS 4
BP 732
EP 740
DI 10.1373/clinchem.2003.029983
PG 9
WC Medical Laboratory Technology
SC Medical Laboratory Technology
GA 807TS
UT WOS:000220524400007
PM 14764644
ER
PT J
AU Rafii, F
Hotchkiss, C
Heinze, TM
Park, M
AF Rafii, F
Hotchkiss, C
Heinze, TM
Park, M
TI Metabolism of daidzein by intestinal bacteria from rhesus monkeys
(Macaca mulatta)
SO COMPARATIVE MEDICINE
LA English
DT Article
ID GUT MICROFLORA; SOY PROTEIN; ISOFLAVONOID DAIDZEIN; SOYBEAN ISOFLAVONES;
CYNOMOLGUS MONKEYS; BREAST-CANCER; C-RING; PHYTOESTROGENS; EQUOL;
GENISTEIN
AB Purpose: To identify the metabolites produced from an isoflavonoid, daidzein, by colonic bacteria of rhesus monkeys.
Methods: The metabolism of daidzein by the fecal bacteria of nine monkeys was investigated. Daidzein was incubated anaerobically with fecal bacteria, and the metabolites were analyzed by use of liquid chromatography and mass spectrometry.
Results: The fecal bacteria of all of the monkeys metabolized daidzein to various extents. Dihydrodaidzein was found in cultures of fecal bacteria from two monkeys; dihydrodaidzein and equol were found in cultures from four monkeys; dihydrodaidzein, equol, and an unknown metabolite (MW = 244) were found in cultures from one monkey; and dihydrodaidzein and the unknown metabolite were found in cultures from two monkeys.
Conclusions: Similar to that in humans, variation was evident in the metabolism of isoflavonoids by fecal bacteria from rhesus monkeys. Some metabolites produced by fecal bacteria from monkeys were the same as those produced by fecal bacteria from humans.
C1 US FDA, Natl Ctr Toxicol Res, Div Microbiol, Jefferson, AR 72079 USA.
Bionet Corp, Natl Ctr Toxicol Res, Jefferson, AR 72079 USA.
Natl Ctr Toxicol Res, Div Chem, Jefferson, AR 72079 USA.
RP Rafii, F (reprint author), US FDA, Natl Ctr Toxicol Res, Div Microbiol, Jefferson, AR 72079 USA.
NR 35
TC 12
Z9 13
U1 0
U2 2
PU AMER ASSOC LABORATORY ANIMAL SCIENCE
PI MEMPHIS
PA 9190 CRESTWYN HILLS DR, MEMPHIS, TN 38125 USA
SN 1532-0820
J9 COMPARATIVE MED
JI Comparative Med.
PD APR
PY 2004
VL 54
IS 2
BP 165
EP 169
PG 5
WC Veterinary Sciences; Zoology
SC Veterinary Sciences; Zoology
GA 817YS
UT WOS:000221213400005
PM 15134361
ER
PT J
AU Turesky, RJ
AF Turesky, RJ
TI The role of genetic polymorphisms in metabolism of carcinogenic
heterocyclic aromatic amines
SO CURRENT DRUG METABOLISM
LA English
DT Review
DE heterocyclic aromatic amines; xenobiotic metabolism enzymes;
polymorphisms; cancer
ID GLUTATHIONE-S-TRANSFERASE; BREAST-CANCER RISK; HUMAN CYTOCHROME-P450
1A2; DONE MEAT INTAKE; HUMAN UDP-GLUCURONOSYLTRANSFERASES;
N-ACETYLTRANSFERASE EXPRESSION; MAMMARY EPITHELIAL-CELLS; DNA ADDUCT
FORMATION; LOS-ANGELES-COUNTY; COLORECTAL-CANCER
AB More than twenty heterocyclic aromatic amines (HAAs) have been identified in grilled meats, Fish, poultry, and tobacco smoke condensate. HAAS are carcinogens and induce tumors at Multiple Sites in experimental laboratory animals. Because of the widespread occurrence of HAAs in foods, these chemicals may contribute to the etiology of several common human cancers that are associated with frequent consumption of grilled meals including colon, rectum, prostate, and breast. HAAs require metabolism in order to exert their genotoxic effects. Metabolic activation occurs by N-hydroxylation, a reaction catalyzed by cytochromes P450 (CYP). Sonic N-hydroxy-HAA metabolites may directly react with DNA. but further metabolism by N-acetyltransferases (NATs) or sulfotransferases (SULTs) may occur to form highly reactive N-acetoxy or N-sulfonyloxy esters that readily react with DNA bases. The N-acetoxy ester of the HAA 2-amino-1-methyl-6-phenylimidazo[4,5-b]pyridine (PhlP) is detoxified by glutathione S-transferases (GSTs), which catalyze the reduction of the reactive intermediate back to the parent amine. Sonic HAAs also undergo detoxification through conjugation reactions with the phase II enzymes Such as UDP-glucuronosyltransferases (UGTs) or SULTs to form stable, polar products that are readily eliminated. All of these xenobiotic metabolism enzyme systems (XMEs) display common genetic polymorphisms, which may affect protein expression, protein stability, catalytic activity, and thus, the biological potency of these procarcinogens. In this review, the roles of common genetic polymorphisms of XMEs involved in HAA metabolism and cancer risk are discussed.
C1 Natl Ctr Toxicol Res, Div Chem, Jefferson, AR 72079 USA.
RP Turesky, RJ (reprint author), Natl Ctr Toxicol Res, Div Chem, Bldg 26 Room A155, Jefferson, AR 72079 USA.
EM RTuresky@nctr.fda.gov
NR 156
TC 43
Z9 45
U1 0
U2 5
PU BENTHAM SCIENCE PUBL LTD
PI HILVERSUM
PA PO BOX 1673, 1200 BR HILVERSUM, NETHERLANDS
SN 1389-2002
J9 CURR DRUG METAB
JI Curr. Drug Metab.
PD APR
PY 2004
VL 5
IS 2
BP 169
EP 180
DI 10.2174/1389200043489036
PG 12
WC Biochemistry & Molecular Biology; Pharmacology & Pharmacy
SC Biochemistry & Molecular Biology; Pharmacology & Pharmacy
GA 812QY
UT WOS:000220855200004
PM 15078194
ER
PT J
AU Ishii, KJ
Gursel, I
Gursel, M
Klinman, DM
AF Ishii, KJ
Gursel, I
Gursel, M
Klinman, DM
TI Immunotherapeutic utility of stimulatory and suppressive
oligodeoxynucleotides
SO CURRENT OPINION IN MOLECULAR THERAPEUTICS
LA English
DT Article
DE CpG DNA; immunotherapy; innate immunity; suppressive ODNs; toll-like
receptor 9
ID BACTERIAL CPG-DNA; TOLL-LIKE RECEPTOR-9; INDUCED IMMUNE ACTIVATION;
IMMUNOSTIMULATORY DNA; MURINE MODEL; PROTEIN-KINASE; IN-VIVO; SYNTHETIC
OLIGODEOXYNUCLEOTIDES; DEPENDENT PROTECTION; AIRWAY INFLAMMATION
AB Bacterial DNA contains immunostimulatory CpG motifs that interact with toll-like receptor 9 on immune cells to stimulate the production of cytokines, chemokines and immunoglobulins. Synthetic oligodeoxynucleotides (ODNs) containing CpG motifs mimic the activity of bacterial DNA. Recently, several structurally distinct types of CpG ODN were identified that differentially activate human immune cells. These ODNs may be useful as vaccine adjuvants, anti-allergens and in the treatment of infectious diseases and cancer. Yet CpG-driven immune activation can have deleterious consequences, such as increasing the host's susceptibility to autoimmune disease. The immunomodulatory activity of CpG DNA can be blocked by DNA containing G-rich 'suppressive' motifs. The therapeutic potential of these immunostimulatory and immunosuppressive ODNs are discussed in this review.
C1 US FDA, Sect Retroviral Immunmol, Ctr Biol Evaluat & Res, Bethesda, MD 20892 USA.
Osaka Univ, Akira Innate Immun Project, ERATO,Res Inst Microbial Dis, Japan Sci & Technol Agcy,Dept Host Def, Osaka 5650871, Japan.
RP Klinman, DM (reprint author), US FDA, Sect Retroviral Immunmol, Ctr Biol Evaluat & Res, Bldg 29A Rm 3D10, Bethesda, MD 20892 USA.
EM Klinman@cber.fda.gov
RI Gursel, Mayda /H-1812-2012; Ishii, Ken/B-1685-2012;
OI Ishii, Ken/0000-0002-6728-3872; Gursel, Ihsan/0000-0003-3761-1166
NR 73
TC 39
Z9 42
U1 0
U2 0
PU CURRENT DRUGS LTD
PI LONDON
PA MIDDLESEX HOUSE, 34-42 CLEVELAND ST, LONDON W1P 6LB, ENGLAND
SN 1464-8431
J9 CURR OPIN MOL THER
JI Curr. Opin. Mol. Ther.
PD APR
PY 2004
VL 6
IS 2
BP 166
EP 174
PG 9
WC Biotechnology & Applied Microbiology; Medicine, Research & Experimental
SC Biotechnology & Applied Microbiology; Research & Experimental Medicine
GA 838UA
UT WOS:000222737600009
PM 15195929
ER
PT J
AU Gendel, SM
AF Gendel, SM
TI Riboprint analysis of Listeria monocytogenes isolates obtained by FDA
from 1999 to 2003
SO FOOD MICROBIOLOGY
LA English
DT Article
DE riboprint; ribotyping; molecular subtyping; Listeria monocytogenes
ID SMOKED FISH; POULTRY; MEAT
AB Listeria monocytogenes is a widespread human and annual pathogen. Despite the potential value of ribotyping for tracking patterns of strain distribution in Listeria monocytogenes, the application of this technology for this species has been limited to sets of isolates that are linked either by epidemiology, geography, or food type. To broadly characterize the population structure of L. monocytogenes, automated ribotyping was carried out on a large set of unrelated isolates obtained by the US FDA from late 1999 to early 2003. The results showed the widespread occurrence of a few strains, and no indication of geographic or food-related stratification. Published by Elsevier Ltd.
C1 US FDA, Biotechnol Studies Branch, Natl Ctr Food Safety & Technol, Summit Argo, IL 60501 USA.
RP Gendel, SM (reprint author), US FDA, Biotechnol Studies Branch, Natl Ctr Food Safety & Technol, 6502 S Archer Rd, Summit Argo, IL 60501 USA.
EM sgendel@cfsan.fda.gov
NR 14
TC 5
Z9 5
U1 0
U2 0
PU ACADEMIC PRESS LTD ELSEVIER SCIENCE LTD
PI LONDON
PA 24-28 OVAL RD, LONDON NW1 7DX, ENGLAND
SN 0740-0020
J9 FOOD MICROBIOL
JI Food Microbiol.
PD APR
PY 2004
VL 21
IS 2
BP 187
EP 191
DI 10.1016/S0740-0020(03)00054-6
PG 5
WC Biotechnology & Applied Microbiology; Food Science & Technology;
Microbiology
SC Biotechnology & Applied Microbiology; Food Science & Technology;
Microbiology
GA 779XX
UT WOS:000189328500008
ER
PT J
AU Brooks, BE
Zhan, M
Cote, T
Baquet, CR
AF Brooks, BE
Zhan, M
Cote, T
Baquet, CR
TI Surveillance, Epidemiology, and End Results analysis of 2677 cases of
uterine sarcoma 1989-1999
SO GYNECOLOGIC ONCOLOGY
LA English
DT Article
DE uterine sarcoma; race; survival
ID ENDOMETRIAL CARCINOMA; CANCER; TAMOXIFEN; UTERUS
AB Objective. To determine the association of race with incidence, histology, treatment, and survival in women with uterine sarcoma during the period 1989-1999.
Method. Uterine sarcomas were defined as leiomyosarcoma, carcinosarcoma, high-grade endometrial stromal sarcoma (HGESS), adenosarcoma, and sarcoma not otherwise specified (NOS). We used cases from Surveillance, Epidemiology, and End Results (SEER) program to compare uterine sarcoma among women >35 years of age. Using data from 1989 to 1999, we compared race-specific age-adjusted incidences, histological distributions, extent of disease at diagnosis, and race-specific survival.
Results. During the period of 1989-1999, 2677 women were diagnosed with uterine sarcoma, 2098 (78%) of whom were white and 420 (16%) of whom were black, and 159 (6%) of whom were of other races. The overall age-adjusted incidence for blacks was twice that of whites and more than twice that of women of other races (7/10(5) vs. 3.6/10(5) vs. 2.7/10(5), p < 0.0001). Racial differences in the incidence of uterine sarcoma existed for leiomyosarcoma (1.51/10(5) for blacks vs. 0.91/10(5) for whites, and 0.89 for women of other races, P < 0.01) and carcinosarcoma (4.3/10(5) for blacks, vs. 1.7/10(5) for whites, and 0.99 for women of other races, P < 0.001), but not for other histological types. Blacks with stage II disease were less likely to receive radiation in addition to surgery compared to whites (33% vs. 54%, P < 0.05). Five-year relative survival of patients with disease beyond the uterus was significantly longer for those that received radiation and surgery compared to those that received surgery alone. There were no racial differences in survival for women that received similar therapy.
Conclusions. Adjuvant therapy improved survival for women with stage II-IV disease. Survival of black and white patients who received comparable treatment was similar. (C) 2004 Elsevier Inc. All rights reserved.
C1 Univ Maryland, Sch Med, Dept Obstet & Gynecol & Reprod Sci, Baltimore, MD 21201 USA.
Univ Maryland, Sch Med, Dept Epidemiol & Prevent Med, Baltimore, MD 21201 USA.
US FDA, Rockville, MD 20857 USA.
RP Brooks, BE (reprint author), Univ Maryland, Sch Med, Dept Obstet & Gynecol & Reprod Sci, 3rd Floor,405 W Redwood St, Baltimore, MD 21201 USA.
EM sbrooks@umm.edu
NR 17
TC 29
Z9 33
U1 0
U2 5
PU ACADEMIC PRESS INC ELSEVIER SCIENCE
PI SAN DIEGO
PA 525 B ST, STE 1900, SAN DIEGO, CA 92101-4495 USA
SN 0090-8258
EI 1095-6859
J9 GYNECOL ONCOL
JI Gynecol. Oncol.
PD APR
PY 2004
VL 93
IS 1
BP 204
EP 208
DI 10.1016/j.ygyno.2003.12.029
PG 5
WC Oncology; Obstetrics & Gynecology
SC Oncology; Obstetrics & Gynecology
GA 812PG
UT WOS:000220850800032
ER
PT J
AU Ak, M
Babaoglu, A
Dagci, H
Turk, M
Bayram, S
Ertabaklar, H
Ozcel, MA
Uner, A
Charoenvit, Y
Kumar, S
Hoffman, SL
AF Ak, M
Babaoglu, A
Dagci, H
Turk, M
Bayram, S
Ertabaklar, H
Ozcel, MA
Uner, A
Charoenvit, Y
Kumar, S
Hoffman, SL
TI Production of monoclonal antibodies against a 19-kD recombinant
Plasmodium vivax MSPI for detection of P-vivax malaria in Turkey
SO HYBRIDOMA AND HYBRIDOMICS
LA English
DT Article
ID MEROZOITE SURFACE PROTEIN-1; YOELII SPOROZOITES; VACCINE CANDIDATE;
IMMUNOGENICITY; BLOOD; EXPRESSION; ANTIGEN; PROTECT; GROWTH
AB Plasmodium vivax malaria, which is transmitted to humans by mosquitoes, is one of the most important parasitic diseases in Turkey. The major protein on the surface of asexual erythrocytic stage merozoites of P. vivax (Pv) is 200 kD and called major merozoite surface protein-1 (PvMSP1). Polyclonal antibodies against the 19-kD C-terminal fragment of PvMSP1 (PvMSP1(19)) are protective in monkey models of P. vivax and associated with protection in field studies. In this research, monoclonal antibodies were produced against PvMSP1(19). A total of 214 IgG(1) antibody-releasing hybridomas were obtained and three monoclonal antibodies were produced (PvMSP1(19).1, PvMSP1(19).2, and PvMSP1(19).3) and selected for further study. They have now been purified from ascitic fluid on a Staphylococcus protein A affinity column. These are the first monoclonal antibodies produced against P. vivax in Turkey and the first monoclonal antibodies produced against this recombinant PvMSP1(19) in the world. The monoclonal antibodies will be used to study the epidemiology of P. vivax in patients with malaria in Turkey, and to develop better strategies for early diagnosis and treatment of the disease in our population.
C1 Ege Univ, Fac Med, Dept Parasitol, Izmir, Turkey.
Izmir State Hosp, Microbiol Lab, Izmir, Turkey.
Eylul Univ 9, Fac Med, Dept Parasitol, Izmir, Turkey.
Adnan Menderes Univ, Fac Med, Dept Parasitol, Aydin, Turkey.
NMRC, IDD, Malaria Program, Silver Spring, MD USA.
US FDA, Ctr Biol Evaluat & Res, Rockville, MD 20857 USA.
Sanaria Inc, Rockville, MD USA.
RP Ak, M (reprint author), Ege Univ, Fac Med, Dept Parasitol, Izmir, Turkey.
EM ak@med.ege.edu.tr
RI Dagci, Hande/B-1840-2008
NR 17
TC 0
Z9 0
U1 2
U2 2
PU MARY ANN LIEBERT INC PUBL
PI LARCHMONT
PA 2 MADISON AVENUE, LARCHMONT, NY 10538 USA
SN 0272-457X
J9 HYBRIDOMA HYBRIDOM
JI Hybrid. Hybridomics
PD APR
PY 2004
VL 23
IS 2
BP 133
EP 136
DI 10.1089/153685904774129748
PG 4
WC Biochemical Research Methods; Biotechnology & Applied Microbiology;
Immunology
SC Biochemistry & Molecular Biology; Biotechnology & Applied Microbiology;
Immunology
GA 822AL
UT WOS:000221505600007
PM 15165487
ER
PT J
AU Cheung, AM
Farizo, KM
Burns, DL
AF Cheung, AM
Farizo, KM
Burns, DL
TI Analysis of relative levels of production of pertussis toxin Subunits
and Ptl proteins in Bordetella pertussis
SO INFECTION AND IMMUNITY
LA English
DT Article
ID AGROBACTERIUM-TUMEFACIENS VIRB; MONOCLONAL-ANTIBODIES;
SUBCELLULAR-LOCALIZATION; BARTONELLA-HENSELAE; T-PILUS; GENES;
SECRETION; OPERON; PROMOTER; CLONING
AB Pertussis toxin is transported across the outer membrane of Bordetella pertussis by the type TV secretion system known as the Ptl transporter, which is composed of nine different proteins. In order to determine the relative levels of production of pertussis toxin subunits and Ptl proteins in B. pertussis, we constructed translational fusions of the gene for alkaline phosphatase, phoA, with various ptx and ptl genes. Comparison of the alkaline phosphatase activity of strains containing ptx'- or ptl'-phoA fusions indicated that pertussis toxin subunits are produced at higher levels than Ptl proteins, which are encoded by genes located toward the 3' end of the ptx-ptl operon. We also engineered strains of B. pertussis by introducing multiple copies of the ptl genes or subsets of these genes and then examined the ability of each of these strains to secrete pertussis toxin. From these studies, we determined that certain Ptl proteins appear to be limiting in the secretion of pertussis toxin from the bacteria. These results represent an important first step in assessing the stoichiometric relationship of pertussis toxin and its transporter within the bacterial cell.
C1 US FDA, CBER, HFM 434, Lab Resp & Special Pathogens, Bethesda, MD 20892 USA.
RP Burns, DL (reprint author), US FDA, CBER, HFM 434, Lab Resp & Special Pathogens, Bldb 29,Room 130,8800 Rockville Pike, Bethesda, MD 20892 USA.
EM burns@cber.fda
NR 33
TC 4
Z9 4
U1 0
U2 0
PU AMER SOC MICROBIOLOGY
PI WASHINGTON
PA 1752 N ST NW, WASHINGTON, DC 20036-2904 USA
SN 0019-9567
J9 INFECT IMMUN
JI Infect. Immun.
PD APR
PY 2004
VL 72
IS 4
BP 2057
EP 2066
DI 10.1128/IAI.72.4.2057-2066.2004
PG 10
WC Immunology; Infectious Diseases
SC Immunology; Infectious Diseases
GA 807DG
UT WOS:000220481600025
PM 15039327
ER
PT J
AU McCutchan, TF
Grim, KC
Li, J
Weiss, W
Rathore, D
Sullivan, M
Graczyk, TK
Kumar, S
Cranfield, MR
AF McCutchan, TF
Grim, KC
Li, J
Weiss, W
Rathore, D
Sullivan, M
Graczyk, TK
Kumar, S
Cranfield, MR
TI Measuring the effects of an ever-changing environment on malaria control
SO INFECTION AND IMMUNITY
LA English
DT Article
ID PENGUINS SPHENISCUS-DEMERSUS; COLONY-STIMULATING FACTOR;
PLASMODIUM-FALCIPARUM; AVIAN MALARIA; CIRCUMSPOROZOITE PROTEIN;
INTERFERON-GAMMA; DNA VACCINES; T-CELL; IMMUNIZATION; PROTECTION
AB The effectiveness of malaria control measures depends not only on the potency of the control measures themselves but also upon the influence of variables associated with the environment. Environmental variables have the capacity either to enhance or to impair the desired outcome. An optimal outcome in the field, which is ultimately the real goal of vaccine research, will result from prior knowledge of both the potency of the control measures and the role of environmental variables. Here we describe both the potential effectiveness of control measures and the problems associated with testing in an area of endemicity. We placed canaries with different immunologic backgrounds (e.g., naive to malaria infection, vaccinated naive, and immune) directly into an area where avian malaria, Plasmodium relictum, is endemic. In our study setting, canaries that are naive to malaria infection routinely suffer approximately 50% mortality during their first period of exposure to the disease. In comparison, birds vaccinated and boosted with a DNA vaccine plasmid encoding the circumsporozoite protein of P. relictum exhibited a moderate degree of protection against natural infection (P < 0.01). In the second year we followed the fate of all surviving birds with no further manipulation. The vaccinated birds from the first year were no longer statistically distinguishable for protection against malaria from cages of naive birds. During this period, 36% of vaccinated birds died of malaria. We postulate that the vaccine-induced protective immune responses prevented the acquisition of natural immunity similar to that concurrently acquired by birds in a neighboring cage. These results indicate that dominant environmental parameters associated with malaria deaths can be addressed before their application to a less malleable human system.
C1 NIAID, Parasit Dis Lab, Sect Growth & Dev, NIH, Bethesda, MD 20892 USA.
US FDA, Ctr Biol Review & Res, Div Emerging Transfus Transmitted Dis, Bethesda, MD 20014 USA.
USN, Med Res Ctr, Malaria Program, Silver Spring, MD 20903 USA.
Johns Hopkins Univ, Johns Hopkins Sch Med, Baltimore, MD USA.
Baltimore Zoo, Dept Med, Baltimore, MD USA.
St Clares Hosp, Dept Pathol, Denville, NJ USA.
RP McCutchan, TF (reprint author), NIAID, Parasit Dis Lab, Sect Growth & Dev, NIH, 9000 Rockville Pike, Bethesda, MD 20892 USA.
EM tmccutchan@niaid.nih.gov
NR 31
TC 5
Z9 5
U1 0
U2 6
PU AMER SOC MICROBIOLOGY
PI WASHINGTON
PA 1752 N ST NW, WASHINGTON, DC 20036-2904 USA
SN 0019-9567
J9 INFECT IMMUN
JI Infect. Immun.
PD APR
PY 2004
VL 72
IS 4
BP 2248
EP 2253
DI 10.1128/IAI.72.4.2248-2253.2004
PG 6
WC Immunology; Infectious Diseases
SC Immunology; Infectious Diseases
GA 807DG
UT WOS:000220481600047
PM 15039349
ER
PT J
AU Mahmood, I
Tammara, V
AF Mahmood, I
Tammara, V
TI A comparison of two sparse sampling population pharmacokinetic
approaches for the estimation of pharmacokinetic parameters in children
SO INTERNATIONAL JOURNAL OF CLINICAL PHARMACOLOGY AND THERAPEUTICS
LA English
DT Article
DE sparse sampling; population pharmacokinetics; Bayesian approach;
variable and fixed sampling
ID MAXIMUM PLASMA-CONCENTRATION; CONCENTRATION C-MAX; UNDER-THE-CURVE;
COMPUTER-SIMULATION; MODEL; AREA; AUC; CARBAMAZEPINE; PERFORMANCE; TIME
AB (Background and objective:) under bar The objectives of this study were to assess pharmacokinetic parameters (clearance, volume and half-life) in children using sparse sampling population as well as Bayesian (post hoc) approach. (Methods:) under bar Three drugs were selected for this study. Two sparse sampling methods (variable or fixed) using population and Bayesian approaches were used to assess pharmacokinetic parameters in children following a single oral dose. The initial estimates of the model parameters and inter- and intrasubject variability were obtained from the pharmacokinetic studies conducted in adults. The estimated pharmacokinetic parameters using sparse sampling (3 blood samples) were compared with the pharmacokinetic parameters obtained by extensive sampling (greater than or equal to7 blood samples). (Results and conclusions:) under bar The results indicated that both variable and fixed sampling approaches could be used to estimate mean population as well as individual pharmacokinetic parameters in children with fair degree of accuracy. The methods described here can be used to assess either population or individual pharmacokinetic parameters in children, provided there is a prior knowledge of the pharmacokinetics of a drug in adult population.
C1 Wyeth Pharmaceut, Collegeville, PA USA.
RP Mahmood, I (reprint author), US FDA, Div Clin Trial Design & Anal, Off Therapeut Res & Review,Ctr Biol Evaluat & Res, Clin Pharmacol & Toxicol Branch HFD 579, Woodmont Off Ctr 1,Suite 200N,1401 Rockville Pike, Rockville, MD 20852 USA.
EM Mahmoodi@CBER.FDA.GOV
NR 18
TC 5
Z9 5
U1 0
U2 0
PU DUSTRI-VERLAG DR KARL FEISTLE
PI OBERHACHING
PA BAJUWARENRING 4, D-82041 OBERHACHING, GERMANY
SN 0946-1965
J9 INT J CLIN PHARM TH
JI Int. J. Clin. Pharmacol. Ther.
PD APR
PY 2004
VL 42
IS 4
BP 240
EP 245
PG 6
WC Pharmacology & Pharmacy
SC Pharmacology & Pharmacy
GA 808LQ
UT WOS:000220571000006
PM 15124982
ER
PT J
AU Monday, SR
Minnich, SA
Feng, PCH
AF Monday, SR
Minnich, SA
Feng, PCH
TI A 12-base-pair deletion in the flagellar master control gene flhC causes
nonmotility of the pathogenic German sorbitol-fermenting Escherichia
coli O157 : H- strains
SO JOURNAL OF BACTERIOLOGY
LA English
DT Article
ID HEMOLYTIC-UREMIC SYNDROME; MOLECULAR CHARACTERIZATION;
MONOCLONAL-ANTIBODY; EXPRESSION; OPERON; IDENTIFICATION; SEROTYPES;
MUTATIONS; SEQUENCE; SHIGELLA
AB An atypical, Stx2-producing, pathogenic Escherichia coli O157:H- strain has been isolated with increasing frequency from hemolytic uremic syndrome patients in Germany. The lack of the H7 antigen coupled with the strain's ability to ferment sorbitol and express beta-glucuronidase have complicated its detection and identification. In this study, we have determined that the loss of motility in these German sorbitol-fermenting (SF) O157 strains is due to a 12-bp in-frame deletion in flhC that is required for transcriptional activation of genes involved in flagellum biosynthesis. Either complementation with a functional flhC or repair of this mutation restored H7 antigen expression and motility. PCR analysis of several nonmotile E. coli O157 strains from various geographical sources confirmed that the 12-bp flhC deletion is found only in the cluster of German SF O157 strains, providing a potentially useful marker by which these atypical strains can be identified. The loss of motility via mutations in the flhDC operon that we observed in the German SF O157 strains is consistent with a similar phenomenon currently observed in a significant subset of other important gram-negative pathogens.
C1 US FDA, Div Microbiol Studies, College Pk, MD 20740 USA.
Univ Idaho, Dept Microbiol Mol Biol & Biochem, Moscow, ID 83843 USA.
RP Feng, PCH (reprint author), US FDA, Div Microbiol Studies, 5100 Paint Branch Pkwy, College Pk, MD 20740 USA.
EM pfeng@cfsan.fda.gov
FU NCRR NIH HHS [P20 RR16454]
NR 35
TC 37
Z9 38
U1 0
U2 2
PU AMER SOC MICROBIOLOGY
PI WASHINGTON
PA 1752 N ST NW, WASHINGTON, DC 20036-2904 USA
SN 0021-9193
J9 J BACTERIOL
JI J. Bacteriol.
PD APR
PY 2004
VL 186
IS 8
BP 2319
EP 2327
DI 10.1128/JB.186.8.2319-2327.2004
PG 9
WC Microbiology
SC Microbiology
GA 809ZE
UT WOS:000220673800012
PM 15060034
ER
PT J
AU Van Do, N
Mino, L
Merriam, GR
LeMar, H
Case, HS
Palinkas, LA
Reedy, K
Reed, HL
AF Van Do, N
Mino, L
Merriam, GR
LeMar, H
Case, HS
Palinkas, LA
Reedy, K
Reed, HL
TI Elevation in serum thyroglobulin during prolonged antarctic residence:
Effect of thyroxine supplement in the polar 3,5,3 '-triiodothyronine
syndrome
SO JOURNAL OF CLINICAL ENDOCRINOLOGY & METABOLISM
LA English
DT Article; Proceedings Paper
CT 83rd Annual Meeting of the Endocrine-Society
CY JUN 20-23, 2001
CL DENVER, CO
SP Endocrine Soc
ID RECOMBINANT HUMAN THYROTROPIN; THYROID-CARCINOMA; CLINICAL-PRACTICE;
PITUITARY; KINETICS
AB Extended Antarctic residence (AR) is associated with an increase in serum TSH, a decrease in free T(4), and an increase in T(3) production and clearance. It is not clear whether these adaptations reflect changes in clearance alone or whether intrinsic thyroidal synthetic activity also changes. Thyroglobulin (Tg) secretion is an independent marker of intrinsic thyroid activity whose kinetics are independent of those of T(3) and T(4). In this study we examined changes in Tg levels in healthy subjects before and during AR and their responses to thyroid supplementation to help determine whether alterations in thyroid activity, and not just kinetics of clearance, underlie the changes seen with the polar T(3) syndrome. In cohort 1, we compared measurements of TSH and Tg in 12 subjects before deployment and monthly for 11 months during AR. In cohort 2, we compared the same measurements in 12 subjects monthly for 11 months of AR. Subjects were randomized to receive either placebo or levothyroxine in cohort 1 for 7 months and in cohort 2 for 11 months. Tg increased over baseline during the first 4 months of AR by 17.0+/-4.6% and after 7 more months by 31.7+/-4.3% over baseline in the placebo group of both cohorts ( P<0.0002). When L-T(4) was taken, Tg returned to a value not different from baseline (4.5 +/- 3.9%). The percent changes from baseline in serum TSH and Tg during AR were highly correlated (P<0.00003) in the placebo group for both cohorts. The rise in Tg with TSH and the reduction in Tg with L-T(4) provide evidence of target tissue response to TSH and further confirm the TSH rise as physiologically significant. The results also suggest that the adaptive changes in thyroid hormone economy with AR reflect TSH-dependent changes in thyroid synthetic activity, which may help explain a portion of the increases in T(3) production found with AR.
C1 Madigan Army Med Ctr, Internal Med Serv, Tacoma, WA 98431 USA.
New Mexico Resonance, Albuquerque, NM USA.
Vet Affairs Puget Sound Hlth Care Syst, Tacoma, WA 98493 USA.
Univ Washington, Div Metab Endocrinol & Nutr, Seattle, WA 98195 USA.
William Beaumont Army Med Ctr, Endocrine Serv, El Paso, TX 79920 USA.
McDaniel Coll, Dept Exercise Sci & Phys Educ, Westminster, MD 21157 USA.
Univ Calif San Diego, Dept Family & Prevent Med, La Jolla, CA 92093 USA.
US FDA, Rockville, MD 20857 USA.
Multicare Med Grp, Tacoma, WA 98415 USA.
RP Van Do, N (reprint author), Stanford Med Informat, Sch Med, Off Bldg,X-215,251 Campus Dr, Stanford, CA 94305 USA.
EM nhan.do@us.army.mil
NR 23
TC 2
Z9 3
U1 0
U2 0
PU ENDOCRINE SOC
PI CHEVY CHASE
PA 8401 CONNECTICUT AVE, SUITE 900, CHEVY CHASE, MD 20815-5817 USA
SN 0021-972X
J9 J CLIN ENDOCR METAB
JI J. Clin. Endocrinol. Metab.
PD APR
PY 2004
VL 89
IS 4
BP 1529
EP 1533
DI 10.1210/jc.2003-031747
PG 5
WC Endocrinology & Metabolism
SC Endocrinology & Metabolism
GA 810OV
UT WOS:000220714500004
PM 15070908
ER
PT J
AU Tsang, RSW
Tsai, CM
Zhu, PX
Ringuette, L
Lorange, M
Law, DKS
AF Tsang, RSW
Tsai, CM
Zhu, PX
Ringuette, L
Lorange, M
Law, DKS
TI Phenotypic and genetic characterization of a unique variant of serogroup
C ET-15 meningococci (with the antigenic formula C : 2a : P1.7,1)
causing invasive meningococcal disease in Quebec, Canada
SO JOURNAL OF CLINICAL MICROBIOLOGY
LA English
DT Article
ID NEISSERIA-MENINGITIDIS SEROTYPE-2A; MASS IMMUNIZATION CAMPAIGN;
OUTER-MEMBRANE PROTEIN; UNITED-STATES; ET-37 COMPLEX;
POPULATION-GENETICS; VIRULENT CLONE; EPIDEMIOLOGY; DIVERSITY; EMERGENCE
AB Serogroup C Neisseria meningitidis belonging to the electrophoretic type (ET) ET-15, a variant of ET-37, is endemic in Canada. Like other serogroup C ET-37 meningococci, the endemic ET-15 strains are usually found to carry the serotype and serosubtype antigens of 2a:P1.5,2. In 2001, a sudden increase in the number of cases of serogroup C meningococcal disease in Quebec, Canada, was caused by an antigenic variant of the ET-15 strain. This antigenic variant carries the unique serosubtype marker of P1.7,1. Strains of C:2a:P1.7,1 meningococci were not isolated in Canada in large numbers prior to 2001, and the characteristics of these meningococcal strains linked to an outbreak in Quebec, Canada, are described in the present study.
C1 CNS, Infect & Vaccine Preventable Bacterial Dis Div, Natl Microbiol Lab, Winnipeg, MB R3E 3R2, Canada.
Inst Natl Sante Publ, Lab Sante Publ, Ste Anne De Bellevue, PQ, Canada.
US FDA, Ctr Biol Evaluat & Res, Div Bacterial Prod, Washington, DC USA.
RP Tsang, RSW (reprint author), CNS, Infect & Vaccine Preventable Bacterial Dis Div, Natl Microbiol Lab, 1015 Arlington St, Winnipeg, MB R3E 3R2, Canada.
EM rtsang@hc-sc.gc.ca
NR 39
TC 18
Z9 19
U1 0
U2 0
PU AMER SOC MICROBIOLOGY
PI WASHINGTON
PA 1752 N ST NW, WASHINGTON, DC 20036-2904 USA
SN 0095-1137
J9 J CLIN MICROBIOL
JI J. Clin. Microbiol.
PD APR
PY 2004
VL 42
IS 4
BP 1460
EP 1465
DI 10.1128/JCM.42.4.1460-1465.2004
PG 6
WC Microbiology
SC Microbiology
GA 814GK
UT WOS:000220963000012
PM 15070989
ER
PT J
AU Williams, TL
Musser, SM
Nordstrom, JL
DePaola, A
Monday, SR
AF Williams, TL
Musser, SM
Nordstrom, JL
DePaola, A
Monday, SR
TI Identification of a protein biomarker unique to the pandemic O3 : K6
clone of Vibrio parahaemolyticus
SO JOURNAL OF CLINICAL MICROBIOLOGY
LA English
DT Article
ID FLIGHT MASS-SPECTROMETRY; STRAINS; MICROORGANISMS; EMERGENCE; CHOLERAE;
PCR; EXPRESSION; SEQUENCE; BACTERIA; SPREAD
AB The present method of characterizing Vibrio parahaemolyticus strains involves serotyping or detection methods based on assessment of the presence or absence of genes thought to be markers of an organism's pathogenicity. It is unclear whether these assays detect all pathogenic V. parahaemolyticus strains since a clear correlation between the presence of a particular gene and the organism's pathogenicity has not yet been observed. We have described a proteomics-based method to distinguish individual V. parahaemolyticus strains on the basis of their protein profiles and identified a specific protein that is characteristic of the pandemic O3:K6 strain and its clonal derivatives. In the pandemic clone of V. parahaemolyticus, a histone-like DNA-binding protein, HU-alpha, has a C-terminal amino acid sequence different from those of other strains of V. parahaemolyticus. Upon further study, it was discovered that the gene encoding this protein has a 16-kbp insert at the 3' terminus of the open reading frame for this protein. By using the protein sequence of the unique biomarker for the pandemic clone of V. parahaemolyticus, it was possible to rationally design specific PCR-based probes and assays that permit the rapid and precise identification of pandemic strains of V. parahaemolyticus.
C1 US FDA, Instrumentat & Biophys Branch, Ctr Food Safety & Appl Nutr, College Pk, MD 20740 USA.
US FDA, Gulf Coast Seafood Lab, Dauphin Isl, AL 36528 USA.
RP Musser, SM (reprint author), US FDA, Instrumentat & Biophys Branch, Ctr Food Safety & Appl Nutr, HFS 717,5100 Paint Branch Pkwy, College Pk, MD 20740 USA.
EM smusser@cfsan.fda.gov
NR 31
TC 36
Z9 39
U1 0
U2 8
PU AMER SOC MICROBIOLOGY
PI WASHINGTON
PA 1752 N ST NW, WASHINGTON, DC 20036-2904 USA
SN 0095-1137
J9 J CLIN MICROBIOL
JI J. Clin. Microbiol.
PD APR
PY 2004
VL 42
IS 4
BP 1657
EP 1665
DI 10.1128/JCM.42.4.1657-1665.2004
PG 9
WC Microbiology
SC Microbiology
GA 814GK
UT WOS:000220963000045
PM 15071022
ER
PT J
AU Soares, CC
Volotao, EM
Albuquerque, MCM
Nozawa, CM
Linhares, REC
Volokhov, D
Chizhikov, V
Lu, XY
Erdman, D
Santos, N
AF Soares, CC
Volotao, EM
Albuquerque, MCM
Nozawa, CM
Linhares, REC
Volokhov, D
Chizhikov, V
Lu, XY
Erdman, D
Santos, N
TI Genotyping of enteric adenoviruses by using single-stranded conformation
polymorphism analysis and Heteroduplex mobility assay
SO JOURNAL OF CLINICAL MICROBIOLOGY
LA English
DT Article
ID RESTRICTION-ENDONUCLEASE ANALYSIS; PCR; IDENTIFICATION; STRAINS
AB Single-stranded conformation polymorphism (SSCP) analysis and heteroduplex mobility assays (HMAs) were used to identify and genotype enteric adenoviruses (EAd). The results were compared to those of restriction endonuclease assays, species-specific PCRs, and direct nucleotide sequence analyses. Of the 31 stool samples tested, 15 isolates were identified as EAd and 7 were identified as nonenteric Ad by all methods. An agreement of 100% was found between the SSCP and HMA results.
C1 Univ Fed Rio de Janeiro, Dept Virol, Inst Microbiol, BR-21941590 Rio De Janeiro, Brazil.
Univ Estadual Londrina, Dept Microbiol, BR-86061970 Londrina, PR, Brazil.
US FDA, Ctr Biol Evaluat & Res, Rockville, MD 20852 USA.
Ctr Dis Control & Prevent, Div Viral & Rickettsial Dis, Atlanta, GA 30333 USA.
RP Santos, N (reprint author), Univ Fed Rio de Janeiro, Dept Virol, Inst Microbiol, Cidade Univ,CCS,Bl I, BR-21941590 Rio De Janeiro, Brazil.
EM nsantos@micro.ufrj.br
RI Santos, Norma/H-6986-2015
OI Santos, Norma/0000-0002-5123-9172
NR 14
TC 6
Z9 6
U1 0
U2 0
PU AMER SOC MICROBIOLOGY
PI WASHINGTON
PA 1752 N ST NW, WASHINGTON, DC 20036-2904 USA
SN 0095-1137
J9 J CLIN MICROBIOL
JI J. Clin. Microbiol.
PD APR
PY 2004
VL 42
IS 4
BP 1723
EP 1726
DI 10.1128/JCM.42.4.1723-1729.2004
PG 4
WC Microbiology
SC Microbiology
GA 814GK
UT WOS:000220963000055
PM 15071032
ER
PT J
AU Sreenivas, G
Raju, BVS
Singh, R
Selvapandiyan, A
Duncan, R
Sarkar, D
Nakhasi, HL
Salotra, P
AF Sreenivas, G
Raju, BVS
Singh, R
Selvapandiyan, A
Duncan, R
Sarkar, D
Nakhasi, HL
Salotra, P
TI DNA polymorphism assay distinguishes isolates of Leishmania donovani
that cause kala-azar from those that cause post-kala-azar dermal
leishmaniasis in humans
SO JOURNAL OF CLINICAL MICROBIOLOGY
LA English
DT Article
ID COMPLEX
AB Leishmania donovani in India causes visceral infection (kala-azar) and dermal infection (post-kala-azar dermal leishmaniasis). We report here the identification of polymorphism in a well-defined genetic locus among the Leishmania parasites causing the visceral and dermal manifestations, in a comparison of 15 post-kala-azar dermal leishmaniasis and 12 kala-azar patient isolates.
C1 ICMR, Inst Pathol, New Delhi 110029, India.
Indian Inst Chem Biol, Kolkata, India.
US FDA, Ctr Biol Evaluat & Res, Div Emerging & Transfus Transmitted Dis, Off Blood Res & Review, Rockville, MD 20892 USA.
RP Salotra, P (reprint author), ICMR, Inst Pathol, Safdarjung Hosp Campus, New Delhi 110029, India.
EM salotra@vsnl.com
RI Duncan, Robert/I-8168-2015;
OI Duncan, Robert/0000-0001-8409-2501; Singh, Ruchi/0000-0001-8094-4703
NR 20
TC 20
Z9 20
U1 0
U2 1
PU AMER SOC MICROBIOLOGY
PI WASHINGTON
PA 1752 N ST NW, WASHINGTON, DC 20036-2904 USA
SN 0095-1137
J9 J CLIN MICROBIOL
JI J. Clin. Microbiol.
PD APR
PY 2004
VL 42
IS 4
BP 1739
EP 1741
DI 10.1128/JCM.42.4.1739-1741.2004
PG 3
WC Microbiology
SC Microbiology
GA 814GK
UT WOS:000220963000059
PM 15071036
ER
PT J
AU Averbuch, M
Katzper, M
AF Averbuch, M
Katzper, M
TI Assessment of visual analog versus categorical scale for measurement of
osteoarthritis pain
SO JOURNAL OF CLINICAL PHARMACOLOGY
LA English
DT Article
DE visual analog; categorical; scale; pain
ID RATING-SCALES; CLINICAL PAIN; SENSITIVITY; QUESTIONNAIRE; DESCRIPTORS;
INTENSITY; PRECISION; EFFICACY; CANCER
AB There is disagreement in the literature regarding which scales to use in pain measurement. The difference has usually been between nonverbal scales, such as visual analog scales and verbal ones, which usually provide only a limited number of response categories. A 12-week, randomized, double-blind naproxen sodium (500 mg bid) and placebo-controlled trial using the hip osteoarthritis (OA) flare-up pain mode, in which pain was measured on both visual analog and categorical scales simultaneously, was analyzed. The authors found a good correlation (> 0.995) between the time-series overage of the unconstrained visual analog scale and a 5-point categorical scale pain measurement in the osteoarthritis pain model in both active and placebo treatment arms. However, for individuals, there is a wide range of VAS responses for each categorical score, with overlaps between categories, The visual analog and categorical scales appear as effective in determining average osteoarthritis pain. However, a combined metric scale for pain measurement that provides the subject with multiple cues may improve communication and concordance between scales for individual pain determination.
C1 US FDA, Ctr Drug Evaluat & Res, Div Analges Anti Inflammatory & Ophthalm Drug Pro, Rockville, MD 20857 USA.
RP Katzper, M (reprint author), US FDA, Ctr Drug Evaluat & Res, Div Analges Anti Inflammatory & Ophthalm Drug Pro, HFD-550,5600 Fishers Lane, Rockville, MD 20857 USA.
NR 25
TC 27
Z9 28
U1 1
U2 4
PU SAGE PUBLICATIONS INC
PI THOUSAND OAKS
PA 2455 TELLER RD, THOUSAND OAKS, CA 91320 USA
SN 0091-2700
J9 J CLIN PHARMACOL
JI J. Clin. Pharmacol.
PD APR
PY 2004
VL 44
IS 4
BP 368
EP 372
DI 10.1177/0091270004263995
PG 5
WC Pharmacology & Pharmacy
SC Pharmacology & Pharmacy
GA 805UD
UT WOS:000220390300005
PM 15051743
ER
PT J
AU Foley, SL
Simjee, S
Meng, JH
White, DG
McDermott, PF
Zhao, SH
AF Foley, SL
Simjee, S
Meng, JH
White, DG
McDermott, PF
Zhao, SH
TI Evaluation of molecular typing methods for Escherichia coli O157 : H7
isolates from cattle, food, and humans
SO JOURNAL OF FOOD PROTECTION
LA English
DT Article
ID FIELD GEL-ELECTROPHORESIS; SEROTYPE O157-H7; EAE GENE; PCR;
MICROORGANISMS; IDENTIFICATION; PATHOGENS
AB Escherichia coli O157:H7, a Shiga toxin-producing E. coli, has been the causative agent of many cases of severe, often life-threatening foodborne illness. Because of the importance of E. coli O157:H7 to public health, many molecular typing methods have been developed to determine its transmission routes and source of infection during epidemiological investigations. Pulsed-field gel electrophoresis (PFGE) is currently used by public health organizations to track infections of E. coli O157:117 and other foodborne pathogens. In this study, we compared the ability of PFGE, multilocus sequence typing (MLST), and repetitive-element PCR (Rep-PCR) to distinguish among 92 E. coli O157:H7 isolates from cattle, food, and infected humans. Several virulence genes, including the intimin gene (eaeA), the hemolysin gene (hlyA), and the H7 fimbrial gene (fliC), and a housekeeping gene for beta-glucuronidase (uidA) were included in MLST Rep-PCR reactions were performed using a commercially available typing kit (Bacterial Barcodes Inc., Houston, Tex.) with the provided Uprime-RI primer set. Results of the study indicated that PFGE provided the most discrimination among the techniques, identifying 72 distinct PFGE profiles for the isolates; Rep-PCR elucidated 14 different profiles, whereas MLST generated five profiles. Additionally, there did not appear to be any correlation among the typing methods examined in this study. Therefore, to date, PFGE remains the technique of choice for molecular subtyping of E. coli O157:H7.
C1 US FDA, Div Anim & Food Microbiol, Res Off, Ctr Vet Med, Laurel, MD 20708 USA.
Univ Cent Arkansas, Dept Biol, Conway, AR 72035 USA.
Univ Maryland, Dept Nutr & Food Sci, College Pk, MD 20742 USA.
RP Zhao, SH (reprint author), US FDA, Div Anim & Food Microbiol, Res Off, Ctr Vet Med, Laurel, MD 20708 USA.
EM szhao@cvm.fda.gov
NR 31
TC 27
Z9 32
U1 0
U2 2
PU INT ASSOC FOOD PROTECTION
PI DES MOINES
PA 6200 AURORA AVE SUITE 200W, DES MOINES, IA 50322-2863 USA
SN 0362-028X
J9 J FOOD PROTECT
JI J. Food Prot.
PD APR
PY 2004
VL 67
IS 4
BP 651
EP 657
PG 7
WC Biotechnology & Applied Microbiology; Food Science & Technology
SC Biotechnology & Applied Microbiology; Food Science & Technology
GA 810LM
UT WOS:000220705800004
PM 15083714
ER
PT J
AU Mills, JL
Schonberger, LB
Wysowski, DK
Brown, P
Durako, SJ
Cox, C
Kong, FH
Fradkin, JE
AF Mills, JL
Schonberger, LB
Wysowski, DK
Brown, P
Durako, SJ
Cox, C
Kong, FH
Fradkin, JE
TI Long-term, mortality in the united states cohort of pituitary-derived
growth hormone recipients
SO JOURNAL OF PEDIATRICS
LA English
DT Article
ID CREUTZFELDT-JAKOB-DISEASE; CHILDREN; THERAPY; DEFICIENCY
AB Objective Patients who received pituitary-derived growth hormone (GH) are at excess risk of mortality from Creutzfeldt-Jakob disease. We investigated whether they were at increased risk of death from other conditions, particularly preventable conditions.
Study design A cohort (N = 6107) from known US pituitary-derived GH recipients (treated 1963-1985) was studied. Deaths were identified by reports from physicians and parents and the National Death Index. Rates were compared with the expected rates for the US population standardized for race, age, and sex.
Results There were 433 deaths versus 114 expected (relative risk [RR], 3.8; 95% confidence interval [CI], 3.4-4.2; P < .0001) from 1963 through 1996. Risk was increased in subjects with GH deficiency caused by any tumor (RR, 10.4; 95% CI, 9.1-12.0; P < .0001). Surprisingly, subjects with hypoglycemia treated within the first 6 months of life were at extremely high risk (RR, 18.3; 95% CI, 9.2-32.8; P < .0001), as were all subjects with adrenal insufficiency (RR, 7.1; 95% CI, 6.2-8.2; P < .0001). A quarter of all deaths were sudden and unexpected. Of the 26 cases of Creutzfeldt-Jakob disease, four cases have died since 2000.
Conclusions The death rate in pituitary-derived GH recipients was almost four times the expected rate. Replacing pituitary derived GH with recombinant GH has eliminated only the risk of Creutzfeldt-Jakob disease. Hypoglycemia and adrenal insufficiency accounted for far more mortality than Creutzfeldt-Jakob disease. The large number of potentially preventable deaths in patients with adrenal insufficiency and hypo glycemia underscores the importance of early intervention when infection occurs in patients with adrenal insufficiency, and aggressive treatment of panhypopituitarism.
C1 NINDS, NICHHD, Bethesda, MD 20892 USA.
NIDDKD, NIH, Dept Hlth & Human Serv, Bethesda, MD 20892 USA.
US FDA, Rockville, MD 20857 USA.
Ctr Dis Control & Prevent, Natl Ctr Infect Dis, Atlanta, GA USA.
RP Mills, JL (reprint author), NICHD, Pediat Epidemiol Sect, NIH, DHHS, 6100 Bldg Room 7B03, Bethesda, MD 20892 USA.
EM jamesmills@nih.gov
NR 14
TC 72
Z9 73
U1 0
U2 2
PU MOSBY-ELSEVIER
PI NEW YORK
PA 360 PARK AVENUE SOUTH, NEW YORK, NY 10010-1710 USA
SN 0022-3476
EI 1097-6833
J9 J PEDIATR-US
JI J. Pediatr.
PD APR
PY 2004
VL 144
IS 4
BP 430
EP 436
DI 10.1016/j.jpeds.2003.12.036
PG 7
WC Pediatrics
SC Pediatrics
GA 811GO
UT WOS:000220760600015
PM 15069388
ER
PT J
AU Jasper, JP
Westenberger, BJ
Spencer, JA
Buhse, LF
Nasr, M
AF Jasper, JP
Westenberger, BJ
Spencer, JA
Buhse, LF
Nasr, M
TI Stable isotopic characterization of active pharmaceutical ingredients
SO JOURNAL OF PHARMACEUTICAL AND BIOMEDICAL ANALYSIS
LA English
DT Article
DE pharmaceutical materials; active pharmaceutical ingredients; stable
isotopes; delta(13)C; delta(15)N; delta(18)O; delta D; isotropic
fingerprinting
ID RATIOS
AB Stable isotopic characterization or "fingerprinting" of active pharmaceutical ingredients (APIs) is a highly-specific means of defining the provenance of these pharmaceutical materials. The isotopic analysts in this study were provided with 20 blind samples of four APIs (tropicamide, hydrocortisone, quinine HCL, and tryptophan) from one-to-five production batch(es) from one-to-five manufacturer(s). Only the chemical identity of the APIs was initially provided to the isotopic analysts. Depending on the API chemical composition, isotopic ratios of either three or four elements ((13)C/(12)C, (15)N/(14)N, (18)O/(16)O, and/or D/H) were measured by either elemental analyzer/isotope ratio mass spectrometry (EV/IRMS: carbon (delta(13)C) and nitrogen (delta(15)N)) or by thermal conversion-EV/IRMS (TCEA/IRMS; hydrogen (deltaD) and oxygen (delta(15)N)); in all cases, the isotopic results are reported in the standard delta-notation which represents part-per-thousand (parts per thousand) variations from the isotopic ratios of international standards.
The stable isotopic analyses of the four suites of APIs spanned broad ranges in absolute value (A 8) and in estimated specificity (a product of dynamic ranges (DR, unitless)-note that these are upper limits of specificity because some of these isotope values may be partially interdependent). The five samples of tropicamide from one production batch and one manufacturer demonstrated the narrowest ranges (Deltadelta(13)C = 0.13parts per thousand; Deltadelta(15)N = 0.52parts per thousand; Delta(18)O = 0.24parts per thousand; DeltadeltaD = 2.8parts per thousand) and the smallest specificity of 1:30.9. By contrast, the five samples of tryptophan that came from five separate manufacturers had some of the widest isotopic ranges observed (Adelta(13)C = 21.32parts per thousand; Deltadelta(15)N = 5.26parts per thousand; Delta(18)O = 22.07parts per thousand; DeltadeltaD = 55.3parts per thousand) and had the largest specificity of 1:19.6 x 10(6). The isotopic provenance of the four suites of APIs readily emerged from bivariate plots of selected isotope ratios, particularly deltaD versus delta(18)O. (C) 2003 Elsevier B.V. All rights reserved.
C1 Mol Isotope Technol LLC, Niantic, CT 06357 USA.
US FDA, Ctr Drug Evaluat & Res, Div Pharmaceut Anal, St Louis, MO 63101 USA.
RP Jasper, JP (reprint author), Mol Isotope Technol LLC, 8 Old Oak Lane, Niantic, CT 06357 USA.
EM jpjasper@molecularisotopes.com
NR 14
TC 29
Z9 30
U1 3
U2 9
PU ELSEVIER SCIENCE BV
PI AMSTERDAM
PA PO BOX 211, 1000 AE AMSTERDAM, NETHERLANDS
SN 0731-7085
J9 J PHARMACEUT BIOMED
JI J. Pharm. Biomed. Anal.
PD APR 1
PY 2004
VL 35
IS 1
BP 21
EP 30
DI 10.1016/S0731-7085(03)00581-8
PG 10
WC Chemistry, Analytical; Pharmacology & Pharmacy
SC Chemistry; Pharmacology & Pharmacy
GA 810JC
UT WOS:000220699600003
PM 15030876
ER
PT J
AU Idowu, OR
Peggins, JO
AF Idowu, OR
Peggins, JO
TI Simple, rapid determination of enrofloxacin and ciprofloxacin in bovine
milk and plasma by high-performance liquid chromatography with
fluorescence detection
SO JOURNAL OF PHARMACEUTICAL AND BIOMEDICAL ANALYSIS
LA English
DT Article
DE enrofloxacin; ciprofloxacin; bovine milk; bovine plasma; HPLC
ID PRIMARY METABOLITE CIPROFLOXACIN; BIOLOGICAL-FLUIDS; 4 FLUOROQUINOLONES;
TISSUES; PHARMACOKINETICS; PEFLOXACIN; RESIDUES; SINGLE; ASSAY; SERUM
AB A rapid and simple procedure for determination of enrofloxacin and ciprofloxacin in bovine milk and plasma is described. Protein precipitation from both milk and plasma samples was achieved by addition of acetonitrile and phosphoric acid. Acetonitrile was removed with methylene chloride, leaving enrofloxacin and ciprofloxacin in the acidic aqueous extract. The aqueous extract was analyzed by high-performance liquid chromatography (HPLC) with fluorescence detection. The limit of quantitation (LOQ) for enrofloxacin and ciprofloxacin in milk was found to be 2 ng/ml. LOQ for enrofloxacin and ciprofloxacin in plasma was found to be I ng/ml. Linear calibration curves were obtained with correlation coefficient (r(2)) greater than or equal to0.99. Analysis of quality control (QC) samples gave results within +/-10% of the nominal values. Inter-assay precision for the analysis of milk QC samples were in the ranges: 4.63-12.49% (for enrofloxacin) and 4.67-9.86% (for ciprofloxacin).
Inter-assay precision for the analysis of plasma QC samples were in the ranges: 6.60-17.31% (for enrofloxacin) and 6.14-13.87% (for ciprofloxacin). Intra-assay precision for the analysis of milk QC samples were in the following ranges: 3.65-7.21% (for enrofloxacin) and 1.58-14.28% (for ciprofloxacin). Intra-assay precision for the analysis of plasma QC samples were in the following ranges: 2.17-16.95% (for enrofloxacin) and 3.31-16.31% (for ciprofloxacin).
The effectiveness of protein precipitants other than phosphoric acid was investigated. The method described has been applied to a study of the pharmacokinetics of enrofloxacin and ciprofloxacin in lactating dairy cows and beef steers. (C) 2004 Elsevier B.V. All rights reserved.
C1 US FDA, Ctr Vet Med, Laurel, MD 20708 USA.
RP Idowu, OR (reprint author), US FDA, Ctr Vet Med, 8401 Muirkirk Rd, Laurel, MD 20708 USA.
EM oidowu@cvm.fda.gov
NR 26
TC 92
Z9 99
U1 0
U2 11
PU PERGAMON-ELSEVIER SCIENCE LTD
PI OXFORD
PA THE BOULEVARD, LANGFORD LANE, KIDLINGTON, OXFORD OX5 1GB, ENGLAND
SN 0731-7085
J9 J PHARMACEUT BIOMED
JI J. Pharm. Biomed. Anal.
PD APR 1
PY 2004
VL 35
IS 1
BP 143
EP 153
DI 10.1016/j.jpba.2004.01.006
PG 11
WC Chemistry, Analytical; Pharmacology & Pharmacy
SC Chemistry; Pharmacology & Pharmacy
GA 810JC
UT WOS:000220699600016
PM 15030889
ER
PT J
AU Spann, KM
Tran, KC
Chi, B
Rabin, RL
Collins, PL
AF Spann, KM
Tran, KC
Chi, B
Rabin, RL
Collins, PL
TI Suppression of the induction of alpha, beta, and gamma interferons by
the NS1 and NS2 proteins of human respiratory syncytial virus in human
epithelial cells and macrophages
SO JOURNAL OF VIROLOGY
LA English
DT Article
ID MESSENGER-RNA; VACCINE; IFN; LIVE; CHIMPANZEES; EXPRESSION; RESPONSES;
MUTANTS; GENES; RSV
AB Wild-type human respiratory syncytial virus (HRSV) is a poor inducer of alpha/beta interferons (IFN-alpha/beta). However, recombinant HRSV lacking the NS1 and NS2 genes (DeltaNSI/2) induced high levels of IFN-alpha and -beta in human pulmonary epithelial cells (A549) as well as in macrophages derived from primary human peripheral blood monocytes. Results with NS1 and NS2 single- and double-gene-deletion viruses indicated that the two proteins function independently as well as coordinately to achieve the full inhibitory effect, with NS1 having a greater independent role. The relative contributions of the individual NS proteins were the converse of that recently described for bovine RSV (J. F. Valarcher, J. Furze, S. Wyld, R. Cook, K. K. Conzelmann, and G. Taylor, J. Virol. 77:8426-8439, 2003). This pattern of inhibition by HRSV NS1 and NS2 also extended to the newly described antiviral cytokines IFN-lambda1, -2 and -3.
C1 NIAID, Infect Dis Lab, NIH, Bethesda, MD 20892 USA.
Ctr Biol Evaluat & Res, Food & Drug Adm, Lab Immunobiochem, Bethesda, MD 20892 USA.
RP Collins, PL (reprint author), NIAID, Infect Dis Lab, NIH, Bldg 50,Room 6507,50 S Dr,MSC 8007, Bethesda, MD 20892 USA.
EM pcollins@niaid.nih.gov
RI Spann, Kirsten/B-4524-2013
OI Spann, Kirsten/0000-0003-0567-8382
NR 28
TC 249
Z9 264
U1 2
U2 6
PU AMER SOC MICROBIOLOGY
PI WASHINGTON
PA 1752 N ST NW, WASHINGTON, DC 20036-2904 USA
SN 0022-538X
J9 J VIROL
JI J. Virol.
PD APR
PY 2004
VL 78
IS 8
BP 4363
EP 4369
DI 10.1128/JVI.78.8.4363-4396.2004
PG 7
WC Virology
SC Virology
GA 809MU
UT WOS:000220641600056
PM 15047850
ER
PT J
AU Hubbard, WK
AF Hubbard, WK
TI High prescription drug prices and the influence of the food and drug
administration - In reply
SO MAYO CLINIC PROCEEDINGS
LA English
DT Letter
C1 US FDA, Rockville, MD 20857 USA.
RP Hubbard, WK (reprint author), US FDA, Rockville, MD 20857 USA.
NR 0
TC 1
Z9 1
U1 0
U2 0
PU MAYO CLINIC PROCEEDINGS
PI ROCHESTER
PA 660 SIEBENS BLDG MAYO CLINIC, ROCHESTER, MN 55905 USA
SN 0025-6196
J9 MAYO CLIN PROC
JI Mayo Clin. Proc.
PD APR
PY 2004
VL 79
IS 4
BP 569
EP 570
PG 2
WC Medicine, General & Internal
SC General & Internal Medicine
GA 807MM
UT WOS:000220505600018
ER
PT J
AU Badano, A
Gagne, RM
Jennings, RJ
Drilling, SE
Imhoff, BR
Muka, E
AF Badano, A
Gagne, RM
Jennings, RJ
Drilling, SE
Imhoff, BR
Muka, E
TI Noise in flat-panel displays with subpixel structure
SO MEDICAL PHYSICS
LA English
DT Article
DE liquid crystal display; medical display; noise; noise-power spectrum
ID RESOLUTION; DEVICES
AB Subpixel structures found in medical monochrome active-matrix liquid crystal displays (AMLCDs) affect noise estimates measured with conventional methods. In this work, we discuss methods that identify sources of noise and permit the comparison of luminance noise estimates across technologies independent of pixel design and device technology. We used a three-million pixel AMLCD with a pixel structure consisting of three color stripes, each in a two-domain, in-plane switching mode. Images of uniform fields displayed on the AMLCD were acquired using a low-noise, high-resolution CCD camera. The camera noise and flat-field response were characterized using a uniform light source constructed for this purpose. We show results in terms of spatial luminance noise and noise power spectrum for high-resolution images and for the same images processed with a pixel-aligned aperture. We find that the pixel-aligned aperture eliminates almost all the noise found in the high-resolution images, suggesting that most of the luminance noise in AMLCDs comes from the subpixel structure and less-than-100% aperture ratio, rather than from interpixel variations. (C) 2004 American Association of Physicists in Medicine.
C1 US FDA, Ctr Devices & Radiol Hlth, Rockville, MD 20857 USA.
Marquette Univ, Milwaukee, WI 53201 USA.
Washington Univ, Mallinckrodt Inst Radiol, St Louis, MO 63110 USA.
RP Badano, A (reprint author), US FDA, Ctr Devices & Radiol Hlth, 12720 Twinbrook Pkwy, Rockville, MD 20857 USA.
EM agb@cdrh.fda.gov
OI badano, aldo/0000-0003-3712-6670
NR 18
TC 26
Z9 26
U1 0
U2 1
PU AMER ASSOC PHYSICISTS MEDICINE AMER INST PHYSICS
PI MELVILLE
PA STE 1 NO 1, 2 HUNTINGTON QUADRANGLE, MELVILLE, NY 11747-4502 USA
SN 0094-2405
J9 MED PHYS
JI Med. Phys.
PD APR
PY 2004
VL 31
IS 4
BP 715
EP 723
DI 10.1118/1.1656529
PG 9
WC Radiology, Nuclear Medicine & Medical Imaging
SC Radiology, Nuclear Medicine & Medical Imaging
GA 813HK
UT WOS:000220898000004
PM 15124988
ER
PT J
AU Haffner, ME
AF Haffner, ME
TI Developing treatments for inborn errors: incentives available to the
clinician
SO MOLECULAR GENETICS AND METABOLISM
LA English
DT Article; Proceedings Paper
CT Workshop on New Developments in Urea Cycle Disorders
CY AUG 31-SEP 01, 2003
CL Sydney, AUSTRALIA
SP Ucyclyd Pharma, Orphan Europe, Swedish Orphan Int AB, Orphan Australia, Abbott Labs, Mead Johnson, Natl Urea Cycle Disorders Fdn
DE orphan; Orphan Drug Act; incentives; research grants; rare disease
AB Disorders resulting from inborn errors of metabolism (IEM) affect very small numbers of individuals. The entire population, however, of patients suffering the results of inherited metabolic disorders is large, and has been of increasing concern to patient groups and health care professionals in the United States as well as other countries throughout the world. The 1983 US Orphan Drug Act (ODA) serves to facilitate the development of drugs to treat rare diseases by providing several economic incentives. The sponsor of a product designated as an orphan by the Food & Drugs Administration (FDA) Office of Orphan Products Development (OPD) qualifies for tax credits on clinical trial expenses, the award of grant funding by FDA, through the OPD, and 7 years of marketing exclusivity for a designated drug, or biological product that receives FDA market approval. Orphan drug legislation in the US has benefited victims of IEM by encouraging development of drugs for metabolic deficiencies affecting populations that otherwise would be ignored. America's solution to the orphan drug problem has had worldwide impact. The success of this legislation was a factor leading to the 1993 orphan drug law in Japan; the 1997 implementation of a process whereby most FDA-approved orphan drugs and biological products will be similarly approved in Australia; and, in 1999, regulation on orphan medicinal products in the European Union (EU). Today, international support for rare disease research is providing stimulus and motivation to overcome the financial barriers and encourage development of treatment for very rare diseases throughout the world. Published by Elsevier Inc.
C1 US FDA, Off Orphan Prod Dev, Rockville, MD 20857 USA.
RP Haffner, ME (reprint author), US FDA, Off Orphan Prod Dev, Rockville, MD 20857 USA.
EM mhaffner@oc.fda.gov
NR 0
TC 1
Z9 3
U1 0
U2 1
PU ACADEMIC PRESS INC ELSEVIER SCIENCE
PI SAN DIEGO
PA 525 B ST, STE 1900, SAN DIEGO, CA 92101-4495 USA
SN 1096-7192
J9 MOL GENET METAB
JI Mol. Genet. Metab.
PD APR
PY 2004
VL 81
SU 1
BP S63
EP S66
DI 10.1016/j.ymgme.2003.10.015
PG 4
WC Endocrinology & Metabolism; Genetics & Heredity; Medicine, Research &
Experimental
SC Endocrinology & Metabolism; Genetics & Heredity; Research & Experimental
Medicine
GA 816QT
UT WOS:000221125100010
PM 15050976
ER
PT J
AU Klinman, DM
AF Klinman, DM
TI Immunotherapeutic uses of CpG oligodeoxynucleotides
SO NATURE REVIEWS IMMUNOLOGY
LA English
DT Review
ID B SURFACE-ANTIGEN; PLASMACYTOID DENDRITIC CELLS; TOLL-LIKE RECEPTORS;
SYSTEMIC-LUPUS-ERYTHEMATOSUS; ALLERGIC LUNG INFLAMMATION; INDUCE
AUTOIMMUNE-DISEASE; NATURAL-KILLER ACTIVITY; SIMPLEX-VIRUS TYPE-2;
BACTERIAL-DNA; IMMUNOSTIMULATORY DNA
AB Synthetic oligodeoxynucleotides (ODNs) that contain immunostimulatory CpG motifs trigger an immunomodulatory cascade that involves B and T cells, natural killer cells and professional antigen-presenting cells. The response to CpG ODNs skews the host's immune milieu in favour of T helper 1 (T(H)1)-cell responses and pro-inflammatory cytokine production-an effect that underlies their use as immunoprotective agents, vaccine adjuvants and anti-allergens. Preclinical studies provide evidence that CpG ODNs are effective for each of these uses. Ongoing clinical studies indicate that CpG ODN use is safe in humans, and that they modulate the immune response to co-administered allergens and vaccines.
C1 US FDA, Ctr Biol Evaluat & Res, Bethesda, MD 20892 USA.
RP Klinman, DM (reprint author), US FDA, Ctr Biol Evaluat & Res, Bldg 29A,Room 3D10, Bethesda, MD 20892 USA.
EM klinman@cber.FDA.gov
NR 145
TC 32
Z9 32
U1 3
U2 22
PU NATURE PUBLISHING GROUP
PI LONDON
PA MACMILLAN BUILDING, 4 CRINAN ST, LONDON N1 9XW, ENGLAND
SN 1474-1733
J9 NAT REV IMMUNOL
JI Nat. Rev. Immunol.
PD APR
PY 2004
VL 4
IS 4
BP 248
EP 257
DI 10.1038/nri1329
PG 10
WC Immunology
SC Immunology
GA 808HI
UT WOS:000220559800011
ER
PT J
AU Rudolf, PM
Bernstein, IBG
AF Rudolf, PM
Bernstein, IBG
TI Counterfeit drugs
SO NEW ENGLAND JOURNAL OF MEDICINE
LA English
DT Editorial Material
C1 US FDA, Rockville, MD 20857 USA.
RP Rudolf, PM (reprint author), US FDA, Rockville, MD 20857 USA.
NR 1
TC 33
Z9 33
U1 0
U2 3
PU MASSACHUSETTS MEDICAL SOC/NEJM
PI WALTHAM
PA WALTHAM WOODS CENTER, 860 WINTER ST,, WALTHAM, MA 02451-1413 USA
SN 0028-4793
J9 NEW ENGL J MED
JI N. Engl. J. Med.
PD APR 1
PY 2004
VL 350
IS 14
BP 1384
EP 1386
DI 10.1056/NEJMp038231
PG 4
WC Medicine, General & Internal
SC General & Internal Medicine
GA 808IJ
UT WOS:000220562500004
PM 15070787
ER
PT J
AU Karadag, A
Riminucci, M
Bianco, P
Cherman, N
Kuznetsov, SA
Nguyen, N
Collins, MT
Robey, PG
Fisher, LW
AF Karadag, A
Riminucci, M
Bianco, P
Cherman, N
Kuznetsov, SA
Nguyen, N
Collins, MT
Robey, PG
Fisher, LW
TI A novel technique based on a PNA hybridization probe and FRET principle
for quantification of mutant genotype in fibrous
dysplasia/McCune-Albright syndrome
SO NUCLEIC ACIDS RESEARCH
LA English
DT Article
ID POLYMERASE-CHAIN-REACTION; MITOCHONDRIAL-DNA; POINT MUTATIONS;
DIABETES-MELLITUS; GENE; BONE; DISEASE; ACCUMULATION; HETEROPLASMY;
CARDIOMYOPATHY
AB Somatic mutations are present in various proportions in numerous developmental pathologies. Somatic activating missense mutations of the GNAS gene encoding the Gs(alpha) protein have previously been shown to be the cause of fibrous dysplasia of bone (FD)/McCune-Albright syndrome (MAS). Because in MAS patients, tissues as diverse as melanocytes, gonads and bone are affected, it is generally accepted that the GNAS mutation in this disease must have occurred early in development. Interestingly, it has been shown that the development of an active FD lesion may require both normal and mutant cells. Studies of the somatic mosaic states of FD/MAS and many other somatic diseases need an accurate method to determine the ratio of mutant to normal cells in a given tissue. A new method for quantification of the mutant:normal ratio of cells using a PNA hybridization probe-based FRET technique was developed. This novel technique, with a linear sensitivity of 2.5% mutant alleles, was used to detect the percentage mutant cells in a number of tissue and cell culture samples derived from FD/MAS lesions and could easily be adapted for the quantification of mutations in a large spectrum of diseases including cancer.
C1 Natl Inst Dent & Craniofacial Res, Craniofacial & Skeletal Dis Branch, NIH, DHHS, Bethesda, MD 20892 USA.
Univ Aquila, Dipartimento Med Sperimentale, I-67100 Laquila, Italy.
Parco Sci Biomed San Raffaele, Rome, Italy.
Univ Roma La Sapienza, Dipartimento Med Sperimentale & Patol, Rome, Italy.
US FDA, Ctr Biol Evaluat & Res, Dept Hlth & Human Serv, Bethesda, MD USA.
RP Karadag, A (reprint author), Natl Inst Dent & Craniofacial Res, Craniofacial & Skeletal Dis Branch, NIH, DHHS, 30 Convent Dr,Bldg 30,Room 223,MSC 4320, Bethesda, MD 20892 USA.
EM akaradag@dir.nidcr.nih.gov
RI Robey, Pamela/H-1429-2011
OI Robey, Pamela/0000-0002-5316-5576
FU Telethon [E.1029]
NR 40
TC 25
Z9 26
U1 1
U2 2
PU OXFORD UNIV PRESS
PI OXFORD
PA GREAT CLARENDON ST, OXFORD OX2 6DP, ENGLAND
SN 0305-1048
J9 NUCLEIC ACIDS RES
JI Nucleic Acids Res.
PD APR
PY 2004
VL 32
IS 7
AR e63
DI 10.1093/nar/gnh059
PG 10
WC Biochemistry & Molecular Biology
SC Biochemistry & Molecular Biology
GA 816YO
UT WOS:000221145400029
PM 15096559
ER
PT J
AU Ornstein, DK
Petricoin, EF
AF Ornstein, DK
Petricoin, EF
TI Proteomies to diagnose human tumors and provide prognostic information
SO ONCOLOGY-NEW YORK
LA English
DT Article
ID LASER CAPTURE MICRODISSECTION; PROSTATE-SPECIFIC ANTIGEN; CODED AFFINITY
TAGS; MASS-SPECTROMETRY; GEL-ELECTROPHORESIS; PROTEIN EXPRESSION;
SWISS-2DPAGE DATABASE; OVARIAN-CANCER; CELL-LINES; SELDI-TOF
AB Proteomics is a rapidly emerging scientific discipline that holds great promise in identifying novel diagnostic and prognostic biomarkers for human cancer. Technologic improvements have made it possible to profile and compare the protein composition within defined populations of cells. Laser capture microdissection is a tool for procuring pure populations of cells from human tissue sections to be used for downstream proteomic analysis. Two-dimensional polyacrylamide gel electrophoresis (2D-PAGE) has been used traditionally to separate complex mixtures of proteins. Improvements in this technology have greatly enhanced resolution and sensitivity providing a more reproducible and comprehensive survey. Image analysis software and robotic instrumentation have been developed to facilitate comparisons of complex protein expression patterns and isolation of differentially expressed proteins spots. Differential in-gel electrophoresis (DIGS) facilitates protein expression by labeling different populations of proteins with fluorescent dyes. Isotope-coded affinity tagging (ICAT) uses mass spectroscopy for protein separation and different isotope tags for distinguishing populations of proteins. Although in the past proteomics has been primarily used for discovery, significant efforts are being made to develop proteomic technologies into clinical tools. Reverse phase protein arrays offer a robust new method of quantitatively assessing expression levels and the activation status of a panel of proteins. Surface-enhanced laser-desorption/ionization time-of-flight (SELDI-TOF) mass spectroscopy rapidly assesses complex protein mixtures in tissue or serum. Combined with artificial intelligence-based pattern recognition algorithms, this emerging technology can generate highly accurate diagnostic in = formation. It is likely that mass spectroscopy-based serum proteomics will evolve into useful clinical tools for the detection and treatment of human cancers.
C1 Univ Calif Irvine, Dept Urol, UCI Med Ctr, Orange, CA 92868 USA.
US FDA, FDA NCI Clin Proteom Program, Ctr Biol Evaluat & Res, Bethesda, MD 20014 USA.
RP Ornstein, DK (reprint author), Univ Calif Irvine, Dept Urol, UCI Med Ctr, 101 City Dr,Bldg 55,Rm300, Orange, CA 92868 USA.
EM dornstei@uci.edu
NR 42
TC 24
Z9 28
U1 0
U2 1
PU P R R INC
PI MELVILLE
PA 48 SOUTH SERVICE RD, MELVILLE, NY 11747 USA
SN 0890-9091
J9 ONCOLOGY-NY
JI Oncology-NY
PD APR
PY 2004
VL 18
IS 4
BP 521
EP 529
PG 9
WC Oncology
SC Oncology
GA 052DG
UT WOS:000238210700021
PM 15134357
ER
PT J
AU Mohan, AK
Braun, MM
Ellenberg, S
Hedje, J
Cote, TR
AF Mohan, AK
Braun, MM
Ellenberg, S
Hedje, J
Cote, TR
TI Deaths among children less than two years of age receiving palivizumab:
an analysis of comorbidities
SO PEDIATRIC INFECTIOUS DISEASE JOURNAL
LA English
DT Article
DE synagis; palivizumab; respiratory syncytial virus
ID RESPIRATORY SYNCYTIAL VIRUS; REDUCES HOSPITALIZATION;
MONOCLONAL-ANTIBODY; INFANT-MORTALITY; PROPHYLAXIS; MEDI-493
AB Background. Palivizumab (Synagis) is used for prophylaxis against respiratory syncytial virus infection among children at high risk for respiratory syncytial virus disease. A number of deaths after palivizumab use among children <2 years have been reported to the Food and Drug Administration. We assessed available information, including the extent to which preexisting medical conditions may have put these children at higher than normal risk of death.
Methods. We reviewed reports of deaths to the Food and Drug Administration (June 1998 to December 2001) among children <2 years of age who received palivizumab.
Results. There were 133 deaths reported after palivizumab use. Median age at death was 5 months, and 54% of the children were male. At least one congenital anomaly was reported in 85 cases (64%), and 44% of cases had multiple anomalies. Of the 100 cases with reported gestational age at birth, 36% were severely premature (<28 weeks), 48% were moderately premature (28 to 36 weeks) and 16% had normal gestational age. Only 2% of all cases were full term and were born without congenital anomalies; 50% had both conditions, 34% had prematurity alone and 14% had congenital anomalies alone. A cause of death was reported for 88 (66%) cases; most (38%) died from their congenital anomalies or from respiratory infections (23%).
Conclusions. Most children dying after palivizumab treatment were at increased risk of death; many had multiple congenital anomalies and/or premature birth. Patterns of outcomes and the reported medical course did not suggest that palivizumab further elevated the risk of death. Current data do not alter the safety and efficacy assessment that led to the licensure of palivizumab.
C1 US FDA, Ctr Biol Evaluat & Res, Off Biostat & Epidemiol, Rockville, MD 20852 USA.
NIAID, Off Global Affairs, NIH, Bethesda, MD 20892 USA.
RP Mohan, AK (reprint author), US FDA, Ctr Biol Evaluat & Res, Off Biostat & Epidemiol, 1404 Rockville Pike,Suite 200S, Rockville, MD 20852 USA.
EM mohan@cber.fda.gov
NR 24
TC 7
Z9 7
U1 0
U2 0
PU LIPPINCOTT WILLIAMS & WILKINS
PI PHILADELPHIA
PA 530 WALNUT ST, PHILADELPHIA, PA 19106-3621 USA
SN 0891-3668
J9 PEDIATR INFECT DIS J
JI Pediatr. Infect. Dis. J.
PD APR
PY 2004
VL 23
IS 4
BP 342
EP 345
DI 10.1097/00006454-200404000-00013
PG 4
WC Immunology; Infectious Diseases; Pediatrics
SC Immunology; Infectious Diseases; Pediatrics
GA 812YD
UT WOS:000220873900012
PM 15071290
ER
PT J
AU Galvez, MP
Vanable, L
Forman, JA
Landrigan, PJ
Akeredolu, E
Leighton, J
Nagin, D
Yip, W
Simmonds, K
AF Galvez, MP
Vanable, L
Forman, JA
Landrigan, PJ
Akeredolu, E
Leighton, J
Nagin, D
Yip, W
Simmonds, K
TI A case of childhood lead poisoning from commercially manufactured
European ceramic dinnerware, New York City, 2003
SO PEDIATRIC RESEARCH
LA English
DT Meeting Abstract
CT Annual Meeting of the Pediatric-Academic-Societies
CY MAY 03-06, 2003
CL SEATTLE, WA
SP Pediat Acad Soc, Amer Pediat Soc, Soc Pediat Res, Ambulatory Pediat Assoc, Tulane Univ Hlth Sci Ctr, Ctr Continuing Educ
C1 CUNY Mt Sinai Sch Med, New York, NY 10029 USA.
New York City Dept Hlth & Mental Hyg, Lead Poisoning Prevent Program, New York, NY USA.
US FDA, Food Chem Branch, NE Reg Lab, Jamaica, NY USA.
NR 0
TC 0
Z9 0
U1 1
U2 3
PU INT PEDIATRIC RESEARCH FOUNDATION, INC
PI BALTIMORE
PA 351 WEST CAMDEN ST, BALTIMORE, MD 21201-2436 USA
SN 0031-3998
J9 PEDIATR RES
JI Pediatr. Res.
PD APR
PY 2004
VL 55
IS 4
SU S
MA 1425
BP 251A
EP 252A
PN 2
PG 2
WC Pediatrics
SC Pediatrics
GA 808TJ
UT WOS:000220591101474
ER
PT J
AU El-Mohandes, AAE
Aly, H
Hammad, TA
Mohamed, M
Janosy, N
Urso, P
AF El-Mohandes, AAE
Aly, H
Hammad, TA
Mohamed, M
Janosy, N
Urso, P
TI Does pre-pregnancy maternal obesity influence length of gestation and
birth weight (BW)?: A multivariate analysis
SO PEDIATRIC RESEARCH
LA English
DT Meeting Abstract
CT Annual Meeting of the Pediatric-Academic-Societies
CY MAY 04, 2004
CL San Francisco, CA
SP Pediatr Acad Soc
C1 George Washington Univ, Med Ctr, Newborn Serv, Washington, DC 20037 USA.
US FDA, Rockville, MD 20857 USA.
Childrens Natl Med Ctr, Washington, DC 20010 USA.
NR 0
TC 0
Z9 0
U1 0
U2 0
PU INT PEDIATRIC RESEARCH FOUNDATION, INC
PI BALTIMORE
PA 351 WEST CAMDEN ST, BALTIMORE, MD 21201-2436 USA
SN 0031-3998
J9 PEDIATR RES
JI Pediatr. Res.
PD APR
PY 2004
VL 55
IS 4
SU S
MA 3370
BP 594A
EP 594A
PN 2
PG 1
WC Pediatrics
SC Pediatrics
GA 808TJ
UT WOS:000220591103447
ER
PT J
AU Mone, SM
Gillman, MW
Miller, TL
Herman, EH
Lipshultz, SE
AF Mone, SM
Gillman, MW
Miller, TL
Herman, EH
Lipshultz, SE
TI Effects of environmental exposures on the cardiovascular system:
Prenatal period through adolescence
SO PEDIATRICS
LA English
DT Review
DE environmental exposures; cardiovascular system; pediatric; fetal
ID HUMAN-IMMUNODEFICIENCY-VIRUS; CONGENITAL HEART-DEFECTS; PERICONCEPTIONAL
MULTIVITAMIN SUPPLEMENTATION; PROSPECTIVE (PCHIV)-C-2-H-2 MULTICENTER;
VITAMIN-A INTAKE; PERSISTENT PULMONARY-HYPERTENSION; EARLY
ATHEROSCLEROTIC LESIONS; ACUTE LYMPHOBLASTIC-LEUKEMIA; DRINKING-WATER
CONTAMINANTS; P(2)C(2) HIV MULTICENTER
AB Exposures to drugs, chemical and biological agents, therapeutic radiation, and other factors before and after birth can lead to pediatric or adult cardiovascular anomalies. Furthermore, nutritional deficiencies in the perinatal period can cause cardiovascular anomalies. These anomalies may affect heart structure, the conduction system, the myocardium, blood pressure, or cholesterol metabolism. Developmental periods before and after birth are associated with different types of risks. The embryonic period is the critical window of vulnerability for congenital malformations. The fetal period seems to have lifelong effects on coronary heart disease and its precursors. During the weeks immediately after birth, susceptibility to myocardial damage seems to be high. Exposure to cancer chemotherapy or radiotherapy in childhood raises the risk of long-term progressive left ventricular dysfunction and other cardiovascular problems. In childhood and adolescence, use of recreational drugs such as cocaine and tobacco poses cardiovascular dangers as well. Where evidence about environmental exposures is limited, we have included models of disease and other exposures that are suggestive of the potential impact of environmental exposures.
C1 Univ Miami, Sch Med, Holtz Childrens Hosp, Jackson Mem Med Ctr, Miami, FL 33136 USA.
Childrens Hosp, Med Ctr, Div Pediat Cardiol, Cincinnati, OH 45229 USA.
Harvard Univ, Sch Med, Dept Ambulatory Care & Prevent, Boston, MA USA.
Harvard Pilgrim Hlth Care, Boston, MA USA.
Harvard Univ, Sch Publ Hlth, Dept Nutr, Boston, MA 02115 USA.
Univ Miami, Sch Med, Div Pediat Clin Res, Miami, FL 33136 USA.
Univ Miami, Sch Med, Dept Pediat, Miami, FL 33136 USA.
Univ Miami, Sch Med, Sylvester Comprehens Canc Ctr, Miami, FL 33136 USA.
US FDA, Div Appl Pharmacol Res HFD910, Laurel, MD USA.
RP Lipshultz, SE (reprint author), Univ Miami, Sch Med, Holtz Childrens Hosp, Jackson Mem Med Ctr, 1601 NW 12th Ave,9th Fl, Miami, FL 33136 USA.
EM SLipshultz@med.miami.edu
FU NCI NIH HHS [CA 34183, CA 68484, CA 79060]; NCRR NIH HHS [RR02172];
NHLBI NIH HHS [HL 59837, HL 07937, HL 48012, HL 48020, HL 53392, HL
58731, HL 64925, HL 68041, HL 68228, HL 72705, HR 96041]; NICHD NIH HHS
[HD 34568]
NR 198
TC 50
Z9 58
U1 2
U2 3
PU AMER ACAD PEDIATRICS
PI ELK GROVE VILLAGE
PA 141 NORTH-WEST POINT BLVD,, ELK GROVE VILLAGE, IL 60007-1098 USA
SN 0031-4005
J9 PEDIATRICS
JI Pediatrics
PD APR 1
PY 2004
VL 113
IS 4
SU S
BP 1058
EP 1069
PG 12
WC Pediatrics
SC Pediatrics
GA 808RC
UT WOS:000220585200017
PM 15060200
ER
PT J
AU Solhaug, MJ
Bolger, PM
Jose, PA
AF Solhaug, MJ
Bolger, PM
Jose, PA
TI The developing kidney and environmental toxins
SO PEDIATRICS
LA English
DT Article
DE kidney; toxins; development; angiotensin; prostanoids
ID RENIN-ANGIOTENSIN SYSTEM; ACUTE-RENAL-FAILURE; FUMONISIN B-1;
RAT-KIDNEY; DEVELOPMENTAL TOXICITY; 2ND-TRIMESTER FETUSES;
POSTNATAL-DEVELOPMENT; PERINATAL-DEVELOPMENT; ADULT HYPERTENSION;
MERCURIC-CHLORIDE
AB The effects of environmental chemicals, drugs, and physical agents on the developing kidney are influenced by the state of renal development and maturation. The development of the kidney, the major excretory organ after birth, consists of 3 stages: the pronephros, or cervical kidney; mesonephros, or thoracic kidney; and metanephros, or abdominal kidney, the definitive kidney. In humans, nephrogenesis and organogenesis occur from the 6th to the 36th weeks of gestational age. After 36 weeks, nephrogenesis is complete and each kidney has a full complement of nephrons. The extent of chemical-induced renal toxicity is related, in part, to the efficiency in which the particular compound is transported by renal tubules. Because renal tubular transport capacities vary with maturation, the degree of nephrotoxicity may also vary with maturation. The signs and symptoms of nephrotoxicity can appear acutely or insidiously. Unexplained acute renal failure, chronic mild proteinuria, or even hypertension can be a manifestation of nephrotoxic agents. Species differences occur, thus the need for studies in humans.
C1 Georgetown Univ, Med Ctr, Dept Pediat, Washington, DC 20007 USA.
Eastern Virginia Med Sch, Dept Physiol, Norfolk, VA 23501 USA.
US FDA, Washington, DC 20204 USA.
Georgetown Univ, Med Ctr, Dept Physiol & Biophys, Washington, DC 20007 USA.
RP Jose, PA (reprint author), Georgetown Univ, Med Ctr, Dept Pediat, 3800 Reservoir Rd NW, Washington, DC 20007 USA.
EM pjose01@georgetown.edu
FU NIDDK NIH HHS [DK52612]
NR 80
TC 32
Z9 32
U1 1
U2 4
PU AMER ACAD PEDIATRICS
PI ELK GROVE VILLAGE
PA 141 NORTH-WEST POINT BLVD,, ELK GROVE VILLAGE, IL 60007-1098 USA
SN 0031-4005
J9 PEDIATRICS
JI Pediatrics
PD APR 1
PY 2004
VL 113
IS 4
SU S
BP 1084
EP 1091
PG 8
WC Pediatrics
SC Pediatrics
GA 808RC
UT WOS:000220585200020
PM 15060203
ER
PT J
AU Haber, P
Chen, RT
Zanardi, LR
Mootrey, GT
English, R
Braun, MM
AF Haber, P
Chen, RT
Zanardi, LR
Mootrey, GT
English, R
Braun, MM
CA VAERS Working Grp
TI An analysis of rotavirus vaccine reports to the vaccine adverse event
reporting system: More than intussusception alone?
SO PEDIATRICS
LA English
DT Article
DE rotavirus vaccine; Vaccine Adverse Event Reporting System; VAERS;
vaccine safety; postmarketing surveillance; rotavirus vaccine
ID SPONTANEOUS REDUCTION; SURVEILLANCE; VAERS; IMMUNIZATION; ASSOCIATION;
PREVENTION; INFECTION; INFANTS; DISEASE; SAFETY
AB Background. The rhesus-human rotavirus reassortant-tetravalent vaccine (RRV-TV) was licensed on August, 31, 1998, and subsequently recommended for routine infant immunizations in the United States. After similar to1 million doses had been administered, an increase in acute risk of intussusception in vaccinees led to the suspension of the use of RRV-TV and its withdrawal from the market. These postmarketing safety studies focused on a single adverse event ( intussusception) and, to minimize the risk of a false-positive finding, accepted only cases that met a strict case definition. Safer rotavirus vaccines are needed to prevent the substantial global morbidity and mortality caused by rotavirus infections; their development and future use may benefit from a better understanding of the postmarketing safety profile of RRV-TV beyond intussusception.
Objective. To characterize more completely the postmarketing surveillance safety profile of RRV-TV more completely by review and analysis of Vaccine Adverse Event Reporting System (VAERS) case reports to better understand 1) whether severe adverse events other than intussusception may have occurred after RRV-TV and 2) the likely scope of gastrointestinal illnesses, of which the previously identified, highly specific intussusception cases may account for just a fraction.
Setting and Participants. Infants vaccinated with RRV-TV and other vaccines in the United States and for whom a report was submitted to VAERS during September 1, 1998, to December 31, 1999.
Methodology. To detect adverse events of interest other than intussusception, we used proportional morbidity analysis to compare the adverse event profile of VAERS reports among infants who received routine vaccines including RRV-TV ( after excluding confirmed and suspected intussusception reports) with infants who received identical vaccine combinations but without RRV-TV. Next, to better capture all described diagnoses, signs, and symptoms associated with the suspected adverse events, a set of new codes was developed and assigned to each VAERS report. All 448 nonfatal RRV-TV-associated reports ( including intussusception) were recoded manually from the clinical description on the VAERS report and categorized into clinical groups to better describe a spectrum of reported illnesses after the vaccine. Each report was assigned to one of the following hierarchical and mutually exclusive clinical groups: 1) diagnosed intussusception; 2) suspected intussusception; 3) illness consistent with either gastroenteritis or intussusception; 4) gastroenteritis; 5) other gastrointestinal diagnoses (ie, not consistent with intussusception or rotavirus-like gastroenteritis); and 6) nongastrointestinal diagnoses.
Results. Even after excluding intussusception cases, a higher proportion of RRV-TV reports than non-RRV-TV reports included fever and various gastrointestinal symptoms, most notably bloody stool but also vomiting, diarrhea, abdominal pain, gastroenteritis, abnormal stool, and dehydration. Distribution of RRV-TV reports by clinical groups was as follows: diagnosed intussusception (109 [24%], suspected intussusception (36 [8%]), and illness consistent with gastroenteritis or intussusception (33 [7%]), gastroenteritis (101 [22%]), other gastrointestinal diagnoses (10 [2%]), and nongastrointestinal outcomes (159 [35%]). The median time interval between vaccination and illness onset decreased incrementally among the first 4 clinical groups: from 7 days for diagnosed intussusceptions to 3 days for gastroenteritis.
Conclusions. Intussusception and gastroenteritis were the most commonly reported outcomes; however, a substantial number of reports indicate signs and symptoms consistent with either illness, possibly suggestive of a spectrum of gastrointestinal illness(es) related to RRV-TV. Although VAERS data have recognized limitations such as underreporting ( that may differ by vaccine) and are nearly always insufficient to prove causality between a vaccine and an adverse event, this safety profile of RRV-TV may aid better understanding of the pathophysiology of intussusception as well as development of future safer rotavirus vaccines.
C1 CDCP, Immunizat Safety Branch, Epidemiol & Surveillance Div, Natl Immunizat Program, Atlanta, GA 30333 USA.
US FDA, Div Epidemiol, Off Biostat & Epidemiol, Rockville, MD 20857 USA.
RP Haber, P (reprint author), CDCP, Immunizat Safety Branch, Epidemiol & Surveillance Div, Natl Immunizat Program, Mail Stop E-61,1600 Clifton Rd, Atlanta, GA 30333 USA.
EM phaber@cdc.gov
NR 34
TC 25
Z9 26
U1 1
U2 2
PU AMER ACAD PEDIATRICS
PI ELK GROVE VILLAGE
PA 141 NORTH-WEST POINT BLVD,, ELK GROVE VILLAGE, IL 60007-1098 USA
SN 0031-4005
J9 PEDIATRICS
JI Pediatrics
PD APR 1
PY 2004
VL 113
IS 4
BP E353
EP E359
DI 10.1542/peds.113.4.e353
PG 7
WC Pediatrics
SC Pediatrics
GA 808RB
UT WOS:000220585100054
PM 15060267
ER
PT J
AU Willy, ME
Li, ZL
AF Willy, ME
Li, ZL
TI What is prescription labeling communicating to doctors about hepatotoxic
drugs? A study of FDA approved product labeling
SO PHARMACOEPIDEMIOLOGY AND DRUG SAFETY
LA English
DT Article; Proceedings Paper
CT Conference of the
American-Society-for-Clinical-Pharmacology-and-Therapeutics
CY MAR, 2002
CL Atlanta, GA
SP Amer Soc Clin Pharmacol Therapeut
DE hepatic failure; labeling; FDA
AB Purpose The objective of this study was to evaluate the informativeness and consistency of product labeling of hepatotoxic drugs marketed in the United States.
Methods We searched the Physicians' Desk Reference-2000 for prescription drugs with hepatic failure and/or hepatic necrosis listed in the labeling. We used a six-item checklist to evaluate the 'informativeness' and consistency of the labeling content. An informativeness score equaled the proportion of checklist items present in each drug's labeling.
Results Ninety-five prescription drugs were included in the study. Eleven (12%) of the drugs had information related to hepatic failure in a Black Boxed Warning, 52 (54%) in the Warnings section and 32 (34%) in the Adverse Reactions section of the label. The mean informativeness score was 35%; the score was significantly higher, 61%, when the risk was perceived to be high. The informativeness of labeling was not affected by the time of the labeling, but differed across the Center for Drug Evaluation and Research (CDER) Review Division responsible for the labeling.
Conclusions The information provided in labeling is variable and affected by many factors, including the perceived level of risk and review division strategy. Product labeling may benefit from current FDA initiatives to improve the consistency of risk-related labeling. Published in 2003 by John Wiley Sons, Ltd.
C1 US FDA, Off Drug Safety, Rockville, MD 20857 USA.
RP Willy, ME (reprint author), US FDA, Off Drug Safety, 5600 Fishers Ln,HDF-440,Room 15B-18, Rockville, MD 20857 USA.
EM WillyM@cder.fda.gov
FU PHS HHS [00-015]
NR 2
TC 18
Z9 18
U1 0
U2 1
PU JOHN WILEY & SONS LTD
PI CHICHESTER
PA THE ATRIUM, SOUTHERN GATE, CHICHESTER PO19 8SQ, W SUSSEX, ENGLAND
SN 1053-8569
J9 PHARMACOEPIDEM DR S
JI Pharmacoepidemiol. Drug Saf.
PD APR
PY 2004
VL 13
IS 4
BP 201
EP 206
DI 10.1002/pds.856
PG 6
WC Public, Environmental & Occupational Health; Pharmacology & Pharmacy
SC Public, Environmental & Occupational Health; Pharmacology & Pharmacy
GA 810VE
UT WOS:000220731000001
PM 15255086
ER
PT J
AU Hanna, GM
AF Hanna, GM
TI NMR regulatory analysis: determination and characterization of
S-adeno-syl-L-methionine in dietary supplements
SO PHARMAZIE
LA English
DT Article
ID DOUBLE-BLIND MULTICENTER; KNEE OSTEO-ARTHRITIS; CLINICAL-TRIAL;
CEREBROSPINAL-FLUID; THERAPEUTIC AGENT; RENAL-FAILURE;
ADENOSYLMETHIONINE; ADENOSYLHOMOCYSTEINE; METHYLATION; OSTEOARTHRITIS
AB H-1 NMR methodology is described for the determination and characterization of the dietary supplement S-adenosyl-L-Imethionine (SAM), recently introduced to the US market, utilizing a 400 MHz spectrometer without the need of pure reference standards. The developed methodology is able to assess chemical structure, differentiate between biologically-active (S)-diastereomer and biologically-inactive (R)-diastereomer, and determine the ratio of each in the dietry supplement formulation. The determination of the percentage of declared SAM was based on the integrals for the methyl proton of 2-methyl-2-propanol served as an internal standard at delta 1.24 and the methine proton H-1, of SAM ribose ring at delta 6.06. The percentage of the active diastereomer was calculated from the relative intensities of the sulfonium methyl singlets corresponding to the major component (S)-diastereomer at delta 2.98 and the minor (R)-counterpart at delta 2.93. The accuracy was established by analyzing synthetic mixtures of the analyte and the internal standard. Excellent agreement was verified between the assay results and the quantities of analyte in the mixture. The mean +/- SD recovery values for SAM and its (R)-diastereomer impurity from a set of 10 synthetic mixtures were 99.6 +/- 0.8% and 22.5 +/- 0.1%, respectively. Using 10 lots, the percentage of SAM ranged from 0 to 110.7% of the declared value and the percentage of the active (S)-diastereomer ranged from 0 to 82.3%.
C1 US FDA, NE Reg Lab, Dept Hlth & Human Serv, Jamaica, NY 11433 USA.
RP Hanna, GM (reprint author), US FDA, NE Reg Lab, Dept Hlth & Human Serv, 158-15 Liberty Ave, Jamaica, NY 11433 USA.
EM ghanna@ora.fda.gov
NR 51
TC 6
Z9 6
U1 0
U2 2
PU GOVI-VERLAG GMBH
PI ESCHBORN
PA PHARMAZEUTISCHER VERLAG GINNHEIMER STRASSE 26, D-65760 ESCHBORN, GERMANY
SN 0031-7144
J9 PHARMAZIE
JI Pharmazie
PD APR
PY 2004
VL 59
IS 4
BP 251
EP 256
PG 6
WC Chemistry, Medicinal; Chemistry, Multidisciplinary; Pharmacology &
Pharmacy
SC Pharmacology & Pharmacy; Chemistry
GA 811IN
UT WOS:000220765700002
PM 15125566
ER
PT J
AU Chen, HZ
Wang, RF
Cerniglia, CE
AF Chen, HZ
Wang, RF
Cerniglia, CE
TI Molecular cloning, overexpression, purification, and characterization of
an aerobic FMN-dependent azoreductase from Enterococcus faecalis
SO PROTEIN EXPRESSION AND PURIFICATION
LA English
DT Article
DE Enterococcus faecalis; aerobic azoreductase; azo dye; human intestinal
microflora
ID HUMAN INTESTINAL MICROFLORA; AZO DYES; ESCHERICHIA-COLI; BACTERIA;
BENZIDINE; METABOLISM; REDUCTION; DRUG; NITROREDUCTASE; DEGRADATION
AB Azo dyes represent a major class of synthetic colorants that are ubiquitous in foods and consumer products. Enterococcus faecalis is a predominant member of the human gastrointestinal microflora. Strain ATCC 19433 grew in the presence of azo dyes and metabolized them to colorless products. A gene encoding a putative FMN-dependent aerobic azoreductase that shares 34% identity with azoreductase (AcpD) of Escherichia coli has been identified in this strain. The gene in E faecalis, designated as azoA, encoded a protein of 208 amino acids with a calculated isoelectric point of 4.8. AzoA was heterologously overexpressed in E. coli with a strong band of 23 kDa on SDS-PAGE. The purified recombinant enzyme was a homodimer with a molecular weight of 43 kDa, probably containing one molecule of FMN per dimer. AzoA required FMN and NADH, but not NADPH, as a preferred electron donor for its activity. The apparent K-m values for both NADH and 2-[4-(dimethylamino)phenylazo]benzoic acid (Methyl red) substrates were 0.14 and 0.024 mM, respectively. The apparent V-max was 86.2 muM/min/mg protein. The enzyme was not only able to decolorize Methyl red, but was also able to convert sulfonated azo dyes Orange II, Amaranth, Ponceau BS, and Ponceau S. AzoA is the first aerobic azoreductase to be identified and characterized from human intestinal gram-positive bacteria. (C) 2004 Elsevier Inc. All rights reserved.
C1 US FDA, Natl Ctr Toxicol Res, Div Microbiol, Jefferson, AR 72079 USA.
RP Chen, HZ (reprint author), US FDA, Natl Ctr Toxicol Res, Div Microbiol, 3900 NCTR Rd, Jefferson, AR 72079 USA.
EM HChen@nctr.fda.gov
NR 36
TC 94
Z9 107
U1 3
U2 21
PU ACADEMIC PRESS INC ELSEVIER SCIENCE
PI SAN DIEGO
PA 525 B ST, STE 1900, SAN DIEGO, CA 92101-4495 USA
SN 1046-5928
J9 PROTEIN EXPRES PURIF
JI Protein Expr. Purif.
PD APR
PY 2004
VL 34
IS 2
BP 302
EP 310
DI 10.1016/j.pep.2003.12.016
PG 9
WC Biochemical Research Methods; Biochemistry & Molecular Biology;
Biotechnology & Applied Microbiology
SC Biochemistry & Molecular Biology; Biotechnology & Applied Microbiology
GA 803LU
UT WOS:000220233400019
PM 15003265
ER
PT J
AU Thomas, K
Aalbers, M
Bannon, GA
Bartels, M
Dearman, RJ
Esdaile, DJ
Fu, TJ
Glatt, CM
Hadfield, N
Hatzos, C
Hefle, SL
Heylings, JR
Goodman, RE
Henry, B
Herouet, C
Holsapple, M
Ladics, GS
Landry, TD
MacIntosh, SC
Rice, EA
Privalle, LS
Steiner, HY
Teshima, R
van Ree, R
Woolhiser, M
Zawodny, J
AF Thomas, K
Aalbers, M
Bannon, GA
Bartels, M
Dearman, RJ
Esdaile, DJ
Fu, TJ
Glatt, CM
Hadfield, N
Hatzos, C
Hefle, SL
Heylings, JR
Goodman, RE
Henry, B
Herouet, C
Holsapple, M
Ladics, GS
Landry, TD
MacIntosh, SC
Rice, EA
Privalle, LS
Steiner, HY
Teshima, R
van Ree, R
Woolhiser, M
Zawodny, J
TI A multi-laboratory evaluation of a common in vitro pepsin digestion
assay protocol used in assessing the safety of novel proteins
SO REGULATORY TOXICOLOGY AND PHARMACOLOGY
LA English
DT Article
DE digestive stability; protein allergenicity; biotechnology; genetically
modified foods; pepsinolysis
ID POLYACRYLAMIDE-GEL ELECTROPHORESIS; IGE-BINDING EPITOPES; FOOD
ALLERGENS; GASTROINTESTINAL PH; STABILITY; DIGESTIBILITY; PRODUCTS;
MILK; EGG; HYPERSENSITIVITY
AB Rationale. Evaluation of the potential allergenicity of proteins derived from genetically modified foods has involved a weight of evidenced approach that incorporates an evaluation,of protein digestibility in pepsin. Currently, there is no standardized protocol to assess the digestibility of proteins using simulated gastric fluid. Potentia I I variations in assay parameters include: pH, pepsin purity, pepsin to target protein ratio, target protein purity, and method of detection. The objective was to assess the digestibility of a common set of proteins in nine independent laboratories to determine the reproducibility of the assay when performed using a common protocol.
Methods. A single lot of each test protein and pepsin was obtained and distributed to each laboratory. The test proteins consisted of Ara h 2 (a peanut conglutin-like protein), beta-lactoglobulin, bovine serum albumin, concanavalin A, horseradish peroxidase, ovalbumin, ovomucoid, phosphinothricin acetyltransferase, ribulose diphosphate carboxylase, and soybean trypsin inhibitor. A ratio of 10 U of pepsin activity/mug test protein was selected for all tests (3: 1 pepsin to protein, w:w). Digestions were performed at pH 1.2 and 2.0, with sampling at 0.5, 2 5, 10, 20, 30, and 60 min. Protein digestibility was assessed from stained gels following SDS-PAGE of digestion samples and controls.
Results. Results were relatively consistent across laboratories for the full-length proteins. The identification of proteolytic fragments was less consistent, being affected by different fixation and staining methods. Overall, assay pH did not influence the time to disappearance of the full-length protein or protein fragments, however, results across laboratories were more consistent at pH 1.2 (91% agreement) than pH 2.0 (77%).
Conclusions. These data demonstrate that this common protocol for evaluating the in vitro digestibility of proteins is reproducible and yields consistent results when performed using the same proteins at different laboratories. (C) 2003 Elsevier Inc. All rights reserved.
C1 ILSI Hlth & Environm Sci Inst, Washington, DC USA.
Sanquin Res, Amsterdam, Netherlands.
Monsanto Co, St Louis, MO USA.
Dow Chem Co USA, Midland, MI 48674 USA.
Syngenta Cent Toxicol Lab, Alderley Pk, England.
Bayer CropSci, Sophia Antipolis, France.
US FDA, Natl Ctr Food Safety & Technol, Summit Argo, IL USA.
DuPont Co Inc, Newark, DE 19714 USA.
Univ Nebraska, Lincoln, NE 68583 USA.
Bayer CropSci, Res Triangle Pk, NC USA.
Syngenta Biotechnol Inc, Res Triangle Pk, NC USA.
Natl Inst Hlth Sci, Tokyo 158, Japan.
RP Thomas, K (reprint author), ILSI Hlth & Environm Sci Inst, Washington, DC USA.
EM kthomas@ilsi.org
NR 47
TC 140
Z9 150
U1 5
U2 37
PU ACADEMIC PRESS INC ELSEVIER SCIENCE
PI SAN DIEGO
PA 525 B ST, STE 1900, SAN DIEGO, CA 92101-4495 USA
SN 0273-2300
J9 REGUL TOXICOL PHARM
JI Regul. Toxicol. Pharmacol.
PD APR
PY 2004
VL 39
IS 2
BP 87
EP 98
DI 10.1016/j.yrtph.2003.11.003
PG 12
WC Medicine, Legal; Pharmacology & Pharmacy; Toxicology
SC Legal Medicine; Pharmacology & Pharmacy; Toxicology
GA 809IY
UT WOS:000220631600003
PM 15041142
ER
PT J
AU Harris, GR
Gammell, PM
Lewin, PA
Radulescu, EG
AF Harris, GR
Gammell, PM
Lewin, PA
Radulescu, EG
TI Interlaboratory evaluation of hydrophone sensitivity calibration from
0.1 to 2 MHz via time delay spectrometry
SO ULTRASONICS
LA English
DT Article; Proceedings Paper
CT Ultrasonics International 2003 Meetng
CY JUN 30-JUL 03, 2003
CL Granada, SPAIN
DE hydrophone; calibration; time delay spectrometry; 1-3 piezocomposite
transducer
AB Knowing the low-frequency response of hydrophones, down to 100 kHz at least, is important for accurate biomedical ultrasound measurements. However, current international standards do not extend below 500 kHz. Furthermore, commercial hydrophone sources typically do not supply sensitivity data below 1-2 MHz. Therefore, to help identify and validate practical calibration methods below 2 MHz, the authors have extended their previous individual efforts in an interlaboratory evaluation of sensitivity calibration using the swept-frequency technique, time delay spectrometry (TDS). Calibrations were performed for needle and membrane PVDF hydrophones using each laboratory's TDS system. Each site employed the same purpose-built broadband source transducers, comprising both plano-concave and biconcave 1-3 piezocomposite elements 4 cm in diameter, with maximum and minimum thicknesses of approximately 1.5 and 0.1 cm. Agreement between laboratories was within the estimated measurement precision of +/-0.6 dB. The results demonstrated that a TDS system employing such transducers constitutes a viable method for hydrophone calibrations in this frequency range. (C) 2003 Elsevier B.V. All rights reserved.
C1 US FDA, Ctr Devices & Radiol Hlth, Rockville, MD 20850 USA.
Gammell Appl Technol, Exmore, VA USA.
Drexel Univ, Dept Elect & Comp Engn, Sch Biomed Engn Sci & Hlth Syst, Philadelphia, PA 19104 USA.
RP Harris, GR (reprint author), FDA, CDRH, 12725 Twinbrook Pkwy,Room 293,HFZ-132, Rockville, MD 20852 USA.
EM grh@cdrh.fda.gov
NR 11
TC 20
Z9 20
U1 0
U2 2
PU ELSEVIER SCIENCE BV
PI AMSTERDAM
PA PO BOX 211, 1000 AE AMSTERDAM, NETHERLANDS
SN 0041-624X
J9 ULTRASONICS
JI Ultrasonics
PD APR
PY 2004
VL 42
IS 1-9
BP 349
EP 353
DI 10.1016/j.ultras.2003.12.008
PG 5
WC Acoustics; Radiology, Nuclear Medicine & Medical Imaging
SC Acoustics; Radiology, Nuclear Medicine & Medical Imaging
GA 812DP
UT WOS:000220820500058
PM 15047310
ER
PT J
AU Hunyady, L
Gaborik, Z
Shah, BH
Jagadeesh, G
Clark, AJL
Catt, KJ
AF Hunyady, L
Gaborik, Z
Shah, BH
Jagadeesh, G
Clark, AJL
Catt, KJ
TI Structural determinants of agonist-induced signaling and regulation of
the angiotensin AT(1) receptor
SO MOLECULAR AND CELLULAR ENDOCRINOLOGY
LA English
DT Article; Proceedings Paper
CT International Symposium on Aldosterone
CY APR 28-30, 2003
CL London, ENGLAND
SP Wellcome Trust, Pharmacia Inc, NIH, Astra Zeneca
DE angiotensin II; Ca2+signaling; inositol phosphate responses; receptor
internalization; site-directed mutagenesis
ID II TYPE-1 RECEPTOR; PROTEIN-COUPLED RECEPTORS; 3RD INTRACELLULAR LOOP;
CARBOXYL-TERMINAL TAIL; GROWTH-FACTOR RECEPTOR; INDUCED INTERNALIZATION;
CYTOPLASMIC LOOP; RAT AT(1A); INDUCED PHOSPHORYLATION; TRANSMEMBRANE
HELIX
AB Angiotensin II (Ang II) regulates aldosterone secretion by stimulating inositol phosphate production and Ca2+ signaling in adrenal glomerulosa cells via the G(q)-coupled AT(1) receptor, which is rapidly internalized upon agonist binding. AngII also binds to the heptahelical AT(2) receptor, which neither activates inositol phosphate signaling nor undergoes receptor internalization. The differential behaviors of the AT, and AT2 receptors were analyzed in chimeric angiotensin receptors created by swapping the second (IL2), the third (IL3) intracellular loops and/or the cytoplasmic tail (CT) between these receptors. When transiently expressed in COS-7 cells, the chimeric receptors showed only minor alterations in their ligand binding properties. Measurements of the internalization kinetics and inositol phosphate responses of chimeric AT(1A) receptors indicated that the CT is required for normal receptor internalization, and IL2 is a determinant of G protein activation. In addition, the amino-terminal portion of IL3 is required for both receptor functions. However, only substitution of IL2 impaired Ang II-induced ERK activation, suggesting that alternative mechanisms are responsible for ERK activation in signaling-deficient mutant AT, receptors. Substitution of 1L2, 1L3, or CT of the AT(1A) receptor into the AT, receptor sequence did not endow the latter with the ability to internalize or to mediate inositol phosphate signaling responses. These data suggest that the lack of receptor internalization and inositol phosphate signal generation by the AT, receptor is a consequence of its different activation mechanism, rather than the inability of its cytoplasmic domains to couple to intracellular effectors. (C) 2003 Elsevier Ireland Ltd. All rights reserved.
C1 Semmelweis Univ, Fac Med, Dept Physiol, H-1088 Budapest, Hungary.
NICHHD, Endocrinol & Reprod Res Branch, NIH, Bethesda, MD 20892 USA.
US FDA, Div Cardio Renal Drug Prod, Ctr Drug Evaluat & Res, Rockville, MD 20857 USA.
Barts & London Queen Marys Sch Med & Dent, Dept Endocrinol, London EC1A 7BE, England.
RP Hunyady, L (reprint author), Semmelweis Univ, Fac Med, Dept Physiol, H-1088 Budapest, Hungary.
EM hunyady@puskin.sote.hu
RI Jagadeesh, Gowraganahalli/G-6408-2010
NR 71
TC 9
Z9 10
U1 0
U2 1
PU ELSEVIER IRELAND LTD
PI CLARE
PA ELSEVIER HOUSE, BROOKVALE PLAZA, EAST PARK SHANNON, CO, CLARE, 00000,
IRELAND
SN 0303-7207
J9 MOL CELL ENDOCRINOL
JI Mol. Cell. Endocrinol.
PD MAR 31
PY 2004
VL 217
IS 1-2
BP 89
EP 100
DI 10.1016/j.mce.2003.10.014
PG 12
WC Cell Biology; Endocrinology & Metabolism
SC Cell Biology; Endocrinology & Metabolism
GA 823TG
UT WOS:000221635500013
PM 15134806
ER
PT J
AU Berkower, I
Raymond, M
Muller, J
Spadaccini, A
Aberdeen, A
AF Berkower, I
Raymond, M
Muller, J
Spadaccini, A
Aberdeen, A
TI Assembly, structure, and antigenic properties of virus-like particles
rich in HIV-1 envelope gp120
SO VIROLOGY
LA English
DT Article
DE virus-like particles; HIV-1; envelope glycoprotein gp120
ID HUMAN-IMMUNODEFICIENCY-VIRUS; B SURFACE-ANTIGEN; HUMAN
MONOCLONAL-ANTIBODY; NEUTRALIZING ANTIBODIES; TYPE-1 PARTICLES;
GLYCOPROTEIN; EPITOPE; PROTEIN; VACCINE; BINDING
AB In order to improve the immunogenicity of HIV-1 envelope glycoproteins, we have fused gp120 to a carrier protein, hepatitis B surface antigen (HBsAg), which is capable of spontaneous assembly into virus-like particles. The HBsAg-gp120 hybrid proteins assembled efficiently into 20-30 nm particles. The particles resemble native HBsAg particles in size and density, consistent with a lipid composition of about 25% and a gp120 content of about 100 per particle. Particulate gp120 folds in its native conformation and is biologically active, as shown by high affinity binding of CD4. The particles express conformational determinants targeted by a panel of broadly cross-reactive neutralizing antibodies, and they show tight packing of gp120. Because the particles are lipoprotein micelles, an array of gp120 on their surface closely mimics gp120 on the surface of HIV-1 virions. These gp120-rich particles can enhance the quality, as well as quantity, of antibodies elicited by a gp120 vaccine. Published by Elsevier Inc.
C1 Off Vaccine Res & Review, Ctr Biol, Div Viral Prod, Lab Immunoregulat, Bethesda, MD 20892 USA.
RP Berkower, I (reprint author), Off Vaccine Res & Review, Ctr Biol, Div Viral Prod, Lab Immunoregulat, FDA,Bldg 29,Room 523,NIH Campus, Bethesda, MD 20892 USA.
EM Berkower@cber.fda.gov
NR 63
TC 23
Z9 24
U1 0
U2 3
PU ACADEMIC PRESS INC ELSEVIER SCIENCE
PI SAN DIEGO
PA 525 B ST, STE 1900, SAN DIEGO, CA 92101-4495 USA
SN 0042-6822
J9 VIROLOGY
JI Virology
PD MAR 30
PY 2004
VL 321
IS 1
BP 75
EP 86
DI 10.1016/j.virol.2003.12.017
PG 12
WC Virology
SC Virology
GA 807KB
UT WOS:000220499300009
PM 15033567
ER
PT J
AU Li, ZQ
Rubin, SA
Taffs, RE
Merchlinsky, M
Ye, ZP
Carbone, KM
AF Li, ZQ
Rubin, SA
Taffs, RE
Merchlinsky, M
Ye, ZP
Carbone, KM
TI Mouse neurotoxicity test for vaccinia-based smallpox vaccines
SO VACCINE
LA English
DT Article
DE smallpox vaccine; vaccinia virus; neurotoxicity
ID CENTRAL NERVOUS-SYSTEM; VIRUS-INFECTION; HERPES-SIMPLEX; MICE;
PATHOGENESIS; NEUROVIRULENCE; ENCEPHALITIS; MATURATION; MENINGITIS;
VIRULENCE
AB The only US FDA licensed smallpox vaccine, Dryvax, was associated with rare but serious neurological adverse events. After smallpox was eradicated in the United States, mass vaccination ceased in 1971. As counter-bioterrorism/biowarfare measures, new smallpox vaccines are now being investigated. However, there are no established pre-clinical neurotoxicity assays with which to evaluate these new vaccines prior to licensure. Here we report the development and initial characterization of a small animal neurotoxicity assay for vaccinia-based smallpox vaccines using Dryvax virus as a reference vaccine strain and the neuroadapted Western Reserve (WR) strain as a neurotoxic positive control. In neonatally inoculated mice, the WR strain produced significantly greater and more rapid onset of mortality than the Dryvax vaccine reference. Expression of virus antigen in neural cells and infectious virus replication in the brain was also significantly different between the two strains. In addition, the appearance of high titer virus antibody correlated with the clearance of virus from brain. With further validation, this assay incorporating a licensed vaccine reference standard and positive control strain may provide important pre-clinical neurotoxicity data on new vaccinia-based smallpox vaccine strains. Published by Elsevier Ltd.
C1 US FDA, CBER, OD, Lab Pediat & Resp Viral Dis, Bethesda, MD 20892 USA.
US FDA, CBER, OVRR,DVP, Lab DNA Viruses, Bethesda, MD 20892 USA.
US FDA, CBER, OBRR,DETTD, Lab Bacterial Parasit & Unconvent Agents, Bethesda, MD 20892 USA.
RP Carbone, KM (reprint author), US FDA, CBER, OD, Lab Pediat & Resp Viral Dis, HFM-460,Bldg 29B,Room 5NN22,8800 Rockville Pike, Bethesda, MD 20892 USA.
EM zli@smtp.salk.edu; rubins@cber.fda.gov; taffs@cber.fda.gov;
merchlinsky@cber.fda.gov; carbonek@cber.fda.gov
NR 31
TC 16
Z9 16
U1 0
U2 1
PU ELSEVIER SCI LTD
PI OXFORD
PA THE BOULEVARD, LANGFORD LANE, KIDLINGTON, OXFORD OX5 1GB, OXON, ENGLAND
SN 0264-410X
J9 VACCINE
JI Vaccine
PD MAR 29
PY 2004
VL 22
IS 11-12
BP 1486
EP 1493
DI 10.1016/vaccine.2003.10.022
PG 8
WC Immunology; Medicine, Research & Experimental
SC Immunology; Research & Experimental Medicine
GA 812EB
UT WOS:000220821700019
PM 15063573
ER
PT J
AU Isaguliants, MG
Iakimtchouk, K
Petrakova, NV
Yermalovich, MA
Zuber, AK
Kashuba, VI
Belikov, SV
Andersson, S
Kochetkov, SN
Klinman, DM
Wahren, B
AF Isaguliants, MG
Iakimtchouk, K
Petrakova, NV
Yermalovich, MA
Zuber, AK
Kashuba, VI
Belikov, SV
Andersson, S
Kochetkov, SN
Klinman, DM
Wahren, B
TI Gene immunization may induce secondary antibodies reacting with DNA
SO VACCINE
LA English
DT Article
DE DNA immunization; anti-DNA antibodies; HIV-1 reverse transcriptase; nef;
HCV core
ID SYSTEMIC-LUPUS-ERYTHEMATOSUS; IMMUNODEFICIENCY-VIRUS TYPE-1; HIV-1
REVERSE-TRANSCRIPTASE; DOUBLE-STRANDED DNA; CORE PROTEIN; ANTI-DSDNA;
AUTOIMMUNE-DISEASE; BACTERIAL-DNA; MAMMALIAN DNA; IN-VIVO
AB The fear of autoimmunity in DNA-vaccine recipients initiated screening for anti-DNA antibodies in rabbits immunized with genes of viral nucleic acid-binding and adapter proteins. Of 11 DNA/protein-immunized rabbits, seven had developed secondary antibodies against DNA detected at weeks 11-50 from the on-start of immunization. Two rabbits immunized with HIV-1 reverse transcriptase gene developed transient anti-double-stranded DNA antibodies of high avidity that recognized DNA in the kinetoplasts of Crithidia luciliae. Others developed antibodies reacting with DNA in ELISA and targeting nuclear-associated antigens in the immunolluoresence test. No anti-DNA antibodies were detected at these time-points in any of the controls (P = 0.036). Induction of anti-DNA antibodies by epitope spreading from protein domains involved in nucleic acid-binding versus maturation of anti-protein antibodies to dual protein-DNA specificity is discussed. (126 words). (C) 2003 Published by Elsevier Ltd.
C1 Karolinska Inst, Ctr Microbiol & Tumor Biol, SE-17182 Solna, Sweden.
DI Ivanovskii Inst Virol, Moscow 123098, Russia.
Karolinska Inst, Dept Mol Cell Biol, SE-17177 Stockholm, Sweden.
Reg Sjukhuset, Dept Clin Microbiol & Immunol, SE-70185 Orebro, Sweden.
VA Engelhardt Mol Biol Inst, Moscow 117984, Russia.
US FDA, CBER, Div Viral Prod, Rockville, MD 20902 USA.
Karolinska Inst, Swedish Inst Infect Dis Control, SE-17182 Solna, Sweden.
RP Isaguliants, MG (reprint author), Karolinska Inst, Ctr Microbiol & Tumor Biol, SE-17182 Solna, Sweden.
EM isaguliats@hotmail.com
NR 51
TC 7
Z9 9
U1 0
U2 0
PU ELSEVIER SCI LTD
PI OXFORD
PA THE BOULEVARD, LANGFORD LANE, KIDLINGTON, OXFORD OX5 1GB, OXON, ENGLAND
SN 0264-410X
J9 VACCINE
JI Vaccine
PD MAR 29
PY 2004
VL 22
IS 11-12
BP 1576
EP 1585
DI 10.1016/j.vaccine.2003.09.033
PG 10
WC Immunology; Medicine, Research & Experimental
SC Immunology; Research & Experimental Medicine
GA 812EB
UT WOS:000220821700030
PM 15063584
ER
PT J
AU Ang, CYW
AF Ang, CYW
TI Challenges in assessing bioactive botanical ingredients in functional
beverages.
SO ABSTRACTS OF PAPERS OF THE AMERICAN CHEMICAL SOCIETY
LA English
DT Meeting Abstract
CT 227th National Meeting of the American-Chemical Society
CY MAR 28-APR 01, 2004
CL Anaheim, CA
SP Amer Chem Soc
C1 US FDA, Natl Ctr Toxicol Res, Div Chem, Jefferson, AR 72079 USA.
EM cang@nctr.fda.gov
NR 0
TC 0
Z9 0
U1 0
U2 1
PU AMER CHEMICAL SOC
PI WASHINGTON
PA 1155 16TH ST, NW, WASHINGTON, DC 20036 USA
SN 0065-7727
J9 ABSTR PAP AM CHEM S
JI Abstr. Pap. Am. Chem. Soc.
PD MAR 28
PY 2004
VL 227
MA 119-AGFD
BP U47
EP U47
PN 1
PG 1
WC Chemistry, Multidisciplinary
SC Chemistry
GA 851AJ
UT WOS:000223655600127
ER
PT J
AU Brorson, K
AF Brorson, K
TI Impact of multiple re-use of chromatography media on virus removal.
SO ABSTRACTS OF PAPERS OF THE AMERICAN CHEMICAL SOCIETY
LA English
DT Meeting Abstract
CT 227th National Meeting of the American-Chemical Society
CY MAR 28-APR 01, 2004
CL Anaheim, CA
SP Amer Chem Soc
C1 Food & Drug Adm, Ctr Drug Evaluat & Res, Div Monoclonal Antibodies, Bethesda, MD 20892 USA.
EM brorson@cber.fda.gov
NR 0
TC 0
Z9 0
U1 0
U2 0
PU AMER CHEMICAL SOC
PI WASHINGTON
PA 1155 16TH ST, NW, WASHINGTON, DC 20036 USA
SN 0065-7727
J9 ABSTR PAP AM CHEM S
JI Abstr. Pap. Am. Chem. Soc.
PD MAR 28
PY 2004
VL 227
MA 037-BIOT
BP U128
EP U128
PN 1
PG 1
WC Chemistry, Multidisciplinary
SC Chemistry
GA 851AJ
UT WOS:000223655600584
ER
PT J
AU Freedberg, SO
Ano, SO
Norris, SE
Venable, RM
AF Freedberg, SO
Ano, SO
Norris, SE
Venable, RM
TI Is there a correlation between lactose's anomeric configuration and its
three-dimensional structure?
SO ABSTRACTS OF PAPERS OF THE AMERICAN CHEMICAL SOCIETY
LA English
DT Meeting Abstract
CT 227th National Meeting of the American-Chemical Society
CY MAR 28-APR 01, 2004
CL Anaheim, CA
SP Amer Chem Soc
C1 US FDA, Ctr Biol Evaluat & Res, Off Vaccines Res & Review, Bethesda, MD 20892 USA.
EM daron_freedberg@nih.gov
NR 0
TC 0
Z9 0
U1 0
U2 0
PU AMER CHEMICAL SOC
PI WASHINGTON
PA 1155 16TH ST, NW, WASHINGTON, DC 20036 USA
SN 0065-7727
J9 ABSTR PAP AM CHEM S
JI Abstr. Pap. Am. Chem. Soc.
PD MAR 28
PY 2004
VL 227
MA 011-CARB
BP U263
EP U264
PN 1
PG 2
WC Chemistry, Multidisciplinary
SC Chemistry
GA 851AJ
UT WOS:000223655600986
ER
PT J
AU Hanson, M
Brorson, K
Moreira, A
AF Hanson, M
Brorson, K
Moreira, A
TI Gene arrays, cell culture process changes and comparability.
SO ABSTRACTS OF PAPERS OF THE AMERICAN CHEMICAL SOCIETY
LA English
DT Meeting Abstract
CT 227th National Meeting of the American-Chemical Society
CY MAR 28-APR 01, 2004
CL Anaheim, CA
SP Amer Chem Soc
C1 Univ Maryland Baltimore Cty, CDER, FDA, Bethesda, MD 20892 USA.
EM mhanson1@umbc.edu
NR 0
TC 0
Z9 0
U1 0
U2 1
PU AMER CHEMICAL SOC
PI WASHINGTON
PA 1155 16TH ST, NW, WASHINGTON, DC 20036 USA
SN 0065-7727
J9 ABSTR PAP AM CHEM S
JI Abstr. Pap. Am. Chem. Soc.
PD MAR 28
PY 2004
VL 227
MA 286-BIOT
BP U234
EP U234
PN 1
PG 1
WC Chemistry, Multidisciplinary
SC Chemistry
GA 851AJ
UT WOS:000223655600839
ER
PT J
AU Jackson, LS
Al-Taher, F
Jablonski, JE
Fleischman, G
AF Jackson, LS
Al-Taher, F
Jablonski, JE
Fleischman, G
TI Effects of consumer food preparation on acrylamide formation.
SO ABSTRACTS OF PAPERS OF THE AMERICAN CHEMICAL SOCIETY
LA English
DT Meeting Abstract
CT 227th National Meeting of the American-Chemical Society
CY MAR 28-APR 01, 2004
CL Anaheim, CA
SP Amer Chem Soc
C1 US FDA, Natl Ctr Food Safety & Technol, Summit Argo, IL 60501 USA.
IIT, Natl Ctr Food Safety & Technol, Chicago, IL USA.
EM Lauren.Jackson@cfsan.fda.gov
NR 0
TC 0
Z9 0
U1 0
U2 1
PU AMER CHEMICAL SOC
PI WASHINGTON
PA 1155 16TH ST, NW, WASHINGTON, DC 20036 USA
SN 0065-7727
J9 ABSTR PAP AM CHEM S
JI Abstr. Pap. Am. Chem. Soc.
PD MAR 28
PY 2004
VL 227
MA 125-AGFD
BP U48
EP U48
PN 1
PG 1
WC Chemistry, Multidisciplinary
SC Chemistry
GA 851AJ
UT WOS:000223655600133
ER
PT J
AU Jackson, LS
Al-Taher, F
Jablonski, JE
Fleischman, G
AF Jackson, LS
Al-Taher, F
Jablonski, JE
Fleischman, G
TI Surface browning as an indicator of acrylamide levels in food.
SO ABSTRACTS OF PAPERS OF THE AMERICAN CHEMICAL SOCIETY
LA English
DT Meeting Abstract
CT 227th National Meeting of the American-Chemical Society
CY MAR 28-APR 01, 2004
CL Anaheim, CA
SP Amer Chem Soc
C1 US FDA, Natl Ctr Food Safety & Technol, Rockville, MD 20857 USA.
IIT, Natl Ctr Food Safety & Technol, Chicago, IL 60616 USA.
EM Lauren.Jackson@cfsan.fda.gov; altaher@iit.edu
NR 0
TC 0
Z9 0
U1 0
U2 0
PU AMER CHEMICAL SOC
PI WASHINGTON
PA 1155 16TH ST, NW, WASHINGTON, DC 20036 USA
SN 0065-7727
J9 ABSTR PAP AM CHEM S
JI Abstr. Pap. Am. Chem. Soc.
PD MAR 28
PY 2004
VL 227
MA 085-AGFD
BP U41
EP U41
PN 1
PG 1
WC Chemistry, Multidisciplinary
SC Chemistry
GA 851AJ
UT WOS:000223655600093
ER
PT J
AU Jia, YP
Alayash, AI
AF Jia, YP
Alayash, AI
TI Cross-linking with 0-raffinose lowers oxygen affinity and stabilizes
hemoglobin in a non-cooperative T-STATE conformation.
SO ABSTRACTS OF PAPERS OF THE AMERICAN CHEMICAL SOCIETY
LA English
DT Meeting Abstract
CT 227th National Meeting of the American-Chemical Society
CY MAR 28-APR 01, 2004
CL Anaheim, CA
SP Amer Chem Soc
C1 FDA, CBER, DH, LBVB,Div Hematol, Rockville, MD 20852 USA.
EM jia@cber.FDA.gov
NR 0
TC 0
Z9 0
U1 0
U2 0
PU AMER CHEMICAL SOC
PI WASHINGTON
PA 1155 16TH ST, NW, WASHINGTON, DC 20036 USA
SN 0065-7727
J9 ABSTR PAP AM CHEM S
JI Abstr. Pap. Am. Chem. Soc.
PD MAR 28
PY 2004
VL 227
MA 035-BIOT
BP U127
EP U127
PN 1
PG 1
WC Chemistry, Multidisciplinary
SC Chemistry
GA 851AJ
UT WOS:000223655600582
ER
PT J
AU Kozlowski, S
AF Kozlowski, S
TI Role of mechanism of action in drug development and regulation.
SO ABSTRACTS OF PAPERS OF THE AMERICAN CHEMICAL SOCIETY
LA English
DT Meeting Abstract
CT 227th National Meeting of the American-Chemical Society
CY MAR 28-APR 01, 2004
CL Anaheim, CA
SP Amer Chem Soc
C1 US FDA, Ctr Drug Evaluat & Res, Div Monoclonal Antibodies, Bethesda, MD 20892 USA.
EM kozlowski@cber.fda.gov
NR 0
TC 0
Z9 0
U1 0
U2 0
PU AMER CHEMICAL SOC
PI WASHINGTON
PA 1155 16TH ST, NW, WASHINGTON, DC 20036 USA
SN 0065-7727
J9 ABSTR PAP AM CHEM S
JI Abstr. Pap. Am. Chem. Soc.
PD MAR 28
PY 2004
VL 227
MA 030-BIOT
BP U127
EP U127
PN 1
PG 1
WC Chemistry, Multidisciplinary
SC Chemistry
GA 851AJ
UT WOS:000223655600577
ER
PT J
AU Lee, CHR
Frasch, CE
AF Lee, CHR
Frasch, CE
TI A method with increased yield for production of polysaccharide-protein
conjugate vaccines using hydrazide chemistry.
SO ABSTRACTS OF PAPERS OF THE AMERICAN CHEMICAL SOCIETY
LA English
DT Meeting Abstract
CT 227th National Meeting of the American-Chemical Society
CY MAR 28-APR 01, 2004
CL Anaheim, CA
SP Amer Chem Soc
C1 Ctr Biol Evaluat & Res, Div Bacterial Prod, Rockville, MD 20852 USA.
US FDA, Div Bacterial Prod, Ctr Biol Evaluat & Res, Rockville, MD 20852 USA.
EM lee_r@cber.fda.gov
NR 0
TC 0
Z9 0
U1 0
U2 0
PU AMER CHEMICAL SOC
PI WASHINGTON
PA 1155 16TH ST, NW, WASHINGTON, DC 20036 USA
SN 0065-7727
J9 ABSTR PAP AM CHEM S
JI Abstr. Pap. Am. Chem. Soc.
PD MAR 28
PY 2004
VL 227
MA 082-BIOT
BP U137
EP U137
PN 1
PG 1
WC Chemistry, Multidisciplinary
SC Chemistry
GA 851AJ
UT WOS:000223655600637
ER
PT J
AU Lee, CHR
AF Lee, CHR
TI A method with increased yield for production of polysaccharide-protein
conjugate vaccines using hydrazide chemistry.
SO ABSTRACTS OF PAPERS OF THE AMERICAN CHEMICAL SOCIETY
LA English
DT Meeting Abstract
CT 227th National Meeting of the American-Chemical Society
CY MAR 28-APR 01, 2004
CL Anaheim, CA
SP Amer Chem Soc
C1 Ctr Biol Evaluat & Res, Div Bacterial Prod, Rockville, MD 20852 USA.
US FDA, Ctr Biol Evaluat & Res, Div Bacterial Prod, Rockville, MD 20852 USA.
EM lee_r@cber.fda.gov
NR 0
TC 0
Z9 0
U1 1
U2 1
PU AMER CHEMICAL SOC
PI WASHINGTON
PA 1155 16TH ST, NW, WASHINGTON, DC 20036 USA
SN 0065-7727
J9 ABSTR PAP AM CHEM S
JI Abstr. Pap. Am. Chem. Soc.
PD MAR 28
PY 2004
VL 227
MA 082-BIOT
BP U135
EP U135
PN 1
PG 1
WC Chemistry, Multidisciplinary
SC Chemistry
GA 851AJ
UT WOS:000223655600627
ER
PT J
AU Swann, PG
AF Swann, PG
TI Regulatory considerations when using model systems in process validation
for biotechnological products.
SO ABSTRACTS OF PAPERS OF THE AMERICAN CHEMICAL SOCIETY
LA English
DT Meeting Abstract
CT 227th National Meeting of the American-Chemical Society
CY MAR 28-APR 01, 2004
CL Anaheim, CA
SP Amer Chem Soc
C1 Ctr Drug Evaluat & Res Food & Drug Adm, Div Monoclonal Antibodies, Bethesda, MD 20892 USA.
EM swannp@cber.fda.gov
NR 0
TC 0
Z9 0
U1 0
U2 0
PU AMER CHEMICAL SOC
PI WASHINGTON
PA 1155 16TH ST, NW, WASHINGTON, DC 20036 USA
SN 0065-7727
J9 ABSTR PAP AM CHEM S
JI Abstr. Pap. Am. Chem. Soc.
PD MAR 28
PY 2004
VL 227
MA 032-BIOT
BP U127
EP U127
PN 1
PG 1
WC Chemistry, Multidisciplinary
SC Chemistry
GA 851AJ
UT WOS:000223655600579
ER
PT J
AU Nomaguchi, M
Teramoto, T
Yu, L
Markoff, L
Padmanabhan, R
AF Nomaguchi, M
Teramoto, T
Yu, L
Markoff, L
Padmanabhan, R
TI Requirements for West Nile virus (-)- and (+)-strand subgenomic RNA
synthesis in vitro by the viral RNA-dependent RNA polymerase expressed
in Escherichia coli
SO JOURNAL OF BIOLOGICAL CHEMISTRY
LA English
DT Article
ID HEPATITIS-C VIRUS; PUTATIVE METHYLTRANSFERASE DOMAIN; FLAVIVIRUS GENOMIC
RNA; 3' UNTRANSLATED REGION; NEGATIVE-STRAND RNA; DE-NOVO SYNTHESIS;
DENGUE VIRUS; SECONDARY STRUCTURE; NS3 PROTEIN; NTPASE ACTIVITY
AB RNA-dependent RNA polymerases (RdRPs) of the Flaviviridae family catalyze replication of positive (+)strand viral RNA through synthesis of minus (-)- and progeny (+)- strand RNAs. West Nile virus (WNV), a mosquito-borne member, is a rapidly re-emerging human pathogen in the United States since its first outbreak in 1999. To study the replication of the WNV RNA in vitro, an assay is described here that utilizes the WNV RdRP and subgenomic (-)- and (+)- strand template RNAs containing 5'- and 3'-terminal regions (TR) with the conserved sequence elements. Our results show that both 5'- and 3'-TRs of the (+)- strand RNA template including the wild type cyclization (CYC) motifs are important for RNA synthesis. However, the 3'-TR of the (-)- strand RNA template alone is sufficient for RNA synthesis. Mutational analysis of the CYC motifs revealed that the (+)- strand 5'- CYC motif is critical for (+)- strand RNA synthesis but neither the (-)- strand 5'- nor 3'-CYC motif is important for the (+)- strand RNA synthesis. Moreover, the 5'- cap inhibits the (+)- strand RNA synthesis from the 3' fold-back structure of (+)- strand RNA template without affecting the de novo synthesis of RNA. These results support a model that "cyclization" of the viral RNA play a role for (-)- strand RNA synthesis but not for (+)- strand RNA synthesis.
C1 Georgetown Univ, Med Ctr, Dept Microbiol & Immunol, Washington, DC 20057 USA.
US FDA, Ctr Biol Evaluat & Res, Bethesda, MD 20892 USA.
RP Padmanabhan, R (reprint author), Georgetown Univ, Med Ctr, Dept Microbiol & Immunol, SW309 Med Dent Bldg,3900 Reservoir Rd, Washington, DC 20057 USA.
EM rp55@georgetown.edu
FU NIAID NIH HHS [AI 32078]
NR 60
TC 38
Z9 40
U1 0
U2 4
PU AMER SOC BIOCHEMISTRY MOLECULAR BIOLOGY INC
PI BETHESDA
PA 9650 ROCKVILLE PIKE, BETHESDA, MD 20814-3996 USA
SN 0021-9258
J9 J BIOL CHEM
JI J. Biol. Chem.
PD MAR 26
PY 2004
VL 279
IS 13
BP 12141
EP 12151
DI 10.1074/jbc.M310839200
PG 11
WC Biochemistry & Molecular Biology
SC Biochemistry & Molecular Biology
GA 804YV
UT WOS:000220334900020
PM 14699096
ER
PT J
AU Turesky, RJ
Vouros, P
AF Turesky, RJ
Vouros, P
TI Formation and analysis of heterocyclic aromatic amine-DNA adducts in
vitro and in vivo
SO JOURNAL OF CHROMATOGRAPHY B-ANALYTICAL TECHNOLOGIES IN THE BIOMEDICAL
AND LIFE SCIENCES
LA English
DT Review
DE reviews; heterocyclic aromatic amine-DNA adducts; DNA
ID CHROMATOGRAPHY/MICROELECTROSPRAY MASS-SPECTROMETRY; MAMMARY
EPITHELIAL-CELLS; FOOD-BORNE CARCINOGEN; P-32 POSTLABELING METHOD;
POST-LABELING ANALYSIS; N-ACETOXY DERIVATIVES; MEA-ALPHA-C;
2-AMINO-1-METHYL-6-PHENYLIMIDAZO<4,5-B>PYRIDINE PHIP;
ELECTROSPRAY-IONIZATION; METABOLIC-ACTIVATION
AB The detection and quantification of heterocyclic aromatic amine (HAA)-DNA adducts, critical biomarkers in interspecies extrapolation of toxicity data for human risk assessment, remains a challenging analytical problem. The two main analytical methods currently in use to screen for HAA-DNA adducts are the P-32-postlabeling assay and mass spectrometry, using either accelerated mass spectrometry (AMS) or liquid chromatography and electrospray ionization mass spectrometry (LC-ESI-MS). In this review, the principal methods to synthesize and characterize DNA adducts, and the methods applied to measure HAA-DNA adduct in vitro and vivo are discussed. (C) 2003 Elsevier B.V. All rights reserved.
C1 Natl Ctr Toxicol Res, Div Chem, Jefferson, AR 72079 USA.
Northeastern Univ, Dept Chem, Boston, MA 02115 USA.
Northeastern Univ, Barnett Inst, Boston, MA 02115 USA.
RP Turesky, RJ (reprint author), Natl Ctr Toxicol Res, Div Chem, 3900 NCTR Rd, Jefferson, AR 72079 USA.
EM rturesky@nctr.fda.gov
FU NCI NIH HHS [1R01CA69390]
NR 102
TC 67
Z9 68
U1 1
U2 13
PU ELSEVIER SCIENCE BV
PI AMSTERDAM
PA PO BOX 211, 1000 AE AMSTERDAM, NETHERLANDS
SN 1570-0232
J9 J CHROMATOGR B
JI J. Chromatogr. B
PD MAR 25
PY 2004
VL 802
IS 1
BP 155
EP 166
DI 10.1016/j.jchromb.2003.10.053
PG 12
WC Biochemical Research Methods; Chemistry, Analytical
SC Biochemistry & Molecular Biology; Chemistry
GA 778NY
UT WOS:000189248700018
PM 15036007
ER
PT J
AU Wysowski, DK
Farinas, E
AF Wysowski, DK
Farinas, E
TI Finasteride in benign prostatic hyperplasia
SO NEW ENGLAND JOURNAL OF MEDICINE
LA English
DT Letter
ID THERAPY
C1 US FDA, Rockville, MD 20857 USA.
RP Wysowski, DK (reprint author), US FDA, Rockville, MD 20857 USA.
NR 4
TC 5
Z9 5
U1 0
U2 0
PU MASSACHUSETTS MEDICAL SOC/NEJM
PI WALTHAM
PA WALTHAM WOODS CENTER, 860 WINTER ST,, WALTHAM, MA 02451-1413 USA
SN 0028-4793
J9 NEW ENGL J MED
JI N. Engl. J. Med.
PD MAR 25
PY 2004
VL 350
IS 13
BP 1359
EP 1359
PG 1
WC Medicine, General & Internal
SC General & Internal Medicine
GA 805VN
UT WOS:000220393900023
PM 15044649
ER
PT J
AU Arcidiacono, JA
Bloom, E
AF Arcidiacono, JA
Bloom, E
TI The role of adhesion molecules in determining the susceptibility of
porcine endothelial cells to lysis by human NK cells
SO FASEB JOURNAL
LA English
DT Meeting Abstract
CT Experimental Biology 2004 Meeting
CY APR 17-21, 2004
CL Washington, DC
C1 US FDA, Bethesda, MD 20892 USA.
NR 0
TC 0
Z9 0
U1 0
U2 0
PU FEDERATION AMER SOC EXP BIOL
PI BETHESDA
PA 9650 ROCKVILLE PIKE, BETHESDA, MD 20814-3998 USA
SN 0892-6638
J9 FASEB J
JI Faseb J.
PD MAR 24
PY 2004
VL 18
IS 5
SU S
BP A1181
EP A1181
PG 1
WC Biochemistry & Molecular Biology; Biology; Cell Biology
SC Biochemistry & Molecular Biology; Life Sciences & Biomedicine - Other
Topics; Cell Biology
GA 806ZB
UT WOS:000220470702017
ER
PT J
AU Belyakov, IM
Klinman, D
Kuznetsov, VA
Moniuszko, M
Ahlers, JD
Kelsall, B
Strober, W
Franchini, G
Berzofsky, JA
AF Belyakov, IM
Klinman, D
Kuznetsov, VA
Moniuszko, M
Ahlers, JD
Kelsall, B
Strober, W
Franchini, G
Berzofsky, JA
TI Progress on new mucosal vaccine strategies for HIV
SO FASEB JOURNAL
LA English
DT Meeting Abstract
CT Experimental Biology 2004 Meeting
CY APR 17-21, 2004
CL Washington, DC
C1 NCI, Metab Branch, Bethesda, MD 20892 USA.
NICHD, Lab Integrat & Med Biophys, Bethesda, MD 20892 USA.
NCI, Basic Res Lab, Bethesda, MD 20892 USA.
NIAID, Clin Invest Lab, Bethesda, MD 20892 USA.
US FDA, Ctr Biol Evaluat & Res, Bethesda, MD USA.
NR 0
TC 3
Z9 3
U1 0
U2 0
PU FEDERATION AMER SOC EXP BIOL
PI BETHESDA
PA 9650 ROCKVILLE PIKE, BETHESDA, MD 20814-3998 USA
SN 0892-6638
J9 FASEB J
JI Faseb J.
PD MAR 24
PY 2004
VL 18
IS 5
SU S
BP A821
EP A821
PG 1
WC Biochemistry & Molecular Biology; Biology; Cell Biology
SC Biochemistry & Molecular Biology; Life Sciences & Biomedicine - Other
Topics; Cell Biology
GA 806ZB
UT WOS:000220470700302
ER
PT J
AU Berkower, I
Ni, YS
Lynch, R
Paul, S
Spadaccini, A
AF Berkower, I
Ni, YS
Lynch, R
Paul, S
Spadaccini, A
TI Assembled particles rich in HIV gp120 for improved vaccine potency
SO FASEB JOURNAL
LA English
DT Meeting Abstract
CT Experimental Biology 2004 Meeting
CY APR 17-21, 2004
CL Washington, DC
C1 US FDA, Ctr Biol, Off Vaccines, Div Viral Prod, Bethesda, MD 20892 USA.
NR 0
TC 0
Z9 0
U1 0
U2 0
PU FEDERATION AMER SOC EXP BIOL
PI BETHESDA
PA 9650 ROCKVILLE PIKE, BETHESDA, MD 20814-3998 USA
SN 0892-6638
J9 FASEB J
JI Faseb J.
PD MAR 24
PY 2004
VL 18
IS 5
SU S
BP A822
EP A823
PG 2
WC Biochemistry & Molecular Biology; Biology; Cell Biology
SC Biochemistry & Molecular Biology; Life Sciences & Biomedicine - Other
Topics; Cell Biology
GA 806ZB
UT WOS:000220470700308
ER
PT J
AU Epstein, SL
AF Epstein, SL
TI Reexamination of archival records from the 1957 influenza pandemic:
Heterosubtypic immunity in humans?
SO FASEB JOURNAL
LA English
DT Meeting Abstract
CT Experimental Biology 2004 Meeting
CY APR 17-21, 2004
CL Washington, DC
C1 US FDA, Ctr Biol Evaluat & Res, Div Cellular & Gene Therapies, Bethesda, MD 20892 USA.
NR 0
TC 1
Z9 1
U1 0
U2 1
PU FEDERATION AMER SOC EXP BIOL
PI BETHESDA
PA 9650 ROCKVILLE PIKE, BETHESDA, MD 20814-3998 USA
SN 0892-6638
J9 FASEB J
JI Faseb J.
PD MAR 24
PY 2004
VL 18
IS 5
SU S
BP A802
EP A802
PG 1
WC Biochemistry & Molecular Biology; Biology; Cell Biology
SC Biochemistry & Molecular Biology; Life Sciences & Biomedicine - Other
Topics; Cell Biology
GA 806ZB
UT WOS:000220470700206
ER
PT J
AU Fernandez, E
Elkins, K
AF Fernandez, E
Elkins, K
TI The role of B cells in immunity to Francisella tularensis LVS
SO FASEB JOURNAL
LA English
DT Meeting Abstract
CT Experimental Biology 2004 Meeting
CY APR 17-21, 2004
CL Washington, DC
C1 US FDA, CBER, Rockville, MD 20852 USA.
NR 0
TC 0
Z9 0
U1 0
U2 0
PU FEDERATION AMER SOC EXP BIOL
PI BETHESDA
PA 9650 ROCKVILLE PIKE, BETHESDA, MD 20814-3998 USA
SN 0892-6638
J9 FASEB J
JI Faseb J.
PD MAR 24
PY 2004
VL 18
IS 5
SU S
BP A805
EP A805
PG 1
WC Biochemistry & Molecular Biology; Biology; Cell Biology
SC Biochemistry & Molecular Biology; Life Sciences & Biomedicine - Other
Topics; Cell Biology
GA 806ZB
UT WOS:000220470700220
ER
PT J
AU Huang, LYC
Ishii, KJ
Bafica, A
Akira, S
Sher, A
Aliberti, J
Golding, B
AF Huang, LYC
Ishii, KJ
Bafica, A
Akira, S
Sher, A
Aliberti, J
Golding, B
TI Toll-like receptor 9 is required for IL-12 induction in response to
bacterial stimulation
SO FASEB JOURNAL
LA English
DT Meeting Abstract
CT Experimental Biology 2004 Meeting
CY APR 17-21, 2004
CL Washington, DC
C1 CBER FDA, Div Hematol, Rockville, MD 20852 USA.
Osaka Univ, RIMD, Suita, Osaka 565, Japan.
NIAID, LPD, NIH, Bethesda, MD 20892 USA.
Duke Univ, Med Ctr, Dept Immunol, Durham, NC 27706 USA.
RI Aliberti, Julio/I-7354-2013; Ishii, Ken/B-1685-2012
OI Aliberti, Julio/0000-0003-3420-8478; Ishii, Ken/0000-0002-6728-3872
NR 0
TC 0
Z9 0
U1 0
U2 0
PU FEDERATION AMER SOC EXP BIOL
PI BETHESDA
PA 9650 ROCKVILLE PIKE, BETHESDA, MD 20814-3998 USA
SN 0892-6638
J9 FASEB J
JI Faseb J.
PD MAR 24
PY 2004
VL 18
IS 5
SU S
BP A1157
EP A1157
PG 1
WC Biochemistry & Molecular Biology; Biology; Cell Biology
SC Biochemistry & Molecular Biology; Life Sciences & Biomedicine - Other
Topics; Cell Biology
GA 806ZB
UT WOS:000220470701903
ER
PT J
AU Inoue, S
Golding, B
Golding, H
Scott, D
AF Inoue, S
Golding, B
Golding, H
Scott, D
TI CD4 T cells are required not for primary but for secondary CTL responses
against protein plus adjuvant
SO FASEB JOURNAL
LA English
DT Meeting Abstract
CT Experimental Biology 2004 Meeting
CY APR 17-21, 2004
CL Washington, DC
C1 US FDA, Ctr Biol Evaluat & Res, Bethesda, MD 20892 USA.
NR 0
TC 0
Z9 0
U1 0
U2 0
PU FEDERATION AMER SOC EXP BIOL
PI BETHESDA
PA 9650 ROCKVILLE PIKE, BETHESDA, MD 20814-3998 USA
SN 0892-6638
J9 FASEB J
JI Faseb J.
PD MAR 24
PY 2004
VL 18
IS 5
SU S
BP A824
EP A824
PG 1
WC Biochemistry & Molecular Biology; Biology; Cell Biology
SC Biochemistry & Molecular Biology; Life Sciences & Biomedicine - Other
Topics; Cell Biology
GA 806ZB
UT WOS:000220470700313
ER
PT J
AU Lumsden, J
Shen, RN
Petiniot, L
McCarty, T
Barlow, C
Wynn, T
Morse, H
Wynshaw-Boris, A
Max, E
Hodes, R
AF Lumsden, J
Shen, RN
Petiniot, L
McCarty, T
Barlow, C
Wynn, T
Morse, H
Wynshaw-Boris, A
Max, E
Hodes, R
TI Immunoglobulin class switch recombination is impaired in Atm-deficient
mice
SO FASEB JOURNAL
LA English
DT Meeting Abstract
CT Experimental Biology 2004 Meeting
CY APR 17-21, 2004
CL Washington, DC
C1 NIH, Expt Immunol Branch, Bethesda, MD 20892 USA.
NIAID, NIH, Bethesda, MD 20892 USA.
NCHGR, NIH, Bethesda, MD USA.
US FDA, Ctr Biol Evaluat & Res, Bethesda, MD USA.
RI Lumsden, Joanne/B-6475-2009
NR 0
TC 0
Z9 0
U1 0
U2 1
PU FEDERATION AMER SOC EXP BIOL
PI BETHESDA
PA 9650 ROCKVILLE PIKE, BETHESDA, MD 20814-3998 USA
SN 0892-6638
J9 FASEB J
JI Faseb J.
PD MAR 24
PY 2004
VL 18
IS 5
SU S
BP A1132
EP A1132
PG 1
WC Biochemistry & Molecular Biology; Biology; Cell Biology
SC Biochemistry & Molecular Biology; Life Sciences & Biomedicine - Other
Topics; Cell Biology
GA 806ZB
UT WOS:000220470701782
ER
PT J
AU Max, EE
Bernstein, RM
Mills, FC
AF Max, EE
Bernstein, RM
Mills, FC
TI Chromatin features suggest a boundary downstream of the murine IgH locus
SO FASEB JOURNAL
LA English
DT Meeting Abstract
CT Experimental Biology 2004 Meeting
CY APR 17-21, 2004
CL Washington, DC
C1 US FDA, OBP, CBER, Bethesda, MD 20892 USA.
NR 0
TC 0
Z9 0
U1 0
U2 0
PU FEDERATION AMER SOC EXP BIOL
PI BETHESDA
PA 9650 ROCKVILLE PIKE, BETHESDA, MD 20814-3998 USA
SN 0892-6638
J9 FASEB J
JI Faseb J.
PD MAR 24
PY 2004
VL 18
IS 5
SU S
BP A812
EP A813
PG 2
WC Biochemistry & Molecular Biology; Biology; Cell Biology
SC Biochemistry & Molecular Biology; Life Sciences & Biomedicine - Other
Topics; Cell Biology
GA 806ZB
UT WOS:000220470700258
ER
PT J
AU Mills, FC
Bernstein, RM
Max, EE
AF Mills, FC
Bernstein, RM
Max, EE
TI Examination of the human 3 ' IgH region for insulator function
SO FASEB JOURNAL
LA English
DT Meeting Abstract
CT Experimental Biology 2004 Meeting
CY APR 17-21, 2004
CL Washington, DC
C1 US FDA, CDER, DTP, OTRR, Bethesda, MD 20892 USA.
US FDA, CDER, OBP, Bethesda, MD 20892 USA.
NR 0
TC 0
Z9 0
U1 0
U2 0
PU FEDERATION AMER SOC EXP BIOL
PI BETHESDA
PA 9650 ROCKVILLE PIKE, BETHESDA, MD 20814-3998 USA
SN 0892-6638
J9 FASEB J
JI Faseb J.
PD MAR 24
PY 2004
VL 18
IS 5
SU S
BP A816
EP A816
PG 1
WC Biochemistry & Molecular Biology; Biology; Cell Biology
SC Biochemistry & Molecular Biology; Life Sciences & Biomedicine - Other
Topics; Cell Biology
GA 806ZB
UT WOS:000220470700274
ER
PT J
AU Porter, CM
Bloom, E
AF Porter, CM
Bloom, E
TI CD4+CD25+ regulatory T cells suppress human anti-porcine responses
SO FASEB JOURNAL
LA English
DT Meeting Abstract
CT Experimental Biology 2004 Meeting
CY APR 17-21, 2004
CL Washington, DC
C1 US FDA, Div Cellular & Gene Therapy, Bethesda, MD 20892 USA.
NR 0
TC 0
Z9 0
U1 0
U2 0
PU FEDERATION AMER SOC EXP BIOL
PI BETHESDA
PA 9650 ROCKVILLE PIKE, BETHESDA, MD 20814-3998 USA
SN 0892-6638
J9 FASEB J
JI Faseb J.
PD MAR 24
PY 2004
VL 18
IS 5
SU S
BP A1178
EP A1179
PG 2
WC Biochemistry & Molecular Biology; Biology; Cell Biology
SC Biochemistry & Molecular Biology; Life Sciences & Biomedicine - Other
Topics; Cell Biology
GA 806ZB
UT WOS:000220470702007
ER
PT J
AU Puri, RK
Bhattacharya, B
Miura, T
Mejido, J
Luo, YQ
Yang, AX
Joshi, BH
Irene, G
Rao, M
AF Puri, RK
Bhattacharya, B
Miura, T
Mejido, J
Luo, YQ
Yang, AX
Joshi, BH
Irene, G
Rao, M
TI Microrray analysis of gene expression identities unique molecular
signature in human embryonic stem cell lines
SO FASEB JOURNAL
LA English
DT Meeting Abstract
CT Experimental Biology 2004 Meeting
CY APR 17-21, 2004
CL Washington, DC
C1 US FDA, Ctr Biol Evaluat & Res, Div Cellular & Gene Therapies, Lab Mol Tumor Biol, Bethesda, MD 20892 USA.
NIA, Neurosci Lab, Baltimore, MD 21224 USA.
NR 0
TC 1
Z9 1
U1 0
U2 0
PU FEDERATION AMER SOC EXP BIOL
PI BETHESDA
PA 9650 ROCKVILLE PIKE, BETHESDA, MD 20814-3998 USA
SN 0892-6638
J9 FASEB J
JI Faseb J.
PD MAR 24
PY 2004
VL 18
IS 5
SU S
BP A1121
EP A1121
PG 1
WC Biochemistry & Molecular Biology; Biology; Cell Biology
SC Biochemistry & Molecular Biology; Life Sciences & Biomedicine - Other
Topics; Cell Biology
GA 806ZB
UT WOS:000220470701726
ER
PT J
AU Smith, GW
Haschek, WM
Fredrickson, RL
Tumbleson, ME
James, SJ
Eppley, RM
Constable, PD
AF Smith, GW
Haschek, WM
Fredrickson, RL
Tumbleson, ME
James, SJ
Eppley, RM
Constable, PD
TI Effect of chronic fumonisin B-1 ingestion on serum folate, homocysteine,
and methionine concentrations in Sinclair minipigs
SO FASEB JOURNAL
LA English
DT Meeting Abstract
CT Experimental Biology 2004 Meeting
CY APR 17-21, 2004
CL Washington, DC
C1 N Carolina State Univ, Dept Farm Anim Hlth, Raleigh, NC 27606 USA.
Univ Illinois, Dept Vet Pathobiol, Urbana, IL 61801 USA.
Univ Illinois, Dept Vet Biosci, Urbana, IL 61801 USA.
Univ Illinois, Dept Vet Clin Med, Urbana, IL 61801 USA.
Natl Ctr Toxicol Res, Div Biochem Toxicol, Jefferson, AR 72079 USA.
US FDA, CFSAN, Laurel, MD USA.
NR 0
TC 0
Z9 0
U1 1
U2 2
PU FEDERATION AMER SOC EXP BIOL
PI BETHESDA
PA 9650 ROCKVILLE PIKE, BETHESDA, MD 20814-3998 USA
SN 0892-6638
J9 FASEB J
JI Faseb J.
PD MAR 24
PY 2004
VL 18
IS 5
SU S
BP A1209
EP A1210
PG 2
WC Biochemistry & Molecular Biology; Biology; Cell Biology
SC Biochemistry & Molecular Biology; Life Sciences & Biomedicine - Other
Topics; Cell Biology
GA 806ZB
UT WOS:000220470702155
ER
PT J
AU Wang, W
Merchlinsky, M
Inman, J
Golding, B
AF Wang, W
Merchlinsky, M
Inman, J
Golding, B
TI Identification of a novel immunodominant CTL epitope derived from human
factor VIII in a murine model of hemophilia A
SO FASEB JOURNAL
LA English
DT Meeting Abstract
CT Experimental Biology 2004 Meeting
CY APR 17-21, 2004
CL Washington, DC
C1 US FDA, Ctr Biol Evaluat & Res, OBRR, DH, Bethesda, MD 20892 USA.
US FDA, Ctr Biol Evaluat & Res, OVRR, Bethesda, MD 20892 USA.
NIAID, Bethesda, MD 20892 USA.
NR 0
TC 0
Z9 0
U1 0
U2 0
PU FEDERATION AMER SOC EXP BIOL
PI BETHESDA
PA 9650 ROCKVILLE PIKE, BETHESDA, MD 20814-3998 USA
SN 0892-6638
J9 FASEB J
JI Faseb J.
PD MAR 24
PY 2004
VL 18
IS 5
SU S
BP A826
EP A826
PG 1
WC Biochemistry & Molecular Biology; Biology; Cell Biology
SC Biochemistry & Molecular Biology; Life Sciences & Biomedicine - Other
Topics; Cell Biology
GA 806ZB
UT WOS:000220470700324
ER
PT J
AU Zhao, ZS
McElroy, M
Lo, CY
Misplon, JA
Tompkins, SM
Ye, ZP
Benton, K
Epstein, SL
AF Zhao, ZS
McElroy, M
Lo, CY
Misplon, JA
Tompkins, SM
Ye, ZP
Benton, K
Epstein, SL
TI Protection against influenza A virus challenge by vaccination with
acidic polymerase (PA) expressed by DNA and recombinant vaccinia virus
SO FASEB JOURNAL
LA English
DT Meeting Abstract
CT Experimental Biology 2004 Meeting
CY APR 17-21, 2004
CL Washington, DC
C1 US FDA, Ctr Biol Evaluat & Res, Div Cellular & Gene Therapies, Bethesda, MD 20892 USA.
Howard Hughes Med Inst, Bethesda, MD 20817 USA.
US FDA, Ctr Biol Evaluat & Res, Div Viral Prod, Bethesda, MD USA.
NR 0
TC 0
Z9 0
U1 0
U2 0
PU FEDERATION AMER SOC EXP BIOL
PI BETHESDA
PA 9650 ROCKVILLE PIKE, BETHESDA, MD 20814-3998 USA
SN 0892-6638
J9 FASEB J
JI Faseb J.
PD MAR 24
PY 2004
VL 18
IS 5
SU S
BP A822
EP A822
PG 1
WC Biochemistry & Molecular Biology; Biology; Cell Biology
SC Biochemistry & Molecular Biology; Life Sciences & Biomedicine - Other
Topics; Cell Biology
GA 806ZB
UT WOS:000220470700305
ER
PT J
AU Zubkova, I
Golding, H
Zaitseva, M
AF Zubkova, I
Golding, H
Zaitseva, M
TI The role of intrathymic IL-7 in restoration of thymopoiesis
SO FASEB JOURNAL
LA English
DT Meeting Abstract
CT Experimental Biology 2004 Meeting
CY APR 17-21, 2004
CL Washington, DC
C1 US FDA, Ctr Biol Evaluat & Res, Bethesda, MD 20892 USA.
NR 0
TC 0
Z9 0
U1 0
U2 0
PU FEDERATION AMER SOC EXP BIOL
PI BETHESDA
PA 9650 ROCKVILLE PIKE, BETHESDA, MD 20814-3998 USA
SN 0892-6638
J9 FASEB J
JI Faseb J.
PD MAR 24
PY 2004
VL 18
IS 5
SU S
BP A794
EP A794
PG 1
WC Biochemistry & Molecular Biology; Biology; Cell Biology
SC Biochemistry & Molecular Biology; Life Sciences & Biomedicine - Other
Topics; Cell Biology
GA 806ZB
UT WOS:000220470700164
ER
PT J
AU Collazo, CM
Sher, A
Elkins, K
AF Collazo, CM
Sher, A
Elkins, K
TI The function of myeloid differentiation factor-88 (MyD88) and Toll-like
receptors in Francisella tularensis LVS infection in mice
SO FASEB JOURNAL
LA English
DT Meeting Abstract
CT Experimental Biology 2004 Meeting
CY APR 17-21, 2004
CL Washington, DC
C1 US FDA, CBER, Rockville, MD 20852 USA.
NIAID, LPD, NIH, Bethesda, MD 20892 USA.
NR 0
TC 0
Z9 0
U1 0
U2 0
PU FEDERATION AMER SOC EXP BIOL
PI BETHESDA
PA 9650 ROCKVILLE PIKE, BETHESDA, MD 20814-3998 USA
SN 0892-6638
J9 FASEB J
JI Faseb J.
PD MAR 23
PY 2004
VL 18
IS 4
SU S
BP A454
EP A454
PG 1
WC Biochemistry & Molecular Biology; Biology; Cell Biology
SC Biochemistry & Molecular Biology; Life Sciences & Biomedicine - Other
Topics; Cell Biology
GA 806ZA
UT WOS:000220470602188
ER
PT J
AU Cook, KK
White, KD
Rader, JI
AF Cook, KK
White, KD
Rader, JI
TI Use of pyrrolizidine alkaloid profiles to distinguish Symphytum
officinale (common comfrey) from S. x uplandicum (Russian Comfrey) in
comfirey products sold in the United States
SO FASEB JOURNAL
LA English
DT Meeting Abstract
CT Experimental Biology 2004 Meeting
CY APR 17-21, 2004
CL Washington, DC
C1 US FDA, Ctr Food Safety & Appl Nutr, College Pk, MD 20740 USA.
NR 0
TC 0
Z9 0
U1 0
U2 2
PU FEDERATION AMER SOC EXP BIOL
PI BETHESDA
PA 9650 ROCKVILLE PIKE, BETHESDA, MD 20814-3998 USA
SN 0892-6638
J9 FASEB J
JI Faseb J.
PD MAR 23
PY 2004
VL 18
IS 4
SU S
BP A128
EP A129
PG 2
WC Biochemistry & Molecular Biology; Biology; Cell Biology
SC Biochemistry & Molecular Biology; Life Sciences & Biomedicine - Other
Topics; Cell Biology
GA 806ZA
UT WOS:000220470600624
ER
PT J
AU Cowley, S
Elkins, K
AF Cowley, S
Elkins, K
TI Membrane TNF contributes to resistance against Francisella tularensis
infection
SO FASEB JOURNAL
LA English
DT Meeting Abstract
CT Experimental Biology 2004 Meeting
CY APR 17-21, 2004
CL Washington, DC
C1 US FDA, CBER, Rockville, MD 20852 USA.
NR 0
TC 0
Z9 0
U1 0
U2 0
PU FEDERATION AMER SOC EXP BIOL
PI BETHESDA
PA 9650 ROCKVILLE PIKE, BETHESDA, MD 20814-3998 USA
SN 0892-6638
J9 FASEB J
JI Faseb J.
PD MAR 23
PY 2004
VL 18
IS 4
SU S
BP A92
EP A92
PG 1
WC Biochemistry & Molecular Biology; Biology; Cell Biology
SC Biochemistry & Molecular Biology; Life Sciences & Biomedicine - Other
Topics; Cell Biology
GA 806ZA
UT WOS:000220470600451
ER
PT J
AU Dalloul, RA
Lillehoj, H
Babu, US
Raybourne, RB
Heckert, RA
AF Dalloul, RA
Lillehoj, H
Babu, US
Raybourne, RB
Heckert, RA
TI CpG-containing oligodeoxynucleotides protect chickens against Eimeria
infections
SO FASEB JOURNAL
LA English
DT Meeting Abstract
CT Experimental Biology 2004 Meeting
CY APR 17-21, 2004
CL Washington, DC
C1 Univ Maryland, College Pk, MD 20742 USA.
USDA, Anim Parasit Dis Lab, Beltsville, MD 20705 USA.
US FDA, Ctr Food Safety & Appl Nutr, Laurel, MD USA.
NR 0
TC 0
Z9 0
U1 0
U2 0
PU FEDERATION AMER SOC EXP BIOL
PI BETHESDA
PA 9650 ROCKVILLE PIKE, BETHESDA, MD 20814-3998 USA
SN 0892-6638
J9 FASEB J
JI Faseb J.
PD MAR 23
PY 2004
VL 18
IS 4
SU S
BP A418
EP A418
PG 1
WC Biochemistry & Molecular Biology; Biology; Cell Biology
SC Biochemistry & Molecular Biology; Life Sciences & Biomedicine - Other
Topics; Cell Biology
GA 806ZA
UT WOS:000220470602016
ER
PT J
AU Delmonte, P
Perry, J
Rader, JI
AF Delmonte, P
Perry, J
Rader, JI
TI Analysis of isoflavones in soy- and red clover-containing foods or
dietary supplements
SO FASEB JOURNAL
LA English
DT Meeting Abstract
CT Experimental Biology 2004 Meeting
CY APR 17-21, 2004
CL Washington, DC
C1 US FDA, College Pk, MD USA.
US FDA, College Pk, MD 20740 USA.
NR 0
TC 0
Z9 0
U1 0
U2 2
PU FEDERATION AMER SOC EXP BIOL
PI BETHESDA
PA 9650 ROCKVILLE PIKE, BETHESDA, MD 20814-3998 USA
SN 0892-6638
J9 FASEB J
JI Faseb J.
PD MAR 23
PY 2004
VL 18
IS 4
SU S
BP A128
EP A128
PG 1
WC Biochemistry & Molecular Biology; Biology; Cell Biology
SC Biochemistry & Molecular Biology; Life Sciences & Biomedicine - Other
Topics; Cell Biology
GA 806ZA
UT WOS:000220470600622
ER
PT J
AU Hansen, CM
Shultz, TD
James, SJ
Melnyk, S
Leklem, JE
Hardin, K
Ames, BN
AF Hansen, CM
Shultz, TD
James, SJ
Melnyk, S
Leklem, JE
Hardin, K
Ames, BN
TI Effects of smoking and vitamin B-6 intake on plasma thiol concentrations
SO FASEB JOURNAL
LA English
DT Meeting Abstract
CT Experimental Biology 2004 Meeting
CY APR 17-21, 2004
CL Washington, DC
C1 Iowa State Univ Sci & Technol, Ames, IA 50011 USA.
Washington State Univ, Pullman, WA 99164 USA.
Natl Ctr Toxicol Res, Div Biochem Toxicol, Jefferson, AR 72079 USA.
Oregon State Univ, Corvallis, OR 97331 USA.
Childrens Hosp, Oakland Res Inst, Nutr Genom Ctr, Oakland, CA 94609 USA.
NR 0
TC 0
Z9 0
U1 0
U2 0
PU FEDERATION AMER SOC EXP BIOL
PI BETHESDA
PA 9650 ROCKVILLE PIKE, BETHESDA, MD 20814-3998 USA
SN 0892-6638
J9 FASEB J
JI Faseb J.
PD MAR 23
PY 2004
VL 18
IS 4
SU S
BP A176
EP A176
PG 1
WC Biochemistry & Molecular Biology; Biology; Cell Biology
SC Biochemistry & Molecular Biology; Life Sciences & Biomedicine - Other
Topics; Cell Biology
GA 806ZA
UT WOS:000220470600850
ER
PT J
AU Harris, DN
Besselink, E
Tolleson, WH
Roberts, DW
Heber, D
AF Harris, DN
Besselink, E
Tolleson, WH
Roberts, DW
Heber, D
TI Estrogenic activity of biochanin A and formononetin compared to
O-demethylated metabolites produced by hepatic microsomes in vitro
SO FASEB JOURNAL
LA English
DT Meeting Abstract
CT Experimental Biology 2004 Meeting
CY APR 17-21, 2004
CL Washington, DC
C1 Natl Ctr Toxicol Res, Div Biochem Toxicol, Jefferson, AR 72079 USA.
Univ Calif Los Angeles, David Geffen Sch Med, Ctr Human Nutr, Los Angeles, CA 90095 USA.
NR 0
TC 0
Z9 0
U1 0
U2 0
PU FEDERATION AMER SOC EXP BIOL
PI BETHESDA
PA 9650 ROCKVILLE PIKE, BETHESDA, MD 20814-3998 USA
SN 0892-6638
J9 FASEB J
JI Faseb J.
PD MAR 23
PY 2004
VL 18
IS 4
SU S
BP A127
EP A127
PG 1
WC Biochemistry & Molecular Biology; Biology; Cell Biology
SC Biochemistry & Molecular Biology; Life Sciences & Biomedicine - Other
Topics; Cell Biology
GA 806ZA
UT WOS:000220470600617
ER
PT J
AU Leak, LV
Liotta, LA
Calvert, VS
Petricoin, EF
AF Leak, LV
Liotta, LA
Calvert, VS
Petricoin, EF
TI Proteomic analysis of lymphangiogenesis
SO FASEB JOURNAL
LA English
DT Meeting Abstract
CT Experimental Biology 2004 Meeting
CY APR 17-21, 2004
CL Washington, DC
C1 Howard Univ, Washington, DC 20059 USA.
NCI, Pathol Lab, NIH, Bethesda, MD 20892 USA.
US FDA, Bethesda, MD 20014 USA.
NR 0
TC 0
Z9 0
U1 0
U2 0
PU FEDERATION AMER SOC EXP BIOL
PI BETHESDA
PA 9650 ROCKVILLE PIKE, BETHESDA, MD 20814-3998 USA
SN 0892-6638
J9 FASEB J
JI Faseb J.
PD MAR 23
PY 2004
VL 18
IS 4
SU S
BP A259
EP A259
PG 1
WC Biochemistry & Molecular Biology; Biology; Cell Biology
SC Biochemistry & Molecular Biology; Life Sciences & Biomedicine - Other
Topics; Cell Biology
GA 806ZA
UT WOS:000220470601247
ER
PT J
AU Manigold, T
Piccirillo, CA
Shin, EC
Mihalik, K
Rice, CM
Feinstone, SM
Rehermann, B
AF Manigold, T
Piccirillo, CA
Shin, EC
Mihalik, K
Rice, CM
Feinstone, SM
Rehermann, B
TI CD4+ CD25+ regulatory T cells control effector functions of HCV-specific
memory CD8+ T cells in HCV-recovered chimpanzees
SO FASEB JOURNAL
LA English
DT Meeting Abstract
CT Experimental Biology 2004 Meeting
CY APR 17-21, 2004
CL Washington, DC
C1 NIDDK, LDS, NIH, Bethesda, MD 20892 USA.
NIAID, NIH, Immunol Lab, Bethesda, MD 20892 USA.
US FDA, Ctr Biol Evaluat & Res, Lab Hepatitis Viruses, Bethesda, MD USA.
Rockefeller Univ, Ctr Study Hepatitis C, New York, NY 10021 USA.
NR 0
TC 0
Z9 0
U1 0
U2 0
PU FEDERATION AMER SOC EXP BIOL
PI BETHESDA
PA 9650 ROCKVILLE PIKE, BETHESDA, MD 20814-3998 USA
SN 0892-6638
J9 FASEB J
JI Faseb J.
PD MAR 23
PY 2004
VL 18
IS 4
SU S
BP A85
EP A85
PG 1
WC Biochemistry & Molecular Biology; Biology; Cell Biology
SC Biochemistry & Molecular Biology; Life Sciences & Biomedicine - Other
Topics; Cell Biology
GA 806ZA
UT WOS:000220470600417
ER
PT J
AU Miyaji, M
Okazaki, T
Bloom, ET
Amakawa, R
Fukuhara, S
Umehara, H
AF Miyaji, M
Okazaki, T
Bloom, ET
Amakawa, R
Fukuhara, S
Umehara, H
TI Functional roles of sphingomyelin in Fas-mediated apoptosis
SO FASEB JOURNAL
LA English
DT Meeting Abstract
CT Experimental Biology 2004 Meeting
CY APR 17-21, 2004
CL Washington, DC
C1 Kansai Med Sch, Dept Med 1, Moriguchi, Osaka 5708506, Japan.
Kyoto Univ, Grad Sch Med, Dept Hematol & Oncol, Kyoto, Japan.
US FDA, CBER, DCGT, LIV, Bethesda, MD USA.
Kyoto Univ, Dept Rheum Clin Immunol, Grad Sch Med, Kyoto, Japan.
NR 0
TC 0
Z9 0
U1 0
U2 0
PU FEDERATION AMER SOC EXP BIOL
PI BETHESDA
PA 9650 ROCKVILLE PIKE, BETHESDA, MD 20814-3998 USA
SN 0892-6638
J9 FASEB J
JI Faseb J.
PD MAR 23
PY 2004
VL 18
IS 4
SU S
BP A41
EP A41
PG 1
WC Biochemistry & Molecular Biology; Biology; Cell Biology
SC Biochemistry & Molecular Biology; Life Sciences & Biomedicine - Other
Topics; Cell Biology
GA 806ZA
UT WOS:000220470600200
ER
PT J
AU Mueller, CL
McCue, J
Ouyang, Y
Portas, M
Lazis, S
Quintana, N
Freed, BM
AF Mueller, CL
McCue, J
Ouyang, Y
Portas, M
Lazis, S
Quintana, N
Freed, BM
TI Acrolein in cigarette smoke inhibits NF-[kappa]B p50 DNA binding
SO FASEB JOURNAL
LA English
DT Meeting Abstract
CT Experimental Biology 2004 Meeting
CY APR 17-21, 2004
CL Washington, DC
C1 Univ Colorado, Denver, CO 80262 USA.
US FDA, CDER 2, Rockville, MD USA.
NR 0
TC 0
Z9 0
U1 0
U2 0
PU FEDERATION AMER SOC EXP BIOL
PI BETHESDA
PA 9650 ROCKVILLE PIKE, BETHESDA, MD 20814-3998 USA
SN 0892-6638
J9 FASEB J
JI Faseb J.
PD MAR 23
PY 2004
VL 18
IS 4
SU S
BP A433
EP A433
PG 1
WC Biochemistry & Molecular Biology; Biology; Cell Biology
SC Biochemistry & Molecular Biology; Life Sciences & Biomedicine - Other
Topics; Cell Biology
GA 806ZA
UT WOS:000220470602088
ER
PT J
AU Shin, EC
Protzer, U
Untergasser, A
Hasselschwert, D
Rice, CM
Feinstone, SM
Rehermann, B
AF Shin, EC
Protzer, U
Untergasser, A
Hasselschwert, D
Rice, CM
Feinstone, SM
Rehermann, B
TI Effect of liver-directed IFN-gamma gene delivery in chronic hepatitis C
virus infection
SO FASEB JOURNAL
LA English
DT Meeting Abstract
CT Experimental Biology 2004 Meeting
CY APR 17-21, 2004
CL Washington, DC
C1 NIDDK, Liver Dis Sect, NIH, Bethesda, MD 20892 USA.
Univ Cologne, Ctr Mol Med, Cologne, Germany.
Univ Louisiana, New Iberia Res Ctr, Lafayette, LA USA.
Rockefeller Univ, Ctr Study Hepatitis C, New York, NY USA.
US FDA, Ctr Biol Evaluat & Res, Lab Hepatitis Viruses, Bethesda, MD USA.
NR 0
TC 0
Z9 0
U1 0
U2 0
PU FEDERATION AMER SOC EXP BIOL
PI BETHESDA
PA 9650 ROCKVILLE PIKE, BETHESDA, MD 20814-3998 USA
SN 0892-6638
J9 FASEB J
JI Faseb J.
PD MAR 23
PY 2004
VL 18
IS 4
SU S
BP A91
EP A92
PG 2
WC Biochemistry & Molecular Biology; Biology; Cell Biology
SC Biochemistry & Molecular Biology; Life Sciences & Biomedicine - Other
Topics; Cell Biology
GA 806ZA
UT WOS:000220470600450
ER
PT J
AU Song, K
Rabin, RL
Hill, BJ
De Rosa, S
Perfetto, SP
Reiner, JS
Zhang, HWH
Foley, JF
Marmol, J
Douek, DC
Roederer, M
Farber, JM
AF Song, K
Rabin, RL
Hill, BJ
De Rosa, S
Perfetto, SP
Reiner, JS
Zhang, HWH
Foley, JF
Marmol, J
Douek, DC
Roederer, M
Farber, JM
TI CXCR3 and CCR4 reveal polarized early central memory CD4+T cells in
humans
SO FASEB JOURNAL
LA English
DT Meeting Abstract
CT Experimental Biology 2004 Meeting
CY APR 17-21, 2004
CL Washington, DC
C1 NIAID, LCI, NIH, Bethesda, MD 20892 USA.
US FDA, Ctr Biol Evaluat & Res, Bethesda, MD 20014 USA.
NIAID, VRC, NIH, Bethesda, MD 20892 USA.
NR 0
TC 0
Z9 0
U1 0
U2 0
PU FEDERATION AMER SOC EXP BIOL
PI BETHESDA
PA 9650 ROCKVILLE PIKE, BETHESDA, MD 20814-3998 USA
SN 0892-6638
J9 FASEB J
JI Faseb J.
PD MAR 23
PY 2004
VL 18
IS 4
SU S
BP A467
EP A467
PG 1
WC Biochemistry & Molecular Biology; Biology; Cell Biology
SC Biochemistry & Molecular Biology; Life Sciences & Biomedicine - Other
Topics; Cell Biology
GA 806ZA
UT WOS:000220470602251
ER
PT J
AU Stolzenberg-Solomon, RZ
Mason, JB
Poirier, LA
Choi, SW
Selhub, J
Crott, J
Rothman, N
Sinha, R
AF Stolzenberg-Solomon, RZ
Mason, JB
Poirier, LA
Choi, SW
Selhub, J
Crott, J
Rothman, N
Sinha, R
TI Evaluation of integrative biochemical and molecular biomarkers of
one-carbon metabolism in healthy
SO FASEB JOURNAL
LA English
DT Meeting Abstract
CT Experimental Biology 2004 Meeting
CY APR 17-21, 2004
CL Washington, DC
C1 NCI, DCEG, Rockville, MD 20852 USA.
Tufts Univ, HNRC, Boston, MA 02111 USA.
US FDA, NCTR, Jefferson, AR USA.
NR 0
TC 0
Z9 0
U1 0
U2 0
PU FEDERATION AMER SOC EXP BIOL
PI BETHESDA
PA 9650 ROCKVILLE PIKE, BETHESDA, MD 20814-3998 USA
SN 0892-6638
J9 FASEB J
JI Faseb J.
PD MAR 23
PY 2004
VL 18
IS 4
SU S
BP A110
EP A111
PG 2
WC Biochemistry & Molecular Biology; Biology; Cell Biology
SC Biochemistry & Molecular Biology; Life Sciences & Biomedicine - Other
Topics; Cell Biology
GA 806ZA
UT WOS:000220470600539
ER
PT J
AU Stratton, SL
Sealey, WM
Hansen, DK
Mock, DM
AF Stratton, SL
Sealey, WM
Hansen, DK
Mock, DM
TI Marginal maternal biotin deficiency in CD-1 mice decreases the abundance
of the biotin-dependent carboxylases in fetal liver
SO FASEB JOURNAL
LA English
DT Meeting Abstract
CT Experimental Biology 2004 Meeting
CY APR 17-21, 2004
CL Washington, DC
C1 Univ Arkansas Med Sci, Little Rock, AR 72205 USA.
Natl Ctr Toxicol Res, Jefferson, AR 72079 USA.
NR 0
TC 0
Z9 0
U1 0
U2 0
PU FEDERATION AMER SOC EXP BIOL
PI BETHESDA
PA 9650 ROCKVILLE PIKE, BETHESDA, MD 20814-3998 USA
SN 0892-6638
J9 FASEB J
JI Faseb J.
PD MAR 23
PY 2004
VL 18
IS 4
SU S
BP A176
EP A176
PG 1
WC Biochemistry & Molecular Biology; Biology; Cell Biology
SC Biochemistry & Molecular Biology; Life Sciences & Biomedicine - Other
Topics; Cell Biology
GA 806ZA
UT WOS:000220470600847
ER
PT J
AU Tompkins, SM
Lo, CY
Tumpey, TM
Epstein, SL
AF Tompkins, SM
Lo, CY
Tumpey, TM
Epstein, SL
TI Protection against lethal influenza virus challenge by RNA interference
in vivo
SO FASEB JOURNAL
LA English
DT Meeting Abstract
CT Experimental Biology 2004 Meeting
CY APR 17-21, 2004
CL Washington, DC
C1 US FDA, Ctr Biol Evaluat & Res, Div Cellular & Gene Therapies, Bethesda, MD 20892 USA.
Ctr Dis Control & Prevent, Div Viral & Rickettsial Dis, Influenza Branch, Atlanta, GA USA.
RI Tompkins, Stephen/A-3317-2008
OI Tompkins, Stephen/0000-0002-1523-5588
NR 0
TC 0
Z9 0
U1 0
U2 4
PU FEDERATION AMER SOC EXP BIOL
PI BETHESDA
PA 9650 ROCKVILLE PIKE, BETHESDA, MD 20814-3998 USA
SN 0892-6638
J9 FASEB J
JI Faseb J.
PD MAR 23
PY 2004
VL 18
IS 4
SU S
BP A460
EP A460
PG 1
WC Biochemistry & Molecular Biology; Biology; Cell Biology
SC Biochemistry & Molecular Biology; Life Sciences & Biomedicine - Other
Topics; Cell Biology
GA 806ZA
UT WOS:000220470602214
ER
PT J
AU Umehara, H
Miyaji, M
Mimori, T
Bloom, ET
Imai, T
AF Umehara, H
Miyaji, M
Mimori, T
Bloom, ET
Imai, T
TI A role of fractalkine as the vascular gateway for cytotoxic lymphocytes
SO FASEB JOURNAL
LA English
DT Meeting Abstract
CT Experimental Biology 2004 Meeting
CY APR 17-21, 2004
CL Washington, DC
C1 Kyoto Univ, Grad Sch Med, Dept Rheumatol & Clin Immunol, Kyoto 6068507, Japan.
Kansai Med Sch, Dept Med 21, Osaka, Japan.
US FDA, Ctr Biol Evaluat & Res, LIV, Bethesda, MD 20014 USA.
Kan Res Inst, Project 2, Kyoto, Japan.
NR 0
TC 0
Z9 0
U1 0
U2 0
PU FEDERATION AMER SOC EXP BIOL
PI BETHESDA
PA 9650 ROCKVILLE PIKE, BETHESDA, MD 20814-3998 USA
SN 0892-6638
J9 FASEB J
JI Faseb J.
PD MAR 23
PY 2004
VL 18
IS 4
SU S
BP A449
EP A449
PG 1
WC Biochemistry & Molecular Biology; Biology; Cell Biology
SC Biochemistry & Molecular Biology; Life Sciences & Biomedicine - Other
Topics; Cell Biology
GA 806ZA
UT WOS:000220470602163
ER
PT J
AU White, KD
Delmonte, P
Rader, JI
AF White, KD
Delmonte, P
Rader, JI
TI Identification of active components in Cimicifuga racemosa
satchithanandam subramaniam
SO FASEB JOURNAL
LA English
DT Meeting Abstract
CT Experimental Biology 2004 Meeting
CY APR 17-21, 2004
CL Washington, DC
C1 US FDA, College Pk, MD 20740 USA.
NR 0
TC 0
Z9 0
U1 0
U2 0
PU FEDERATION AMER SOC EXP BIOL
PI BETHESDA
PA 9650 ROCKVILLE PIKE, BETHESDA, MD 20814-3998 USA
SN 0892-6638
J9 FASEB J
JI Faseb J.
PD MAR 23
PY 2004
VL 18
IS 4
SU S
BP A128
EP A128
PG 1
WC Biochemistry & Molecular Biology; Biology; Cell Biology
SC Biochemistry & Molecular Biology; Life Sciences & Biomedicine - Other
Topics; Cell Biology
GA 806ZA
UT WOS:000220470600623
ER
PT J
AU Zhao, CWL
Andrews, KW
Holden, JM
Brandt, MM
Spease, C
Dwyer, J
Picciano, MF
AF Zhao, CWL
Andrews, KW
Holden, JM
Brandt, MM
Spease, C
Dwyer, J
Picciano, MF
TI Caffeine containing dietary supplements
SO FASEB JOURNAL
LA English
DT Meeting Abstract
CT Experimental Biology 2004 Meeting
CY APR 17-21, 2004
CL Washington, DC
C1 NIH, Off Dietary Supplements, Bethesda, MD 20892 USA.
US FDA, Ctr Food Safety & Appl Nutr, College Pk, MD USA.
ARS, Nutrient Data Lab, USDA, Beltsville, MD 20705 USA.
NR 0
TC 0
Z9 0
U1 0
U2 0
PU FEDERATION AMER SOC EXP BIOL
PI BETHESDA
PA 9650 ROCKVILLE PIKE, BETHESDA, MD 20814-3998 USA
SN 0892-6638
J9 FASEB J
JI Faseb J.
PD MAR 23
PY 2004
VL 18
IS 4
SU S
BP A128
EP A128
PG 1
WC Biochemistry & Molecular Biology; Biology; Cell Biology
SC Biochemistry & Molecular Biology; Life Sciences & Biomedicine - Other
Topics; Cell Biology
GA 806ZA
UT WOS:000220470600620
ER
PT J
AU Baric, I
Fumic, K
Glenn, B
Cuk, M
Schulze, A
Finkelstein, JD
James, SJ
Mejaski-Bosnjak, V
Pazanin, L
Pogribny, IP
Rados, M
Sarnavka, V
Scukanec-Spoljar, M
Allen, RH
Stabler, S
Uzelac, L
Vugrek, O
Wagner, C
Zeisel, S
Mudd, SH
AF Baric, I
Fumic, K
Glenn, B
Cuk, M
Schulze, A
Finkelstein, JD
James, SJ
Mejaski-Bosnjak, V
Pazanin, L
Pogribny, IP
Rados, M
Sarnavka, V
Scukanec-Spoljar, M
Allen, RH
Stabler, S
Uzelac, L
Vugrek, O
Wagner, C
Zeisel, S
Mudd, SH
TI S-adenosylhomocysteine hydrolase deficiency in a human: A genetic
disorder of methionine metabolism
SO PROCEEDINGS OF THE NATIONAL ACADEMY OF SCIENCES OF THE UNITED STATES OF
AMERICA
LA English
DT Article
ID GLYCINE N-METHYLTRANSFERASE; TOTAL HOMOCYSTEINE; DNA METHYLATION; PLASMA
HOMOCYSTEINE; CREATINE DEFICIENCY; MASS-SPECTROMETRY; FOLATE-DEFICIENCY;
COPPER-BINDING; INBORN ERROR; SERUM
AB We report studies of a Croatian boy, a proven case of human S-adenosylhomocysteine (AdoHcy) hydrolase deficiency. Psychomotor development was slow until his fifth month; thereafter, virtually absent until treatment was started. He had marked hypotonia with elevated serum creatine kinase and transaminases, prolonged prothrombin time and low albumin. Electron microscopy of muscle showed numerous abnormal myelin figures; liver biopsy showed mild hepatitis with sparse rough endoplasmic reticulum. Brain MRI at 12.7 months revealed white matter atrophy and abnormally slow myelination. Hypermethioninemia was present in the initial metabolic study at age 8 months, and persisted (up to 784 muM) without tyrosine elevation. Plasma total homocysteine was very slightly elevated for an infant to 14.5-15.9 muM. In plasma, S-adenosylmethionine was 30-fold and AdoHcy 150-fold elevated. Activity of AdoHcy hydrolase was approximate to3% of control in liver and was 5-10% of the control values in red blood cells and cultured fibroblasts. We found no evidence of a soluble inhibitor of the enzyme in extracts of the patient's cultured fibroblasts. Additional pretreatment abnormalities in plasma included low concentrations of phosphatidylcholine and choline, with elevations of guanidinoacetate, betaine, dimethylglycine, and cystathionine. Leukocyte DNA was hypermethylated. Gene analysis revealed two mutations in exon 4: a maternally derived stop codon, and a paternally derived missense mutation. We discuss reasons for biochemical abnormalities and pathophysiological aspects of AdoHcy hydrolase deficiency.
C1 Univ Zagreb, Hosp Ctr, Dept Pediat, Zagreb 10000, Croatia.
Univ Zagreb, Hosp Ctr, Dept Neuropathol, Zagreb 10000, Croatia.
Univ Zagreb, Hosp Ctr, Dept Radiol, Zagreb 10000, Croatia.
Univ Zagreb, Hosp Ctr, Dept Pathol, Zagreb 10000, Croatia.
Univ Zagreb, Hosp Ctr, Clin Inst Lab Diag, Zagreb 10000, Croatia.
NIMH, Mol Biol Lab, Bethesda, MD 20892 USA.
Univ N Carolina, Sch Publ Hlth, Dept Nutr, Chapel Hill, NC 27599 USA.
Univ N Carolina, Sch Med, Chapel Hill, NC 27599 USA.
Rudjer Boskovic Inst, Dept Mol Med, Zagreb 10000, Croatia.
Univ Colorado, Hlth Sci Ctr, Div Hematol, Denver, CO 80262 USA.
Natl Ctr Toxicol Res, Div Biochem Toxicol, Jefferson, AR 72079 USA.
Univ Zagreb, Childrens Hosp, Zagreb 10000, Croatia.
Univ Arkansas Med Sci, Dept Pediat, Little Rock, AR 72202 USA.
George Washington Univ, Washington, DC 20422 USA.
Vet Affairs Med Ctr, Washington, DC 20422 USA.
Univ Heidelberg, Childrens Hosp, D-69120 Heidelberg, Germany.
Vanderbilt Univ, Dept Biochem, Nashville, TN 37232 USA.
Dept Vet Affairs Med Ctr, Nashville, TN 37232 USA.
RP Baric, I (reprint author), Univ Zagreb, Hosp Ctr, Dept Pediat, Kispaticeva 12, Zagreb 10000, Croatia.
EM ibaric@kbc-zagreb.hr
FU NIDDK NIH HHS [DK 15289, DK 55865, R37 DK015289, DK 54849, R01 DK015289,
R01 DK055865]
NR 52
TC 105
Z9 110
U1 0
U2 12
PU NATL ACAD SCIENCES
PI WASHINGTON
PA 2101 CONSTITUTION AVE NW, WASHINGTON, DC 20418 USA
SN 0027-8424
J9 P NATL ACAD SCI USA
JI Proc. Natl. Acad. Sci. U. S. A.
PD MAR 23
PY 2004
VL 101
IS 12
BP 4234
EP 4239
DI 10.1073/pnas.0400658101
PG 6
WC Multidisciplinary Sciences
SC Science & Technology - Other Topics
GA 806ZQ
UT WOS:000220472200045
PM 15024124
ER
PT J
AU Manjanatha, MG
Shelton, SD
Bishop, M
Shaddock, JG
Dobrovolsky, VN
Heflich, RH
Webb, PJ
Blankenship, LR
Beland, FA
Greenlees, KJ
Culp, SJ
AF Manjanatha, MG
Shelton, SD
Bishop, M
Shaddock, JG
Dobrovolsky, VN
Heflich, RH
Webb, PJ
Blankenship, LR
Beland, FA
Greenlees, KJ
Culp, SJ
TI Analysis of mutations and bone marrow micronuclei in Big Blue (R) rats
fed leucomalachite green
SO MUTATION RESEARCH-FUNDAMENTAL AND MOLECULAR MECHANISMS OF MUTAGENESIS
LA English
DT Article
DE leucomalachite green; lacI; Big Blue rats; mutant frequency; mutation
frequency
ID LACI TRANSGENIC MICE; DNA ADDUCT FORMATION; MOLECULAR ANALYSIS;
MALACHITE GREEN; MUTAGENICITY; SEQUENCE; SPECTRA; TISSUE; LIVER; GENE
AB Leucomalachite green (LMG) is the major metabolite of malachite green (MG), a triphenylmethane dye that has been used widely as an antifungal agent in the fish industry. Concern over MG and LMG is due to the potential for consumer exposure, suggestive evidence of tumor promotion in rodent liver, and suspicion of carcinogenicity based on structure-activity relationships. In order to evaluate the risks associated with exposure to LMG, female Big Blue rats were fed up to 543 ppm LMG; groups of these rats were killed after 4, 16, or 32 weeks of exposure and evaluated for genotoxicity. We previously reported that this treatment resulted in a dose-dependent induction of liver DNA adducts, and that the liver lacl mutant frequency (MF) was increased, but only in rats fed 543 ppm LMG for 16 weeks [Mutation Res. 506/507 (2002) 55-63]. In the present study, we report the results from lymphocyte Hprt mutant assays and bone marrow micronucleus assays performed on these same rats. In addition, we have determined the types of lacI mutations induced in the rats fed 543 ppm LMG for 16 weeks and the rats fed control diet. No significant increases in the frequency of micronuclei or Hprt mutants were observed for any of the doses or time points assayed. Molecular analysis of 80 liver lacI mutants from rats fed 543 ppm LMG for 16 weeks revealed that 21% (17/80) were clonal in origin and that most (55/63) of the independent mutations were base pair substitutions. The predominant type of mutation was G:C --> A:T transition (31/63) and the majority (68%) of these involved CpG sites. When corrected for clonality, the 16-week lacl mutation frequency ((36 +/- 10) X 10(-6)) in treated rats was not significantly different from the clonally corrected control frequency ((17 +/- 9) X 10(-6); p = 0.06). Furthermore, the lacI mutational spectrum in treated rats was not significantly different from that found for control rats (P = 0.09). Taken together, these data indicate that the DNA adducts produced by LMG in female rats do not result in detectable levels of genotoxicity, and that the increase in lacI MF observed previously in the liver of treated rats may be due to the disproportionate expansion of spontaneous lacI mutations. (C) 2004 Elsevier B.V. All rights reserved.
C1 US FDA, Natl Ctr Toxicol Res, Jefferson, AR 72079 USA.
US FDA, Ctr Vet Med, Rockville, MD 20855 USA.
RP Manjanatha, MG (reprint author), US FDA, Natl Ctr Toxicol Res, 3900 NCTR Rd, Jefferson, AR 72079 USA.
EM mmanjanatha@nctr.fda.gov
NR 26
TC 9
Z9 12
U1 0
U2 2
PU ELSEVIER SCIENCE BV
PI AMSTERDAM
PA PO BOX 211, 1000 AE AMSTERDAM, NETHERLANDS
SN 0027-5107
J9 MUTAT RES-FUND MOL M
JI Mutat. Res.-Fundam. Mol. Mech. Mutagen.
PD MAR 22
PY 2004
VL 547
IS 1-2
BP 5
EP 18
DI 10.1016/j.mrfmmm.2003.11.009
PG 14
WC Biotechnology & Applied Microbiology; Genetics & Heredity; Toxicology
SC Biotechnology & Applied Microbiology; Genetics & Heredity; Toxicology
GA 806FD
UT WOS:000220418900002
PM 15013694
ER
PT J
AU Mittelstaedt, RA
Von Tungeln, LS
Shaddock, JG
Dobrovolsky, VN
Beland, FA
Heflich, RH
AF Mittelstaedt, RA
Von Tungeln, LS
Shaddock, JG
Dobrovolsky, VN
Beland, FA
Heflich, RH
TI Analysis of mutations in the Tk gene of Tk(+/-) mice treated as neonates
with 3 '-azido-3 '-deoxythymidine (AZT)
SO MUTATION RESEARCH-FUNDAMENTAL AND MOLECULAR MECHANISMS OF MUTAGENESIS
LA English
DT Article
DE zidovudine; microsatellites; transgenic mouse model; loss of
heterozygosity
ID IMMUNODEFICIENCY-VIRUS TYPE-1; ZIDOVUDINE TREATMENT; DNA INCORPORATION;
MUTANT FREQUENCY; OXIDATIVE DAMAGE; APRT LOCUS; HETEROZYGOSITY; CELLS;
TRANSMISSION; GENOTOXICITY
AB Mother-to-child transmission of the human immunodeficiency virus (HIV) is reduced by perinatal treatment with the antiretroviral nucleoside analogue 3'-azido-3-deoxythymidine (AZT, zidovudine). AZT, however, is genotoxic and carcinogenic in mice when administered either transplacentally or neonatally, suggesting a possible cancer risk for children later in life. In a previous study [Carcinogenesis 23 (2002) 1427-1432] we found that treating B6C3F1/Tk(+/-) mice on postnatal days I through 8 with intraperitoneal injections of 200 mg AZT per kg body weight per day significantly increased spleen lymphocyte mutant frequencies in the autosomal Tk gene. Allele-specific PCR of Tk mutants from treated mice indicated that 61 % had lost the Tk(+) allele (loss of heterozygosity; LOH), compared with 35% of Tk mutants from control mice, a difference that was significant. In the present study, Tk mutant lymphocyte clones were analyzed further using polymorphic microsatellite markers that flank the Tk gene along the length of mouse chromosome 11. The analysis indicated that allele-loss mutations in control mice were due to either total chromosome loss, mitotic recombination, or both. The pattern of marker loss in mutants from AZT-treated mice differed significantly from the control mice and was consistent with chromosome loss, mitotic recombination, interstitial deletion, gene conversion, and an unusual discontinuous LOH. The results indicate that AZT induced a unique pattern of mutations in the Tk gene of mice and that the major mechanisms of mutation by AZT involved deletion and recombination. (C) 2004 Elsevier B.V. All rights reserved.
C1 US FDA, Natl Ctr Toxicol Res, Div Genet & Reprod Toxicol, Jefferson, AR 72079 USA.
US FDA, Natl Ctr Toxicol Res, Div Biochem Toxicol, Jefferson, AR 72079 USA.
RP Mittelstaedt, RA (reprint author), US FDA, Natl Ctr Toxicol Res, Div Genet & Reprod Toxicol, 3900 NCTR Rd, Jefferson, AR 72079 USA.
EM rmittelstaedt@nctr.fda.gov
NR 18
TC 15
Z9 15
U1 0
U2 0
PU ELSEVIER SCIENCE BV
PI AMSTERDAM
PA PO BOX 211, 1000 AE AMSTERDAM, NETHERLANDS
SN 0027-5107
J9 MUTAT RES-FUND MOL M
JI Mutat. Res.-Fundam. Mol. Mech. Mutagen.
PD MAR 22
PY 2004
VL 547
IS 1-2
BP 63
EP 69
DI 10.1016/j.mrfmmm.2003.12.008
PG 7
WC Biotechnology & Applied Microbiology; Genetics & Heredity; Toxicology
SC Biotechnology & Applied Microbiology; Genetics & Heredity; Toxicology
GA 806FD
UT WOS:000220418900008
PM 15013700
ER
PT J
AU Muthyala, RS
Ju, YH
Sheng, SB
Williams, LD
Doerge, DR
Katzenellenbogen, BS
Helferich, WG
Katzenellenbogen, JA
AF Muthyala, RS
Ju, YH
Sheng, SB
Williams, LD
Doerge, DR
Katzenellenbogen, BS
Helferich, WG
Katzenellenbogen, JA
TI Equol, a natural estrogenic metabolite from soy isoflavones: convenient
preparation and resolution of R- and S-equols and their differing
binding and biological activity through estrogen receptors alpha and
beta
SO BIOORGANIC & MEDICINAL CHEMISTRY
LA English
DT Article
ID CANCER MCF-7 CELLS; BREAST-CANCER; ER-BETA; DIETARY PHYTOESTROGENS;
INTESTINAL BACTERIA; SELECTIVE LIGANDS; AMMONIUM FORMATE;
PHYTO-ESTROGENS; GUT MICROFLORA; HABITUAL DIET
AB Equol is a metabolite produced in vivo from the soy phytoestrogen daidzein by the action of gut microflora. It is known to be estrogenic, so human exposure to equol could have significant biological effects. Equol is a chiral molecule that can exist as the enantiomers R-equol and S-equol. To study the biological activity of racemic (+/-)-equol, as well as that of its pure enantiomers, we developed an efficient and convenient method to prepare (+/-)-equol from available isollavanoid precursors. Furthermore, we optimized a method to separate the enantiomers of equol by chiral HPLC, and we studied for the first time, the activities of the enantiomers on the two estrogen receptors, ERalpha and ERbeta. In binding assays, S-equol has a high binding affinity, preferential for ERbeta (K-i[ERbeta] = 16 nM; beta/alpha = 13 fold), that is comparable to that of genistein (K-i[ERbeta] = 6.7 nM; beta/alpha= 16), whereas R-equol binds more weakly and with a preference for ERalpha (K-i[ERalpha] = 50 nM; beta/alpha = 0.29). All equol isomers have higher affinity for both ERs than does the biosynthetic precursor daidzein. The availability an the in vitro characterization of the equol enantiomers should enable their biological effects to be studied in detail. (C) 2004 Elsevier Ltd. All rights reserved.
C1 Univ Illinois, Dept Chem, Urbana, IL 61801 USA.
Univ Illinois, Dept Mol & Integrat Physiol, Urbana, IL 61801 USA.
Univ Illinois, Dept Food Sci & Human Nutr, Urbana, IL 61801 USA.
Natl Ctr Toxicol Res, Jefferson, AR 72079 USA.
RP Helferich, WG (reprint author), Univ Illinois, Dept Chem, 600 S Mathews Ave, Urbana, IL 61801 USA.
EM helferic@staff.uiuc.edu; jkatzene@uiuc.edu
RI Muthyala, Rajeev/H-5245-2013
OI Muthyala, Rajeev/0000-0003-0811-9877
FU NCI NIH HHS [5R01 CA19118, 5R01 CA77355]; NIDDK NIH HHS [5R37 DK15556]
NR 68
TC 221
Z9 244
U1 2
U2 21
PU PERGAMON-ELSEVIER SCIENCE LTD
PI OXFORD
PA THE BOULEVARD, LANGFORD LANE, KIDLINGTON, OXFORD OX5 1GB, ENGLAND
SN 0968-0896
J9 BIOORGAN MED CHEM
JI Bioorg. Med. Chem.
PD MAR 15
PY 2004
VL 12
IS 6
BP 1559
EP 1567
DI 10.1016/j.bmc.2003.11.035
PG 9
WC Biochemistry & Molecular Biology; Chemistry, Medicinal; Chemistry,
Organic
SC Biochemistry & Molecular Biology; Pharmacology & Pharmacy; Chemistry
GA 803NM
UT WOS:000220237800032
PM 15018930
ER
PT J
AU Begier, EM
Burwen, DR
Haber, P
Ball, R
AF Begier, EM
Burwen, DR
Haber, P
Ball, R
CA Vaccine Adverse Event Reporting Sy
TI Postmarketing safety surveillance for typhoid fever vaccines from the
Vaccine Adverse Event Reporting System, July 1990 through June 2002
SO CLINICAL INFECTIOUS DISEASES
LA English
DT Article
ID VI-CAPSULAR POLYSACCHARIDE; ENTERIC-COATED CAPSULES; SALMONELLA-TYPHI;
UNITED-STATES; FIELD TRIAL; EFFICACY; IMMUNOGENICITY; IMMUNIZATION
AB Vaccines against Salmonella enterica serotype Typhi are used for prophylaxis of international travelers and have potential use as counterbioterrorism agents. The Vaccine Adverse Event Reporting System (VAERS) cannot usually establish causal relationships between vaccines and reported adverse events without further research but has successfully detected unrecognized side effects of vaccine. We reviewed reports to VAERS for US-licensed typhoid fever vaccines for the period of July 1990 through June 2002. We received 321 reports for parenteral Vi capsular polysaccharide vaccine and 345 reports for live, oral, attenuated Ty21a vaccine, with 7.5% and 5.5%, respectively, describing death, hospitalization, permanent disability, or life-threatening illness. Unexpected frequently reported symptoms included dizziness and pruritus for Vi vaccine and fatigue and myalgia for Ty21a vaccine. Gastroenteritis-like illness after receipt of Ty21a vaccine and abdominal pain after receipt of Vi vaccine, which are previously recognized events, occasionally required hospitalization. Nonfatal anaphylaxis was reported after both vaccines. VAERS reports do not indicate any unexpected serious side effects that compromise these vaccines' use for travelers' prophylaxis.
C1 US FDA, Ctr Biol Evaluat & Res, Off Biostat & Epidemiol, Div Epidemiol,Vaccine Safety Branch, Rockville, MD 20852 USA.
Ctr Dis Control & Prevent, Immunizat Safety Branch, Epidemiol & Surveillance Div, Natl Immunizat Program, Atlanta, GA USA.
RP Ball, R (reprint author), US FDA, Ctr Biol Evaluat & Res, Off Biostat & Epidemiol, Div Epidemiol,Vaccine Safety Branch, HFM-222,1401 Rockville Pike, Rockville, MD 20852 USA.
EM ballr@cber.fda.gov
NR 34
TC 21
Z9 25
U1 1
U2 1
PU UNIV CHICAGO PRESS
PI CHICAGO
PA 1427 E 60TH ST, CHICAGO, IL 60637-2954 USA
SN 1058-4838
J9 CLIN INFECT DIS
JI Clin. Infect. Dis.
PD MAR 15
PY 2004
VL 38
IS 6
BP 771
EP 779
DI 10.1086/381548
PG 9
WC Immunology; Infectious Diseases; Microbiology
SC Immunology; Infectious Diseases; Microbiology
GA 800QI
UT WOS:000220042400008
PM 14999618
ER
PT J
AU Al-Khaldi, SF
Villanueva, D
Chizhikov, V
AF Al-Khaldi, SF
Villanueva, D
Chizhikov, V
TI Identification and characterization of Clostridium perfringens using
single target DNA microarray chip
SO INTERNATIONAL JOURNAL OF FOOD MICROBIOLOGY
LA English
DT Article
DE Clostridium perfringens; single target DNA microarray chip; toxin genes
ID ESCHERICHIA-COLI; ENTEROTOXIN GENE; PHOSPHOLIPASE-C; ALPHA-TOXIN;
SEQUENCE; HOMOLOGY; BORNE
AB A DNA microarray method was developed to identify the presence of toxin genes: encoding beta toxin (cpb), epsilon toxin (etx), enterotoxin (cpe), alpha toxin (cpa), and iota toxin (iA) in Clostridium perfringens. To build the DNA chip, each gene sequence was represented by one similar to 22-bp amino-modified oligonucleotide printed twice on aldehyde-coated slides. Multiplex PCR with Cy3 and Cy5-dCTP derivatized fluorescent nucleotides was used to label five genes and fluorescent probes were prepared. The PCR probes were denatured and single-strand-labeled DNAs were separated and purified using magnetic beads. The presence of toxin genes in C. perfringens was detected by hybridization of amplified ssDNA probes to oligonucleotides on the chip representing one target sequence of each toxin gene. The DNA chip was able to identify eight strains of C. perfringens. (C) 2003 Elsevier B.V. All rights reserved.
C1 US FDA, Ctr Food Safety & Appl Nutr, Div Microbiol Studies, HSF 517, College Pk, MD 20740 USA.
US FDA, Ctr Biol Evaluat & Res, Rockville, MD 20857 USA.
RP Al-Khaldi, SF (reprint author), US FDA, Ctr Food Safety & Appl Nutr, Div Microbiol Studies, HSF 517, 5100 Paint Branch Pkwy, College Pk, MD 20740 USA.
EM Sufian.Al-Khaldi@cfsan.fda.gov
NR 14
TC 21
Z9 26
U1 1
U2 2
PU ELSEVIER SCIENCE BV
PI AMSTERDAM
PA PO BOX 211, 1000 AE AMSTERDAM, NETHERLANDS
SN 0168-1605
J9 INT J FOOD MICROBIOL
JI Int. J. Food Microbiol.
PD MAR 15
PY 2004
VL 91
IS 3
BP 289
EP 296
DI 10.1016/j.ijfoodmicro.2003.07.009
PG 8
WC Food Science & Technology; Microbiology
SC Food Science & Technology; Microbiology
GA 800GW
UT WOS:000220017900006
PM 14984776
ER
PT J
AU Bhattacharya, SS
Kulka, M
Lampel, KA
Cebula, TA
Goswami, BB
AF Bhattacharya, SS
Kulka, M
Lampel, KA
Cebula, TA
Goswami, BB
TI Use of reverse transcription and PCR to discriminate between infectious
and non-infectious hepatitis A virus
SO JOURNAL OF VIROLOGICAL METHODS
LA English
DT Article
DE hepatitis A virus; infectious; inactivated; discrimination by RT-PCR
ID POLYMERASE CHAIN-REACTION; HUMAN ENTERIC VIRUSES; RT-PCR;
ENVIRONMENTAL-SAMPLES; TEMPLATE PREPARATION; CAPTURE PCR; AMPLIFICATION;
SHELLFISH; OYSTERS; FOODS
AB Hepatitis A virus (HAV) is a major cause of infectious hepatitis worldwide. Detection of HAV in contaminated food or water is a priority research area in laboratories worldwide. Our laboratory has reported previously the development of reverse transcription-polymerase chain reaction (RT-PCR) based detection and typing methods for HAV in contaminated shellfish and produce. It is commonly held that RT-PCR can detect viral genome, but cannot distinguish between infectious and inactivated virus. Therefore, signals obtained after PCR should be considered as false positives unless it can be shown that the sample contains virus capable of infecting a suitable host cell line in culture. We present data to show that this general assumption is not valid. Evidence is provided that demonstrate that signals generated after RT-PCR amplification of viral genome correlated well with the presence of infectious virus in the sample. Viral samples inactivated by heat or UV treatment produced significantly lower signal strength that paralleled infectivity of the sample in cultured cells. The loss of signal strength is most likely the result of damage to the viral RNA that renders it unsuitable for RT-PCR. The correlation between PCR signal and infectivity was better following UV inactivation than heat treatment. The procedure may be adapted to other viruses and inactivating agents. Published by Elsevier B.V.
C1 US FDA, Div Mol Biol, Off Appl Res & Safety Assessment, Laurel, MD 20708 USA.
RP Goswami, BB (reprint author), US FDA, Div Mol Biol, Off Appl Res & Safety Assessment, HFS-025,8301 Muirkirk Rd, Laurel, MD 20708 USA.
EM bgoswami@cfsan.fda.gov
NR 22
TC 41
Z9 42
U1 1
U2 7
PU ELSEVIER SCIENCE BV
PI AMSTERDAM
PA PO BOX 211, 1000 AE AMSTERDAM, NETHERLANDS
SN 0166-0934
J9 J VIROL METHODS
JI J. Virol. Methods
PD MAR 15
PY 2004
VL 116
IS 2
BP 181
EP 187
DI 10.1016/j.jviromet.2003.11.008
PG 7
WC Biochemical Research Methods; Biotechnology & Applied Microbiology;
Virology
SC Biochemistry & Molecular Biology; Biotechnology & Applied Microbiology;
Virology
GA 776AP
UT WOS:000189093100011
PM 14738986
ER
PT J
AU Karrow, NA
Guo, TL
Delclos, KB
Newbold, RR
Weis, C
Germolec, DR
White, KL
McCay, JA
AF Karrow, NA
Guo, TL
Delclos, KB
Newbold, RR
Weis, C
Germolec, DR
White, KL
McCay, JA
TI Nonylphenol alters the activity of splenic NK cells and the numbers of
leukocyte subpopulations in Sprague-Dawley rats: a two-generation
feeding study
SO TOXICOLOGY
LA English
DT Article
DE nonylphenol (NP); in utero exposure; immunomodulation; rat; feeding
study
ID ESTROGENIC ACTIVITY; RAINBOW-TROUT; EXPOSURE; 4-NONYLPHENOL; TOXICOLOGY;
TOXICITY; IMMUNITY
AB Nonylphenol (NP) has been identified at low levels in surface waters throughout North America. This industrial chemical is primarily used for the production of certain non-ionic surfactants, and has been reported to have weak estrogen-like activity. As estrogen has immunoregulatory properties and is crucial for normal fetal development, it was hypothesized that adult and developmental exposures to NP had the potential to adversely affect the immune system. Furthermore, developmental exposure to NP might also produce differential immunomodulation in F-1 male and female rats. Thus, a two-generation feeding study was conducted to evaluate the potential for NP to modulate certain immune parameters. Pregnant female Sprague-Dawley rats were exposed to NP (0, 25, 500, and 2000 ppm) in their feed for 65 days, beginning 7 days into gestation. The F-1 generation male and female offspring were exposed in utero at the respective treatment levels, commencing the 7th day of gestation, and continuing through to 64 days of age. Changes in splenic antibody-forming cell response, natural killer cell activity, and leukocyte numbers were used to evaluate NP immunotoxicity. The results from the present study indicate that dietary exposure to NP can increase splenic natural killer (NK) cell activity and splenocyte subpopulation numbers in the F-1 generation rats, without similar changes to the F-0 generation. The immunological changes that were observed in the F-1 generation also appeared to be gender-specific. (C) 2003 Elsevier Ireland Ltd. All rights reserved.
C1 Virginia Commonwealth Univ, Dept Pharmacol & Toxicol, Richmond, VA 23298 USA.
US FDA, Natl Ctr Toxicol Res, Div Biochem Toxicol, Jefferson, AR 72079 USA.
NIEHS, Mol Toxicol Lab, Res Triangle Pk, NC 27709 USA.
RP White, KL (reprint author), Virginia Commonwealth Univ, Dept Pharmacol & Toxicol, Med Coll Virginia Campus, Richmond, VA 23298 USA.
EM kwhite@hsc.vcu.edu
FU NIEHS NIH HHS [ES 55094]
NR 23
TC 20
Z9 24
U1 0
U2 1
PU ELSEVIER SCI IRELAND LTD
PI CLARE
PA CUSTOMER RELATIONS MANAGER, BAY 15, SHANNON INDUSTRIAL ESTATE CO, CLARE,
IRELAND
SN 0300-483X
J9 TOXICOLOGY
JI Toxicology
PD MAR 15
PY 2004
VL 196
IS 3
BP 237
EP 245
DI 10.1016/j.tox.2003.11.009
PG 9
WC Pharmacology & Pharmacy; Toxicology
SC Pharmacology & Pharmacy; Toxicology
GA 800EE
UT WOS:000220010900007
PM 15036750
ER
PT J
AU Younick, JJ
Koenig, ML
Yourick, DL
Bronaugh, RL
AF Younick, JJ
Koenig, ML
Yourick, DL
Bronaugh, RL
TI Fate of chemicals in skin after dermal application: does the in vitro
skin reservoir affect the estimate of systemic absorption?
SO TOXICOLOGY AND APPLIED PHARMACOLOGY
LA English
DT Article
DE chemicals; skin; absorption
ID INVITRO PERCUTANEOUS-ABSORPTION; CARBONYL-COMPOUNDS; DIHYDROXYACETONE;
MUTAGENICITY; INDUCTION; DNA
AB Recent international guidelines for the conduct of in vitro skin absorption studies put forward different approaches for addressing the status of chemicals remaining in the stratum corneum and epidermis/dermis at the end of a study. The present study investigated the fate of three chemicals [dihydroxyacetone (DHA), 7-(2H-naphtho[1,2-d]triazol-2-yl)-3-phenylcoumarin (7NTPC), and disperse blue 1 (DB1)] in an in vitro absorption study. In these studies, human and fuzzy rat skin penetration and absorption were determined over 24 or 72 h in flow-through diffusion cells. Skin penetration of these chemicals resulted in relatively low receptor fluid levels but high skin levels. For DHA, penetration studies found approximately 22% of the applied dose remaining in the skin (in both the stratum corneum and viable tissue) as a reservoir after 24 h. Little of the DHA that penetrates into skin is actually available to become systemically absorbed. 7NTPC remaining in the skin after 24 h was approximately 14.7% of the applied dose absorbed. Confocal laser cytometry studies with 7NTPC showed that it is present across skin in mainly the epidermis and dermis with intense fluorescence around hair. For DB1, penetration studies found approximately 10% (ethanol vehicle) and 3% (formulation vehicle) of the applied dose localized in mainly the stratum corneum after 24 h. An extended absorption study (72 h) revealed that little additional DB1 was absorbed into the receptor fluid. Skin levels should not be considered as absorbed material for DHA or DB1, while 7NTPC requires further investigation. These studies illustrate the importance of determining the fate of chemicals remaining in skin, which could significantly affect the estimates of systemically available material to be used in exposure estimates. We recommend that a more conclusive means to determine the fate of skin levels is to perform an extended study as conducted for DB1. Published by Elsevier Inc.
C1 US FDA, Skin Absorpt & Metab Sect, Cosmet Toxicol Branch, Off Cosmet & Colors, Laurel, MD 20708 USA.
Walter Reed Army Inst Res, Div Neurosci, Silver Spring, MD 20910 USA.
RP Younick, JJ (reprint author), US FDA, Skin Absorpt & Metab Sect, Cosmet Toxicol Branch, Off Cosmet & Colors, 8301 Muirkirk Rd,Bldg BRF,HFS-128, Laurel, MD 20708 USA.
EM jyourick@cfsan.fda.gov
RI Yourick, Debra/A-2121-2011
NR 34
TC 29
Z9 31
U1 0
U2 3
PU ACADEMIC PRESS INC ELSEVIER SCIENCE
PI SAN DIEGO
PA 525 B ST, STE 1900, SAN DIEGO, CA 92101-4495 USA
SN 0041-008X
J9 TOXICOL APPL PHARM
JI Toxicol. Appl. Pharmacol.
PD MAR 15
PY 2004
VL 195
IS 3
BP 309
EP 320
DI 10.1016/j.taap.2003.07.015
PG 12
WC Pharmacology & Pharmacy; Toxicology
SC Pharmacology & Pharmacy; Toxicology
GA 804FO
UT WOS:000220284800006
ER
PT J
AU Wang, ZH
Plakas, SM
El Said, KR
Jester, ELE
Granade, HR
Dickey, RW
AF Wang, ZH
Plakas, SM
El Said, KR
Jester, ELE
Granade, HR
Dickey, RW
TI LC/MS analysis of brevetoxin metabolites in the Eastern oyster
(Crassostrea virginica)
SO TOXICON
LA English
DT Article
DE brevetoxins; metabolism; Eastern oyster; cytotoxicity; liquid
chromatography/mass spectrometry
ID RED TIDE; CYTOTOXICITY; TOXINS
AB Brevetoxin (PbTx) metabolism was examined in the Eastern oyster (Crassostrea virginica) following exposure to a Karenia brevis red tide. by using, LC/MS(/MS) and cytotoxicity assay. Metabolites observed in field-exposed oysters were confirmed in oysters exposed to K. brevis Cultures in the laboratory. Previously, we identified a cysteine conjugate and its sulfoxide (MH+: m/z 1018 and 1034) as metabolites of the brevetoxin congener PbTx-2. In the present study, we found a cysteine conjugate and its sulfoxide with A-type brevetoxin backbone structure (MH+ : m/z 990 and 1006), as probable derivatives of PbTx- 1. We also found glycine-cysteine-PbTx (m/z 1047 and 1075), gamma-glutamyl-cysteine-PbTx (m/z 1147), and glutathione-PbTx (m/z 1176 and 1204) conjugates with A- and B-type backbone structures. Amino acid-PbTx conjugates react with fatty acids through amide linkage to form a series of fatty acid-amino acid-PbTx conjugates. These fatty acid conjugates are major contributors to the composite cytototoxic responses obtained in extracts of brevetoxin-contaminated oysters. Other brevetoxin derivatives found in oysters are consistent with hydrolytic ring-opening and oxidation/reduction reactions. Published by Elsevier Ltd.
C1 US FDA, Gulf Coast Seafood Lab, Dauphin Isl, AL 36528 USA.
RP Plakas, SM (reprint author), US FDA, Gulf Coast Seafood Lab, POB 158,1 Iberville Dr, Dauphin Isl, AL 36528 USA.
EM splakas@cfsan.fda.gov
NR 9
TC 56
Z9 59
U1 0
U2 5
PU PERGAMON-ELSEVIER SCIENCE LTD
PI OXFORD
PA THE BOULEVARD, LANGFORD LANE, KIDLINGTON, OXFORD OX5 1GB, ENGLAND
SN 0041-0101
J9 TOXICON
JI Toxicon
PD MAR 15
PY 2004
VL 43
IS 4
BP 455
EP 465
DI 10.1016/j.toxicon.2004.02.017
PG 11
WC Pharmacology & Pharmacy; Toxicology
SC Pharmacology & Pharmacy; Toxicology
GA 815CW
UT WOS:000221021400013
PM 15051410
ER
PT J
AU Ruley, KM
Ansede, JH
Pritchett, CL
Talaat, AM
Reimschuessel, R
Trucksis, M
AF Ruley, KM
Ansede, JH
Pritchett, CL
Talaat, AM
Reimschuessel, R
Trucksis, M
TI Identification of Mycobacterium marinum virulence genes using
signature-tagged mutagenesis and the goldfish model of mycobacterial
pathogenesis
SO FEMS MICROBIOLOGY LETTERS
LA English
DT Article
DE Mycobacterium marinum; signature-tagged mutagenesis; mycobacterium;
virulence; pathogenesis; goldfish model
ID TRANSPOSON MUTAGENESIS; TUBERCULOSIS; DNA; SEQUENCE; GENOME; ACIDS
AB Mycobacterium marinum, a causative agent of fish tuberculosis, is one of the most closely related Mycobacterium species (outside the M. tuberculosis complex) to M. tuberculosis, the etiologic agent of human tuberculosis. Signature-tagged mutagenesis was used to identify genes of M. marinum required for in vivo survival in a goldfish model of mycobacterial pathogenesis. Screening the first 1008 M. marinum mutants led to the identification of 40 putative virulence mutants. DNA sequence analysis of these 40 mutants identified transposon insertions in 35 unique loci. Twenty-eight out of 33 (85%) loci encoding putative virulence genes have homologous genes in M. tuberculosis. (C) 2004 Federation of European Microbiological Societies. Published by Elsevier B.V. All rights reserved.
C1 Univ Maryland, Sch Med, Ctr Vaccine Dev, Baltimore, MD 21201 USA.
US FDA, Ctr Vet Med, Laurel, MD 20857 USA.
Univ Maryland, Sch Med, Med Serv, Vet Affairs Med Ctr, Baltimore, MD 21201 USA.
RP Trucksis, M (reprint author), Univ Massachusetts, Sch Med, Div Infect Dis & Immunol, Worcester, MA 01605 USA.
EM michele.trucksis@umassmed.edu
NR 22
TC 25
Z9 27
U1 0
U2 6
PU ELSEVIER SCIENCE BV
PI AMSTERDAM
PA PO BOX 211, 1000 AE AMSTERDAM, NETHERLANDS
SN 0378-1097
J9 FEMS MICROBIOL LETT
JI FEMS Microbiol. Lett.
PD MAR 12
PY 2004
VL 232
IS 1
BP 75
EP 81
DI 10.1016/S0378-1097(04)00017-5
PG 7
WC Microbiology
SC Microbiology
GA 805DJ
UT WOS:000220346700011
PM 15019737
ER
PT J
AU Muthukkumar, S
Stein, KE
AF Muthukkumar, S
Stein, KE
TI Immunization with meningococcal polysaccharide-tetanus toxoid conjugate
induces polysaccharide-reactive T cells in mice
SO VACCINE
LA English
DT Article
DE meningococcal group C polysaccharide; tetanus toxoid; T cell cones
ID MAJOR HISTOCOMPATIBILITY COMPLEX; B-CELLS; CAPSULAR POLYSACCHARIDE;
LISTERIA-MONOCYTOGENES; DENDRITIC CELLS; IMMUNE-RESPONSE; II COLLAGEN;
TNP-FICOLL; RECOGNITION; ANTIGEN
AB T cell clones were generated from mice immunized with a meningococcal group C (alpha2 --> 9-sialic acid) polysaccharide-tetanus toxoid (MCPS-TT) conjugate. Many clones were found to be specific for tetanus toxoid (TT), however, clones reactive with MCPS-TT and polysaccharide (PS) were isolated. Two clones were specific for MCPS and two cross-reacted with Escherichia coli K1-PS (alpha2 --> 8-sialic acid). Both TT and PS reactive clones were CD4(+) and CD8(-). TT and MCPS-TT-specific T cell clones were major histocompatibility complex (MHC) restricted, however, the PS-reactive clones were not. Both MHC-restricted TT clones and non-restricted PS clones, however, were dependent on contact with antigen presenting cells (APC) for maximal stimulation. The data suggest that multivalent repeating epitopes on PS antigen (Ag) can overcome the need for MHC restricted interactions, but not the requirement for cell-cell contact. Published by Elsevier Ltd.
C1 US FDA, Ctr Biol Evaluat & Res, Div Monoclonal Antibodies, Bethesda, MD 20892 USA.
RP Muthukkumar, S (reprint author), US FDA, Ctr Biol Evaluat & Res, Div Monoclonal Antibodies, 8800 Rockville Pike, Bethesda, MD 20892 USA.
EM muthukkumar@cber.fda.gov
NR 58
TC 15
Z9 19
U1 0
U2 1
PU ELSEVIER SCI LTD
PI OXFORD
PA THE BOULEVARD, LANGFORD LANE, KIDLINGTON, OXFORD OX5 1GB, OXON, ENGLAND
SN 0264-410X
J9 VACCINE
JI Vaccine
PD MAR 12
PY 2004
VL 22
IS 9-10
BP 1290
EP 1299
DI 10.1016/j.vaccine.2003.08.047
PG 10
WC Immunology; Medicine, Research & Experimental
SC Immunology; Research & Experimental Medicine
GA 804WF
UT WOS:000220328100027
PM 15003659
ER
PT J
AU Landry, R
Wolffe, M
Burrows, C
Rassow, B
Byrnes, G
AF Landry, R
Wolffe, M
Burrows, C
Rassow, B
Byrnes, G
TI Study of the effect of involuntary user movement on the potential light
hazards from some ophthalmic instruments
SO APPLIED OPTICS
LA English
DT Article
ID EXTRACAPSULAR CATARACT-EXTRACTION; INTRAOCULAR-LENS IMPLANTATION;
INDUCED MACULOPATHY; OPERATING MICROSCOPE; PHOTIC MACULOPATHY;
PENETRATING KERATOPLASTY; RETINAL DAMAGE; SURGERY; RECOVERY
AB A study was undertaken to determine whether involuntary user movement provides a basis for relaxing the measurement conditions for evaluating the potential optical radiation hazards to the eye from slit lamps and indirect ophthalmoscopes. This was accomplished by assessment of the extent to which light from these devices can be maintained in focus on a 1-mm-diameter fiber-optic cable for 45 s. The results suggest that, although involuntary user movements can be significant, they do not provide a basis for relaxing the measurement conditions for evaluating the potential optical radiation hazards to the cornea and lens from slit lamps and indirect ophthalmoscopes. (C) 2004 Optical Society of America.
C1 US FDA, Ctr Devices & Radiol Hlth, Rockville, MD 20850 USA.
Keeler Ltd, Windsor SL4 4AA, Berks, England.
Augen & Poliklin, D-20242 Hamburg, Germany.
RP Landry, R (reprint author), US FDA, Ctr Devices & Radiol Hlth, 9200 Corp Blvd, Rockville, MD 20850 USA.
EM ijl@cdrh.fda.gov
NR 21
TC 2
Z9 2
U1 0
U2 1
PU OPTICAL SOC AMER
PI WASHINGTON
PA 2010 MASSACHUSETTS AVE NW, WASHINGTON, DC 20036 USA
SN 1559-128X
EI 2155-3165
J9 APPL OPTICS
JI Appl. Optics
PD MAR 10
PY 2004
VL 43
IS 8
BP 1643
EP 1647
DI 10.1364/AO.43.001643
PG 5
WC Optics
SC Optics
GA 800YZ
UT WOS:000220064900006
PM 15046166
ER
PT J
AU Miller, SA
Landry, RJ
Byrnes, GA
AF Miller, SA
Landry, RJ
Byrnes, GA
TI Endoilluminators: evaluation of potential retinal hazards
SO APPLIED OPTICS
LA English
DT Article
ID MACULAR HOLE SURGERY; PIGMENT EPITHELIOPATHY; VITRECTOMY; LIGHT; INJURY;
DAMAGE; TRIAL
AB The potential for retinal photic injury from exposure to endoilluminators was evaluated. The spectral irradiance for each endoilluminator configuration was weighted with the American Conference of Government Industrial Hygienists (ACGIH) aphakic action spectrum. The result was compared with the threshold limit value (TLV) published by the ACGIH and a time to TLV (time(TLV)) was calculated for each configuration. The calculated time(TLV) ranged from 0.27 to 3.5 min, times that are significantly shorter than typical operating times. The effects of incorporating short-wavelength cutoff filters were evaluated and found to significantly increase the time(TLV). Exposure reduction techniques for use during surgery are discussed. (C) 2004 Optical Society of America.
C1 US FDA, Ctr Devices & Radiol Hlth, Rockville, MD 20850 USA.
USN, Med Res Inst, Dept Ophthalmol, Bethesda, MD 20889 USA.
RP Miller, SA (reprint author), US FDA, Ctr Devices & Radiol Hlth, 9200 Corp Blvd, Rockville, MD 20850 USA.
EM sym@cdrh.fda.gov; rjl@cdrh.fda.gov
NR 18
TC 8
Z9 10
U1 0
U2 0
PU OPTICAL SOC AMER
PI WASHINGTON
PA 2010 MASSACHUSETTS AVE NW, WASHINGTON, DC 20036 USA
SN 1559-128X
EI 2155-3165
J9 APPL OPTICS
JI Appl. Optics
PD MAR 10
PY 2004
VL 43
IS 8
BP 1648
EP 1653
DI 10.1364/AO.43.001648
PG 6
WC Optics
SC Optics
GA 800YZ
UT WOS:000220064900007
PM 15046167
ER
PT J
AU Eswaramoorthy, S
Kumaran, D
Keller, J
Swaminathan, S
AF Eswaramoorthy, S
Kumaran, D
Keller, J
Swaminathan, S
TI Role of metals in the biological activity of clostridium botulinum
neurotoxins
SO BIOCHEMISTRY
LA English
DT Article
ID BACTERIAL PROTEIN TOXINS; LIGHT-CHAIN; NEUROTRANSMITTER RELEASE;
CRYSTAL-STRUCTURE; TETANUS TOXIN; ZINC-BINDING; DIFFRACTION DATA;
SPINAL-CORD; PH; THERMOLYSIN
AB Clostridium botulinum neurotoxins are the most potent toxins to humans and cause paralysis by blocking neurotransmitter release at the presynaptic nerve terminals. The toxicity involves four steps, viz., binding to neuronal cells, internalization, translocation, and catalytic activity. While the catalytic activity is a zinc endopeptidase activity on the SNARE complex proteins, the translocation is believed to be a pH-dependent process allowing the translocation domain to change its conformation to penetrate the endosomal membrane. Here, we report the crystal structures of botulinum neurotoxin type B at various pHs and of an apo form of the neurotoxin, and discuss the role of metal ions and the effect of pH variation in the biological activity. Except for the perturbation of a few side chains, the conformation of the catalytic domain is unchanged in the zinc-depleted apotoxin, suggesting that zinc's role is catalytic. We have also identified two calcium ions in the molecule and present biochemical evidence to show that they play a role in the translocation of the light chain through the membrane.
C1 Brookhaven Natl Lab, Dept Biol, Upton, NY 11973 USA.
US FDA, Lab Bacterial Toxins, Bethesda, MD 20892 USA.
RP Swaminathan, S (reprint author), Brookhaven Natl Lab, Dept Biol, Upton, NY 11973 USA.
EM swami@bnl.gov
NR 53
TC 39
Z9 39
U1 1
U2 2
PU AMER CHEMICAL SOC
PI WASHINGTON
PA 1155 16TH ST, NW, WASHINGTON, DC 20036 USA
SN 0006-2960
J9 BIOCHEMISTRY-US
JI Biochemistry
PD MAR 2
PY 2004
VL 43
IS 8
BP 2209
EP 2216
DI 10.1021/bi035844k
PG 8
WC Biochemistry & Molecular Biology
SC Biochemistry & Molecular Biology
GA 777PA
UT WOS:000189185700008
PM 14979717
ER
PT J
AU Voegtlin, DJ
Halbert, SE
Qiao, GX
AF Voegtlin, DJ
Halbert, SE
Qiao, GX
TI A guide to separating Aphis glycines Matsumura and morphologically
similar species that share its hosts
SO ANNALS OF THE ENTOMOLOGICAL SOCIETY OF AMERICA
LA English
DT Article
DE Aphis glycines; Aphis nasturtii; Aphis gossypii; Rhamnus cathartica;
morphology
AB Aphis glycines Matsumura shares its hosts with two other aphid species, Aphis nasturtii Kaltenbach and Aphis gossypii Glover. Tables of characters and photographs are provided to assist in the separation of these three species. A photographic plate showing a gynopara, male, ovipara, and late summer apterous vivipara of A. glycines is included.
C1 Illinois Nat Hist Survey, Ctr Econ Entomol, Champaign, IL 61820 USA.
FDACS, Div Plant Ind, Gainesville, FL 32614 USA.
Chinese Acad Sci, Inst Zool, Beijing 100080, Peoples R China.
RP Voegtlin, DJ (reprint author), Illinois Nat Hist Survey, Ctr Econ Entomol, Champaign, IL 61820 USA.
EM dvoegtli@uiuc.edu
NR 6
TC 23
Z9 23
U1 1
U2 5
PU ENTOMOL SOC AMER
PI LANHAM
PA 9301 ANNAPOLIS RD, LANHAM, MD 20706 USA
SN 0013-8746
J9 ANN ENTOMOL SOC AM
JI Ann. Entomol. Soc. Am.
PD MAR
PY 2004
VL 97
IS 2
BP 227
EP 232
DI 10.1603/0013-8746(2004)097[0227:AGTSAG]2.0.CO;2
PG 6
WC Entomology
SC Entomology
GA 803AI
UT WOS:000220203600005
ER
PT J
AU Li, XL
Ljungdahl, LG
Ximenes, EA
Chen, HH
Felix, CR
Cotta, MA
Dien, BS
AF Li, XL
Ljungdahl, LG
Ximenes, EA
Chen, HH
Felix, CR
Cotta, MA
Dien, BS
TI Properties of a recombinant beta-glucosidase from polycentric anaerobic
fungus Orpinomyces PC-2 and its application for cellulose hydrolysis
SO APPLIED BIOCHEMISTRY AND BIOTECHNOLOGY
LA English
DT Article; Proceedings Paper
CT 25th Symposium on Biotechnology for Fuels and Chemicals
CY MAY 04-07, 2003
CL Breckenridge, CO
SP US DOE, Off Biomass Program, Natl Renewable Energy Lab, Oak Ridge Natl Lab, Argonne Natl Lab, Idaho Natl Engn & Envirnom Lab, Pacific NW Natl Lab, USDA, Alltech, Archer Daniels Midland, BBI Int, Biotechnol Ind Org, Breckenridge Brewery, Cargill Inc, Cargill Dow LLC, Coors Brewing Co, Corn Refiners Assoc, E I Du Pont Nemours & Co Inc, Genencor Int, Iogen Corp, Katzen Int, Nat Resources Canada, Novozymes Biotech, Proctor & Gamble, Syngenta, Tate & Lyle, Tembec Ind
DE cellulose; cellulase; beta-glucosiclase; Orpinomyces; cellobiase
ID NEOCALLIMASTIX-FRONTALIS EB188; SP STRAIN PC-2;
SACCHAROMYCES-CEREVISIAE; GLYCOSYL HYDROLASES; SEQUENCE-ANALYSIS;
DOCKING DOMAINS; GENE; PURIFICATION; CELLULASES; SECRETION
AB A beta-glucosidase (Bg1A, EC 3.2.1.21) gene from the polycentric anaerobic fungus Orpinomyces PC-2 was cloned and sequenced. The enzyme containing 657 amino acid residues was homologous to certain animal, plant, and bacterial beta-glucosidases but lacked significant similarity to those from aerobic fungi. Neither cellulose- nor protein-binding domains were found in BgIA. When expressed in Saccharomyces cerevisiae, the enzyme was secreted in two forms with masses of about 110 kDa and also found in two forms associated with the yeast cells. K-m and V-max values of the secreted Bg1A were 0.762 mM and 8.20 mumol/(min(.)mg), respectively, with p-nitrophenyl-beta-D-glucopyranoside (pNPG) as the substrate and 0.310 mM and 6.45 mumol/(min(.)mg), respectively, for the hydrolysis of cellobiose. Glucose competitively inhibited the hydrolysis of pNPG with a K-i of 3.6 mM. beta-Glucosidase significantly enhanced the conversion of cellulosic materials into glucose by Trichoderma reesei cellulase preparations, demonstrating its potential for use in biofuel and feedstock chemical production.
C1 USDA ARS, Natl Ctr Agr Utilizat Res, Fermentat Biotechnol Res Unit, Peoria, IL 61604 USA.
Univ Georgia, Dept Biochem & Mol Biol, Athens, GA 30602 USA.
Univ Georgia, Ctr Biol Resource Recovery, Athens, GA 30602 USA.
Univ Brasilia, Dept Biol Celular, Lab Enzimol, BR-70910900 Brasilia, DF, Brazil.
US FDA, Div Microbiol, Natl Ctr Toxicol Res, Jefferson, AR 72079 USA.
RP USDA ARS, Natl Ctr Agr Utilizat Res, Fermentat Biotechnol Res Unit, 1815 N Univ St, Peoria, IL 61604 USA.
EM lix@ncaur.usda.gov
OI Ximenes, Eduardo/0000-0001-9087-0218; Cotta, Michael/0000-0003-4565-7754
NR 49
TC 12
Z9 13
U1 0
U2 11
PU HUMANA PRESS INC
PI TOTOWA
PA 999 RIVERVIEW DRIVE SUITE 208, TOTOWA, NJ 07512 USA
SN 0273-2289
EI 1559-0291
J9 APPL BIOCHEM BIOTECH
JI Appl. Biochem. Biotechnol.
PD SPR
PY 2004
VL 113
BP 233
EP 250
DI 10.1385/ABAB:113:1-3:233
PG 18
WC Biochemistry & Molecular Biology; Biotechnology & Applied Microbiology
SC Biochemistry & Molecular Biology; Biotechnology & Applied Microbiology
GA 817OG
UT WOS:000221186200021
PM 15054209
ER
PT J
AU Markovic, I
Stantchev, TS
Fields, KH
Tiffany, LJ
Tomic, M
Weiss, CD
Broder, CC
Strebel, K
Clouse, KA
AF Markovic, I
Stantchev, TS
Fields, KH
Tiffany, LJ
Tomic, M
Weiss, CD
Broder, CC
Strebel, K
Clouse, KA
TI Thiol/disulfide exchange is a prerequisite for CXCR4-tropic HIV-1
envelope-mediated T-cell fusion during viral entry
SO BLOOD
LA English
DT Article
ID HUMAN-IMMUNODEFICIENCY-VIRUS; PROTEIN-DISULFIDE-ISOMERASE;
MEMBRANE-FUSION; PLASMA-MEMBRANE; INFLUENZA HEMAGGLUTININ;
DETERGENT-RESISTANT; SURFACE ASSOCIATION; LIPID RAFTS; CD4; MICRODOMAINS
AB Attachment of gp120 to CD4 during HIV-1 entry triggers structural rearrangement in gp120 that enables binding to an appropriate coreceptor. Following coreceptor engagement, additional conformational changes occur in the envelope (Env), resulting in fusion of virion and cell membranes. Catalysts with redox-isomerase activity, such as protein disulfide isomerase (PDI), facilitate Env conversion from its inactive to its fusion-competent conformation. We report here that anti-PDI agents effectively block CXCR4 Env-mediated fusion and spread of virus infection. Exogenously added PDI, in turn, can rescue fusion from this blockade. We further find that PDI facilitates thiol/disulfide rearrangement in gp120 during conformational change, whereas inhibition of this redox shuffling prevents gp41 from assuming the fusogenic 6-helix bundle conformation. At the virus-cell contact site, gp120 induces assembly of PDI, CD4, and CXCR4 into a tetramolecular protein complex serving as a portal for viral entry. Our findings support the hypothesis that Env conformational change depends on a well-coordinated action of a tripartite system in which PDI works in concert with the receptor and the coreceptor to effectively lower the activation energy barrier required for Env conformational rearrangement. (C) 2004 by The American Society of Hematology.
C1 CDER, Bethesda, MD USA.
US FDA, Ctr Biol Evaluat & Res, Bethesda, MD USA.
Uniformed Serv Univ Hlth Sci, F Edward Hebert Sch Med, Bethesda, MD 20814 USA.
NICHHD, Bethesda, MD 20892 USA.
NIAID, NIH, Bethesda, MD 20892 USA.
RP Markovic, I (reprint author), Bldg 29B,Rm 3E18,29 Lincoln Dr, Bethesda, MD 20892 USA.
EM markovic@cber.fda.gov
RI Weiss, Carol/F-6438-2011; Tomic, Melanija/C-3371-2016
OI Weiss, Carol/0000-0002-9965-1289;
NR 44
TC 90
Z9 96
U1 0
U2 7
PU AMER SOC HEMATOLOGY
PI WASHINGTON
PA 1900 M STREET. NW SUITE 200, WASHINGTON, DC 20036 USA
SN 0006-4971
J9 BLOOD
JI Blood
PD MAR 1
PY 2004
VL 103
IS 5
BP 1586
EP 1594
DI 10.1182/blood-2003-05-1390
PG 9
WC Hematology
SC Hematology
GA 778NM
UT WOS:000189247700013
PM 14592831
ER
PT J
AU Sherman, ME
Mink, PJ
Curtis, R
Cote, TR
Brooks, S
Hartge, P
Devesa, S
AF Sherman, ME
Mink, PJ
Curtis, R
Cote, TR
Brooks, S
Hartge, P
Devesa, S
TI Survival among women with borderline ovarian tumors and ovarian
carcinoma - A population-based analysis
SO CANCER
LA English
DT Article
DE ovary; neoplasia; borderline; low malignant potential; survival; serous;
mucinous
ID MICROPAPILLARY SEROUS CARCINOMA; K-RAS MUTATIONS;
PSEUDOMYXOMA-PERITONEI; CIGARETTE-SMOKING; MUCINOUS TUMORS;
RISK-FACTORS; CLINICOPATHOLOGICAL ANALYSIS; HISTOLOGIC TYPE;
INTESTINAL-TYPE; UNITED-STATES
AB BACKGROUND. Serous and mucinous ovarian tumors of low malignant potential (LMP-S and LMP-M, respectively) are noninvasive tumors that portend excellent survival when confined to the ovary. Comparison of the survival for women with LMP tumors staged as distant with women who have carcinoma may have important implications for diagnostic terminology and clinical management.
METHODS. The authors compared relative survival rates among patients diagnosed with ovarian tumors during the period 1988-1999 (with follow-up through 2000) by histologic type, disease stage, tumor grade (for carcinomas), and patient age, using data from the Surveillance, Epidemiology, and End Results Program.
RESULTS. The overall relative survival rate at 10 years (+/- 1.96 standard errors) was 96.9% +/- 2.3% for women with LMP-S tumors, 30.4% +/- 1.7% for women with serous carcinoma (CA-S); 94.0% +/- 3.1% for women with LMP-M tumors, and 64.7% +/- 3.4% for women with mucinous carcinoma (CA-M). The survival rate at 10 years for women with distant-stage LMP-S tumors was 89.9% +/- 5.3%, compared with 96.1% +/- 8.6% for women with well differentiated, localized CA-S. The survival rate for women with distant-stage LMP-M tumors at 5 years was 85.5% +/- 9.0%, compared with 95.5% +/- 3.4% for women with well differentiated, localized CA-M (data for 10 years were limited). Mucinous ovarian neoplasms were associated with all excess of second malignancies of the digestive tract.
CONCLUSIONS. Relative survival among women with distant-stage LMP tumors was not 100% and resembled the survival of women who had carcinoma exhibiting favorable prognostic features (localized stage). Future studies of women with high-stage LMP tumors are required to clarify the pathogenesis of extraovarian lesions and their implications for management and prognosis. Published 2004 by the American Cancer Society.*
C1 NCI, Div Canc Epidemiol & Genet, Bethesda, MD 20892 USA.
Exponent, Washington, DC USA.
US FDA, Therapeut & Blood Safety Branch, Rockville, MD 20857 USA.
Univ Maryland, Sch Med, Dept Obstet & Gynecol, Baltimore, MD 21201 USA.
RP Sherman, ME (reprint author), NCI, Div Canc Epidemiol & Genet, 6120 Execut Blvd,Room 7080, Bethesda, MD 20892 USA.
EM shermanm@mail.nih.gov
NR 47
TC 78
Z9 82
U1 0
U2 0
PU JOHN WILEY & SONS INC
PI HOBOKEN
PA 111 RIVER ST, HOBOKEN, NJ 07030 USA
SN 0008-543X
J9 CANCER
JI Cancer
PD MAR 1
PY 2004
VL 100
IS 5
BP 1045
EP 1052
DI 10.1002/cncr.20080
PG 8
WC Oncology
SC Oncology
GA 775XB
UT WOS:000189085000022
PM 14983501
ER
PT J
AU Toraason, M
Albertini, R
Bayard, S
Bigbee, W
Blair, A
Boffetta, P
Bonassi, S
Chanock, S
Christiani, D
Eastmond, D
Hanash, S
Henry, C
Kadlubar, F
Mirer, F
Nebert, D
Rapport, S
Rest, K
Rothman, N
Ruder, A
Savage, R
Schulte, P
Siemiatycki, J
Shields, P
Smith, M
Tolbert, P
Vermeulen, R
Vineis, P
Wacholder, S
Ward, E
Waters, M
Weston, A
AF Toraason, M
Albertini, R
Bayard, S
Bigbee, W
Blair, A
Boffetta, P
Bonassi, S
Chanock, S
Christiani, D
Eastmond, D
Hanash, S
Henry, C
Kadlubar, F
Mirer, F
Nebert, D
Rapport, S
Rest, K
Rothman, N
Ruder, A
Savage, R
Schulte, P
Siemiatycki, J
Shields, P
Smith, M
Tolbert, P
Vermeulen, R
Vineis, P
Wacholder, S
Ward, E
Waters, M
Weston, A
TI Applying new biotechnologies to the study of occupational cancer - A
workshop summary
SO ENVIRONMENTAL HEALTH PERSPECTIVES
LA English
DT Article
DE biomarkers; chemical exposure; epidemiology; gene-environment
interactions; genomics; occupational cancer; polymorphisms; proteomics;
risk assessment; toxicogenomics
AB As high-throughput technologies in genomics, transcriptomics, and proteomics evolve, questions arise about their use in the assessment of occupational cancers. To address these questions, the National Institute for Occupational Safety and Health, the National Cancer Institute, the National Institute of Environmental Health Sciences, and the American Chemistry Council sponsored a workshop 8-9 May 2002 in Washington, DC. The workshop brought together 80 international specialists whose objective was to identify the means for best exploiting new technologies to enhance methods for laboratory investigation, epidemiologic evaluation, risk assessment, and prevention of occupational cancer. The workshop focused on identifying and interpreting markers for early biologic effect and inherited modifiers of risk.
C1 NIOSH, Cincinnati, OH 45226 USA.
Univ Vermont, Burlington, VT USA.
Occupat Safety & Hlth Adm, Washington, DC USA.
Univ Pittsburgh, Inst Canc, Pittsburgh, PA USA.
NCI, Dept Hlth & Human Serv, NIH, Bethesda, MD 20892 USA.
Int Agcy Res Canc, F-69372 Lyon, France.
Natl Inst Canc Res, Genoa, Italy.
Harvard Univ, Sch Publ Hlth, Boston, MA 02115 USA.
Univ Calif Riverside, Riverside, CA 92521 USA.
Univ Michigan, Ann Arbor, MI 48109 USA.
Amer Chem Council, Arlington, VA USA.
Natl Ctr Toxicol Res, Jefferson, AR USA.
United Auto Workers Union, Int Union, Hlth & Safety Dept, Detroit, MI USA.
Univ Cincinnati, Cincinnati, OH USA.
Univ N Carolina, Chapel Hill, NC USA.
NIOSH, Washington, DC USA.
Univ Montreal, Montreal, PQ, Canada.
Georgetown Univ, Washington, DC USA.
Univ Calif Berkeley, Berkeley, CA 94720 USA.
Emory Univ, Atlanta, GA 30322 USA.
Univ Turin, Turin, Italy.
Amer Canc Soc, Atlanta, GA 30329 USA.
NIEHS, Dept Hlth & Human Serv, NIH, Res Triangle Pk, NC 27709 USA.
NIOSH, Morgantown, WV 26505 USA.
RP Toraason, M (reprint author), NIOSH, C23,4676 Columbia Pkwy, Cincinnati, OH 45226 USA.
EM mtoraason@cdc.gov
RI Waters, Martha/B-7441-2011; Shields, Peter/I-1644-2012; Ruder,
Avima/I-4155-2012; Tolbert, Paige/A-5676-2015; Vermeulen,
Roel/F-8037-2011;
OI Ruder, Avima/0000-0003-0419-6664; Vermeulen, Roel/0000-0003-4082-8163;
bonassi, stefano/0000-0003-3833-6717
NR 5
TC 21
Z9 23
U1 0
U2 3
PU US DEPT HEALTH HUMAN SCIENCES PUBLIC HEALTH SCIENCE
PI RES TRIANGLE PK
PA NATL INST HEALTH, NATL INST ENVIRONMENTAL HEALTH SCIENCES, PO BOX 12233,
RES TRIANGLE PK, NC 27709-2233 USA
SN 0091-6765
J9 ENVIRON HEALTH PERSP
JI Environ. Health Perspect.
PD MAR
PY 2004
VL 112
IS 4
BP 413
EP 416
DI 10.1289/txg.6343
PG 4
WC Environmental Sciences; Public, Environmental & Occupational Health;
Toxicology
SC Environmental Sciences & Ecology; Public, Environmental & Occupational
Health; Toxicology
GA 807BS
UT WOS:000220477600012
PM 15033588
ER
PT J
AU Kramer, JA
Pettit, SD
Amin, RP
Bertram, TA
Car, B
Cunningham, M
Curtiss, SW
Davis, JW
Kind, C
Lawton, M
Naciff, JM
Oreffo, V
Roman, RJ
Sistare, FD
Stevens, J
Thompson, K
Vickers, AE
Wild, S
Afsharif, CA
AF Kramer, JA
Pettit, SD
Amin, RP
Bertram, TA
Car, B
Cunningham, M
Curtiss, SW
Davis, JW
Kind, C
Lawton, M
Naciff, JM
Oreffo, V
Roman, RJ
Sistare, FD
Stevens, J
Thompson, K
Vickers, AE
Wild, S
Afsharif, CA
TI Overview of the application of transcription profiling using selected
nephrotoxicants for toxicology assessment
SO ENVIRONMENTAL HEALTH PERSPECTIVES
LA English
DT Article
DE cisplatin; gentamicin; nephrotoxicity; puromycin; risk assessment
ID GENTAMICIN
AB Microarrays allow for the simultaneous measurement of changes in the levels of thousands of messenger RNAs within a single experiment. As such, the potential for the application of transcription profiling to preclinical safety assessment and mechanism-based risk assessment is profound. However, several practical and technical challenges remain. Among these are nomenclature issues, platform-specific data formats, and the lack of uniform analysis methods and tools. Experiments were designed to address biological, technical, and methodological variability, to evaluate different approaches to data analysis, and to understand the application of the technology to other profiling methodologies and to mechanism-based risk assessment. These goals were addressed using experimental information derived from analysis of the biological response to three mechanistically distinct nephrotoxins: cisplatin, gentamicin, and puromycin aminonucleoside. In spite of the technical challenges, the transcription profiling data yielded mechanistically and topographically valuable information. The analyses detailed in the articles from the Nephrotoxicity Working Group of the International Life Sciences Institute Health and Environmental Sciences Institute suggest at least equal sensitivity of microarray technology compared to traditional end points. Additionally, microarray analysis of these prototypical nephrotoxicants provided an opportunity for the development of candidate bridging biomarkers of nephrotoxicity. The potential future extension of these applications for risk assessment is also discussed.
C1 ILSI Hlth & Environm Sci Inst, Washington, DC 20005 USA.
Pfizer Inc, St Louis, MO USA.
Pfizer Inc, Groton, CT 06340 USA.
NIEHS, Dept Hlth & Human Serv, NIH, Res Triangle Pk, NC USA.
Bristol Myers Squibb Co, Wilmington, DE USA.
Schering Plough Res Inst, Lafayette, NJ USA.
AstraZeneca, Charnwood, Leics, England.
Procter & Gamble Co, Miami Valley Labs, Cincinnati, OH USA.
Med Coll Wisconsin, Milwaukee, WI 53226 USA.
US FDA, Ctr Drug Evaluat & Res, Laurel, MD USA.
Eli Lilly & Co, Greenfield, IN 46140 USA.
Novartis Pharmaceut Corp, E Hanover, NJ USA.
Amgen Inc, Thousand Oaks, CA 91320 USA.
RP Pettit, SD (reprint author), ILSI Hlth & Environm Sci Inst, 1 Thomas Circle NW,9th Floor, Washington, DC 20005 USA.
EM spettit@ilsi.org
NR 16
TC 39
Z9 47
U1 1
U2 3
PU US DEPT HEALTH HUMAN SCIENCES PUBLIC HEALTH SCIENCE
PI RES TRIANGLE PK
PA NATL INST HEALTH, NATL INST ENVIRONMENTAL HEALTH SCIENCES, PO BOX 12233,
RES TRIANGLE PK, NC 27709-2233 USA
SN 0091-6765
J9 ENVIRON HEALTH PERSP
JI Environ. Health Perspect.
PD MAR
PY 2004
VL 112
IS 4
BP 460
EP 464
DI 10.1289/txg.6673
PG 5
WC Environmental Sciences; Public, Environmental & Occupational Health;
Toxicology
SC Environmental Sciences & Ecology; Public, Environmental & Occupational
Health; Toxicology
GA 807BS
UT WOS:000220477600020
PM 15033596
ER
PT J
AU Amin, RA
Vickers, AE
Sistare, F
Thompson, KL
Roman, RJ
Lawton, M
Kramer, J
Hamadeh, HK
Collins, J
Grissom, S
Bennett, L
Tucker, CJ
Wild, S
Kind, C
Oreffo, V
Davis, JW
Curtiss, S
Naciff, JM
Cunningham, M
Tennant, R
Stevens, J
Car, B
Bertram, TA
Afsharil, CA
AF Amin, RA
Vickers, AE
Sistare, F
Thompson, KL
Roman, RJ
Lawton, M
Kramer, J
Hamadeh, HK
Collins, J
Grissom, S
Bennett, L
Tucker, CJ
Wild, S
Kind, C
Oreffo, V
Davis, JW
Curtiss, S
Naciff, JM
Cunningham, M
Tennant, R
Stevens, J
Car, B
Bertram, TA
Afsharil, CA
TI Identification of putative gene-based markers of renal toxicity
SO ENVIRONMENTAL HEALTH PERSPECTIVES
LA English
DT Article
DE biomarkers; cisplatin; gentamicin; microarrays; nephrotoxicity; proximal
tubule; puromycin; toxicogenomics
ID PROSTAGLANDIN-D SYNTHASE; KIDNEY INJURY MOLECULE-1; LIPOCALIN PROTEIN
FAMILY; RETINOL-BINDING PROTEIN; BETA-TRACE PROTEIN; MESSENGER-RNA;
OSTEOPONTIN EXPRESSION; INDUCED NEPHROTOXICITY; MICROARRAY ANALYSIS;
EPITHELIAL-CELLS
AB This study, designed and conducted as part of the International Life Sciences Institute working group on the Application of Genomics and Proteomics, examined the changes in the expression profile of genes associated with the administration of three different nephrotoxicants-cisplatin, gentamicin, and puromycin-to assess the usefulness of microarrays in the understanding of mechanism(s) of nephrotoxicity. Male Sprague-Dawley rats were treated with daily doses of puromycin (5-20 mg/kg/day for 21 days), gentamicin (2-240 mg/kg/day for 7 days), or a single dose of cisplatin (0.1-5 mg/kg). Groups of rats were sacrificed at various times after administration of these compounds for standard clinical chemistry, urine analysis, and histological evaluation of the kidney. RNA was extracted from the kidney for microarray analysis. Principal component analysis and gene expression-based clustering of compound effects confirmed sample separation based on dose, time, and degree of renal toxicity. In addition, analysis of the profile components revealed some novel changes in the expression of genes that appeared to be associated with injury in specific portions of the nephron and reflected the mechanism of action of these various nephrotoxicants. For example, although puromycin is thought to specifically promote injury of the podocytes in the glomerulus, the changes in gene expression after chronic exposure of this compound suggested a pattern similar to the known proximal tubular nephrotoxicants cisplatin and gentamicin; this prediction was confirmed histologically. We conclude that renal gene expression profiling coupled with analysis of classical end points affords promising opportunities to reveal potential new mechanistic markers of renal toxicity.
C1 NIEHS, Dept Hlth & Human Serv, NIH, Res Triangle Pk, NC 27709 USA.
Novartis Pharmaceut Corp, E Hanover, NJ USA.
US FDA, Ctr Drug Evaluat & Res, Laurel, MD USA.
Med Coll Wisconsin, Milwaukee, WI 53226 USA.
Physiogenix Inc, Milwaukee, WI USA.
Pfizer Inc, St Louis, MO USA.
Pfizer Inc, Groton, CT 06340 USA.
Amgen Inc, Thousand Oaks, CA 91320 USA.
Schering Plough Res Inst, Lafayette, NJ USA.
Procter & Gamble Co, Miami Valley Labs, Cincinnati, OH USA.
Eli Lilly & Co, Indianapolis, IN 46285 USA.
Bristol Myers Squibb Co, Wilmington, DE USA.
RP Afsharil, CA (reprint author), NIEHS, Dept Hlth & Human Serv, NIH, POB 12233, Res Triangle Pk, NC 27709 USA.
EM cafshari@amgen.com
NR 80
TC 155
Z9 174
U1 1
U2 6
PU US DEPT HEALTH HUMAN SCIENCES PUBLIC HEALTH SCIENCE
PI RES TRIANGLE PK
PA NATL INST HEALTH, NATL INST ENVIRONMENTAL HEALTH SCIENCES, PO BOX 12233,
RES TRIANGLE PK, NC 27709-2233 USA
SN 0091-6765
J9 ENVIRON HEALTH PERSP
JI Environ. Health Perspect.
PD MAR
PY 2004
VL 112
IS 4
BP 465
EP 479
DI 10.1289/txg.6683
PG 15
WC Environmental Sciences; Public, Environmental & Occupational Health;
Toxicology
SC Environmental Sciences & Ecology; Public, Environmental & Occupational
Health; Toxicology
GA 807BS
UT WOS:000220477600021
PM 15033597
ER
PT J
AU Rosenzweig, BA
Pine, PS
Domon, OE
Morris, SM
Chen, JJ
Sistare, FD
AF Rosenzweig, BA
Pine, PS
Domon, OE
Morris, SM
Chen, JJ
Sistare, FD
TI Dye-bias correction in dual-labeled cDNA microarray gene expression
measurements
SO ENVIRONMENTAL HEALTH PERSPECTIVES
LA English
DT Article
DE cDNA; dye bias; dye swap; genomics; microarray
ID NORMALIZATION; MODELS
AB A significant limitation to the analytical accuracy and precision of dual-labeled spotted cDNA microarrays is the signal error due to dye bias. Transcript-dependent dye bias may be due to gene-specific differences of incorporation of two distinctly different chemical dyes and the resultant differential hybridization efficiencies of these two chemically different targets for the same probe. Several approaches were used to assess and minimize the effects of dye bias on fluorescent hybridization signals and maximize the experimental design efficiency of a cell culture experiment. Dye bias was measured at the individual transcript level within each batch of simultaneously processed arrays by replicate dual-labeled split-control sample hybridizations and accounted for a significant component of fluorescent signal differences. This transcript-dependent dye bias alone could introduce unacceptably high numbers of both false-positive and false-negative signals. We found that within a given set of concurrently processed hybridizations, the bias is remarkably consistent and therefore measurable and correctable. The additional microarrays and reagents required for paired technical replicate dye-swap corrections commonly performed to control for dye bias could be costly to end users. Incorporating split-control microarrays within a set of concurrently processed hybridizations to specifically measure dye bias can eliminate the need for technical dye swap replicates and reduce microarray and reagent costs while maintaining experimental accuracy and technical precision. These data support a practical and more efficient experimental design to measure and mathematically correct for dye bias.
C1 US FDA, Ctr Drug Evaluat & Res, Div Appl Pharmacol Res, Silver Spring, MD 20993 USA.
US FDA, Natl Ctr Toxicol Res, Jefferson, AR 72079 USA.
RP Rosenzweig, BA (reprint author), US FDA, Ctr Drug Evaluat & Res, Div Appl Pharmacol Res, HFD-910,10903 New Hapshire Ave,Life Sci Bldg 64, Silver Spring, MD 20993 USA.
EM rosenzweigb@cder.fda.gov
NR 14
TC 58
Z9 60
U1 0
U2 4
PU US DEPT HEALTH HUMAN SCIENCES PUBLIC HEALTH SCIENCE
PI RES TRIANGLE PK
PA NATL INST HEALTH, NATL INST ENVIRONMENTAL HEALTH SCIENCES, PO BOX 12233,
RES TRIANGLE PK, NC 27709-2233 USA
SN 0091-6765
J9 ENVIRON HEALTH PERSP
JI Environ. Health Perspect.
PD MAR
PY 2004
VL 112
IS 4
BP 480
EP 487
DI 10.1289/txg.6694
PG 8
WC Environmental Sciences; Public, Environmental & Occupational Health;
Toxicology
SC Environmental Sciences & Ecology; Public, Environmental & Occupational
Health; Toxicology
GA 807BS
UT WOS:000220477600022
PM 15033598
ER
PT J
AU Thompson, KL
Afshari, CA
Amin, RA
Bertram, TA
Car, B
Cunningham, M
Kind, C
Kramer, JA
Lawton, M
Mirsky, M
Naciff, JM
Oreffo, V
Pine, PS
Sistare, FD
AF Thompson, KL
Afshari, CA
Amin, RA
Bertram, TA
Car, B
Cunningham, M
Kind, C
Kramer, JA
Lawton, M
Mirsky, M
Naciff, JM
Oreffo, V
Pine, PS
Sistare, FD
TI Identification of platform-independent gene expression markers of
cisplatin nephrotoxicity
SO ENVIRONMENTAL HEALTH PERSPECTIVES
LA English
DT Article
DE cisplatin; cross-platform; kidney; microarrays; nephrotoxicity
ID GLOBAL ANALYSIS; PROFILES
AB Within the International Life Sciences Institute Committee on Genomics, a working group was formed to focus on the application of microarray technology to preclinical assessments of drug-induced nephrotoxicity. As part of this effort, Sprague-Dawley rats were treated with the nephrotoxicant cisplatin at doses of 0.3-5 mg/kg over a 4- to 144-hr time course. RNA prepared from these animals was run on a variety of microarray formats at multiple sites. A set of 93 differentially expressed genes associated with cisplatin-induced renal injury was identified on the National Institute of Environmental Health Sciences (NIEHS) custom cDNA microarray platform using quadruplicate measurements of pooled animal RNA. The reproducibility of this profile of statistically significant gene changes on other platforms, in pooled and individual animal replicate samples, and in an independent study was investigated. A good correlation in response between platforms was found among the 48 genes in the NIEHS data set that could be matched to probes on the Affymetrix RGU34A array by UniGene identifier or sequence alignment. Similar results were obtained with genes that could be linked between the NIEHS and Incyte or PHASE-1 arrays. The degree of renal damage induced by cisplatin in individual animals was commensurate with the number of differentially expressed genes in this data set. These results suggest that gene profiles linked to specific types of tissue injury or mechanisms of toxicity and identified in well-performed replicated microarray experiments may be extrapolatable across platform technologies, laboratories, and in-life studies.
C1 US FDA, CDER, Div Appl Pharmacol Res, Silver Spring, MD 20993 USA.
Amgen Inc, Thousand Oaks, CA 91320 USA.
NIEHS, Dept Hlth & Human Serv, NIH, Res Triangle Pk, NC 27709 USA.
Pfizer Inc, St Louis, MO USA.
Pfizer Inc, Groton, CT 06340 USA.
Bristol Myers Squibb Co, Wilmington, DE USA.
AstraZeneca Res & Dev, Charnwood, Leics, England.
Procter & Gamble Co, Cincinnati, OH USA.
RP Thompson, KL (reprint author), US FDA, CDER, Div Appl Pharmacol Res, HFD-910,Life Sci Bldg 64,10903 New Hampshire Ave, Silver Spring, MD 20993 USA.
EM Thompsonk@cder.fda.gov
NR 19
TC 54
Z9 59
U1 0
U2 2
PU US DEPT HEALTH HUMAN SCIENCES PUBLIC HEALTH SCIENCE
PI RES TRIANGLE PK
PA NATL INST HEALTH, NATL INST ENVIRONMENTAL HEALTH SCIENCES, PO BOX 12233,
RES TRIANGLE PK, NC 27709-2233 USA
SN 0091-6765
J9 ENVIRON HEALTH PERSP
JI Environ. Health Perspect.
PD MAR
PY 2004
VL 112
IS 4
BP 488
EP 494
DI 10.1289/txg.6676
PG 7
WC Environmental Sciences; Public, Environmental & Occupational Health;
Toxicology
SC Environmental Sciences & Ecology; Public, Environmental & Occupational
Health; Toxicology
GA 807BS
UT WOS:000220477600023
PM 15033599
ER
PT J
AU Sreenivas, G
Singh, R
Selvapandiyan, A
Negi, NS
Nakhasi, HL
Salotra, P
AF Sreenivas, G
Singh, R
Selvapandiyan, A
Negi, NS
Nakhasi, HL
Salotra, P
TI Arbitrary-primed PCR for genomic fingerprinting and identification of
differentially regulated genes in Indian isolates of Leishmania donovani
SO EXPERIMENTAL PARASITOLOGY
LA English
DT Article
DE Leishmania donovani; AP-PCR; arbitrary-primed polymerase chain reaction;
genomic fingerprinting; polymorphic fragment; differentially expressed
genes
ID POLYMERASE CHAIN-REACTIONS; POLYMORPHIC DNA; AMASTIGOTES; EXPRESSION;
MEXICANA; CLONING; ELECTROPHORESIS; STRAINS; COMPLEX
AB The arbitrary-primed PCR (AP-PCR) technique was employed with the twin goals of identifying genetic polymorphisms within the Indian isolates and to identify differentially expressed gene sequences. The parasite isolates from Indian Kala-azar patients could be differentiated from Leishmania donovani isolates from distinct geographic regions. Moreover, differences within the Indian isolates could also be identified. A majority (17/19) of the Indian isolates gave identical AP-PCR pattern, while two isolates gave consistently divergent pattern. The distinctive AP-PCR fragments obtained with Indian isolates were used as probes in Northern blot analysis. Three such fragments were found to represent transcribed sequences that were differentially expressed in the two stages of the parasite. These sequences led to cloning and characterization of Leishmania Centrin gene and a novel gene termed A-1 that is over-expressed in amastigote stage of the parasite. The study demonstrates the utility of random genome sampling methods in genomic fingerprinting and in identifying differentially transcribed sequences that could potentially contribute to parasite virulence. (C) 2004 Elsevier Inc. All rights reserved.
C1 Safdarjang Hosp, ICMR, Inst Pathol, New Delhi 110029, India.
US FDA, CBER, OBRR, Div Emerging & Transfus Transmitted Dis, Bethesda, MD 20892 USA.
Safdarjang Hosp, Dept Med, New Delhi 110029, India.
RP Salotra, P (reprint author), Safdarjang Hosp, ICMR, Inst Pathol, New Delhi 110029, India.
EM salotra@vsnl.com
OI Singh, Ruchi/0000-0001-8094-4703
NR 37
TC 9
Z9 10
U1 1
U2 2
PU ACADEMIC PRESS INC ELSEVIER SCIENCE
PI SAN DIEGO
PA 525 B ST, STE 1900, SAN DIEGO, CA 92101-4495 USA
SN 0014-4894
EI 1090-2449
J9 EXP PARASITOL
JI Exp. Parasitol.
PD MAR-APR
PY 2004
VL 106
IS 3-4
BP 110
EP 118
DI 10.1016/j.exppara.2004.03.011
PG 9
WC Parasitology
SC Parasitology
GA 828SD
UT WOS:000221992300006
PM 15172218
ER
PT J
AU Smith, JS
Tian, J
Muller, J
Byrnes, AP
AF Smith, JS
Tian, J
Muller, J
Byrnes, AP
TI Unexpected pulmonary uptake of adenovirus vectors in animals with
chronic liver disease
SO GENE THERAPY
LA English
DT Article
DE adenovirus; reticuloendothelial system; biodistribution; pulmonary
intravascular macrophage; cirrhosis
ID MEDIATED GENE-TRANSFER; CIRRHOTIC RAT LIVERS; KUPFFER CELL; IN-VIVO;
INTRAVASCULAR MACROPHAGES; ALVEOLAR MACROPHAGES; LUNG UPTAKE;
OBSTRUCTIVE-JAUNDICE; RESPIRATORY-TRACT; EXPRESSION
AB When adenovirus vectors are injected intravenously, most of the virions are quickly taken up by the reticuloendothelial system, primarily by the liver macrophages known as Kupffer cells. However, little is known about the behavior of adenovirus vectors when there is pre-existing liver disease. To study this, we examined the biodistribution of intravenously injected vector in a rat model of cirrhosis induced by bile duct ligation. Using quantitative PCR and fluorescently tagged adenovirus vectors, we observed a significant reduction in vector uptake by the cirrhotic liver and increased accumulation in the lungs. Immunocytochemistry and electron microscopy demonstrated that this was due to changes in the reticuloendothelial system, with the vector being taken up by large numbers of pulmonary intravascular macrophages in the lungs of cirrhotic rats. Interestingly, expression of vector-encoded luciferase was significantly reduced in the livers of cirrhotic rats, but was not increased in the lungs. These data demonstrate that the biodistribution of adenovirus vectors in rats is altered by cirrhosis, which suggests the possibility that these vectors might behave unexpectedly in patients with pre-existing liver conditions, particularly since pulmonary reticuloendothelial changes are known to occur in human disease.
C1 FDA Ctr Biol Evaluat & Res, Div Cellular & Gene Therapies, Bethesda, MD 20892 USA.
US FDA, Ctr Biol Evaluat & Res, Div Viral Prod, Bethesda, MD USA.
RP Byrnes, AP (reprint author), FDA Ctr Biol Evaluat & Res, Div Cellular & Gene Therapies, HFM-725,8800 Rockville Pike,29B-2E20, Bethesda, MD 20892 USA.
RI Byrnes, Andrew/D-2808-2013
OI Byrnes, Andrew/0000-0003-1135-2629
NR 57
TC 35
Z9 37
U1 0
U2 1
PU NATURE PUBLISHING GROUP
PI LONDON
PA MACMILLAN BUILDING, 4 CRINAN ST, LONDON N1 9XW, ENGLAND
SN 0969-7128
J9 GENE THER
JI Gene Ther.
PD MAR
PY 2004
VL 11
IS 5
BP 431
EP 438
DI 10.1038/sj.gt.3302149
PG 8
WC Biochemistry & Molecular Biology; Biotechnology & Applied Microbiology;
Genetics & Heredity; Medicine, Research & Experimental
SC Biochemistry & Molecular Biology; Biotechnology & Applied Microbiology;
Genetics & Heredity; Research & Experimental Medicine
GA 774WE
UT WOS:000189008600002
PM 14973536
ER
PT J
AU Marti, GE
AF Marti, GE
TI Familial lymphoid neoplasms in patients with mantle cell lymphoma
SO HAEMATOLOGICA
LA English
DT Editorial Material
ID CHRONIC LYMPHOCYTIC-LEUKEMIA; B-CLL; MONOCLONAL LYMPHOCYTOSIS; RELATIVES
C1 US FDA, Div Cell Gene Therapy, Lab Med & Mol Genet, Flow & Image Cytometry Sect, Bethesda, MD 20892 USA.
RP Marti, GE (reprint author), US FDA, Div Cell Gene Therapy, Lab Med & Mol Genet, Flow & Image Cytometry Sect, Bethesda, MD 20892 USA.
NR 22
TC 1
Z9 1
U1 0
U2 0
PU FERRATA STORTI FOUNDATION
PI PAVIA
PA STRADA NUOVA 134, 27100 PAVIA, ITALY
SN 0390-6078
J9 HAEMATOLOGICA
JI Haematologica
PD MAR
PY 2004
VL 89
IS 3
BP 262
EP 263
PG 2
WC Hematology
SC Hematology
GA 801VT
UT WOS:000220124100002
PM 15020260
ER
PT J
AU Derrick, SC
Repique, C
Snoy, P
Yang, AL
Morris, S
AF Derrick, SC
Repique, C
Snoy, P
Yang, AL
Morris, S
TI Immunization with a DNA vaccine cocktail protects mice lacking CD4 cells
against an aerogenic infection with Mycobacterium tuberculosis
SO INFECTION AND IMMUNITY
LA English
DT Article
ID CD8(+) T-CELLS; TOLL-LIKE RECEPTORS; CD8-T-CELL MEMORY; CD4-T-CELL HELP;
CUTTING EDGE; RESPONSES; IMMUNITY; IMMUNOGENICITY; PROTEINS
AB Tuberculosis (TB) is the most common opportunistic disease and a potentially fatal complication among immunocompromised individuals infected with human immunodeficiency virus (HIV). Effective vaccination against TB in persons with HIV has been considered unlikely because of the central role that CD4 cells play in controlling tuberculous infections. Here we show that the vaccination of CD8(-/-) mice with a TB DNA vaccine cocktail did not significantly enhance protective responses to a Mycobacterium tuberculosis infection. In contrast, immunization with a DNA vaccine cocktail or with the current TB vaccine, Mycobacterium bovis BCG, induced considerable antituberculosis protective immunity in immune-deficient mice lacking CD4 cells. In vaccinated CD4(-/-) animals, substantially reduced bacterial burdens in organs and much improved lung pathology were seen I month after an aerogenic M. tuberculosis challenge. Importantly, the postchallenge mean times to death of vaccinated CD4(-/-) mice were significantly extended (mean with DNA cocktail, 172 +/- days; mean with BCG, 156 +/- 22 days) compared to that of naive CD4(-/-) mice (33 +/- 6 days). Furthermore, the treatment of DNA-vaccinated CD4(-/-) mice with an anti-CD8 or anti-gamma interferon (IFN-gamma) antibody significantly reduced the effect of immunization, and neither IFN-gamma(-/-) nor tumor necrosis factor receptor-deficient mice were protected by DNA immunization; therefore, the primary vaccine-induced protective mechanism in these immune-deficient mice likely involves the secretion of cytokines from activated CD8 cells. The substantial CD8-mediated protective immunity that was generated in the absence of CD4 cells suggests that it may be possible to develop effective TB vaccines for use in HIV-infected populations.
C1 US FDA, Ctr Biol Evaluat & Res, LMDCI, Bethesda, MD 20892 USA.
US FDA, Ctr Biol Evaluat & Res, Div Vet Sci, Bethesda, MD 20892 USA.
RP Morris, S (reprint author), US FDA, Ctr Biol Evaluat & Res, LMDCI, 29 Lincoln Dr, Bethesda, MD 20892 USA.
EM morris@cber.fda.gov
NR 36
TC 52
Z9 61
U1 0
U2 1
PU AMER SOC MICROBIOLOGY
PI WASHINGTON
PA 1752 N ST NW, WASHINGTON, DC 20036-2904 USA
SN 0019-9567
J9 INFECT IMMUN
JI Infect. Immun.
PD MAR
PY 2004
VL 72
IS 3
BP 1685
EP 1692
DI 10.1128/IAI.72.3.1685-1692.2004
PG 8
WC Immunology; Infectious Diseases
SC Immunology; Infectious Diseases
GA 778ZH
UT WOS:000189270800055
PM 14977976
ER
PT J
AU Yoshitomi, K
AF Yoshitomi, K
TI Alkaline phosphatase activity in cheeses measured by fluorometry
SO INTERNATIONAL JOURNAL OF FOOD SCIENCE AND TECHNOLOGY
LA English
DT Article
DE 4-methylumbelliferyl phosphate; ALP; fluorometric screening;
pasteurization
ID MILK
C1 US FDA, Pacific Reg Lab NW, Seafood Prod Res Ctr, Bothell, WA 98021 USA.
RP Yoshitomi, K (reprint author), US FDA, Pacific Reg Lab NW, Seafood Prod Res Ctr, 22201 23rd Dr SE, Bothell, WA 98021 USA.
EM ken.yoshitomi@fda.gov
NR 14
TC 11
Z9 11
U1 1
U2 5
PU BLACKWELL PUBLISHING LTD
PI OXFORD
PA 9600 GARSINGTON RD, OXFORD OX4 2DG, OXON, ENGLAND
SN 0950-5423
J9 INT J FOOD SCI TECH
JI Int. J. Food Sci. Technol.
PD MAR
PY 2004
VL 39
IS 3
BP 349
EP 353
DI 10.1111/j.1365-2621.2004.00786.x
PG 5
WC Food Science & Technology
SC Food Science & Technology
GA 774NX
UT WOS:000188990300015
ER
PT J
AU Kim, YH
Heinze, TM
Beger, R
Pothuluri, JV
Cerniglia, CE
AF Kim, YH
Heinze, TM
Beger, R
Pothuluri, JV
Cerniglia, CE
TI A kinetic study on the degradation of erythromycin A in aqueous solution
SO INTERNATIONAL JOURNAL OF PHARMACEUTICS
LA English
DT Article
DE acid-catalysis; base-catalysis; erythromycin; kinetics
ID CHROMATOGRAPHY; DECOMPOSITION; DERIVATIVES; STEREOCHEMISTRY;
ERYTHRONOLIDE; CONFORMATION; MACROLIDES; STABILITY; AGLYCONE
AB The pH is a critical factor determining the rate of the degradation of erythromycin A in aqueous solutions. However, the kinetics of the acid- and base-catalyzed degradation is still uncertain. This study used a sensitive coulometric detection method to determine concentrations of erythromycin A and its degradation products. To determine the buffer-independent rate constants, sodium acetate (0.05-0.2 M) and Tris-HCl (0.1-0.5 M) were used in a pH range of 3.5-5.5 and 7.0-9.0, respectively. In acidic conditions, anhydroerythromycin A appeared to be produced directly through an internal dehydration of erythromycin A-6,9-hemiketal which simultaneously established an equilibrium with erythromycin A enol ether on the other hand. In weakly alkaline conditions, hydroxide ion appeared to catalyze the hydrolysis of the lactonyl ester bond of erythromycin A-6,9-hemiketal by the pseudo-first-order kinetics, and the C13 --> C11 translactonization and internal dehydration reactions subsequently occurred to form pseudoerythromycin A enol ether. We suggest here a predictive model for reasonable interpretation of the kinetics of erythromycin A degradation in aqueous solutions, in which the observed rate constant was expressed by the sum of the partial reaction rate constants for the acid- and base-catalyzed degradation of erythromycin A-6,9-hemiketal as a function of pH in a range of 3.0-10.0. (C) 2003 Elsevier B.V. All rights reserved.
C1 US FDA, Natl Ctr Toxicol Res, Div Microbiol, Jefferson, AR 72079 USA.
RP Cerniglia, CE (reprint author), US FDA, Natl Ctr Toxicol Res, Div Microbiol, 3900 NCTR Rd, Jefferson, AR 72079 USA.
EM ccerniglia@nctr.fda.gov
NR 25
TC 35
Z9 37
U1 2
U2 25
PU ELSEVIER SCIENCE BV
PI AMSTERDAM
PA PO BOX 211, 1000 AE AMSTERDAM, NETHERLANDS
SN 0378-5173
J9 INT J PHARM
JI Int. J. Pharm.
PD MAR 1
PY 2004
VL 271
IS 1-2
BP 63
EP 76
DI 10.1016/j.ijpharm.2003.10.023
PG 14
WC Pharmacology & Pharmacy
SC Pharmacology & Pharmacy
GA 778NQ
UT WOS:000189248000008
PM 15129974
ER
PT J
AU Bohlke, K
Davis, RL
DeStefano, F
Marcy, SM
Braun, MM
Thompson, RS
AF Bohlke, K
Davis, RL
DeStefano, F
Marcy, SM
Braun, MM
Thompson, RS
CA Vaccine Safety Datalink Team
TI Epidemiology of anaphylaxis among children and adolescents enrolled in a
health maintenance organization
SO JOURNAL OF ALLERGY AND CLINICAL IMMUNOLOGY
LA English
DT Article
DE anaphylaxis; children; adolescents; epidemiology
ID VACCINE SAFETY DATALINK; EMERGENCY; TREND
AB Background: There is little information about the incidence of anaphylaxis from all causes.
Objective: The objects of this study were (1) to estimate the incidence of anaphylaxis; (2) to explore the range of diagnoses attributed to an anaphylactic episode; and (3) to describe the clinical features of anaphylaxis.
Methods: The study population consisted of children and adolescents enrolled at a health maintenance organization. We identified potential episodes of anaphylaxis occurring between 1991 and 1997 from automated databases and reviewed the medical record to confirm the diagnosis. We reviewed all diagnoses specific for anaphylaxis (eg, ICD-9 995.0, anaphylactic shock) and sampled from among other related diagnoses (eg, ICD-9 995.3, allergy unspecified). Estimation of the incidence of provider-diagnosed anaphylaxis was based on cases confirmed from among the specific diagnosis codes. Description of the clinical features of anaphylaxis involved all confirmed cases regardless of diagnosis.
Results: We identified 67 episodes of anaphylaxis among children with diagnosis codes specific for anaphylaxis (10.5 episodes per 100,000 person-years). There was no increase in incidence over time. Review of samples of diagnoses not specific for anaphylaxis yielded an additional 18 episodes. Among all identified episodes (n = 85), mucocutaneous and respiratory manifestations were the most common. Seventy-one percent of episodes were treated in the emergency department. Nine episodes (11%) resulted in hospitalization.
Conclusions: The incidence of anaphylaxis did not increase during these years. A majority of episodes were treated in the emergency department. Anaphylaxis in this population was frequently diagnosed as another related condition, and the basis and implications of diagnostic practices in this disorder warrant further exploration.
C1 Grp Hlth Cooperat Puget Sound, Ctr Hlth Studies, Seattle, WA 98101 USA.
Grp Hlth Cooperat Puget Sound, Dept Prevent Care, Seattle, WA 98101 USA.
US FDA, Div Epidemiol, Off Biostat & Epidemiol, Ctr Biol Evaluat & Res, Rockville, MD 20857 USA.
Kaiser Fdn Hosp, Panorama City, CA USA.
Ctr Dis Control & Prevent, Natl Immunizat Program, Atlanta, GA USA.
Univ Washington, Sch Med, Dept Epidemiol, Seattle, WA USA.
Univ Washington, Sch Med, Dept Pediat, Seattle, WA 98195 USA.
Univ Washington, Sch Publ Hlth, Seattle, WA 98195 USA.
RP Bohlke, K (reprint author), Grp Hlth Cooperat Puget Sound, Ctr Hlth Studies, 1730 Minor Ave,Suite 1600, Seattle, WA 98101 USA.
FU PHS HHS [200-0957]
NR 22
TC 162
Z9 168
U1 0
U2 2
PU MOSBY, INC
PI ST LOUIS
PA 11830 WESTLINE INDUSTRIAL DR, ST LOUIS, MO 63146-3318 USA
SN 0091-6749
J9 J ALLERGY CLIN IMMUN
JI J. Allergy Clin. Immunol.
PD MAR
PY 2004
VL 113
IS 3
BP 536
EP 542
DI 10.1016/j.jaci.2003.11.033
PG 7
WC Allergy; Immunology
SC Allergy; Immunology
GA 802DM
UT WOS:000220144200028
PM 15007358
ER
PT J
AU Letarte, S
Morency, D
Wilkes, J
Bertrand, MJ
AF Letarte, S
Morency, D
Wilkes, J
Bertrand, MJ
TI Py-MAB-Tof detection and identification of microorganisms in urine
SO JOURNAL OF ANALYTICAL AND APPLIED PYROLYSIS
LA English
DT Article
DE pyrolysis; microorganisms; bacteria; MAB; mass spectrometry; urine;
diagnostic
ID PYROLYSIS MASS-SPECTROMETRY; CHEMICAL-IONIZATION; BACTERIA;
DIFFERENTIATION; ELECTRON
AB Rapid detection and identification of bacteria and other microorganisms has become a field where new analytical methods are needed. An approach, based on the use of pyrolysis coupled to mass spectrometry (Py-MS), for the detection and identification of bacteria in urine and other aqueous samples is described. In this procedure, the sample is placed on a direct insertion probe and pyrolysis is conducted directly into the ion source of the mass spectrometer. Ionization is achieved with a metastable atom bombardment source (MAB). In contrast to electron ionization, this novel ionization source, by providing discrete ionization energies, allows selective ionization and control over fragmentation. The MAB source is coupled to a time-of-flight (Tof) mass analyzer that provides high sensitivity and fast spectral acquisition. Experiments conducted with a number of uropathogenic bacteria, such as Escherichia coli, Citrobacter freundii, Proteus mirabilis and Pseudomonas aeruginosa, reveal that they provide discernable fingerprints when analyzed in urine samples by Py-MAB-Tof. Results can be obtained in minutes and the sensitivity is such that 10(4) bacteria on the pyrolysis probe are required for analysis. (C) 2003 Published by Elsevier B.V.
C1 Univ Montreal, Dept Chem, Reg Ctr Mass Spectrometry, Montreal, PQ H3C 3J7, Canada.
Univ Montreal, Dept Microbiol & Immunol, Montreal, PQ H3C 3J7, Canada.
Natl Ctr Toxicol Res, Jefferson, AK USA.
RP Bertrand, MJ (reprint author), Univ Montreal, Dept Chem, Reg Ctr Mass Spectrometry, CP 6128, Montreal, PQ H3C 3J7, Canada.
EM michelj.bertrand@sympatico.ca
NR 18
TC 6
Z9 6
U1 2
U2 5
PU ELSEVIER SCIENCE BV
PI AMSTERDAM
PA PO BOX 211, 1000 AE AMSTERDAM, NETHERLANDS
SN 0165-2370
J9 J ANAL APPL PYROL
JI J. Anal. Appl. Pyrolysis
PD MAR
PY 2004
VL 71
IS 1
BP 13
EP 25
DI 10.1016/S0165-2370(03)00095-0
PG 13
WC Chemistry, Analytical; Spectroscopy
SC Chemistry; Spectroscopy
GA 813BE
UT WOS:000220881800002
ER
PT J
AU Shah, M
Kannamkumarath, SS
Wuilloud, JCA
Wuilloud, RG
Caruso, JA
AF Shah, M
Kannamkumarath, SS
Wuilloud, JCA
Wuilloud, RG
Caruso, JA
TI Identification and characterization of selenium species in enriched
green onion (Allium fistulosum) by HPLC-ICP-MS and ESI-ITMS
SO JOURNAL OF ANALYTICAL ATOMIC SPECTROMETRY
LA English
DT Article
ID PERFORMANCE LIQUID-CHROMATOGRAPHY; MASS-SPECTROMETRIC DETECTION; CANCER
PREVENTION; SUPPLEMENTS; SPECIATION; ACID; YEAST
AB In this study speciation of selenium in selenium-enriched green onions (Allium fistulosum) was done with reversed-phase ion-pairing high performance liquid chromatography (RP-IP-HPLC) and size-exclusion chromatography (SEC) coupled on-line to ICP-MS for selenium specific detection. The plant extract obtained using sodium hydroxide (0.1 mol l(-1)) analyzed by SEC (CAPS 10 mmol l(-1), pH 10.0) with ICP-MS detection showed the incorporation of selenium in both high (similar to 12 kDa) and low molecular weight (0.36-2 kDa) fractions. Presumably protein bound selenoamino acids were released using enzymes (Proteinase K and Protease XIV) and selenoamino acids found in cytosol in their free form were extracted using 0.1 M HCl. The extracts were analyzed for speciation studies by RP-IP-HPLC [0.1% (v/v) heptafluorobutyric acid, 5% (v/v) methanol, pH 2.5]. Matching the chromatographic retention times with commercially available standards provided evidence for the presence of Se-cystine, methylselenocysteine, Se-methionine, and inorganic selenium. Electrospray ionization ion trap mass spectrometry (ESI-ITMS) confirmed the presence Of gamma-glutamyl-Semethylselenocysteine in green onions as has been reported in other onion types.
C1 Univ Cincinnati, Dept Chem, Cincinnati, OH 45221 USA.
US FDA, Forens Chem Ctr, Cincinnati, OH 45237 USA.
RP Caruso, JA (reprint author), Univ Cincinnati, Dept Chem, Cincinnati, OH 45221 USA.
EM joseph.caruso@uc.edu
RI Wuilloud, Rodolfo/N-6821-2014
OI Wuilloud, Rodolfo/0000-0002-2962-7718
NR 16
TC 65
Z9 68
U1 1
U2 17
PU ROYAL SOC CHEMISTRY
PI CAMBRIDGE
PA THOMAS GRAHAM HOUSE, SCIENCE PARK, MILTON RD, CAMBRIDGE CB4 0WF, CAMBS,
ENGLAND
SN 0267-9477
J9 J ANAL ATOM SPECTROM
JI J. Anal. At. Spectrom.
PD MAR
PY 2004
VL 19
IS 3
BP 381
EP 386
DI 10.1039/b312320k
PG 6
WC Chemistry, Analytical; Spectroscopy
SC Chemistry; Spectroscopy
GA 808AS
UT WOS:000220542600007
ER
PT J
AU Trucksess, MW
Brewer, VA
Williams, KM
Westphal, CD
Heeres, JT
AF Trucksess, MW
Brewer, VA
Williams, KM
Westphal, CD
Heeres, JT
TI Preparation of peanut butter suspension for determination of peanuts
using enzyme-linked immunoassay kits
SO JOURNAL OF AOAC INTERNATIONAL
LA English
DT Article
ID ALLERGY
AB Peanuts are one of the 8 most common allergenic foods and a large proportion of peanut-allergic individuals have severe reactions, some to minimal exposure. Specific protein constituents in the peanuts are the cause of the allergic reactions in sensitized individuals who ingest the peanuts. To avoid accidental ingestion of peanut-contaminated food, methods of analysis for the determination of the allergenic proteins in foods are important tools. Such methods could help identify foods inadvertently contaminated with peanuts, thereby reducing the incidence of allergic reactions to peanuts. Commercial immunoassay kits are available but need study for method performance, which requires reference materials for within- and between-laboratory validations. In this study, National Institute of Standards and Technology Standard Reference Material 2387 peanut butter was used. A polytron homogenizer was used to prepare a homogenous aqueous Peanut Butter suspension for the evaluation of method performance of some commercially available immunoassay kits such as Veratox for Peanut Allergen Test (Neogen Corp.), Ridascreen Peanut (R-Biopharm GmbH), and Bio-Kit Peanut Protein Assay Kit (Tepnel). Each gram of the aqueous peanut butter suspension contained 20 mg carboxymethylcellulose sodium salt, 643 mug peanut, 0.5 mg thimerosal, and 2.5 mg bovine serum albumin. The suspension was homogenous, stable, reproducible, and applicable for adding to ice cream, cookies, breakfast cereals, and chocolate for recovery studies at spike levels ranging from 12 to 90 mug/g.
C1 US FDA, Ctr Food Safety & Appl Nutr, College Pk, MD 20740 USA.
Univ Maryland, Joint Inst Food Safety & Appl Nutr, College Pk, MD 20740 USA.
RP Trucksess, MW (reprint author), US FDA, Ctr Food Safety & Appl Nutr, 5100 Paint Branch Pkwy, College Pk, MD 20740 USA.
EM mary.trucksess@cfsan.fda.gov
NR 7
TC 11
Z9 12
U1 0
U2 2
PU AOAC INTERNATIONAL
PI GAITHERSBURG
PA 481 NORTH FREDRICK AVE, STE 500, GAITHERSBURG, MD 20877-2504 USA
SN 1060-3271
J9 J AOAC INT
JI J. AOAC Int.
PD MAR-APR
PY 2004
VL 87
IS 2
BP 424
EP 428
PG 5
WC Chemistry, Analytical; Food Science & Technology
SC Chemistry; Food Science & Technology
GA 818DK
UT WOS:000221225600016
PM 15164837
ER
PT J
AU Mossoba, MM
Yurawecz, MP
Delmonte, P
Kramer, JKG
AF Mossoba, MM
Yurawecz, MP
Delmonte, P
Kramer, JKG
TI Overview of infrared methodologies for trans fat determination
SO JOURNAL OF AOAC INTERNATIONAL
LA English
DT Article
ID RAPID-DETERMINATION; VEGETABLE-OILS; METHYL-ESTERS; LINOLEIC-ACID;
DOUBLE-BONDS; HUMAN-MILK; SPECTROSCOPY; ISOMERS; SPECTROPHOTOMETRY;
CHROMATOGRAPHY
AB trans Fatty acids are present in a variety of foods like dairy products, but the major sources are products that contain commercially hydrogenated fats. Some studies have shown that trans fatty acids elevate levels of serum low-density lipoprotein (LDL)-cholesterol and lower high-density lipoprotein (HDL)-cholesterol. The quantitation and identification of trans fatty acid isomers is difficult because of the wide range of positional monoene, diene, and triene fatty acid isomers present in hydrogenated oils. This is complicated by the cis positional isomers that are also present, as well as the lack of commercial chromatographic standards for many fatty acid isomers. In this review, infrared methodologies for the determination of total trans fat are presented. Using an attenuated total reflection (ATR) infrared cell, a novel Fourier transform infrared (FTIR) spectroscopic method that was developed for the rapid (5 min) quantitation of the total trans fatty acid levels in neat (without solvent) fats and oils measured as triacylglycerols (TAG) Is discussed. TAG required no derivatization, but had to be melted prior to measurement. The lower limit of trans quantitation was 5% of total fat. The precision of this ATR method was found to be superior to that of transmission infrared official methods. Accuracy was enhanced by generating a symmetric absorption trans infrared band at 966 cm(-1) on a horizontal background. This was achieved by "ratioing" the single-beam spectrum of the trans-containing fat or oil against that of a reference oil or standard having only cis double bonds. Attempts to apply this ATR-FTIR method to food matrixes with low trans fat and/or low total fat content were not satisfactory due to interfering infrared absorptions in the trans region. To overcome this interference, the method was modified by applying the standard addition technique to the ATR-FTIR determination. The modified procedure required more time, but eliminated any adverse impact on accuracy arising from interfering minor food components having absorption bands near 966 cm(-1).
C1 US FDA, Ctr Food Safety & Appl Nutr, Off Sci Anal & Support, College Pk, MD 20740 USA.
US FDA, Ctr Food Safety & Appl Nutr, Off Nutr Prod Labeling & Dietary Supplements, College Pk, MD 20740 USA.
Agr & Agri Food Canada, Food Res Program, Guelph, ON, Canada.
RP Mossoba, MM (reprint author), US FDA, Ctr Food Safety & Appl Nutr, Off Sci Anal & Support, HFS 717,BE-012,5100 Paint Branch Pkwy, College Pk, MD 20740 USA.
EM mmossoba@cfsan.fda.gov
NR 36
TC 25
Z9 25
U1 1
U2 13
PU AOAC INT
PI GAITHERSBURG
PA 481 N FREDRICK AVE, STE 500, GAITHERSBURG, MD 20877-2504 USA
SN 1060-3271
J9 J AOAC INT
JI J. AOAC Int.
PD MAR-APR
PY 2004
VL 87
IS 2
BP 540
EP 544
PG 5
WC Chemistry, Analytical; Food Science & Technology
SC Chemistry; Food Science & Technology
GA 818DK
UT WOS:000221225600031
PM 15164852
ER
PT J
AU Cruz-Hernandez, C
Deng, ZY
Zhou, JQ
Hill, AR
Yurawecz, MP
Delmonte, P
Mossoba, MM
Dugan, MER
Kramer, JKG
AF Cruz-Hernandez, C
Deng, ZY
Zhou, JQ
Hill, AR
Yurawecz, MP
Delmonte, P
Mossoba, MM
Dugan, MER
Kramer, JKG
TI Methods for analysis of conjugated linoleic acids and trans-18 : 1
isomers in dairy fats by using a combination of gas chromatography,
silver-ion thin-layer chromatography/gas chromatography, and silver-ion
liquid chromatography
SO JOURNAL OF AOAC INTERNATIONAL
LA English
DT Review
ID HUMAN-MILK LIPIDS; COWS FED CANOLA; OCTADECENOIC ACIDS; VACCENIC ACID;
CLA ISOMERS; POSITIONAL ISOMERS; ADIPOSE-TISSUE; METHYL-ESTERS; RUMENIC
ACID; BOVINE-MILK
AB Conjugated linoleic acids (CLA) are octadecadienoic acids (18:2) that have a conjugated double-bond system. Interest in these compounds has expanded since CLA were found to be associated with a number of physiological and pathological responses such as cancer, metastases, atherosclerosis, diabetes, immunity, and body fat/protein composition. The main sources of these conjugated fatty acids are dairy fats. Rumen bacteria convert polyunsaturated fatty acids, especially linoleic and linolenic acids, to CLA and numerous trans-containing mono- and diunsaturated fatty acids. It has been established that an additional route of CLA synthesis in ruminants and monogastric animals, including humans, occurs via Delta9 desaturation of the trans-18:1 isomers. To date, a total of 6 positional CLA isomers have been found in dairy fats, each occurring in 4 geometric forms (cis,trans; trans,cis; cis,cis; and trans,trans) for a total of 24. All of these CLA isomers can be resolved only by a combination of gas chromatography (GC), using 100 m highly polar capillary columns, and silver-ion liquid chromatography, using 3 of these 25 cm columns in series. Complete analysis of all the trans-18:1 isomers requires prior isolation of trans monoenes by silver-ion thin-layer chromatography (TLC), followed by GC analysis using the same 100 m capillary columns operated at low temperatures starting from 120degreesC. These analytical techniques are required to assess the purity of commercial CLA preparations, because their purity will affect the interpretation of any physiological and/or biochemical response obtained. Prior assessment of CLA preparations by TLC is also recommended to determine the presence of any other impurities. The availability of pure CLA isomers will permit the evaluation and analysis of individual CLA isomers for their nutritional and biological activity in model systems, animals, and humans. These techniques are also essential to evaluate dairy fats for their content of specific CLA isomers and to help design experimental diets to increase the level of the desired CLA isomers in dairy fats. These improved techniques are further required to evaluate the CLA profile in monogastric animals fed commercial CLA preparations for CLA enrichment of animal products. This is particularly important because absorption and metabolism will alter the ingested-CLA profile in the animal fed.
C1 Agr & Agri Food Canada, Food Res Program, Guelph, ON, Canada.
Univ Guelph, Dept Food Sci, Guelph, ON N1G 2W1, Canada.
Univ Nanching, Dept Food Sci, Nanchang, Peoples R China.
US FDA, College Pk, MD USA.
Agr & Agri Food Canada, Lacombe Res Ctr, Lacombe, AB, Canada.
RP Kramer, JKG (reprint author), Agr & Agri Food Canada, Food Res Program, 93 Stone Rd W, Guelph, ON, Canada.
EM kramej@agr.gc.ca
OI deng, zeyuan/0000-0001-5650-1507
NR 142
TC 190
Z9 199
U1 5
U2 47
PU AOAC INTERNATIONAL
PI GAITHERSBURG
PA 481 NORTH FREDRICK AVE, STE 500, GAITHERSBURG, MD 20877-2504 USA
SN 1060-3271
J9 J AOAC INT
JI J. AOAC Int.
PD MAR-APR
PY 2004
VL 87
IS 2
BP 545
EP 562
PG 18
WC Chemistry, Analytical; Food Science & Technology
SC Chemistry; Food Science & Technology
GA 818DK
UT WOS:000221225600032
PM 15164853
ER
PT J
AU Delmonte, P
Yurawecz, MP
Mossoba, MM
Cruz-Hernandez, C
Kramer, JKG
AF Delmonte, P
Yurawecz, MP
Mossoba, MM
Cruz-Hernandez, C
Kramer, JKG
TI Improved identification of conjugated linoleic acid isomers using
silver-ion HPLC separations
SO JOURNAL OF AOAC INTERNATIONAL
LA English
DT Article
ID PERFORMANCE LIQUID-CHROMATOGRAPHY; FATTY-ACIDS; DERIVATIVES; CLA
AB Silver-ion high-performance liquid chromatography (Ag+-HPLC) has been shown to be effective in the resolution of most of the isomers of conjugated octadecadienoic acids (18:2), also, known as conjugated linoleic acid (CLA). The CLA isomers identified in natural fats from ruminants; are a mixture of numerous positional and geometric isomers from 7,9- to 12,14-18:2. Ag+-HPLC separates both geometric (trans,trans < cis/trans < cis,cis) and positional CLA isomers using the mobile phase hexane/acetonitrile (99.9:0.1). The elution volumes for the CLA isomers were not only affected by the concentration of acetonitrile (in the prepared mobile phase) but also with successive runs during the day using a prepared mobile phase batch, due to the partial solubility of acetonitrile in hexane. However, this drift does not affect the relative resolution of the CLA isomers. The addition of diethyl ether to the mobile phase partly stabilizes the solvent mixture. In order to facilitate the interpretation of Ag-+HPLC chromatograms, the relative retention volumes (RRV) were calculated for each CLA isomer. Toluene was added to all the test portions and served as an estimator of dead volume, whereas the elution of the ubiquitous 9c,11t-CLA isomer was chosen as unity (1.00). Expressing the elution of all the CLA isomers as their RRV greatly helped to standardize each CLA isomer, resulting in relatively small coefficients of variation (% CV) for the trans,trans (<1.5%) and cis/trans (<0.5%) CLA isomers. The identification of the CLA isomers was further facilitated by synthesis of authentic CLA isomers. All the geometric CLA fatty acid methyl esters (FAME) from positions 6,8- to 13,15-CLA were commercially available or synthesized by a combination of partial hydrazine reduction of known polyunsaturated fatty acids followed by alkali isomerization, isolation of products, and further iodine-catalyzed geometric isomerization. Based on expressing the elution volume as RRV and the availability of the synthetic CLA isomers, a unique reversal of the elution order of the c/t CLA isomers was found. It is also proposed that the retention times of CLA isomers by gas chromatography (GC) should be expressed as their relative retention times (RRT) relative to methyl gamma-linoleneate. The availability of CLA reference materials and the application of RRV and RRT to Ag+-HPLC and GC separations, respectively, will greatly improve in the identifications of CLA isomers.
C1 US FDA, Ctr Food Safety & Appl Nutr, College Pk, MD 20740 USA.
Agr & Agri Food Canada, Food Res Program, Guelph, ON, Canada.
RP Yurawecz, MP (reprint author), US FDA, Ctr Food Safety & Appl Nutr, 5100 Paint Branch Pkwy, College Pk, MD 20740 USA.
EM mpy@cfsan.fda.gov
NR 16
TC 17
Z9 17
U1 1
U2 9
PU AOAC INTERNATIONAL
PI GAITHERSBURG
PA 481 NORTH FREDRICK AVE, STE 500, GAITHERSBURG, MD 20877-2504 USA
SN 1060-3271
J9 J AOAC INT
JI J. AOAC Int.
PD MAR-APR
PY 2004
VL 87
IS 2
BP 563
EP 568
PG 6
WC Chemistry, Analytical; Food Science & Technology
SC Chemistry; Food Science & Technology
GA 818DK
UT WOS:000221225600033
PM 15164854
ER
PT J
AU Baldwin, AL
Wiley, EB
Alayash, AI
AF Baldwin, AL
Wiley, EB
Alayash, AI
TI Differential effects of sodium selenite in reducing tissue damage caused
by three hemoglobin-based oxygen carriers
SO JOURNAL OF APPLIED PHYSIOLOGY
LA English
DT Article
DE rat mesentery; mast cell degranulation; intestinal mucosal epithelium
ID CROSS-LINKED HEMOGLOBIN; GLUTATHIONE-PEROXIDASE ACTIVITY; BLOOD
SUBSTITUTES; INTESTINAL-MUCOSA; LIPID-PEROXIDATION; RAT MESENTERY;
IN-VIVO; SITE; METHEMOGLOBIN; OXIDATION
AB Three "blood substitutes," a diaspirin crosslinked human hemoglobin (DBBF-Hb), a bovine polymerized hemoglobin (PolyHbBv), and a human polymerized hemoglobin (O-R-PolyHbA(0)), that have undergone clinical trials are used in this study. Previously, we showed in the rat that coadministration of sodium selenite (Na2SeO3) and DBBF-Hb significantly decreased mesenteric venular leakage and epithelial disruption produced by DBBF-Hb alone but did not reduce mast cell degranulation unless given orally. The purpose of this study was to determine whether Na2SeO3 produced similar beneficial responses when used with PolyHbBv and O-R-PolyHbA(0). In anesthetized Sprague-Dawley rats, the mesenteric microvasculature was perfused with PolyHbBv or O-R-PolyHbA(0), with and without Na2SeO3 in the perfusate and suffusate, for 10 min, followed by FITC-albumin for 3 min, and then fixed for microscopy. Na2SeO3 did not reduce leak number or area in preparations perfused with PolyHbBv and only reduced leak number (but not significantly) in preparations perfused with O-R-PolyHbA(0). Na2SeO3 significantly increased mesenteric mast cell degranulation and impaired epithelial integrity in animals treated with PolyHbBv. In vitro, Na2SeO3 significantly reduced the oxidation rate of DBBF-Hb in the presence of oxidants, had little effect on PolyHbBv, and increased the oxidation rate of O-R-PolyHbA(0). These results suggest that Na2SeO3 moderates hemoglobin-induced damage, at least partly, through its redox interactions with the heme sites in the hemoglobin molecules studied and that accessibility of the heme site to Na2SeO3 governs those interactions.
C1 Univ Arizona, Coll Med, Dept Physiol, Tucson, AZ 85724 USA.
US FDA, Lab Biochem & Vasc Biol, Div Hematol, Ctr Biol Evaluat & Res, Bethesda, MD 20892 USA.
RP Baldwin, AL (reprint author), Univ Arizona, Coll Med, Dept Physiol, Tucson, AZ 85724 USA.
EM abaldwin@u.arizona.edu
FU NHLBI NIH HHS [HL-53047]
NR 37
TC 12
Z9 13
U1 1
U2 3
PU AMER PHYSIOLOGICAL SOC
PI BETHESDA
PA 9650 ROCKVILLE PIKE, BETHESDA, MD 20814 USA
SN 8750-7587
J9 J APPL PHYSIOL
JI J. Appl. Physiol.
PD MAR 1
PY 2004
VL 96
IS 3
BP 893
EP 903
DI 10.1152/japplphysiol.00615.2003
PG 11
WC Physiology; Sport Sciences
SC Physiology; Sport Sciences
GA 771AM
UT WOS:000188763400010
PM 14555684
ER
PT J
AU Buzatu, DA
Nguyen, FT
Reddy, SN
Darsey, JA
AF Buzatu, Dan A.
Nguyen, Freddy T.
Reddy, Shreedhar N.
Darsey, Jerry A.
TI Computational Analysis of Transition Metal Doped Nanotubes and Their
Application to Molecular Electronics
SO JOURNAL OF COMPUTATIONAL AND THEORETICAL NANOSCIENCE
LA English
DT Article
DE Metal Doped Nanotubes; Molecular Electronics; DFT-SCF Calculations;
Nanotube Transistor; Nanowires; Nanocircuits
AB We have previously proposed molecular circuits designed from polyaniline polymer strands, polyacetylene polymer strands and charge transfer salts acting as transistors. Due to unique properties that are demonstrated in this manuscript, we propose the use of carbon single wall nanotubes and transition metal endohedrally doped single wall carbon nanotubes (SWNTs) for utilization in molecular electronics. Different transition metals were used in a systematic fashion to manipulate the molecular orbital energy gap (HOMO-LUMO gap) of metallic (C(h) = (n = m)) nanotubes. Gradient corrected, Density Functional Theory (DFT) Self Consistent Field (SCF) calculations were used to calculate molecular orbital energy levels, HOMO-LUMO gaps, electron affinities, ionization energies and other electronic properties for these molecules. The effect that a SWNTs length has on its HOMO-LUMO gap was investigated. DFT-SCF calculations were also used to demonstrate how multiple metal filled nanotubes could be used to construct a molecular nanotube based transistor.
C1 [Reddy, Shreedhar N.; Darsey, Jerry A.] Univ Arkansas, Dept Chem, Little Rock, AR 72204 USA.
[Buzatu, Dan A.] Natl Ctr Toxicol Res, Div Chem, Jefferson, AR 72079 USA.
[Nguyen, Freddy T.] MIT, George R Harrison Spect Lab, Cambridge, MA 02139 USA.
RP Darsey, JA (reprint author), Univ Arkansas, Dept Chem, 2801 S Univ Ave, Little Rock, AR 72204 USA.
RI Nguyen, Freddy/A-2541-2008
OI Nguyen, Freddy/0000-0003-0106-8114
NR 17
TC 2
Z9 2
U1 0
U2 2
PU AMER SCIENTIFIC PUBLISHERS
PI STEVENSON RANCH
PA 25650 NORTH LEWIS WAY, STEVENSON RANCH, CA 91381-1439 USA
SN 1546-1955
J9 J COMPUT THEOR NANOS
JI J. Comput. Theor. Nanosci.
PD MAR
PY 2004
VL 1
IS 1
BP 99
EP 105
DI 10.1166/jctn.2004.012
PG 7
WC Chemistry, Multidisciplinary; Nanoscience & Nanotechnology; Materials
Science, Multidisciplinary; Physics, Applied; Physics, Condensed Matter
SC Chemistry; Science & Technology - Other Topics; Materials Science;
Physics
GA V03TK
UT WOS:000207012900012
ER
PT J
AU Borucinska, JD
Harshbarger, JC
Reimschuessel, R
Bogicevic, T
AF Borucinska, JD
Harshbarger, JC
Reimschuessel, R
Bogicevic, T
TI Gingival neoplasms in a captive sand tiger shark, Carcharias taurus
(Rafinesque), and a wild-caught blue shark, Prionace glauca (L.)
SO JOURNAL OF FISH DISEASES
LA English
DT Article
DE elasmobranchs; epulis; neoplasia; oral tumours; sharks
ID PAPILLOMA; FISH
C1 Univ Hartford, Dept Biol, Hartford, CT 06117 USA.
George Washington Univ, Med Ctr, Dept Pathol, Washington, DC 20037 USA.
US FDA, Res Off, Laurel, MD USA.
RP Borucinska, JD (reprint author), Univ Hartford, Dept Biol, 200 Bloomfield Ave, Hartford, CT 06117 USA.
EM borucinsk@hartford.edu
NR 37
TC 10
Z9 10
U1 0
U2 7
PU BLACKWELL PUBLISHING LTD
PI OXFORD
PA 9600 GARSINGTON RD, OXFORD OX4 2DG, OXON, ENGLAND
SN 0140-7775
J9 J FISH DIS
JI J. Fish Dis.
PD MAR
PY 2004
VL 27
IS 3
BP 185
EP 191
DI 10.1111/j.1365-2761.2004.00532.x
PG 7
WC Fisheries; Marine & Freshwater Biology; Veterinary Sciences
SC Fisheries; Marine & Freshwater Biology; Veterinary Sciences
GA 801AN
UT WOS:000220068900009
PM 15009246
ER
PT J
AU Jones, RC
Gerber, SI
Diaz, PS
Williams, LL
Dennis, SB
Parish, ES
Paul, WS
AF Jones, RC
Gerber, SI
Diaz, PS
Williams, LL
Dennis, SB
Parish, ES
Paul, WS
TI Intensive investigation of bacterial foodborne disease outbreaks:
Proposed guidelines and tools for the collection of dose-response data
by local health departments
SO JOURNAL OF FOOD PROTECTION
LA English
DT Article; Proceedings Paper
CT 38th Annual Meeting of the Infectious-Diseases-Society-of-America
CY SEP 06-11, 2000
CL NEW ORLEANS, LOUISIANA
SP Infect Dis Soc Amer
ID LISTERIA-MONOCYTOGENES; SALMONELLA-ENTERITIDIS; INCUBATION PERIOD;
RISK-ASSESSMENT; CHEDDAR CHEESE; MILK; FOOD; SEVERITY
AB Local health departments that investigate foodborne disease outbreaks do not have adequate guidelines for collecting data that could be used to estimate dose-response relationships, a key component of hazard characterization in quantitative microbial risk assessment. To meet this need, criteria and a questionnaire template for the collection of appropriate dose-response data in the context of outbreaks were developed and applied in the investigation of a point-source outbreak linked to Salmonella serotype Enteritidis in a salmon entree in February 2000. In this outbreak, the attack rate and risk of hospitalization increased with the amount of salmon entree consumed, and detailed data were obtained on illness severity measures and host susceptibility factors. Local health departments might consider broadening investigations to include the collection of additional data when investigating outbreaks that have met a specific set of conditions. These data could provide information needed by federal regulatory agencies and other organizations for quantitative microbial risk assessment. Intensive investigations of outbreaks could prevent future illnesses by providing information needed to develop approaches to minimizing risk.
C1 Chicago Dept Publ Hlth, Chicago, IL 60612 USA.
Illinois Dept Publ Hlth, Chicago, IL 60612 USA.
US FDA, Ctr Food Safety & Appl Nutr, College Pk, MD 20740 USA.
RP Jones, RC (reprint author), Chicago Dept Publ Hlth, 2160 W Ogden Ave, Chicago, IL 60612 USA.
EM Jones_Roderick@cdph.org
NR 30
TC 8
Z9 8
U1 0
U2 1
PU INT ASSOC FOOD PROTECTION
PI DES MOINES
PA 6200 AURORA AVE SUITE 200W, DES MOINES, IA 50322-2863 USA
SN 0362-028X
J9 J FOOD PROTECT
JI J. Food Prot.
PD MAR
PY 2004
VL 67
IS 3
BP 616
EP 623
PG 8
WC Biotechnology & Applied Microbiology; Food Science & Technology
SC Biotechnology & Applied Microbiology; Food Science & Technology
GA 801DS
UT WOS:000220077200032
PM 15035384
ER
PT J
AU Zink, DL
AF Zink, DL
TI Agroterrorism: Issues of reality
SO JOURNAL OF FOOD SCIENCE
LA English
DT Article; Proceedings Paper
CT Conference on Agroterrorism held in Conjunction with the 12th World
Congress of Food Science and Technology
CY JUL 16-20, 2003
CL Inst Food Technol, Chicago, IL
SP Int Union Food Sci & Technol
HO Inst Food Technol
AB In the past, deliberate contamination of foods in the U.S. has been committed by individual criminals, disgruntled employees, or political activists with a narrow agenda. After September 11, 2001, every nation has had to consider a much wider range of food security issues. Food is a global commodity and nearly every country both exports and imports foods. Every nation must consider the security of its domestic production and look beyond its borders to its trading partners to assure the safety of its food supply. In the nearly 2 years since September 11, 2001, many steps have been taken to improve food security. New legislation has been enacted to strengthen the ability of government to respond to terrorist threats. New relationships have been forged between food security agencies, law enforcement, and the intelligence community. Virtually every segment of the domestic and. imported food supply has come under scrutiny in an effort to identify points of weakness and appropriate protective measures. Gaps in our knowledge about specific agents and food processes have been identified and research to fill these gaps has been initiated. This effort will continue for the foreseeable future and could have a wide range of benefits, including improvements to food safety, a reduction in product counterfeiting, and a reduction in the "gray market" food trade. The scale and diversity of the U.S. food supply makes it an attractive target, but at the same time makes it very resilient and responsive to emerging threats.
C1 US FDA, CFSAN OPDFB, College Pk, MD USA.
RP Zink, DL (reprint author), US FDA, CFSAN OPDFB, College Pk, MD USA.
NR 0
TC 0
Z9 0
U1 0
U2 2
PU INST FOOD TECHNOLOGISTS
PI CHICAGO
PA 525 WEST VAN BUREN, STE 1000, CHICAGO, IL 60607-3814 USA
SN 0022-1147
J9 J FOOD SCI
JI J. Food Sci.
PD MAR
PY 2004
VL 69
IS 2
BP R47
EP R47
PG 1
WC Food Science & Technology
SC Food Science & Technology
GA 848TE
UT WOS:000223489200008
ER
PT J
AU Weinberg, WC
Yamashita, T
Tokino, T
Young, M
Ponnamperuma, R
King, K
AF Weinberg, WC
Yamashita, T
Tokino, T
Young, M
Ponnamperuma, R
King, K
TI Delta Np63 isotypes differentially regulate keratinocyte proliferation
and differentiation
SO JOURNAL OF INVESTIGATIVE DERMATOLOGY
LA English
DT Meeting Abstract
CT 65th Annual Meeting of the Society-for-Investigative-Dermatology
CY APR 28-MAY 01, 2004
CL Providence, RI
SP Soc Investigat Dermatol
C1 OBP FDA, Immunobiol Lab, Bethesda, MD USA.
Sapporo Med Univ, Sapporo, Hokkaido, Japan.
NIDCR, NIH, Bethesda, MD USA.
RI Weinberg, Wendy/A-8920-2009
NR 0
TC 0
Z9 0
U1 0
U2 2
PU BLACKWELL PUBLISHING INC
PI MALDEN
PA 350 MAIN ST, MALDEN, MA 02148 USA
SN 0022-202X
J9 J INVEST DERMATOL
JI J. Invest. Dermatol.
PD MAR
PY 2004
VL 122
IS 3
MA 134
BP A23
EP A23
PG 1
WC Dermatology
SC Dermatology
GA 809UB
UT WOS:000220660500189
ER
PT J
AU Petricoin, E
Wulfkuhle, J
Espina, V
Liotta, LA
AF Petricoin, E
Wulfkuhle, J
Espina, V
Liotta, LA
TI Clinical proteomics: Revolutionizing disease detection and patient
tailoring therapy
SO JOURNAL OF PROTEOME RESEARCH
LA English
DT Review
DE proteomics; pharmacoproteomics; patterns; mass spectrometry; protein
microarrays
ID PROTEIN IDENTIFICATION TECHNOLOGY; TYROSINE KINASE INHIBITOR;
IMMOBILIZED PH GRADIENTS; OVARIAN-CANCER; MASS-SPECTROMETRY;
PROSTATE-CANCER; BREAST-CANCER; 2-DIMENSIONAL ELECTROPHORESIS;
TRASTUZUMAB HERCEPTIN; MYELOID-LEUKEMIA
AB The evolving discipline of Clinical Proteomics is more than simply describing and enumerating the systematic changes in the protein constituency of a cell, or just generating lists of proteins that increase or decrease in expression as a cause or consequence of disease. Clinical applications of proteomics involve the use of proteomic technologies at the bedside with the ultimate goal to characterize the information flow through the intra- and extracellular molecular protein networks that interconnect organ and circulatory systems together. These networks are both new targets for therapeutics themselves as well as underpin the dynamic changes that give rise to cascades of new diagnostic biomarkers. The analysis of human cancer can be used as a model for how clinical proteomics is having an impact at the bedside for early detection, rational therapeutic targeting, and patient-tailored therapy.
C1 US FDA, NCI FDA Clin Proteom Program, Off Cell & Gene Therapy, Ctr Biol Evaluat & Res, Bethesda, MD 20892 USA.
NCI, NCI FDA Clin Proteom Program, Pathol Lab, Ctr Canc Res,NIH, Bethesda, MD 20892 USA.
RP Petricoin, E (reprint author), US FDA, NCI FDA Clin Proteom Program, Off Cell & Gene Therapy, Ctr Biol Evaluat & Res, Bldg 29A-2D12,8800 Rockville Pike, Bethesda, MD 20892 USA.
EM petricoin@cber.fda.gov; liottal@mail.nih.gov
OI Espina, Virginia/0000-0001-5080-5972
NR 82
TC 68
Z9 76
U1 0
U2 3
PU AMER CHEMICAL SOC
PI WASHINGTON
PA 1155 16TH ST, NW, WASHINGTON, DC 20036 USA
SN 1535-3893
J9 J PROTEOME RES
JI J. Proteome Res.
PD MAR-APR
PY 2004
VL 3
IS 2
BP 209
EP 217
DI 10.1021/pr049972m
PG 9
WC Biochemical Research Methods
SC Biochemistry & Molecular Biology
GA 812IK
UT WOS:000220833000006
PM 15113096
ER
PT J
AU Shvartsburg, AA
Jones, RC
AF Shvartsburg, AA
Jones, RC
TI Attachment of metal trications to peptides
SO JOURNAL OF THE AMERICAN SOCIETY FOR MASS SPECTROMETRY
LA English
DT Article
ID IONIZATION MASS-SPECTROMETRY; GAS-PHASE; ELECTROSPRAY-IONIZATION;
ARGENTINATED PEPTIDES; COMPLEXES; IONS; COORDINATION; DISSOCIATION;
ACETONITRILE; CHEMISTRY
AB Gas-phase complexes of triply charged metal ions with peptides may be readily produced using electrospray ionization, including for small peptides such as bradykinin and peptides with no basic residues such as insulin chain A. Attachment without charge-reduction is demonstrated for all trications studied: La3+, Al3+, Ga3+, Fe3+, V3+, and Cr3+. The intensities of adducts are often comparable to, or even exceed, those of protonated analogs in any charge state. (C) 2004 American Society for Mass Spectrometry.
C1 Natl Ctr Toxicol Res, Div Chem, Jefferson, AR USA.
RP Shvartsburg, AA (reprint author), Pacific NW Natl Lab, MSIN K8-98,3335 Q Ave, Richland, WA 99352 USA.
EM alexandre.shvartsburg@pnl.gov
NR 30
TC 16
Z9 16
U1 1
U2 2
PU ELSEVIER SCIENCE INC
PI NEW YORK
PA 360 PARK AVE SOUTH, NEW YORK, NY 10010-1710 USA
SN 1044-0305
J9 J AM SOC MASS SPECTR
JI J. Am. Soc. Mass Spectrom.
PD MAR
PY 2004
VL 15
IS 3
BP 406
EP 408
DI 10.1016/j.jasms.2003.11.005
PG 3
WC Chemistry, Analytical; Chemistry, Physical; Spectroscopy
SC Chemistry; Spectroscopy
GA 800JB
UT WOS:000220023500014
PM 14998543
ER
PT J
AU Foreman, JH
Constable, PD
Waggoner, AL
Levy, M
Eppley, RM
Smith, GW
Tumbleson, ME
Haschek, WM
AF Foreman, JH
Constable, PD
Waggoner, AL
Levy, M
Eppley, RM
Smith, GW
Tumbleson, ME
Haschek, WM
TI Neurologic abnormalities and cerebrospinal fluid changes in horses
administered fumonisin B-1 intravenously
SO JOURNAL OF VETERINARY INTERNAL MEDICINE
LA English
DT Article
DE cerebrospinal fluid; equine leukoencephalomalacia; Fusarium; moldy corn
poisoning; mycotoxin
ID EQUINE LEUKOENCEPHALOMALACIA; FUSARIUM-MONILIFORME; CONSCIOUS HORSES;
CULTURE MATERIAL; SPHINGOSINE; PONIES; FEEDS; PROLIFERATUM; SPHINGANINE;
TOXICOSIS
AB The objective of this experiment was to characterize a dose-dependent toxic effect of fumonisin B-1 (FB1) and to document initial neurologic signs, clinical progression, and terminal cerebrospinal fluid (CSF) changes in horses administered FB1 IV. Seventeen healthy horses were administered 0.00 (n = 4), 0.01 (n = 3), 0.05 (n = 3), 0.10 (n 3), or 0.20 mg (n = 4) of purified FB1 IV q24h. When neurologic abnormalities observed by a masked observer became severe, atlanto-occipital CSF taps were performed and CSF pressure, cell count, cytology, protein, albumin and glucose concentrations, and creatine kinase activity were measured. Changes in CSF and number of days to 1st observation of neurologic abnormalities were compared between doses by ANOVA, with the level of significance set at P < .05. Control horses and low-dose horses (0.01 mg/kg) remained neurologically normal. In higher dose FB1-treated horses (n = 10), initial clinical signs (days 4-10) included hindlimb ataxia, delayed forelimb placing, and decreased tongue tone and movement. Hindlimb and trunkal ataxia, depression, hyperesthesia, and intermittent dementia gradually became apparent. When data from all horses with neurologic abnormalities were pooled (0.05-0.20 mg/kg FB1), mild clinical signs (mean day 6.3) occurred significantly earlier than did more severe (mean day 8.9) clinical signs (P = .009). Neurologic horses had high CSF protein, albumin, and IgG concentrations and increased albumin quotients (P < .05). It was concluded that FB1-induced neurologic and CSF changes in a dose-dependent manner, with a no-observable-limit of 0.01 mg FB1/kg IV q24h for 28 days. The neurologic and CSF changes were consistent with vasogenic cerebral edema.
C1 Univ Illinois, Coll Vet Med, Dept Vet Clin Med, Urbana, IL 61802 USA.
Univ Illinois, Coll Vet Med, Dept Vet Pathobiol, Urbana, IL 61802 USA.
Univ Illinois, Coll Vet Med, Dept Vet Biosci, Urbana, IL 61802 USA.
US FDA, Washington, DC 20204 USA.
Purdue Univ, W Lafayette, IN 47907 USA.
RP Foreman, JH (reprint author), Univ Illinois, Coll Vet Med, Dept Vet Clin Med, 1008 W Hazelwood Dr, Urbana, IL 61802 USA.
EM jforeman@cvm.uiuc.edu
NR 57
TC 16
Z9 17
U1 0
U2 8
PU AMER COLL VETERINARY INTERNAL MEDICINE
PI LAKEWOOD
PA 7175 W JEFFERSON AVE, STE 2125, LAKEWOOD, CO 80235 USA
SN 0891-6640
J9 J VET INTERN MED
JI J. Vet. Intern. Med.
PD MAR-APR
PY 2004
VL 18
IS 2
BP 223
EP 230
DI 10.1892/0891-6640(2004)18<223:NAACFC>2.0.CO;2
PG 8
WC Veterinary Sciences
SC Veterinary Sciences
GA 802TX
UT WOS:000220186900015
PM 15058775
ER
PT J
AU de Rosny, E
Vassell, R
Jiang, S
Kunert, R
Weiss, CD
AF de Rosny, E
Vassell, R
Jiang, S
Kunert, R
Weiss, CD
TI Binding of the 2F5 monoclonal antibody to native and fusion-intermediate
forms of human immunodeficiency virus type 1 gp41: Implications for
fusion-inducing conformational changes
SO JOURNAL OF VIROLOGY
LA English
DT Article
ID TRANSMEMBRANE PROTEIN GP41; CELL-CELL FUSION; ENVELOPE GLYCOPROTEIN;
HIV-1 GP41; NEUTRALIZING EPITOPE; INHIBITORY PEPTIDE; SYNTHETIC PEPTIDE;
ATOMIC-STRUCTURE; ENTRY; ECTODOMAIN
AB We investigated how the broadly neutralizing monoclonal antibody 2F5 affects the human immunodeficiency virus type 1 envelope glycoprotein as it undergoes receptor-induced conformational changes and show that 2F5 binds both native and fusion-intermediate conformations, suggesting inhibition of a late step in virus entry. We also demonstrate conformational changes in the C heptad of gp41.
C1 US FDA, Ctr Biol Evaluat & Res, Bethesda, MD 20892 USA.
New York Blood Ctr, Lindsley F Kimball Res Inst, New York, NY 10021 USA.
Univ Nat Resources & Appl Life Sci Vienna, Inst Appl Microbiol, A-1180 Vienna, Austria.
RP Weiss, CD (reprint author), US FDA, Ctr Biol Evaluat & Res, HFM-466,Bldg 29,Room 532,8800 Rockville Pike, Bethesda, MD 20892 USA.
EM cdweiss@helix.nih.gov
RI Weiss, Carol/F-6438-2011; Jiang, Shibo/L-4500-2014
OI Weiss, Carol/0000-0002-9965-1289;
NR 41
TC 69
Z9 70
U1 0
U2 2
PU AMER SOC MICROBIOLOGY
PI WASHINGTON
PA 1752 N ST NW, WASHINGTON, DC 20036-2904 USA
SN 0022-538X
J9 J VIROL
JI J. Virol.
PD MAR
PY 2004
VL 78
IS 5
BP 2627
EP 2631
DI 10.1128/JVI.78.5.2627-2631.2004
PG 5
WC Virology
SC Virology
GA 775AV
UT WOS:000189019300053
PM 14963170
ER
PT J
AU Czarneski, J
Lin, YC
Chong, S
McCarthy, B
Fernandes, H
Parker, G
Mansour, A
Huppi, K
Marti, GE
Raveche, E
AF Czarneski, J
Lin, YC
Chong, S
McCarthy, B
Fernandes, H
Parker, G
Mansour, A
Huppi, K
Marti, GE
Raveche, E
TI Studies in NZB IL-10 knockout mice of the requirement of IL-10 for
progression of B-cell lymphoma
SO LEUKEMIA
LA English
DT Article
DE B-lymphocytes; cytokines; knockout
ID CHRONIC LYMPHOCYTIC-LEUKEMIA; NON-HODGKINS-LYMPHOMA; IN-VIVO; B-1 CELLS;
SPEED CONGENICS; INTERLEUKIN-10; APOPTOSIS; GROWTH; EXPRESSION;
INHIBITION
AB NZB mice develop an age-related malignant expansion of a subset of B cells, B-1 cells, with autocrine production of IL-10. IL-10, a pleiotropic cytokine with anti-inflammatory properties, is a potent growth and survival factor for malignant B cells. To further examine the in vivo requirement for IL-10 in the development and expansion of malignant B-1 clones in NZB mice, we developed a strain of homozygous IL-10 knockout (KO) mice on an NZB background. The NZB IL-10 KO mice develop peritoneal B-1 cells with approximately the same frequency as heterozygous and wild-type littermates. In contrast, the development of malignant B-1 cells in the peripheral blood and spleen, observed in wild-type NZB, rarely occurred in the NZB IL-10 KO. Phenotypic analysis of surface marker expression in splenic B cells indicated that, in contrast to the NZB with malignant B-1 splenic lymphoma, the surface marker expression of NZB IL-10 KO splenic B cells indicated that the majority of the B cells were typical B-2 cells. In the absence of IL-10, spontaneously activated B cells and antiapoptotic gene expression were reduced and lymphoma incidence was decreased. These results indicate that IL-10 is a critical factor for the progression of this B-cell malignant disease.
C1 Univ Med & Dent New Jersey, New Jersey Med Sch, Dept Pathol, Newark, NJ 07103 USA.
NCI, Canc Prevent Studies Branch, NIH, Rockville, MD USA.
US FDA, Ctr Biol Evaluat & Res, Bethesda, MD USA.
RP Raveche, E (reprint author), Univ Med & Dent New Jersey, New Jersey Med Sch, Dept Pathol, 185 S Orange Ave, Newark, NJ 07103 USA.
EM raveches@umdnj.edu
FU NCI NIH HHS [R01 CA 71478-11]
NR 40
TC 38
Z9 39
U1 0
U2 0
PU NATURE PUBLISHING GROUP
PI LONDON
PA MACMILLAN BUILDING, 4 CRINAN ST, LONDON N1 9XW, ENGLAND
SN 0887-6924
J9 LEUKEMIA
JI Leukemia
PD MAR
PY 2004
VL 18
IS 3
BP 597
EP 606
DI 10.1038/sj.leu.2403244
PG 10
WC Oncology; Hematology
SC Oncology; Hematology
GA 777UT
UT WOS:000189197800029
PM 14712288
ER
PT J
AU Slater, JE
AF Slater, JE
TI Recombinant allergens in the US
SO METHODS
LA English
DT Article
ID EXTRACTS; POTENCY
AB Recombinant allergens may increase the safety and efficacy of allergen immunodiagnostics and immunotherapy, and may prove to be excellent tools for the standardization of existing, natural allergens. However, there are several biological and regulatory issues that need to be addressed as these products are moved from bench to bedside. This article discusses some of these issues. (C) 2003 Elsevier Inc. All rights reserved.
C1 US FDA, Lab Immunobiochem, Div Bacterial Parasit & Allergen Prod, Off Vaccines Regulat & Res,Ctr Biol Evaluat & Res, Bethesda, MD 20014 USA.
RP Slater, JE (reprint author), US FDA, Lab Immunobiochem, Div Bacterial Parasit & Allergen Prod, Off Vaccines Regulat & Res,Ctr Biol Evaluat & Res, Bethesda, MD 20014 USA.
NR 7
TC 1
Z9 1
U1 0
U2 0
PU ACADEMIC PRESS INC ELSEVIER SCIENCE
PI SAN DIEGO
PA 525 B ST, STE 1900, SAN DIEGO, CA 92101-4495 USA
SN 1046-2023
J9 METHODS
JI Methods
PD MAR
PY 2004
VL 32
IS 3
BP 209
EP 211
DI 10.1016/j.ymeth.2003.08.002
PG 3
WC Biochemical Research Methods; Biochemistry & Molecular Biology
SC Biochemistry & Molecular Biology
GA 777MC
UT WOS:000189181300002
PM 14962753
ER
PT J
AU Kamp, HG
Turesky, R
Schlatter, J
Eisenbrand, G
Janzowski, C
AF Kamp, HG
Turesky, R
Schlatter, J
Eisenbrand, G
Janzowski, C
TI Ochratoxin A: Induction of oxidative DNA damage in primary rat tubular
cells and in rats
SO NAUNYN-SCHMIEDEBERGS ARCHIVES OF PHARMACOLOGY
LA English
DT Meeting Abstract
CT 45th Spring Meeting of the
German-Society-for-Experimental-and-Clinical-Pharmacology-and-Toxicology
CY MAR 09-11, 2004
CL Mainz, GERMANY
SP German Soc Exptl & Clin Pharmacol & Toxicol
C1 Univ Kaiserslautern, Dept Chem, Div Food Chem & Environm Toxicol, Kaiserslautern, 72079, Germany.
Natl Ctr Toxicol Res, Jefferson, AR USA.
Swiss Fed Off Publ Hlth, Bern, Switzerland.
NR 0
TC 0
Z9 0
U1 0
U2 0
PU SPRINGER
PI NEW YORK
PA 233 SPRING ST, NEW YORK, NY 10013 USA
SN 0028-1298
J9 N-S ARCH PHARMACOL
JI Naunyn-Schmiedebergs Arch. Pharmacol.
PD MAR
PY 2004
VL 369
SU 1
MA 495
BP R124
EP R124
PG 1
WC Pharmacology & Pharmacy
SC Pharmacology & Pharmacy
GA 808UA
UT WOS:000220592800496
ER
PT J
AU Cisneros, FJ
Branch, S
AF Cisneros, FJ
Branch, S
TI Transplacental exposure to the DNA demethylating agent, 5-AZA-CdR,
affects the sexual behavior of CD-1 male mice
SO NEUROTOXICOLOGY
LA English
DT Article
DE 5-AZA-2 '-deoxycytidine (5-AZA-CdR); daily sperm production; Sry gene;
reproductive behavior; reproductive toxicity
ID DE-NOVO METHYLATION; MAMMALIAN DEVELOPMENT; MOUSE FETUSES; GENE;
5-AZA-2'-DEOXYCYTIDINE; SRY; REPRODUCTION; EXPRESSION; MUTATION;
DYSMORPHOGENESIS
AB Intrauterine exposure to 5-AZ4-2'-deoxycytidine (5-AZ4-CdR) alters gene expression causing malformations, abnormal post-natal growth and altered reproductive capacity. To elucidate whether the phenomenon observed in 5-AZA-CdR in utero exposed male mice was a behavioral alteration, at gestation day (GD) 10, CD-1 pregnant mice were administered 1 mg/kg i.p. of 5-AZ4-CdR or saline solution. After parturition, the number and sex of pups were recorded. While litter size was not affected, the ratio of male to female offspring was altered in treated mice. To determine whether the phenotypic observation of male gender corresponded to the appropriate genotype, presence of Sry gene in 5-AZA-CdR F1 males was determined. At 3 months of age, the male sexual behavior test outlined by Chubb was conducted. Presence of vaginal plug and pregnancy were determined in the natural breeding phase. Mount latency and number of mounts per mouse were assessed in the behavioral test phase. In utero exposed male mice resulted in diminished mating behavior (as measured by vaginal plug presence, mount latency and number of mounts) and reduced sexual interest while exposed to a receptive female. While normal presence of Sry gene was observed, mating behavior was altered in exposed males suggesting that the reproductive alteration could be attributed to a behavioral phenomenon. (C) 2003 Elsevier Inc. All rights reserved.
C1 US FDA, Natl Ctr Toxicol Res, Jefferson, AR 72079 USA.
N Carolina State Univ, Dept Environm & Mol Toxicol, Raleigh, NC 27695 USA.
RP Cisneros, FJ (reprint author), US FDA, Natl Ctr Toxicol Res, 3900 NCTR Dr, Jefferson, AR 72079 USA.
EM fcisneros@nctr.fda.gov
RI Matthews Branch, Stacy/E-6200-2017
OI Matthews Branch, Stacy/0000-0002-1048-6097
FU NIEHS NIH HHS [ES08452]
NR 52
TC 4
Z9 8
U1 0
U2 0
PU ELSEVIER SCIENCE BV
PI AMSTERDAM
PA PO BOX 211, 1000 AE AMSTERDAM, NETHERLANDS
SN 0161-813X
J9 NEUROTOXICOLOGY
JI Neurotoxicology
PD MAR
PY 2004
VL 25
IS 3
BP 411
EP 417
DI 10.1016/j.neuro.2003.09.002
PG 7
WC Neurosciences; Pharmacology & Pharmacy; Toxicology
SC Neurosciences & Neurology; Pharmacology & Pharmacy; Toxicology
GA 803XF
UT WOS:000220263100008
PM 15019304
ER
PT J
AU Scallet, AC
Kowalke, PK
Rountree, RL
Thorn, BT
Binienda, ZK
AF Scallet, AC
Kowalke, PK
Rountree, RL
Thorn, BT
Binienda, ZK
TI Electroencephalographic, behavioral, and c-fos responses to acute dombic
acid exposure
SO NEUROTOXICOLOGY AND TERATOLOGY
LA English
DT Article
DE limbic system; hippocampus; olfactory bulb; amnesia; excitotoxins; algal
blooms; shellfish toxins; electrocorticogram; fast fourier
transformation; electroencephalogram; epilepsy; seizures
ID KAINATE RECEPTOR ACTIVATION; RAT DORSAL HIPPOCAMPUS; TEMPORAL-LOBE
EPILEPSY; DOMOIC ACID; GENE-EXPRESSION; PROTEIN IMMUNOHISTOCHEMISTRY;
MONOAMINE CONCENTRATIONS; MEDIATED EXCITOTOXICITY; REDUCED PERFUSION;
INDUCED SEIZURES
AB Domoic acid, a potent excitotoxic analogue of glutamate and kainate, may cause seizures, amnesia, and sometimes death in humans consuming contaminated shellfish. Continuous behavioral observations and recordings of the electrocorticogram (ECoG, via bipolar, epidural electrodes) were obtained from nonanesthetized rats for 2 h after intraperitoneal injection with either saline, 2.2, or 4.4 mg/kg of domoic acid. Rats were then sacrificed for c-fos immunohistochemistry. Fast Fourier transformation (FFT) of the ECoG data to obtain the voltage as a function of frequency indicated that the lower frequency bands (theta, 4.75-6.75 Hz and delta, 1.25-4.50 Hz) were the first to respond, with a significant elevation by 30 min after the high dose of domoic acid. The lower dose of domoic, acid also caused a significant elevation of ECoG voltage, but not until later in the session. Sixty minutes after dosing the behavioral biomarkers of "ear scratching" and "rearing, praying" (RP) seizures became significantly elevated in the high-dose rats. The low-dose rats showed no significant alterations in behavior at any time during the session. In postmortem brains obtained immediately after, the sessions, c-fos was activated in the anterior olfactory nucleus by both the low and high doses of domoic acid. However, only the high dose increased c-fos immunoreactivity in the hippocampus, affecting both the granule and pyramidal neurons. These data indicate that electroencephalographic and c-fos responses can be obtained at a dose of domoic acid that fails to activate the behavioral response most commonly used as a bioassay, for this marine toxin: ear scratching with the ipsilateral foot. (C) 2004 Published by Elsevier Inc.
C1 US FDA, Natl Ctr Toxicol Res, Div Neurotoxicol, Jefferson, AR 72079 USA.
RP Scallet, AC (reprint author), US FDA, Natl Ctr Toxicol Res, Div Neurotoxicol, 3900 NCTR Dr, Jefferson, AR 72079 USA.
EM AScallet@nctr.fda.gov
NR 85
TC 21
Z9 23
U1 0
U2 1
PU PERGAMON-ELSEVIER SCIENCE LTD
PI OXFORD
PA THE BOULEVARD, LANGFORD LANE, KIDLINGTON, OXFORD OX5 1GB, ENGLAND
SN 0892-0362
J9 NEUROTOXICOL TERATOL
JI Neurotoxicol. Teratol.
PD MAR-APR
PY 2004
VL 26
IS 2
BP 331
EP 342
DI 10.1016/j.ntt.2003.10.004
PG 12
WC Neurosciences; Toxicology
SC Neurosciences & Neurology; Toxicology
GA 806OY
UT WOS:000220444400016
PM 15019966
ER
PT J
AU Ferguson, SA
Cada, AM
AF Ferguson, SA
Cada, AM
TI Spatial learning/memory and social and nonsocial behaviors in the
spontaneously hypertensive, Wistar-Kyoto and Sprague-Dawley rat strains
SO PHARMACOLOGY BIOCHEMISTRY AND BEHAVIOR
LA English
DT Article
DE spontaneously hypertensive; Wistar-Kyoto; play behavior; dominance;
spatial learning; memory; motor coordination; acoustic startle; prepulse
inhibition
ID ELEVATED PLUS-MAZE; CENTRAL NICOTINIC RECEPTORS; MORRIS WATER MAZE;
NORMOTENSIVE RATS; ANIMAL-MODEL; WKY RATS; COGNITIVE IMPAIRMENT;
AUDITORY STARTLE; WORKING-MEMORY; SHR
AB The Spontaneously Hypertensive rat (SHR) is often described as less behaviorally reactive than its normotensive strain, the Wistar-Kyoto (WKY), although results are somewhat inconsistent across studies. In part, this may be due to the lack of a definitive characterization of "reactivity." Still, results from identical behavioral tests of SHR and WXY across studies are sometimes conflicting. Further, few comparisons with other rodent strains are available and these might provide guidance in outlining the meaning of reactivity. Here, social and nonsocial behaviors and spatial learning and memory were measured in male and female SHR, WKY, and Sprague-Dawley (SD) rats. Systolic blood pressure measurements at adulthood confirmed hypertension in the SHR. Juvenile play behavior indicated that SHRs were more sensitive to the strain of their play partner than were the WKY or SD, playing less with different strain partners than with same strain partners. However, adult dominance behavior (restricted access in a water competition test) indicated no strain differences. The SHR appeared to exhibit attenuated acoustic startle relative to the WXY and SD and their prepulse inhibition was substantially less at higher prepulse decibel intensities; however, this decreased prepulse inhibition was not the result of decreased startle during the test. Anxiety-related behavior in the elevated plus maze was most prominent in the SD strain, possibly as a result of poorer motor coordination as measured by rotarod performance. Elevated plus maze behavior as well as motor coordination did not differ between the SHR and WKY strains. Performance in the NCTR complex maze and the Morris water maze was significantly better in the SHR. These results do not support hypotheses of decreased behavioral reactivity in the SHR strain. Rather, they suggest complex interactions between social and nonsocial environments and the behavioral capabilities and requirements of the rat strain. (C) 2004 Elsevier Inc. All rights reserved.
C1 US FDA, Natl Ctr Toxicol Res, Div Neurotoxicol, Jefferson, AR 72079 USA.
RP Ferguson, SA (reprint author), US FDA, Natl Ctr Toxicol Res, Div Neurotoxicol, HFT-132,3900 NCTR Rd, Jefferson, AR 72079 USA.
EM sferguson@nctr.fda.gov
NR 67
TC 66
Z9 66
U1 0
U2 5
PU PERGAMON-ELSEVIER SCIENCE LTD
PI OXFORD
PA THE BOULEVARD, LANGFORD LANE, KIDLINGTON, OXFORD OX5 1GB, ENGLAND
SN 0091-3057
J9 PHARMACOL BIOCHEM BE
JI Pharmacol. Biochem. Behav.
PD MAR
PY 2004
VL 77
IS 3
BP 583
EP 594
DI 10.1016/j.pbb.2003.12.014
PG 12
WC Behavioral Sciences; Neurosciences; Pharmacology & Pharmacy
SC Behavioral Sciences; Neurosciences & Neurology; Pharmacology & Pharmacy
GA 803ZD
UT WOS:000220268100020
PM 15006470
ER
PT J
AU Powell, JR
AF Powell, JR
TI Clinical pharmacists save thousands of lives: Big decrease in
dose-related adverse effects
SO PHARMACOTHERAPY
LA English
DT Editorial Material
ID PHYSICIANS
C1 US FDA, Off Clin Pharmacol & Biopharmaceut, Rockville, MD 20857 USA.
RP Powell, JR (reprint author), 7620 Old Georgetown Rd,Apartment 813, Bethesda, MD 20814 USA.
EM bobpowell@comcast.net
NR 6
TC 1
Z9 1
U1 0
U2 0
PU PHARMACOTHERAPY PUBLICATIONS INC
PI BOSTON
PA NEW ENGLAND MEDICAL CENTER, 806, 750 WASHINGTON ST, BOSTON, MA 02111 USA
SN 0277-0008
J9 PHARMACOTHERAPY
JI Pharmacotherapy
PD MAR
PY 2004
VL 24
IS 3
BP 422
EP 425
DI 10.1592/phco.24.4.422.33176
PG 4
WC Pharmacology & Pharmacy
SC Pharmacology & Pharmacy
GA 779QY
UT WOS:000189312800017
PM 15040659
ER
PT J
AU Hanna, GM
AF Hanna, GM
TI NMR regulatory analysis: determination and characterization of
chinese-herb aristolochic acids
SO PHARMAZIE
LA English
DT Article
ID RENAL-FAILURE; UROTHELIAL CARCINOMA; SLIMMING REGIMEN; RAT FORESTOMACH;
NEPHROPATHY; IDENTIFICATION; MUTAGENICITY; MEDICINE; TOXICITY; FANGCHI
AB H-1 NMR methodology for the simultaneous determination and characterization of the nephrotoxic components of Aristolochia plants aristolochic acid I (AA-I) and aristolochic acid II (AA-II) was developed utilizing a 400 MHz spectrometer without the need of reference standards. The developed methodology is able to differentiate and assess chemical structures of these toxic injurious compounds. The quantity of each was calculated on the basis of the integrals for the signals of the H-7 and H-8 of the phenanthrene ring of AA-I and AA-II at delta7.38 and delta8.31, respectively, and the vinylic protons of the internal standard maleic acid at delta6.06. The accuracy of the method was established through the analysis of synthetic mixtures containing the internal standard maleic acid, with purified AA-I or combined AA-I and AA-II sodium salts. Excellent agreements were verified between the assay results and the quantities in the mixtures. The mean +/- SD recovery values for purified AA-I and combined AA-I and AA-II from two sets of 10 synthetic mixtures were 99.8 +/- 0.6% and 99.6 +/- 0.8%, respectively. The assay of 4 lots of commercial aristolochic acid by H-1 NMR spectroscopy indicated AA-I and AA-II contents in the ranges 45.3-97.1% and 0-15.4%, respectively.
C1 US FDA, NE Reg Lab, Dept Hlth & Human Serv, Jamaica, NY 11433 USA.
RP Hanna, GM (reprint author), US FDA, NE Reg Lab, Dept Hlth & Human Serv, 158-15 Liberty Ave, Jamaica, NY 11433 USA.
EM ghanna@ora.fda.gov
NR 29
TC 4
Z9 5
U1 1
U2 1
PU GOVI-VERLAG GMBH
PI ESCHBORN
PA PHARMAZEUTISCHER VERLAG GINNHEIMER STRASSE 26, D-65760 ESCHBORN, GERMANY
SN 0031-7144
J9 PHARMAZIE
JI Pharmazie
PD MAR
PY 2004
VL 59
IS 3
BP 170
EP 174
PG 5
WC Chemistry, Medicinal; Chemistry, Multidisciplinary; Pharmacology &
Pharmacy
SC Pharmacology & Pharmacy; Chemistry
GA 804PY
UT WOS:000220311800002
PM 15074585
ER
PT J
AU Leak, LV
Liotta, LA
Krutzsch, H
Jones, M
Fusaroa, VA
Ross, SJ
Zhaos, YM
Petricoin, EF
AF Leak, LV
Liotta, LA
Krutzsch, H
Jones, M
Fusaroa, VA
Ross, SJ
Zhaos, YM
Petricoin, EF
TI Proteomic analysis of lymph
SO PROTEOMICS
LA English
DT Article
DE biomarkers; cancer; lymph; surface-enhanced laser
desorption/ionization-time of flight-mass spectrometry
ID HUMAN PROSTATE-CANCER; HUMAN-PLASMA PROTEINS; MASS-SPECTROMETRY;
2-DIMENSIONAL ELECTROPHORESIS; ANCHORING FILAMENTS; HEMOSTATIC FACTORS;
DENDRITIC CELLS; FLUID; IMMUNODETECTION; GLYCOPROTEIN
AB This report provides the first proteomic analysis of normal ovine lymph. By establishing the fact that lymph is more than an ultrafiltrate of blood plasma, it documents that the lymph proteome contains an array of proteins that differentiates it from plasma. The protein chip technology, surface-enhanced laser desorption/ionization-time of flight-mass spectrometry (SELDI-TOF-MS), two-dimensional gel electrophoresis (2-D PAGE) and MS, were employed to examine the protein expression profiles of ovine lymph. Using a weak cation exchange chip surface to assay lymph and plasma samples by SELDI-TOF-MS showed that the analysis of peak maps from lymph contained three protein peaks that were found only in lymph, while analysis of peak maps from plasma samples showed that five protein peaks were found only in plasma. Lymph and plasma samples showed eight peaks that were common to both. There were also more ions present in plasma than in lymph, which is consistent with the 2-D PAGE analysis. MS analysis of a large number of protein spots from 2-D PAGE gels of lymph produced MS/MS sequences for 18 proteins that were identified by searching against a comprehensive protein sequence database. As in plasma, large protein spots of albumin dominated the protein pattern in lymph. Other major proteins identified in 2-D PAGE gels of lymph included, fibrinogen alpha- and beta-chains, immunoglobulin G (IgG) heavy chain, serotransferrin precursor, lactoferrin, and apolipoprotein A-1. Two Proteins that were identified and were differentially expressed in lymph were glial fibrillary astrocyte acidic protein and neutrophil cytosol factor-1. By bringing the technologies of proteomics to bear on the analysis of lymph, it is possible to detect proteins in lymph that are quantitatively and qualitatively differentially expressed from those of plasma.
C1 US FDA, Ctr Biol Evaluat & Res, Clin Proteom Program Therapeut Prot, Bethesda, MD 20892 USA.
NCI, Pathol Lab, NIH, Bethesda, MD 20892 USA.
Howard Univ, Coll Med, Ernest E Just Lab Cellular Med, Washington, DC 20059 USA.
NHLBI, Lab Anim Surg, NIH, Bethesda, MD 20892 USA.
Univ Texas, SW Med Ctr, Dept Biochem, Dallas, TX 75230 USA.
RP Petricoin, EF (reprint author), US FDA, Ctr Biol Evaluat & Res, Clin Proteom Program Therapeut Prot, 800 Rockville Pike,Bldg 29A,Room 2A17, Bethesda, MD 20892 USA.
EM petricoin@cber.fda.gov
NR 50
TC 48
Z9 51
U1 0
U2 3
PU WILEY-V C H VERLAG GMBH
PI WEINHEIM
PA PO BOX 10 11 61, D-69451 WEINHEIM, GERMANY
SN 1615-9853
J9 PROTEOMICS
JI Proteomics
PD MAR
PY 2004
VL 4
IS 3
BP 753
EP 765
DI 10.1002/pmic.200300573
PG 13
WC Biochemical Research Methods; Biochemistry & Molecular Biology
SC Biochemistry & Molecular Biology
GA 802QX
UT WOS:000220179100019
PM 14997497
ER
PT J
AU Alexe, G
Alexe, S
Liotta, LA
Petricoin, E
Reiss, M
Hammer, PL
AF Alexe, G
Alexe, S
Liotta, LA
Petricoin, E
Reiss, M
Hammer, PL
TI Ovarian cancer detection by logical analysis of proteomic data
SO PROTEOMICS
LA English
DT Article
DE logical analysis of data; ovarian cancer
ID PROSTATE-CANCER; BREAST-CANCER; SERUM; PATTERNS; IDENTIFICATION;
PREDICTION; CARCINOMA; MARKERS; RISK
AB A new type of efficient and accurate proteomic ovarian cancer diagnosis systems is proposed. The system is developed using the combinatorics and optimization-based methodology of logical analysis of data (LAD) to the Ovarian Dataset 8-7-02 (http://clinicalproteomics.steem.com), which updates the one used by Petricoin et al, in The Lancet 2002, 359, 572-577. This mass spectroscopy-generated dataset contains expression profiles of 15154 peptides defined by their mass/charge ratios (m/z) in serum of 162 ovarian cancer and 91 control cases. Several fully reproducible models using only 7-9 of the 15 154 peptides were constructed, and shown in multiple cross-validation tests (k-folding and leave-one-out) to provide sensitivities and specificities of up to 100%. A special diagnostic system for stage I ovarian cancer patients is shown to have similarly high accuracy. Other results: (i) expressions of peptides with relatively low m/z values in the dataset are shown to be better at distinguishing ovarian cancer cases from controls than those with higher m/z values; (ii) two large groups of patients with a high degree of similarities among their formal (mathematical) profiles are detected; (iii) several peptides with a blocking or promoting effect on ovarian cancer are identified.
C1 Rutgers State Univ, Rutgers Ctr Operat Res, RUTCOR, Piscataway, NJ 08854 USA.
NCI, Pathol Lab, NIH, Bethesda, MD 20892 USA.
US FDA, Ctr Biol Evaluat & Res, NIH, Clin Proteom Program,Dept Therapeut, Bethesda, MD 20014 USA.
Univ Med & Dent New Jersey, Robert Wood Johnson Med Sch, Inst Canc, Dept Med, New Brunswick, NJ USA.
RP Hammer, PL (reprint author), Rutgers State Univ, Rutgers Ctr Operat Res, RUTCOR, 640 Bartholomew Rd, Piscataway, NJ 08854 USA.
EM hammer@rutcor.rutgers.edu
RI Reiss, Michael/A-8314-2009
NR 38
TC 54
Z9 56
U1 0
U2 3
PU WILEY-V C H VERLAG GMBH
PI WEINHEIM
PA PO BOX 10 11 61, D-69451 WEINHEIM, GERMANY
SN 1615-9853
J9 PROTEOMICS
JI Proteomics
PD MAR
PY 2004
VL 4
IS 3
BP 766
EP 783
DI 10.1002/pmic.200300574
PG 18
WC Biochemical Research Methods; Biochemistry & Molecular Biology
SC Biochemistry & Molecular Biology
GA 802QX
UT WOS:000220179100020
PM 14997498
ER
PT J
AU Berman, DM
Shih, LM
Burke, LA
Veenstra, TD
Zhao, YM
Conrads, TP
Kwon, SW
Hoang, V
Yu, LR
Zhou, M
Kurman, RJ
Petricoin, EF
Liotta, LA
AF Berman, DM
Shih, LM
Burke, LA
Veenstra, TD
Zhao, YM
Conrads, TP
Kwon, SW
Hoang, V
Yu, LR
Zhou, M
Kurman, RJ
Petricoin, EF
Liotta, LA
TI Profiling the activity of G proteins in patient-derived tissues by rapid
affinity-capture of signal transduction proteins (GRASP)
SO PROTEOMICS
LA English
DT Article
DE affinity capture; G protein signal transduction; mass spectrometry;
ovarian carcinoma; protein-protein interactions
ID GUANINE-NUCLEOTIDE EXCHANGE; GTP-BINDING PROTEIN; RHO-GTPASES; PROTEOMIC
ANALYSIS; CANCER; SPECIFICITY; PATHWAYS; BIOLOGY
AB The next phase in molecular medicine will require the ability to identify signal transduction events inside a cell, in the biologic context of the disease-host interface and at a given point in time. New technologies are needed to profile the activity of these signaling pathways in patient tissue rather than cultured cell lines since the tumor-host microenvironment influences the cellular proteome. We introduce such a technology, rapid affinity capture of signaling proteins (GRASP), to investigate the activity of signaling pathways from patient-derived carcinomas and benign epithelial surfaces and apply it to studying important signaling events in ovarian carcinoma. During the progression from benign ovarian epithelium to invasive carcinoma, there is loss of repression of Rho A as evidenced by its dissociation from its inhibitor, Rho Guanine Nucleotide Dissociation Inhibitor (RhoGDI). GRASP is more informative than simply profiling transcript or protein levels. Furthermore, GRASP coupled with mass spectrometry allowed us to identify a protein-binding partner of RhoGDI, demonstrating the power of this technology in the discovery of potentially novel protein-protein interactions. GRASP represents an advance in the field of proteomics as it detects protein interactions present in cells as they exist in their native tissue microenvironment.
C1 NCI, Pathol Lab, NIH, Bethesda, MD 20892 USA.
Johns Hopkins Univ, Sch Med, Dept Pathol, Baltimore, MD 21218 USA.
NCI, SAIC Frederick, Frederick, MD 21701 USA.
Univ Texas, SW Med Sch, Dept Biochem, Dallas, TX USA.
US FDA, Ctr Biol Evaluat & Res, NCI, Clin Proteom Program, Bethesda, MD 20014 USA.
RP Berman, DM (reprint author), NCI, Pathol Lab, NIH, 10-2N212,Ctr Dr, Bethesda, MD 20892 USA.
EM bermand@mail.nih.gov
RI Burke, Luke/C-7655-2011
NR 27
TC 11
Z9 11
U1 0
U2 1
PU WILEY-V C H VERLAG GMBH
PI WEINHEIM
PA PO BOX 10 11 61, D-69451 WEINHEIM, GERMANY
SN 1615-9853
J9 PROTEOMICS
JI Proteomics
PD MAR
PY 2004
VL 4
IS 3
BP 812
EP 818
DI 10.1002/pmic.200300579
PG 7
WC Biochemical Research Methods; Biochemistry & Molecular Biology
SC Biochemistry & Molecular Biology
GA 802QX
UT WOS:000220179100023
PM 14997501
ER
PT J
AU Li, H
AF Li, H
TI A widely applicable extension of the random effects two-way layout: Its
definition and statistical analysis based on group invariance
SO PSYCHOMETRIKA
LA English
DT Article; Proceedings Paper
CT Conference and Workshop on Random Utility and Probabilistic Measurement
Theory
CY AUG 03-08, 2000
CL Duke Univ, Durham, NC
SP Natl Sci Fdn, Fuqua Sch Business, Ctr Int Business Educ & Res
HO Duke Univ
DE disattenuation; group invariance; measurement error; reliability
ID STRATIFIED-PARALLEL TESTS; CORRELATION-COEFFICIENTS;
MAXIMAL-RELIABILITY; MODELS; VARIANCE; SYMMETRY; DESIGNS
AB A type of data layout that may be considered as an extension of the two-way random effects analysis of variance is characterized and modeled based on group invariance. The data layout seems to be suitable for several scenarios in psychometrics, including the one in which multiple measurements are taken on each of a set of variables, and the measurements can be divided into exchangeable subsets. The algebraic structure of the model is studied, which leads to results that are applicable to such problems as estimating correlation matrix corrected for attenuation and testing symmetry hypotheses.
C1 Univ Rochester, Rochester, NY 14627 USA.
RP Li, H (reprint author), FDA CDRH, HRZ 550,1350 Piccard Dr, Rockville, MD 20850 USA.
NR 26
TC 0
Z9 0
U1 0
U2 0
PU PSYCHOMETRIC SOC
PI WILLIAMSBURG
PA COLLEGE OF WILLIAM AND MARY DEPT PSYCHOLOGY, WILLIAMSBURG, VA 23185 USA
SN 0033-3123
J9 PSYCHOMETRIKA
JI Psychometrika
PD MAR
PY 2004
VL 69
IS 1
BP 55
EP 64
DI 10.1007/BF02295839
PG 10
WC Mathematics, Interdisciplinary Applications; Social Sciences,
Mathematical Methods; Psychology, Mathematical
SC Mathematics; Mathematical Methods In Social Sciences; Psychology
GA 858KF
UT WOS:000224190000003
ER
PT J
AU Feldman, AL
Espina, V
Petricoin, EF
Liotta, LA
Rosenblatt, KP
AF Feldman, AL
Espina, V
Petricoin, EF
Liotta, LA
Rosenblatt, KP
TI Use of proteomic patterns to screen for gastrointestinal malignancies
SO SURGERY
LA English
DT Review
ID COLORECTAL-CANCER; PROTEIN MICROARRAYS; MARKERS; SERUM
C1 NCI, Pathol Lab, Canc Res Ctr, NIH, Bethesda, MD 20892 USA.
US FDA, Ctr Biol Evaluat & Res, Bethesda, MD 20892 USA.
RP Feldman, AL (reprint author), NCI, Pathol Lab, Canc Res Ctr, NIH, Bldg 10,Rm 2A33,10 Ctr Dr, Bethesda, MD 20892 USA.
RI Feldman, Andrew/D-5028-2012;
OI Espina, Virginia/0000-0001-5080-5972
NR 15
TC 22
Z9 22
U1 0
U2 0
PU MOSBY, INC
PI ST LOUIS
PA 11830 WESTLINE INDUSTRIAL DR, ST LOUIS, MO 63146-3318 USA
SN 0039-6060
J9 SURGERY
JI Surgery
PD MAR
PY 2004
VL 135
IS 3
BP 243
EP 247
DI 10.1016/j.surg.2003.08.019
PG 5
WC Surgery
SC Surgery
GA 779QE
UT WOS:000189310900001
PM 14976472
ER
PT J
AU Krieg, RC
Liotta, LA
Petricoin, EF
Herrmann, PC
AF Krieg, RC
Liotta, LA
Petricoin, EF
Herrmann, PC
TI Trapping radioactive carbon dioxide during cellular metabolic assays
under standard culture conditions: description of a unique gas-capturing
device
SO JOURNAL OF BIOCHEMICAL AND BIOPHYSICAL METHODS
LA English
DT Article
DE metabolism; physiological; carbon dioxide; radioactivity
ID DECARBOXYLATION; GLUCOSE; CELLS
AB Measurement of carbon dioxide levels has been employed to follow cellular metabolic reactions for quite some time. By radio-labeling substrate molecules and evaluating the radioactivity levels of the carbon dioxide released, insight into metabolic pathways can be gleaned. Currently, no carbon dioxide capturing device is available that can be used with large volume cell monolayers growing under standard conditions within a regular commercially available culture flask. In this note we describe a simple device for collecting radio-labeled carbon dioxide from a standard culture flask. The device is independent of the culture flask, but can be attached for metabolic measurements allowing cells to be grown under standard conditions prior to study. The presented design permits convenient transfer of the device between flasks without contaminating or disturbing cells growing within the flasks. Data are presented demonstrating the reproducibility of measurements made with multiple devices with different substrate concentrations and varying periods of time, ranging up to 3 h. Published by Elsevier B.V.
C1 NCI, FDA, Clin Proteom Program, Pathol Lab,NIH, Bethesda, MD 20892 USA.
US FDA, CBER, Off Director, Clin Proteom Program, Bethesda, MD 20892 USA.
RP Herrmann, PC (reprint author), NCI, FDA, Clin Proteom Program, Pathol Lab,NIH, 10 Ctr Dr,Bldg 10 Room 2n212, Bethesda, MD 20892 USA.
EM herrmanp@mail.nih.gov
NR 8
TC 6
Z9 6
U1 0
U2 2
PU ELSEVIER SCIENCE BV
PI AMSTERDAM
PA PO BOX 211, 1000 AE AMSTERDAM, NETHERLANDS
SN 0165-022X
J9 J BIOCHEM BIOPH METH
JI J. Biochem. Biophys. Methods
PD FEB 27
PY 2004
VL 58
IS 2
BP 119
EP 124
DI 10.1016/j.jbbm.2003.10.002
PG 6
WC Biochemical Research Methods; Biochemistry & Molecular Biology;
Biophysics
SC Biochemistry & Molecular Biology; Biophysics
GA 801SF
UT WOS:000220114900003
PM 14980785
ER
PT J
AU Watabe, H
Valencia, JC
Yasumoto, K
Kushimoto, T
Ando, H
Muller, J
Vieira, WD
Mizoguchi, M
Appella, E
Hearing, VJ
AF Watabe, H
Valencia, JC
Yasumoto, K
Kushimoto, T
Ando, H
Muller, J
Vieira, WD
Mizoguchi, M
Appella, E
Hearing, VJ
TI Regulation of tyrosinase processing and trafficking by organellar pH and
by proteasome activity
SO JOURNAL OF BIOLOGICAL CHEMISTRY
LA English
DT Article
ID HERMANSKY-PUDLAK-SYNDROME; MOUSE MELANOMA-CELLS; B-16 MURINE MELANOMA;
VACUOLAR H+-ATPASE; ENDOPLASMIC-RETICULUM; OCULOCUTANEOUS ALBINISM;
MAMMALIAN TYROSINASE; GENE-PRODUCT; HUMAN-SKIN; INTRACELLULAR
TRAFFICKING
AB Pigmentation of the hair, skin, and eyes of mammals results from a number of melanocyte-specific proteins that are required for the biosynthesis of melanin. Those proteins comprise the structural and enzymatic components of melanosomes, the membrane-bound organelles in which melanin is synthesized and deposited. Tyrosinase (TYR) is absolutely required for melanogenesis, but other melanosomal proteins, such as TYRP1, DCT, and gp100, also play important roles in regulating mammalian pigmentation. However, pigmentation does not always correlate with the expression of TYR mRNA/protein, and thus its function is also regulated at the post-translational level. Thus, TYR does not necessarily exist in a catalytically active state, and its post-translational activation could be an important control point for regulating melanin synthesis. In this study, we used a multidisciplinary approach to examine the processing and sorting of TYR through the endoplasmic reticulum ( ER), Golgi apparatus, coated vesicles, endosomes and early melanosomes because those organelles hold the key to understanding the trafficking of TYR to melanosomes and thus the regulation of melanogenesis. In pigmented cells, TYR is trafficked through those organelles rapidly, but in amelanotic cells, TYR is retained within the ER and is eventually degraded by proteasomes. We now show that TYR can be released from the ER in the presence of protonophore or proton pump inhibitors which increase the pH of intracellular organelles, after which TYR is transported correctly to the Golgi, and then to melanosomes via the endosomal sorting system. The expression of TYRP1, which facilitates TYR processing in the ER, is down-regulated in the amelanotic cells; this is analogous to a hypopigmentary disease known as oculocutaneous albinism type 3 and further impairs melanin production. The sum of these results shows that organellar pH, proteasome activity, and down-regulation of TYRP1 expression all contribute to the lack of pigmentation in TYR-positive amelanotic melanoma cells.
C1 NCI, Cell Biol Lab, NIH, Bethesda, MD 20892 USA.
US FDA, Div Viral Prod, Rockville, MD 20852 USA.
St Marianna Univ, Sch Med, Dept Dermatol, Kawasaki, Kanagawa 2168511, Japan.
RP Hearing, VJ (reprint author), NCI, Cell Biol Lab, NIH, Bldg 37,Rm 1B25, Bethesda, MD 20892 USA.
EM hearingv@nih.gov
NR 81
TC 74
Z9 75
U1 1
U2 8
PU AMER SOC BIOCHEMISTRY MOLECULAR BIOLOGY INC
PI BETHESDA
PA 9650 ROCKVILLE PIKE, BETHESDA, MD 20814-3996 USA
SN 0021-9258
J9 J BIOL CHEM
JI J. Biol. Chem.
PD FEB 27
PY 2004
VL 279
IS 9
BP 7971
EP 7981
DI 10.1074/jbc.M309714200
PG 11
WC Biochemistry & Molecular Biology
SC Biochemistry & Molecular Biology
GA 776EG
UT WOS:000189103300075
PM 14634018
ER
PT J
AU Puig, M
Major, ME
Mihalik, K
Feinstone, SM
AF Puig, M
Major, ME
Mihalik, K
Feinstone, SM
TI Immunization of chimpanzees with an envelope protein-based vaccine
enhances specific humoral and cellular immune responses that delay
hepatitis C virus infection
SO VACCINE
LA English
DT Article
DE hepatitis C; vaccine; envelope
ID RECOVERED CHIMPANZEES; FOLLOW-UP; CELLS; ANTIBODY; E2; TRANSMISSION;
RECHALLENGE; PERSISTENCE; CLEARANCE; BINDING
AB Two chimpanzees, one naive (Ch1601) and one recovered from hepatitis C virus (HCV) acute infection (Ch1587), were vaccinated with recombinant envelope glycoproteins (E1E2) and then challenged with 100 CID50 of HCV. Results of the challenge were compared to infection in a non-vaccinated control animal. Immunization generated high antibody titers to E1E2 including antibody specifically directed to the hypervariable region 1 (HVR1) in addition to strong and specific HVR1 T-cell proliferative responses. Upon challenge with HCV, viremia was delayed 3 weeks in both vaccinated animals compared to the non-immunized (control) animal. Ch1601 HCV RNA titers were maintained below 5 x 10(4) copies/ml, and alanine aminotransferase levels were only minimally elevated. An increase in intrahepatic cytokine mRNA levels coincided with a fall in HCV RNA to non-quantifiable levels. Despite this apparent control of virus replication the animal became persistently infected. Ch1587 had a significantly shorter and milder viremia, compared to the re-infection of the non-vaccinated control animal. This data indicates that a strategy inducing a T-cell immune response combined with antibody responses to E1E2 would make a viable candidate for an HCV vaccine.. Published by Elsevier Ltd.
C1 US FDA, CBER, Div Viral Prod, Lab Hepatitis Viruses, Bethesda, MD 20892 USA.
RP Feinstone, SM (reprint author), US FDA, CBER, Div Viral Prod, Lab Hepatitis Viruses, Bldg 29A,Room 1D02,8800 Rockville Pike, Bethesda, MD 20892 USA.
EM feinstone@cber.fda.gov
FU NCI NIH HHS [CA85883]
NR 30
TC 54
Z9 58
U1 0
U2 3
PU ELSEVIER SCI LTD
PI OXFORD
PA THE BOULEVARD, LANGFORD LANE, KIDLINGTON, OXFORD OX5 1GB, OXON, ENGLAND
SN 0264-410X
J9 VACCINE
JI Vaccine
PD FEB 25
PY 2004
VL 22
IS 8
BP 991
EP 1000
DI 10.1016/j.vaccine.2003.09.010
PG 10
WC Immunology; Medicine, Research & Experimental
SC Immunology; Research & Experimental Medicine
GA 778XN
UT WOS:000189266800010
PM 15161076
ER
PT J
AU Passerini, AG
Polacek, DC
Shi, CZ
Francesco, NM
Manduchi, E
Grant, GR
Pritchard, WF
Powell, S
Chang, GY
Stoeckert, CJ
Davies, PF
AF Passerini, AG
Polacek, DC
Shi, CZ
Francesco, NM
Manduchi, E
Grant, GR
Pritchard, WF
Powell, S
Chang, GY
Stoeckert, CJ
Davies, PF
TI Coexisting proinflammatory and antioxidative endothelial transcription
profiles in a disturbed flow region of the adult porcine aorta
SO PROCEEDINGS OF THE NATIONAL ACADEMY OF SCIENCES OF THE UNITED STATES OF
AMERICA
LA English
DT Article
ID NF-KAPPA-B; LAMINAR SHEAR-STRESS; ADHESION MOLECULE-1 EXPRESSION;
GENE-EXPRESSION; ATHEROSCLEROTIC LESIONS; VASCULAR ENDOTHELIUM; RESPONSE
ELEMENT; CELLS; ATHEROGENESIS; ACTIVATION
AB In the arterial circulation, regions of disturbed flow (DF), which are characterized by flow separation and transient vortices, are susceptible to atherogenesis, whereas regions of undisturbed laminar flow (UF) appear protected. Coordinated regulation of gene expression by endothelial cells (EC) may result in differing regional phenotypes that either favor or inhibit atherogenesis. Linearly amplified RNA from freshly isolated EC of DF (inner aortic arch) and UF (descending thoracic aorta) regions of normal adult pigs was used to profile differential gene expression reflecting the steady state in vivo. By using human cDNA arrays, approximate to2,000 putatively differentially expressed genes were identified through false-discovery-rate statistical methods. A sampling of these genes was validated by quantitative real-time PCR and/or immunostaining en face. Biological pathway analysis revealed that in DF there was up-regulation of several broad-acting inflammatory cytokines and receptors, in addition to elements of the NF-kappaB system, which is consistent with a proinflammatory phenotype. However, the NF-kappaB complex was predominantly cytoplasmic (inactive) in both regions, and no significant differences were observed in the expression of key adhesion molecules for inflammatory cells associated with early atherogenesis. Furthermore, there was no histological evidence of inflammation. Protective profiles were observed in DF regions, notably an enhanced antioxidative gene expression. This study provides a public database of regional EC gene expression in a normal animal, implicates hemodynamics as a contributory mechanism to athero-susceptibility, and reveals the coexistence of pro- and antiatherosclerotic transcript profiles in susceptible regions. The introduction of additional risk factors may shift this balance to favor lesion development.
C1 Univ Penn, Inst Med & Engn, Vagelos Labs 1010, Philadelphia, PA 19104 USA.
Univ Penn, Dept Bioengn, Philadelphia, PA 19104 USA.
Univ Penn, Dept Pathol & Lab Med, Philadelphia, PA 19104 USA.
Univ Penn, Dept Genet, Philadelphia, PA 19104 USA.
Univ Penn, Ctr Bioinformat, Philadelphia, PA 19104 USA.
US FDA, Rockville, MD 20852 USA.
AstraZeneca Pharmaceut, Macclesfield SK10 4TG, Cheshire, England.
RP Davies, PF (reprint author), Univ Penn, Inst Med & Engn, Vagelos Labs 1010, 3340 Smith Walk, Philadelphia, PA 19104 USA.
EM pfd@pobox.upenn.edu
FU NHGRI NIH HHS [K25 HG002296, K25 HG000052, K25-HG-00052, K25-HG-02296];
NHLBI NIH HHS [HL62250, HL70128, P01 HL062250, P50 HL070128]
NR 49
TC 221
Z9 224
U1 1
U2 16
PU NATL ACAD SCIENCES
PI WASHINGTON
PA 2101 CONSTITUTION AVE NW, WASHINGTON, DC 20418 USA
SN 0027-8424
J9 P NATL ACAD SCI USA
JI Proc. Natl. Acad. Sci. U. S. A.
PD FEB 24
PY 2004
VL 101
IS 8
BP 2482
EP 2487
DI 10.1073/pnas.0305938101
PG 6
WC Multidisciplinary Sciences
SC Science & Technology - Other Topics
GA 802CA
UT WOS:000220140400046
PM 14983035
ER
PT J
AU Raw, AS
Yu, LX
AF Raw, AS
Yu, LX
TI Pharmaceutical solid polymorphism in drug development and regulation -
Preface
SO ADVANCED DRUG DELIVERY REVIEWS
LA English
DT Editorial Material
C1 US FDA, Ctr Drug Evaluat & Res, Off Gener Drugs, Rockville, MD 20855 USA.
RP Raw, AS (reprint author), US FDA, Ctr Drug Evaluat & Res, Off Gener Drugs, Metro Pk N 2,Room E204,7500 Standish Pl, Rockville, MD 20855 USA.
EM rawa@cder.fda.gov; yul@cder.fda.gov
RI Yu, Lawrence/L-6280-2016
NR 3
TC 22
Z9 25
U1 1
U2 8
PU ELSEVIER SCIENCE BV
PI AMSTERDAM
PA PO BOX 211, 1000 AE AMSTERDAM, NETHERLANDS
SN 0169-409X
J9 ADV DRUG DELIVER REV
JI Adv. Drug Deliv. Rev.
PD FEB 23
PY 2004
VL 56
IS 3
BP 235
EP 236
DI 10.1016/j.addr.2003.10.004
PG 2
WC Pharmacology & Pharmacy
SC Pharmacology & Pharmacy
GA 778FG
UT WOS:000189228300001
ER
PT J
AU Yu, LX
Lionberger, RA
Raw, AS
D'Costa, R
Wu, HQ
Hussain, AS
AF Yu, LX
Lionberger, RA
Raw, AS
D'Costa, R
Wu, HQ
Hussain, AS
TI Applicatlons of process analytical technology to crystallization
processes
SO ADVANCED DRUG DELIVERY REVIEWS
LA English
DT Review
DE process analytical technology; polymorphism; crystallization; in situ;
modeling; simulation; control
ID PROCESS ANALYTICAL-CHEMISTRY; SODIUM-CHLORATE CRYSTALS; SITU
RAMAN-SPECTROSCOPY; ATR-FTIR SPECTROSCOPY; PHARMACEUTICAL
CRYSTALLIZATION; INFRARED-SPECTROSCOPY; CONCENTRATION PREDICTION;
COLLOIDAL SUSPENSIONS; DITHIONATE IMPURITY; POLYMORPHIC FORMS
AB Crystallizations of pharmaceutical active ingredients, particularly those that posses multiple polymorphic forms, are among the most critical and least understood pharmaceutical manufacturing processes. Many process and product failures can be traced to a poor understanding and control of crystallization processes. The Food and Drug Administration's process analytical technology (PAT) initiative is a collaborative effort with industry to introduce new and efficient manufacturing technologies into the pharmaceutical industry. PAT's are systems for design, analysis, and control of manufacturing processes. They aim to assure high quality through timely measurements of critical quality and performance attributes of raw materials, in-process materials, and final products. Implementation of PAT involves scientifically based process design and optimization, appropriate sensor technologies, statistical and information tools (chemometrics), and feedback process control strategies working together to produce quality products. This review introduces the concept of PAT and discusses its application to crystallization processes through review of several case studies. A variety of in situ analytical methods combined with chemometric tools for analysis of multivariate process information provide a basis for future improvements in modeling, simulation, and control of crystallization processes. (C) 2003 Elsevier B.V. All fights reserved.
C1 US FDA, Ctr Drug Evaluat & Res, Off Pharmaceut Sci, Rockville, MD 20857 USA.
US FDA, Ctr Drug Evaluat & Res, Off Pharmaceut Sci, Off Gener Drugs, Rockville, MD 20857 USA.
RP Hussain, AS (reprint author), US FDA, Ctr Drug Evaluat & Res, Off Pharmaceut Sci, 5600 Fishers Lane, Rockville, MD 20857 USA.
EM hussaina@cder.fda.gov
NR 48
TC 162
Z9 165
U1 5
U2 75
PU ELSEVIER SCIENCE BV
PI AMSTERDAM
PA PO BOX 211, 1000 AE AMSTERDAM, NETHERLANDS
SN 0169-409X
J9 ADV DRUG DELIVER REV
JI Adv. Drug Deliv. Rev.
PD FEB 23
PY 2004
VL 56
IS 3
BP 349
EP 369
DI 10.1016/j.addr.2003.10.012
PG 21
WC Pharmacology & Pharmacy
SC Pharmacology & Pharmacy
GA 778FG
UT WOS:000189228300008
PM 14962586
ER
PT J
AU Raw, AS
Furness, MS
Gill, DS
Adams, RC
Holcombe, FO
Yu, LX
AF Raw, AS
Furness, MS
Gill, DS
Adams, RC
Holcombe, FO
Yu, LX
TI Regulatory considerations of pharmaceutical solid polymorphism in
abbreviated new drug applications (ANDAs)
SO ADVANCED DRUG DELIVERY REVIEWS
LA English
DT Review
DE polymorphism; polymorph; abbreviated new drug application (ANDA); drug
substance; drug product; pharmaceutical solid
ID ENALAPRIL MALEATE; SOLUTION CALORIMETRY; TABLET FORMULATION; FORM-II;
CARBAMAZEPINE; BIOAVAILABILITY; TRANSFORMATION; CLASSIFICATION;
STABILIZATION; SPECTROSCOPY
AB A sponsor of an Abbreviated New Drug Application (ANDA) must have information to show that the proposed generic product and the innovator product are both pharmaceutically equivalent and bioequivalent, and therefore, therapeutically equivalent. Many pharmaceutical solids exist in several crystalline forms and thus exhibit polymorphism. Polymorphism may result in differences in the physico-chemical properties of the active ingredient and variations in these properties may render a generic drug product to be bioinequivalent to the innovator brand. For this reason, in ANDAs, careful attention is paid to the effect of polymorphism in the context of generic drug product equivalency. This review discusses the impact of polymorphism on drug product manufacturability, quality, and performance. Conclusions from this analysis demonstrate that pharmaceutical solid polymorphism has no relevance to the determination of drug substance "sameness" in ANDAs. Three decision trees for solid oral dosage forms or liquid suspensions are provided for evaluating when and how polymorphs of drug substances should be monitored and controlled in ANDA submissions. Case studies from ANDAs are provided which demonstrate the irrelevance of polymorphism to the determination of drug substance "sameness". These case studies also illustrate the conceptual framework from these decision trees and illustrate how their general principles are sufficient to assure both the quality and the therapeutic equivalence of marketed generic drug products. (C) 2003 Elsevier B.V. All rights reserved.
C1 US FDA, Ctr Drug Evaluat & Res, Off Gener Drugs, Rockville, MD 20855 USA.
RP Raw, AS (reprint author), US FDA, Ctr Drug Evaluat & Res, Off Gener Drugs, Metro Pk N 2,Room E204,7500 Standish Pl, Rockville, MD 20855 USA.
EM rawa@cder.fda.gov
RI Yu, Lawrence/L-6280-2016
NR 64
TC 73
Z9 80
U1 7
U2 35
PU ELSEVIER SCIENCE BV
PI AMSTERDAM
PA PO BOX 211, 1000 AE AMSTERDAM, NETHERLANDS
SN 0169-409X
J9 ADV DRUG DELIVER REV
JI Adv. Drug Deliv. Rev.
PD FEB 23
PY 2004
VL 56
IS 3
BP 397
EP 414
DI 10.1016/j.addr.2003.10.011
PG 18
WC Pharmacology & Pharmacy
SC Pharmacology & Pharmacy
GA 778FG
UT WOS:000189228300011
PM 14962589
ER
PT J
AU Lopez, H
Beer, JZ
Miller, SA
Zmudzka, BZ
AF Lopez, H
Beer, JZ
Miller, SA
Zmudzka, BZ
TI Ultrasound measurements of skin thickness after UV exposure: a
feasibility study
SO JOURNAL OF PHOTOCHEMISTRY AND PHOTOBIOLOGY B-BIOLOGY
LA English
DT Article
DE ultraviolet radiation; ultrasound; human skin; skin exposure; dermis;
epidermis; skin thickness
ID HIGH-FREQUENCY ULTRASOUND; ULTRAVIOLET-IRRADIATION; IN-VIVO; ERYTHEMA;
PIGMENTATION; INFLAMMATION; RADIATION; HUMANS; AGE; US
AB High-frequency ultrasound images were used to measure the thickness of the dermis and epidermis of four human subjects. These measurements were performed before and after a single exposure to ultraviolet radiation (UV). Doses ranging from 0.5 to 3 minimal erythema doses (MED) were delivered to the skin of the back of four human subjects, and thickness measurements were made over a period of 16 days. We found: (1) exposures greater than or equal to 2 MED caused a 10-30% increase in the thickness of the dermis-epidermis layer; (2) the thickening response was not always in direct proportion to the UV dose; (3) maximum thickening response time was 48 h for the 2.8-3.0 MED exposure levels; (4) "diffusion" or spreading of the thickening response to neighboring areas occurred in some cases, as far as 4 cm from the exposed region (center-to-center), with changes ranging from 12% to 17%; (5) decreased thickness of the dermis-epidermis layer of up to 12% was observed for 3 out of 4 of the subjects. (C) 2003 Elsevier B.V. All rights reserved.
C1 US FDA, Dept Hlth & Human Serv, Ctr Devices & Radiol Hlth, Off Sci & Technol, Rockville, MD 20850 USA.
RP Lopez, H (reprint author), US FDA, Dept Hlth & Human Serv, Ctr Devices & Radiol Hlth, Off Sci & Technol, 9200 Corp Blvd,HFZ-132, Rockville, MD 20850 USA.
EM hx18@cdrh.fda.gov
NR 24
TC 3
Z9 3
U1 2
U2 3
PU ELSEVIER SCIENCE SA
PI LAUSANNE
PA PO BOX 564, 1001 LAUSANNE, SWITZERLAND
SN 1011-1344
J9 J PHOTOCH PHOTOBIO B
JI J. Photochem. Photobiol. B-Biol.
PD FEB 20
PY 2004
VL 73
IS 3
BP 123
EP 132
DI 10.1016/j.jphotobiol.2003.11.004
PG 10
WC Biochemistry & Molecular Biology; Biophysics
SC Biochemistry & Molecular Biology; Biophysics
GA 800TN
UT WOS:000220050700001
PM 14975400
ER
PT J
AU Walker, RI
Blanchard, T
Braun, JM
Cebra, JJ
Cross, AS
Fattom, A
Giannasca, PJ
Holder, IA
Huebner, J
Matthews, R
Pier, GB
Romani, L
von Specht, BU
AF Walker, RI
Blanchard, T
Braun, JM
Cebra, JJ
Cross, AS
Fattom, A
Giannasca, PJ
Holder, IA
Huebner, J
Matthews, R
Pier, GB
Romani, L
von Specht, BU
TI Meeting summary - Possibilities for active and passive vaccination
against opportunistic infections
SO VACCINE
LA English
DT Editorial Material
C1 US FDA, Ctr Biol Evaluat & Res, Rockville, MD 20851 USA.
RP Walker, RI (reprint author), US FDA, Ctr Biol Evaluat & Res, 1401 Rockville Pike,HFM 425, Rockville, MD 20851 USA.
EM walkerri@cber.fda.gov
RI Braun, Jan/B-1001-2009;
OI Pier, Gerald/0000-0002-9112-2331
NR 0
TC 1
Z9 1
U1 0
U2 0
PU ELSEVIER SCI LTD
PI OXFORD
PA THE BOULEVARD, LANGFORD LANE, KIDLINGTON, OXFORD OX5 1GB, OXON, ENGLAND
SN 0264-410X
J9 VACCINE
JI Vaccine
PD FEB 17
PY 2004
VL 22
IS 7
BP 801
EP 804
DI 10.1016/j.vaccine.2003.11.042
PG 4
WC Immunology; Medicine, Research & Experimental
SC Immunology; Research & Experimental Medicine
GA 778GL
UT WOS:000189231100001
PM 15040930
ER
PT J
AU Kirma, N
Ferreira, JL
Baumstark, BR
AF Kirma, N
Ferreira, JL
Baumstark, BR
TI Characterization of six type A strains of Clostridium botulinum that
contain type B toxin gene sequences
SO FEMS MICROBIOLOGY LETTERS
LA English
DT Article
DE Clostridium botulinum; neurotoxin gene sequence; polymerase chain
reaction
ID NUCLEOTIDE-SEQUENCE; INFANT BOTULISM; NEUROTOXIN GENE; CLONING
AB Six Clostridium botulinum isolates exhibiting type A toxicity as measured by the mouse bioassay were found to contain both type A and type B neurotoxin DNA sequences. The six strains were divided into three groups based on the DNA sequence of the type B neurotoxin gene. Members of each group exhibited 100% sequence identity over the 3876 by type B toxin open reading frame. The type B toxin sequence of all groups differed at more than 60 positions when compared to the BGB control strain. (C) 2003 Federation of European Microbiological Societies. Published by Elsevier B.V. All rights reserved.
C1 Georgia State Univ, Dept Biol, Atlanta, GA 30302 USA.
Food & Drug Adm, Atlanta, GA 30309 USA.
RP Kirma, N (reprint author), Emory Univ, Sch Med, Div Endocrinol & Metab, 1639 Pierce Dr,WMB 1331, Atlanta, GA 30322 USA.
EM nkirma@emory.edu
NR 17
TC 20
Z9 21
U1 0
U2 0
PU ELSEVIER SCIENCE BV
PI AMSTERDAM
PA PO BOX 211, 1000 AE AMSTERDAM, NETHERLANDS
SN 0378-1097
J9 FEMS MICROBIOL LETT
JI FEMS Microbiol. Lett.
PD FEB 16
PY 2004
VL 231
IS 2
BP 159
EP 164
DI 10.1016/S0378-1097(03)00911-X
PG 6
WC Microbiology
SC Microbiology
GA 778LN
UT WOS:000189243200002
PM 14987759
ER
PT J
AU Williams, TL
Callahan, JH
Monday, SR
Feng, PCH
Musser, SM
AF Williams, TL
Callahan, JH
Monday, SR
Feng, PCH
Musser, SM
TI Relative quantitation of intact proteins of bacterial cell extracts
using coextracted proteins as internal standards
SO ANALYTICAL CHEMISTRY
LA English
DT Article
ID PERFORMANCE LIQUID-CHROMATOGRAPHY; DESORPTION/IONIZATION
MASS-SPECTROMETRY; NONPOROUS RP HPLC; COMPARATIVE PROTEOMICS; RAPID
IDENTIFICATION; GEL-ELECTROPHORESIS; MAPPING METHOD; PHASE; SEPARATION;
EXPRESSION
AB A method for quantitating protein expression using LC/MS of whole proteins is described. This method is based on the fact that some proteins present in cells are abundant universal proteins whose expression levels exhibit little variation. This method demonstrates that these coextracted proteins can be used as internal standards to which the other proteins in the sample can be compared. By comparing the intensities of a selected protein to marker proteins, or internal standards, a relative ratio is obtained. This ratio can then be used to determine the relative amount of protein expression between cellular extracts. The validity of this approach is described for a standard protein mixture, as well as, E. coli cells that were known to differentially express green fluorescent protein.
C1 US FDA, Ctr Food Safety & Appl Nutr, College Pk, MD 20740 USA.
RP Williams, TL (reprint author), US FDA, Ctr Food Safety & Appl Nutr, College Pk, MD 20740 USA.
EM tracie.williams@cfsan.fda.gov
NR 29
TC 12
Z9 12
U1 0
U2 6
PU AMER CHEMICAL SOC
PI WASHINGTON
PA 1155 16TH ST, NW, WASHINGTON, DC 20036 USA
SN 0003-2700
J9 ANAL CHEM
JI Anal. Chem.
PD FEB 15
PY 2004
VL 76
IS 4
BP 1002
EP 1007
DI 10.1021/ac034820g
PG 6
WC Chemistry, Analytical
SC Chemistry
GA 776QC
UT WOS:000189127100018
PM 14961731
ER
PT J
AU Cohen, MH
Williams, GA
Sridhara, R
Chen, G
McGuinn, WD
Morse, D
Abraham, S
Rahman, A
Liang, CY
Lostritto, R
Baird, A
Pazdur, R
AF Cohen, MH
Williams, GA
Sridhara, R
Chen, G
McGuinn, WD
Morse, D
Abraham, S
Rahman, A
Liang, CY
Lostritto, R
Baird, A
Pazdur, R
TI United States Food and Drug Administration drug approval summary:
Gefitinib (ZD1839; Iressa) tablets
SO CLINICAL CANCER RESEARCH
LA English
DT Article
ID EPIDERMAL-GROWTH-FACTOR; RECEPTOR TYROSINE KINASE; INHIBITOR; ANTISENSE;
CARCINOMA
AB On May 5, 2003, gefitinib (Iressa; ZD1839) 250-mg tablets (AstraZeneca Inc.) received accelerated approval by the United States Food and Drug Administration as monotherapy for patients with locally advanced or metastatic non-small cell lung cancer after failure of both platinum-based and docetaxel chemotherapies. Information provided in this summary includes chemistry manufacturing and controls, clinical pharmacology, and clinical trial efficacy and safety results. Gefitinib is an anilinoquinazoline compound with the chemical name 4-quinazolinamine,N-(3-chloro-4-flurophenyl)-7-methoxy-6-[3-(4-morpholinyl)propoxy]. It has the molecular formula C22H24ClFN4O3. Gefitinib is often referred to as a "specific" or "selective" inhibitor of epidermal growth factor receptor. Studies demonstrate, however, that gefitinib inhibits the activity of other intracellular transmembrane tyrosine-specific protein kinases at concentrations similar to those at which it inhibits the epidermal growth factor signal. Maximum plasma concentrations resulting from clinically relevant doses are 0.5-1 mum or more, well within the IC50 values of several tyrosine kinases. No clinical studies have been performed that demonstrate a correlation between epidermal growth factor receptor expression and response to gefitinib. Gefitinib is 60% available after oral administration and is widely distributed throughout the body. Gefitinib is extensively metabolized in the liver by cytochrome P450 3A4 enzyme. Over a 10-day period., approximately 86% of an orally administered radioactive dose is recovered in the feces, with <4% of the dose in the urine. After daily oral administration, steady-state plasma levels are reached in 10 days and are 2-fold higher than those achieved after single doses. Gefitinib effectiveness was demonstrated in a randomized, double-blind, Phase II, multicenter trial comparing two oral doses of gefitinib (250 versus 500 mg/day). A total of 216 patients were enrolled. The 142 patients who were refractory to or intolerant of a platinum and docetaxel comprised the evaluable population for the efficacy analysis. A partial tumor response occurred in 14% (9 of 66) of patients receiving 250 mg/day gefitinib and in 8% (6 of 76) of patients receiving 500 mg/day gefitinib. The overall objective response rate (RR) for both doses combined was 10.6% (15 of 142 patients; 95% confidence interval, 6.0-16.8%). Responses were more frequent in females and in nonsmokers. The median duration of response was 7.0 months (range, 4.6-18.6+ months). Other submitted data included the results of two large trials conducted in chemotherapy-naive, stage III and IV non-small cell lung cancer patients. Patients were randomized to receive gefitinib (250 or 500 mg daily) or placebo, in combination with either gemcitabine plus cisplatin (n = 1093) or carboplatin plus paclitaxel (n = 1037). Results from this study showed no benefit (RR, time to progression, or survival) from adding gefitinib to chemotherapy. Consequently, gefinitib is only recommended for use as monotherapy. Common adverse events associated with gefitinib treatment included diarrhea, rash, acne, dry skin, nausea, and vomiting. Interstitial lung disease has been observed in patients receiving gefitinib. Worldwide, the incidence of interstitial lung disease was about 1% (2% in the Japanese postmarketing experience and about 0.3% in a United States expanded access program).
Approximately one-third of the cases have been fatal.
Gefitinib was approved under accelerated approval regulations on the basis of a surrogate end point, RR. No controlled gefitinib trials, to date, demonstrate a clinical benefit, such as improvement in disease-related symptoms or increased survival. Accelerated approval regulations require the sponsor to conduct additional studies to verify that gefitinib therapy produces such benefit.
C1 US FDA, Div Oncol Drug Prod, Ctr Drug Evaluat & res, Rockville, MD 20857 USA.
RP US FDA, Div Oncol Drug Prod, Ctr Drug Evaluat & res, HFD 150,5600 Fishers Lane, Rockville, MD 20857 USA.
EM cohenma@cder.fda.gov
NR 14
TC 304
Z9 316
U1 0
U2 19
PU AMER ASSOC CANCER RESEARCH
PI PHILADELPHIA
PA 615 CHESTNUT ST, 17TH FLOOR, PHILADELPHIA, PA 19106-4404 USA
SN 1078-0432
EI 1557-3265
J9 CLIN CANCER RES
JI Clin. Cancer Res.
PD FEB 15
PY 2004
VL 10
IS 4
BP 1212
EP 1218
DI 10.1158/1078-0432.CCR-03-0564
PG 7
WC Oncology
SC Oncology
GA 776JE
UT WOS:000189112200003
PM 14977817
ER
PT J
AU Liang, XJ
Yin, JJ
Zhou, JW
Wang, PC
Taylor, B
Cardarelli, C
Kozar, M
Forte, R
Aszalos, A
Gottesman, MM
AF Liang, XJ
Yin, JJ
Zhou, JW
Wang, PC
Taylor, B
Cardarelli, C
Kozar, M
Forte, R
Aszalos, A
Gottesman, MM
TI Changes in biophysical parameters of plasma membranes influence
cisplatin resistance of sensitive and resistant epidermal carcinoma
cells
SO EXPERIMENTAL CELL RESEARCH
LA English
DT Article
DE cisplatin resistance; heptadecanoic acid; plasma membrane fluidity;
membrane potential; fluorescence polarization; human epidermal carcinoma
KB cells
ID MULTIDRUG-RESISTANCE; INDUCED APOPTOSIS; DNA DAMAGE; LINES;
ACCUMULATION; PACKING; DRUGS; ACID
AB The mechanism of resistance of cancer cells to the anticancer drug cisplatin is not fully understood. Using cisplatin-sensitive KB-3-1 and -resistant KCP-20 cells, we found that the resistant cells have higher membrane potential, as determined by membrane potential sensing oxonol dye. Electron spin resonance and fluorescence polarization studies revealed that the-resistant cells have more "fluid" plasma membranes than the sensitive cells. Because of this observed difference in membrane "fluidity," we attempted modification of the plasma membrane fluidity by the incorporation of heptadecanoic acid into KB-3-1 and KCP-20 cell membranes. We found that such treatment resulted in increased heptadecanoic acid content and increased fluidity in the plasma membranes of both cell types, and also resulted in increased cisplatin resistance in the KCP-20 cells. This finding is in accord with our results, which showed that the cisplatin-resistant KCP-20 cells have more fluid membranes than the cisplatin-sensitive KB-3-1 cells. It remains to be determined whether the observed differences in biophysical status and/or fatty acid composition alone, or the secondary effect of these differences on the structure or function of some transmembrane protein(s), is the reason for increased cisplatin resistance. (C) 2003 Elsevier Inc. All rights reserved.
C1 NCI, Cell Biol Lab, Canc Res Ctr, NIH, Bethesda, MD 20892 USA.
US FDA, Instrumentat & Biophys Branch, Ctr Food Safety & Appl Nutr, College Pk, MD 20740 USA.
Howard Univ, Dept Radiol, Washington, DC 20060 USA.
Walter Reed Army Inst Res, Div Expt Therapeut, Silver Spring, MD 20910 USA.
RP Gottesman, MM (reprint author), NCI, Cell Biol Lab, Canc Res Ctr, NIH, Room 1A-09,37 Convent Dr, Bethesda, MD 20892 USA.
EM mgottesman@nih.gov
RI Kozar, Michael/A-9155-2011; Yin, Jun Jie /E-5619-2014
NR 31
TC 18
Z9 26
U1 0
U2 10
PU ACADEMIC PRESS INC ELSEVIER SCIENCE
PI SAN DIEGO
PA 525 B ST, STE 1900, SAN DIEGO, CA 92101-4495 USA
SN 0014-4827
J9 EXP CELL RES
JI Exp. Cell Res.
PD FEB 15
PY 2004
VL 293
IS 2
BP 283
EP 291
DI 10.1016/j.yexcr.2003.10.012
PG 9
WC Oncology; Cell Biology
SC Oncology; Cell Biology
GA 767QB
UT WOS:000188462700011
PM 14729466
ER
PT J
AU Nayak, R
Stewart, T
Wang, RF
Lin, J
Cerniglia, CE
Kenney, PB
AF Nayak, R
Stewart, T
Wang, RF
Lin, J
Cerniglia, CE
Kenney, PB
TI Genetic diversity and virulence gene determinants of
antibiotic-resistant Salmonella isolated from preharvest turkey
production sources
SO INTERNATIONAL JOURNAL OF FOOD MICROBIOLOGY
LA English
DT Article
DE Salmonella; molecular typing; antibiotic resistance; Turkey
ID POLYMERASE CHAIN-REACTION; PRODUCTION FACILITY; FOOD ANIMALS;
TYPHIMURIUM; ENTERITIDIS; ENTERICA; INVA; PCR; SEQUENCE; SEROVARS
AB This study evaluated the molecular diversity of 29 Salmonella serotypes isolated from turkey ceca and the production environment. Isolates were resistant to bacitracin (100%), erythromycin (100%), novobiocin (100%), rifampin (100%), streptomycin (62%), gentamicin (52%), spectinomycin (48%), tetracycline (31%), sulfamethoxazole/trimethoprim (SXT) (3%) and tobramycin (3%). The minimum inhibitory concentration (MIC) values ranged from 32 to greater than or equal to 1024 mug/ml. The pulsed-field gel electrophoresis (PFGE) and ribotyping patterns were identical within each of the scrotypes Heidelberg, Worthington and Muenster. The plasmid profiles were identical within each of the Salmonella serotypes. Two different clones of Salmonella anatum were differentiated by PFGE typing but not by ribotyping. Heidelberg isolates from nine turkey ceca and three drinker samples had identical antibiotic resistance, PFGE, ribotype and plasmid patterns, Suggesting that transmission of this particular clone may have occurred between the birds and the drinkers. Identical PFGE, ribotype and plasmid patterns were observed ill one Salmonella worthington isolate from turkey ceca in one flock and two S. worthington isolates front feeder contents and drinkers from a subsequent flock, suggesting transmission of this pathogen between flocks. Individual and Multiple polymerase chain reaction (PCR) analyses revealed the presence of the virulence genes invA, aceK and sopB and the absence of the h-1i gene in all isolates. A combination of genotypic and phenotypic markers can be useful in studying genetic variation among natural salmonellae Populations in turkey production and delineating possible transmission pathways. (C) 2003 Elsevier B.V. All rights reserved.
C1 US FDA, Natl Ctr Toxicol Res, Div Microbiol, Jefferson, AR 72079 USA.
US FDA, Pacific Reg Lab SW, Los Angeles, CA 90015 USA.
W Virginia Univ, Div Anim & Vet Sci, Morgantown, WV 26505 USA.
RP Nayak, R (reprint author), US FDA, Natl Ctr Toxicol Res, Div Microbiol, Jefferson, AR 72079 USA.
EM RNayak@nctr.fda.gov
NR 39
TC 41
Z9 43
U1 0
U2 7
PU ELSEVIER SCIENCE BV
PI AMSTERDAM
PA PO BOX 211, 1000 AE AMSTERDAM, NETHERLANDS
SN 0168-1605
J9 INT J FOOD MICROBIOL
JI Int. J. Food Microbiol.
PD FEB 15
PY 2004
VL 91
IS 1
BP 51
EP 62
DI 10.1016/S0168-1605(03)00330-1
PG 12
WC Food Science & Technology; Microbiology
SC Food Science & Technology; Microbiology
GA 780PG
UT WOS:000189389700006
PM 14967560
ER
PT J
AU Sheikh, F
Baurin, VV
Antes, A
Shah, NK
Smirnov, SV
Anantha, S
Dickensheets, H
Dumoutier, L
Renauld, JC
Zdanov, A
Donnelly, RP
Kotenko, SV
AF Sheikh, F
Baurin, VV
Antes, A
Shah, NK
Smirnov, SV
Anantha, S
Dickensheets, H
Dumoutier, L
Renauld, JC
Zdanov, A
Donnelly, RP
Kotenko, SV
TI Cutting edge: IL-26 signals through a novel receptor complex composed of
IEL-20 receptor 1 and IL-10 receptor 2
SO JOURNAL OF IMMUNOLOGY
LA English
DT Article
ID II CYTOKINE RECEPTOR; INDUCIBLE FACTOR; INTERLEUKIN-10; IDENTIFICATION;
CLONING; FAMILY; HOMOLOG; CHAIN; CELLS
C1 Univ Med & Dent New Jersey, New Jersey Med Sch, Dept Biochem & Mol Biol, Newark, NJ 07103 USA.
US FDA, Ctr Biol Evaluat & Res, Div Therapeut Prot, Bethesda, MD 20892 USA.
NCI, Prot Struct Sect, Macromol Crystallog Lab, Canc Res Ctr,NIH, Ft Detrick, MD 21702 USA.
Univ Louvain, Ludwig Inst Canc Res, Brussels, Belgium.
Univ Louvain, Expt Med Unit, Christian De Duvre Inst Cellular Pathol, Brussels, Belgium.
RP Kotenko, SV (reprint author), Univ Med & Dent New Jersey, New Jersey Med Sch, Dept Biochem & Mol Biol, 185 S Orange Ave,Room E-641, Newark, NJ 07103 USA.
EM kotenkse@umdnj.edu
FU NIAID NIH HHS [R01 AI51139, R01 AI051139]
NR 22
TC 93
Z9 106
U1 1
U2 7
PU AMER ASSOC IMMUNOLOGISTS
PI BETHESDA
PA 9650 ROCKVILLE PIKE, BETHESDA, MD 20814 USA
SN 0022-1767
J9 J IMMUNOL
JI J. Immunol.
PD FEB 15
PY 2004
VL 172
IS 4
BP 2006
EP 2010
PG 5
WC Immunology
SC Immunology
GA 771LZ
UT WOS:000188788600004
PM 14764663
ER
PT J
AU Yu, LX
Carlin, AS
Amidon, GL
Hussain, AS
AF Yu, LX
Carlin, AS
Amidon, GL
Hussain, AS
TI Feasibility studies of utilizing disk intrinsic dissolution rate to
classify drugs
SO INTERNATIONAL JOURNAL OF PHARMACEUTICS
LA English
DT Article
DE disk intrinsic dissolution rate; biopharmaceutics classification system;
dissolution; solubility
ID CLASSIFICATION
AB The purpose of this report was to investigate the feasibility of using disk intrinsic dissolution rate (DIDR) to determine solubility class membership. We employed a VanKel dissolution apparatus fitted with a Wood's intrinsic dissolution die. To test the robustness of the method, variations of DIDR with compression force, dissolution volume, distance of the drug disk from the bottom of the dissolution vessel, and drug disk rotation speed were studied using furosemide and metoprolol in pH 4.5 acetate buffer as a model system. The DIDRs of six low solubility and nine high solubility model drugs were then determined at pH 1.2, 4.5, and 6.8 and compared to their BCS solubility class membership. It was found that the compression force, dissolution medium volume, and die position had no significant effect on DIDR for the system studied. The proposed compression force, dissolution volume, die position, and rotation speed are 2000 psi, 900 ml, 0.5 in., and 100 rpm, respectively. The test results obtained from 15 model BCS drugs show a good relationship between the DIDR and BCS solubility classification with 0.1 mg/min/cm(2) as a class boundary unless the dose is either extremely low or high where discrepancies may exist between the solubility and DIDR methods. Therefore, more scientific research and debates are needed before considered for regulatory purpose. (C) 2003 Published by Elsevier B.V.
C1 US FDA, Off Pharmaceut Sci, Ctr Drug Evaluat & Res, Rockville, MD 20857 USA.
Univ Michigan, Coll Pharm, Dept Pharmaceut, Ann Arbor, MI 48109 USA.
RP Yu, LX (reprint author), US FDA, Off Pharmaceut Sci, Ctr Drug Evaluat & Res, 5600 Fishers Lane, Rockville, MD 20857 USA.
EM yul@cder.fda.gov
NR 14
TC 80
Z9 84
U1 2
U2 16
PU ELSEVIER SCIENCE BV
PI AMSTERDAM
PA PO BOX 211, 1000 AE AMSTERDAM, NETHERLANDS
SN 0378-5173
J9 INT J PHARM
JI Int. J. Pharm.
PD FEB 11
PY 2004
VL 270
IS 1-2
BP 221
EP 227
DI 10.1016/j.ijpharm.2003.10.016
PG 7
WC Pharmacology & Pharmacy
SC Pharmacology & Pharmacy
GA 768BY
UT WOS:000188509400021
PM 14726137
ER
PT J
AU Yu, HN
Yin, JJ
Shen, SR
AF Yu, HN
Yin, JJ
Shen, SR
TI Growth inhibition of prostate cancer cells by epigallocatechin gallate
in the presenceof Cu2+
SO JOURNAL OF AGRICULTURAL AND FOOD CHEMISTRY
LA English
DT Article
DE Epigallocatechin gallate Cu2+; PCA cells; chemiluminescence intensity;
free radicals
ID GREEN TEA; (-)-EPIGALLOCATECHIN GALLATE; METAL-IONS; CATECHINS;
CONSTITUENT; COPPER
AB Green tea is an effective chemopreventive agent to human prostate cancer adenoma (PCA). Epigallocatechin gallate (EGCG) inhibited the growth of PCA cells and induced apoptosis. Cu2+ is a trace element necessary to our health. Many studies proved that bioactivity of EGCG is altered in the presence of Cu2+. We investigated the effects of EGCG on PCA cells in the presence of Cu2+. Also, we explored potential mechanisms via measurement of the relative chemiluminescence of growth medium for PCA cells. Chemiluminscence can be an indication of free radicals. Our test results showed that the addition of EGCG and Cu2+ to the growth medium decreased the relative viability of androgen-sensitive and androgen-insensitive human prostate cancer cells. However, the effects of EGCG on PCA cells depended on (1) the relative concentrations of added EGCG and Cu2+ and (2) their order of addition. Our results indicated that few free radicals may be generated in vitro. If so, free radicals generated intracellularly may be a major factor behind apoptosis and growth inhibition observed in the PCA cells. Thus, EGCG might exert its effects intracellularly.
C1 Zhejiang Univ, Dept Tea Sci, Hangzhou 310029, Peoples R China.
US FDA, Ctr Food Safety & Appl Nutr, College Pk, MD 20740 USA.
RP Shen, SR (reprint author), Zhejiang Univ, Dept Tea Sci, Hangzhou 310029, Peoples R China.
EM shrshen@zju.edu.cn
RI Yin, Jun Jie /E-5619-2014
NR 24
TC 30
Z9 36
U1 0
U2 2
PU AMER CHEMICAL SOC
PI WASHINGTON
PA 1155 16TH ST, NW, WASHINGTON, DC 20036 USA
SN 0021-8561
J9 J AGR FOOD CHEM
JI J. Agric. Food Chem.
PD FEB 11
PY 2004
VL 52
IS 3
BP 462
EP 466
DI 10.1021/jf035057u
PG 5
WC Agriculture, Multidisciplinary; Chemistry, Applied; Food Science &
Technology
SC Agriculture; Chemistry; Food Science & Technology
GA 772FH
UT WOS:000188830300010
PM 14759133
ER
PT J
CA US Dept Agr
US Food Drug Adm
CDC
TI Bovine spongiform encephalopathy in a dairy cow - Washington State, 2003
(Reprinted from MMWR, vol 52, pg 1280-1285, 2004)
SO JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION
LA English
DT Reprint
C1 Anim & Plant Hlth Inspect Serv, USDA, Washington, DC 20250 USA.
Food Safety & Inspect Serv, USDA, Washington, DC 20250 USA.
CDC, Div Vital Stat, Natl Ctr Hlth Stat, Atlanta, GA 30333 USA.
CDC, Div Viral & Rickettsial Dis, Natl Ctr Infect Dis, Atlanta, GA 30333 USA.
US FDA, Rockville, MD 20857 USA.
RP Anim & Plant Hlth Inspect Serv, USDA, Washington, DC 20250 USA.
NR 1
TC 0
Z9 0
U1 0
U2 0
PU AMER MEDICAL ASSOC
PI CHICAGO
PA 330 N WABASH AVE, STE 39300, CHICAGO, IL 60611-5885 USA
SN 0098-7484
EI 1538-3598
J9 JAMA-J AM MED ASSOC
JI JAMA-J. Am. Med. Assoc.
PD FEB 4
PY 2004
VL 291
IS 5
BP 553
EP 555
PG 3
WC Medicine, General & Internal
SC General & Internal Medicine
GA 769LC
UT WOS:000188650700006
ER
PT J
AU Duffy, PH
Lewis, SM
Mayhugh, MA
Trotter, RW
Thorn, BT
Feuers, RJ
Turturro, A
AF Duffy, PH
Lewis, SM
Mayhugh, MA
Trotter, RW
Thorn, BT
Feuers, RJ
Turturro, A
TI The effects of different levels of dietary restriction on non-neoplastic
diseases in male Sprague-Dawley rats
SO AGING CLINICAL AND EXPERIMENTAL RESEARCH
LA English
DT Article
DE aging; dietary restriction; non-neoplastic diseases; rats
ID CHRONIC CALORIC RESTRICTION; FISCHER-344 RATS; BODY-WEIGHT; DOSE LEVELS;
AD-LIBITUM; LIFE-SPAN; SURVIVAL; PATHOLOGY; GROWTH; INITIATION
AB Background and aims: The primary purpose of the present study was to investigate the effects of 10, 25, and 40% dietary restriction (DR) on non-neoplastic diseases in rodents at 58 and 110 weeks of age, and to determine whether low-level DR (10 and 25%) can increase the survival rate and decrease variability in chronic bioassay studies. Methods: Male Sprague-Dawley (SD) rats (NCTR colony) were divided into four nutritional groups, consisting of an ad libitum (AL) group with unlimited access to the NIH-31 diet, and three dietary restricted (DR) groups given the NIH-31 diet reduced in amount by 10, 25, and 40%. Results: At 110 weeks of age, the incidence of cardiomyopathy was 95, 75, 45, and 15% for AL and 10, 25, and 40% DR rats, respectively; the incidence of nephropathy was 55, 20, 15, and 0% for AL and 10, 25, and 40% DR rats, respectively. The severity of chronic heart and kidney diseases was significantly reduced in all DR rat groups, with significant DR-dependent linear trends for these diseases. Moreover, DR prevented the progression of skin irritation to foot ulcers, and reduced the age-related degeneration in the adrenal, lacrimal, and thymus glands, and the liver. Conclusions: These results clearly indicate that even low DR levels were effective in preventing or slowing the progression of these non-neoplastic diseases. (C) 2004, Editrice Kurtis.
C1 Natl Ctr Toxicol Res, Div Genet & Reprod Toxicol, Jefferson, AR 72079 USA.
Bionet Corp, Jefferson, AR USA.
Pathol Associates Int, Jefferson, AR USA.
ROW Sci Inc, Jefferson, AR USA.
US FDA, Natl Ctr Toxicol Res, Div Biometry, Jefferson, AR 72079 USA.
US FDA, Div Chem, Jefferson, AR 72079 USA.
RP Duffy, PH (reprint author), Natl Ctr Toxicol Res, Div Genet & Reprod Toxicol, 3900 NCTR Rd, Jefferson, AR 72079 USA.
EM pduffy@nctr.fda.gov
NR 31
TC 11
Z9 11
U1 0
U2 0
PU EDITRICE KURTIS S R L
PI MILAN
PA VIA LUIGI ZOJA 30, 20153 MILAN, ITALY
SN 1594-0667
J9 AGING CLIN EXP RES
JI Aging Clin. Exp. Res.
PD FEB
PY 2004
VL 16
IS 1
BP 68
EP 78
PG 11
WC Geriatrics & Gerontology
SC Geriatrics & Gerontology
GA 810RN
UT WOS:000220721500012
PM 15132295
ER
PT J
AU Wuilloud, JCA
Gratz, SR
Gamble, BM
Wolnik, KA
AF Wuilloud, JCA
Gratz, SR
Gamble, BM
Wolnik, KA
TI Simultaneous analysis of hepatotoxic pyrrolizidine alkaloids and
N-oxides in comfrey root by LC-ion trap mass spectrometry
SO ANALYST
LA English
DT Article
ID PERFORMANCE LIQUID-CHROMATOGRAPHY; COUNTERCURRENT CHROMATOGRAPHY;
RUSSIAN COMFREY; BORAGINACEAE
AB The purpose of the current study was to develop a LC-MSn method for the analysis of pyrrolizidine alkaloids (PAs) in comfrey. Published data presents an extensive list of PAs and their N-oxides present in comfrey. However, standards are not commercially available for any of the PAs typically present in cornfrey. Those PAs that are not stereoisomers were readily resolved on a C-18 column using a water-acetonitrile gradient as the mobile phase. The use of a selective technique, LC-MS/MS, allowed us to identify groups of PAs and their N-oxides, as well as identify the number of PAs present in each group, including those that were not completely resolved chromatographically.
C1 US FDA, Forens Chem Ctr, Cincinnati, OH 45237 USA.
RP Wuilloud, JCA (reprint author), US FDA, Forens Chem Ctr, Cincinnati, OH 45237 USA.
EM sgratz@ora.fda.gov
NR 23
TC 23
Z9 23
U1 2
U2 11
PU ROYAL SOC CHEMISTRY
PI CAMBRIDGE
PA THOMAS GRAHAM HOUSE, SCIENCE PARK, MILTON RD, CAMBRIDGE CB4 0WF, CAMBS,
ENGLAND
SN 0003-2654
J9 ANALYST
JI Analyst
PD FEB
PY 2004
VL 129
IS 2
BP 150
EP 156
DI 10.1039/b311030c
PG 7
WC Chemistry, Analytical
SC Chemistry
GA 779MC
UT WOS:000189303500013
PM 14752559
ER
PT J
AU Grant, MA
AF Grant, MA
TI Improved laboratory enrichment for enterohemorrhagic Escherichia coli by
exposure to extremely acidic conditions
SO APPLIED AND ENVIRONMENTAL MICROBIOLOGY
LA English
DT Article
ID O157-H7; PREVALENCE; STRESS
AB Analysis of food samples for E. coli O157:H7 using the standard U.S. Food and Drug Administration procedure is frequently complicated by overgrowth of nontarget microorganisms. A new procedure was developed for enrichment of enterohemorrhagic E. coli (EHEC) which utilizes exposure to pH 2.00 for 2 h. This procedure yielded larger populations of EHEC than the standard method by factors ranging from 2.7 to 7.7 and, when age-stressed cultures were used, by factors ranging from 2.7 to 11.5. Cultures of competing enterics were more effectively inhibited by the new enrichment protocol as well.
C1 US FDA, Bothell, WA 98021 USA.
RP Grant, MA (reprint author), US FDA, 22201 23rd Dr SE, Bothell, WA 98021 USA.
EM mgrant@ora.fda.gov
NR 20
TC 14
Z9 14
U1 0
U2 3
PU AMER SOC MICROBIOLOGY
PI WASHINGTON
PA 1752 N ST NW, WASHINGTON, DC 20036-2904 USA
SN 0099-2240
J9 APPL ENVIRON MICROB
JI Appl. Environ. Microbiol.
PD FEB
PY 2004
VL 70
IS 2
BP 1226
EP 1230
DI 10.1128/AEM.70.2.1226-1230.2004
PG 5
WC Biotechnology & Applied Microbiology; Microbiology
SC Biotechnology & Applied Microbiology; Microbiology
GA 772RK
UT WOS:000188854900074
PM 14766610
ER
PT J
AU Nowell, S
Ratnasinghe, DL
Ambrosone, CB
Williams, S
Teague-Ross, T
Trimble, L
Runnels, G
Carrol, A
Green, B
Stone, A
Johnson, D
Greene, G
Kadlubar, FF
Lang, NP
AF Nowell, S
Ratnasinghe, DL
Ambrosone, CB
Williams, S
Teague-Ross, T
Trimble, L
Runnels, G
Carrol, A
Green, B
Stone, A
Johnson, D
Greene, G
Kadlubar, FF
Lang, NP
TI Association of SULT1A1 phenotype and genotype with prostate cancer risk
in African-Americans and Caucasians
SO CANCER EPIDEMIOLOGY BIOMARKERS & PREVENTION
LA English
DT Article
ID HETEROCYCLIC AMINES; BREAST-CANCER; HUMAN-PLATELET; IMMUNOHISTOCHEMICAL
DETECTION; CYTOSOLIC SULFOTRANSFERASES; SULFATION PHARMACOGENETICS;
BIOCHEMICAL-PROPERTIES; HEALTH-PROFESSIONALS; METABOLIC-ACTIVATION;
COLORECTAL-CANCER
AB Exposure to heterocyclic amines may increase prostate cancer risk. Human sulfotransferase 1A1 (SULT1A1) is involved in the bioactivation of some dietary procarcinogens, including the N-hydroxy metabolite of the food-borne heterocyclic amine, 2-amino-1-methyl-6-phenylimidazo(4,5-b) pyridine. This study compares a polymorphism in the SULT1A1 gene, SULT1A1 enzyme activity, meat consumption, and the risk of prostate cancer in a population based case-control study. Prostate cancer patients (n = 464) and control individuals (n = 459), frequency matched on age and ethnicity, provided informed consent, answered a survey, and provided a blood sample. Platelets were isolated for phenotype analysis, and DNA was isolated from lymphocytes for genotype determination. Meat consumption was assessed using a dietary questionnaire. Caucasians homozygous for the SULT1A1*1 high activity allele were at increased risk for prostate cancer [odds ratio (OR), 1.68; 95% confidence interval (CI), 1.05-2.68] compared with individuals homozygous for the low-activity allele. The association between SULT1A1 genotype and prostate cancer risk in African-Americans did not reach significance (OR, 1.60; 95% CI, 0.46-5.62). When SULT1A1 activity was considered, there was a strong association between increased SULT1A1 activity and prostate cancer risk in Caucasians (OR, 3.04; 95% CI, 1.8-5.1 and OR, 4.96; 95% CI, 3.0-8.3, for the second and third tertiles of SULT1A1 activity, respectively) compared with individuals in the low enzyme activity tertile. A similar association was also found in African-American patients, with ORs of 6.7 and 9.6 for the second and third tertiles of SULT1A1 activity (95% CI, 2.1-21.3 and 2.9-31.3, respectively). When consumption of well-done meat was considered, there was increased risk of prostate cancer (OR, 1.42; 95% CI, 1.01-1.99 and OR, 1.68; 95% CI, 1.20-2.36 for the second and third tertiles, respectively). When SULT1A1 activity was stratified by tertiles of meat consumption, there was greater risk of prostate cancer in the highest tertile of meat consumption. These results indicate that variations in SULT1A1 activity contributes to prostate cancer risk and the magnitude of the association may differ by ethnicity and be modified by meat consumption.
C1 Natl Ctr Toxicol Res, Div Mol Epidemiol, Jefferson, AR 72079 USA.
Univ Arkansas Med Sci, Dept Pharmacol & Toxicol, Little Rock, AR 72205 USA.
Cent Arkansas Hlth Care Syst, Little Rock, AR USA.
Roswell Pk Canc Inst, Div Canc Prevent & Populat Sci, Buffalo, NY 14263 USA.
Univ Arkansas Med Sci, Coll Med, Dept Surg, Little Rock, AR 72205 USA.
Arkansas Canc Res Ctr, Little Rock, AR USA.
RP Nowell, S (reprint author), Natl Ctr Toxicol Res, Div Mol Epidemiol, 3900 NCTR Rd, Jefferson, AR 72079 USA.
EM snowell@nctr.fda.gov
FU NCI NIH HHS [R01CA55751]; NIA NIH HHS [R01 AG15722-02]
NR 57
TC 59
Z9 64
U1 0
U2 1
PU AMER ASSOC CANCER RESEARCH
PI PHILADELPHIA
PA 615 CHESTNUT ST, 17TH FLOOR, PHILADELPHIA, PA 19106-4404 USA
SN 1055-9965
J9 CANCER EPIDEM BIOMAR
JI Cancer Epidemiol. Biomarkers Prev.
PD FEB
PY 2004
VL 13
IS 2
BP 270
EP 276
DI 10.1158/1055-9965.EPI-03-0047
PG 7
WC Oncology; Public, Environmental & Occupational Health
SC Oncology; Public, Environmental & Occupational Health
GA 774XG
UT WOS:000189011200014
PM 14973106
ER
PT J
AU Pack, SD
Alper, OM
Stromberg, K
Augustus, M
Ozdemirli, M
Miermont, AM
Klus, G
Rusin, M
Slack, R
Hacker, NF
Ried, T
Szallasi, Z
Alper, O
AF Pack, SD
Alper, OM
Stromberg, K
Augustus, M
Ozdemirli, M
Miermont, AM
Klus, G
Rusin, M
Slack, R
Hacker, NF
Ried, T
Szallasi, Z
Alper, O
TI Simultaneous suppression of epidermal growth factor receptor and
c-erbB-2 reverses aneuploidy and malignant phenotype of a human ovarian
carcinoma cell line
SO CANCER RESEARCH
LA English
DT Article
ID COMPARATIVE GENOMIC HYBRIDIZATION; CANCER CELLS; ZD1839 IRESSA;
PROLIFERATION; AMPLIFICATION; APOPTOSIS; DOMAIN; PARP
AB Coexpression of epidermal growth factor receptor (EGFR) and c-erbB-2 in 47-68% of ovarian cancer cells indicate their strong association with tumor formation. We examined the effects of simultaneous antisense- or immunosuppression of EGFR and c-erbB-2 expression on the invasive phenotype, aneuploidy, and genotype of cultured human ovarian carcinoma cells (NIH:OVCAR-8). We report here that suppression of both EGFR and c-erbB-2 results in regression of aneuploidy and genomic imbalances in NIH:OVCAR-8 cells, restores a more normal phenotype, and results in a more normal gene expression profile. Combined with cytogenetic analysis, our data demonstrate that the regression of aneuploidy is due to the selective apoptosis of double antisense transfected cells with highly abnormal karyotype.
C1 NCI, NIH, Human Carcinogenesis Lab, Bethesda, MD 20892 USA.
NIAID, Immunopathol Lab, Bethesda, MD 20892 USA.
US FDA, Div Therapeut Prot,NCI,NIH, Ctr Biol Evaluat & Res, Off Therapeut Res & Review, Bethesda, MD 20014 USA.
NCI, Genet Branch, Ctr Canc Res, NIH, Bethesda, MD USA.
Georgetown Univ, Sch Med, Inst Mol & Human Genet, Vincent T Lombardi Canc Ctr, Washington, DC USA.
Georgetown Univ, Sch Med, Pathol Lab, Vincent T Lombardi Canc Ctr, Washington, DC USA.
Georgetown Univ, Sch Med, Dept Oncol, Vincent T Lombardi Canc Ctr, Washington, DC USA.
Georgetown Univ, Sch Med, Dept Biostat, Vincent T Lombardi Canc Ctr, Washington, DC USA.
Harvard Univ, Sch Med, Childrens Hosp Informat Program, Boston, MA 02115 USA.
RP Alper, OM (reprint author), NCI, NIH, Human Carcinogenesis Lab, Bldg 10,Room 5D37,9000 Rockville Pike, Bethesda, MD 20892 USA.
EM oa4@georgetown.edu
RI Pack, Svetlana/C-2020-2014
FU NCI NIH HHS [2P30-CA-51008]; NCRR NIH HHS [1S10RR15768-01]
NR 19
TC 26
Z9 28
U1 0
U2 1
PU AMER ASSOC CANCER RESEARCH
PI PHILADELPHIA
PA 615 CHESTNUT ST, 17TH FLOOR, PHILADELPHIA, PA 19106-4404 USA
SN 0008-5472
J9 CANCER RES
JI Cancer Res.
PD FEB 1
PY 2004
VL 64
IS 3
BP 789
EP 794
DI 10.1158/0008-5472.CAN-03-1982
PG 6
WC Oncology
SC Oncology
GA 771VF
UT WOS:000188806200002
PM 14871800
ER
PT J
AU Horn, EJ
Albor, A
Liu, YG
El-Hizawi, S
Vanderbeek, GE
Babcock, M
Bowden, GT
Hennings, H
Lozano, G
Weinberg, WC
Kulesz-Martin, M
AF Horn, EJ
Albor, A
Liu, YG
El-Hizawi, S
Vanderbeek, GE
Babcock, M
Bowden, GT
Hennings, H
Lozano, G
Weinberg, WC
Kulesz-Martin, M
TI RING protein Trim32 associated with skin carcinogenesis has
anti-apoptotic and E3-ubiquitin ligase properties
SO CARCINOGENESIS
LA English
DT Article
ID INDUCED TERMINAL DIFFERENTIATION; MOUSE EPIDERMAL-CELLS; B-RADIATION;
KERATINOCYTE APOPTOSIS; UBIQUITIN LIGASE; GENE-EXPRESSION; WILD-TYPE;
P53; GROWTH; LOCALIZATION
AB (Tri) under bar partite (m) under bar otif protein 32, Trim32, mRNA and protein expression was elevated in independently transformed and tumorigenic keratinocytes of a mouse epidermal carcinogenesis model, in ultraviolet B (UVB)-induced squamous cell carcinomas (SCC), and in similar to20-25% of chemically induced mouse papillomas and human head and neck SCCs. This suggests that elevated Trim32 expression occurs frequently in experimental epidermal carcinogenesis and is relevant to human cancer. Transduced Trim32 increased colony number in an epidermal in vitro transformation assay and epidermal thickening in vivo when skin-grafted to athymic nu/nu mice. These effects were not associated with proliferation and were not sufficient for tumorigenesis, even with 12-O-tetradecanoylphorbol-13-acetate treatment or defects in the tumor suppressor p53. However, transduced Trim32 inhibited the synergistic effect of tumor necrosis factor alpha (TNFalpha) on UVB-induced apoptosis of keratinocytes in vitro and the apoptotic response of keratinocyte grafts exposed to UVB-light in vivo. Consistent with its RING domain, Trim32 exhibited characteristics of E3-ubiquitin ligases, including being ubiquitylated itself and interacting with ubiquitylated proteins, with increases in these properties following treatment of cultured keratinocytes with TNFalpha/UVB. Interestingly, missense point mutation of human TRIM32 has been reported in Limb-Girdle Muscular Dystrophy Type 2H, an autosomal recessive disease. We propose a model in which Trim32 activities as an E3-ubiquitin ligase favor initiated cell survival in carcinogenesis by blocking UVB-induced TNFalpha apoptotic signaling.
C1 Oregon Hlth & Sci Univ, Dept Dermatol, Portland, OR 97239 USA.
Oregon Hlth & Sci Univ, Dept Cell & Dev Biol, Portland, OR 97239 USA.
SUNY Buffalo, Roswell Pk Canc Inst, Dept Pharmacol & Therapeut, Buffalo, NY 14263 USA.
Univ Arizona, Dept Radiat Oncol, Tucson, AZ 85724 USA.
NCI, Cellular Carcinogenesis & Tumor Promot Lab, NIH, Bethesda, MD 20892 USA.
Univ Texas, MD Anderson Canc Ctr, Dept Mol Genet, Houston, TX 77030 USA.
US FDA, Immunobiol Lab, Rockville, MD 20857 USA.
RP Kulesz-Martin, M (reprint author), Oregon Hlth & Sci Univ, Dept Dermatol, Portland, OR 97239 USA.
EM kuleszma@ohsu.edu
RI Weinberg, Wendy/A-8920-2009
FU NCI NIH HHS [CA16056, R01 CA098577, CA69533, CA31101]
NR 43
TC 67
Z9 73
U1 0
U2 5
PU OXFORD UNIV PRESS
PI OXFORD
PA GREAT CLARENDON ST, OXFORD OX2 6DP, ENGLAND
SN 0143-3334
J9 CARCINOGENESIS
JI Carcinogenesis
PD FEB
PY 2004
VL 25
IS 2
BP 157
EP 167
DI 10.1093/carcin/bgh003
PG 11
WC Oncology
SC Oncology
GA 771NQ
UT WOS:000188792800001
PM 14578165
ER
PT J
AU Allred, CD
Allred, KF
Ju, YH
Clausen, LM
Doerge, DR
Schantz, SL
Korol, DL
Wallig, MA
Helferich, WG
AF Allred, CD
Allred, KF
Ju, YH
Clausen, LM
Doerge, DR
Schantz, SL
Korol, DL
Wallig, MA
Helferich, WG
TI Dietary genistein results in larger MNU-induced, estrogen-dependent
mammary tumors following ovariectomy of Sprague-Dawley rats
SO CARCINOGENESIS
LA English
DT Article
ID HORMONE REPLACEMENT THERAPY; BREAST-CANCER CELLS; POSTMENOPAUSAL WOMEN;
N-NITROSOMETHYLUREA; STIMULATE GROWTH; MCF-7 TUMORS; SOY PROTEIN;
INDUCTION; CHEMOPREVENTION; TUMORIGENESIS
AB Due to the estrogenic properties of soy-derived isoflavones, many postmenopausal women are using these compounds as a natural alternative to hormone replacement therapy (HRT). How isoflavones impact breast cancer in postmenopausal women is important, because a majority of breast cancer cases occur in this age group. Chemical induction of mammary tumors in female rats has been used to determine that exposure of the mammary gland to soy isoflavones prior to tumor induction is protective against tumor formation. Here we investigate the effect of dietary genistein on mammary tumors that have already formed. The study was designed to determine the action of dietary genistein in a low endogenous estrogen environment as is observed in postmenopausal women. Animals were ovariectomized (OVX) after mammary tumor development and were then placed into one of three treatment groups: positive-control (OVX+ estradiol implant), genistein (OVX+ 750 p.p.m. genistein) and negative-control (OVX alone). Tumors were distinguished as malignant or benign by histopathological examination and were further characterized as either estrogen-dependent or estrogen-independent using immunohistochemistry to identify the presence of both estrogen receptor (ER) alpha and the progesterone receptor (PR). Genistein at 750 p.p.m. increased the weight of estrogen-dependent adenocarcinomas in ovariectomized rats compared with the negative-control animals. Genistein treatment also resulted in a higher percentage of proliferative cells in tumors and increased uterine weights when compared with negative-control animals. Collectively, these effects are probably due to the estrogenic activity of genistein. Plasma genistein concentrations in animals fed the isoflavone-containing diet were at physiological levels relevant to human exposure. Estradiol concentrations in ovariectomized animals not receiving an estradiol supplement were similar to those observed in postmenopausal women. The data suggest that in an endogenous estrogen environment similar to that of a postmenopausal woman, dietary genistein can stimulate the growth of a mammary carcinogen MNU-induced estrogen-dependent mammary tumors.
C1 Univ Illinois, Dept Food Sci & Human Nutr, Urbana, IL 61801 USA.
Natl Ctr Toxicol Res, Jefferson, AR 72079 USA.
Univ Illinois, Dept Vet Biosci, Urbana, IL 61802 USA.
Univ Illinois, Dept Psychol, Champaign, IL 61820 USA.
Univ Illinois, Dept Vet Pathobiol, Urbana, IL 61802 USA.
RP Helferich, WG (reprint author), Univ Illinois, Dept Food Sci & Human Nutr, Urbana, IL 61801 USA.
EM helferic@uiuc.edu
FU NCI NIH HHS [CA77355]; NIEHS NIH HHS [T32 ES 07320]
NR 39
TC 91
Z9 101
U1 1
U2 3
PU OXFORD UNIV PRESS
PI OXFORD
PA GREAT CLARENDON ST, OXFORD OX2 6DP, ENGLAND
SN 0143-3334
J9 CARCINOGENESIS
JI Carcinogenesis
PD FEB
PY 2004
VL 25
IS 2
BP 211
EP 218
DI 10.1093/carcin/bgg198
PG 8
WC Oncology
SC Oncology
GA 771NQ
UT WOS:000188792800007
PM 14578162
ER
PT J
AU Geho, DH
Petricoin, EF
Liotta, LA
AF Geho, DH
Petricoin, EF
Liotta, LA
TI Blasting into the microworld of tissue proteomics: A new window on
cancer - Commentary re S. A. Schwartz et al, protein profiling in brain
tumors using mass spectrometry: Feasibility of a new technique for the
analysis of protein expression. Clin. Cancer Res., 10 : 981-987, 2004.
SO CLINICAL CANCER RESEARCH
LA English
DT Editorial Material
ID IMMOBILIZED PH GRADIENTS; PROSTATE-CANCER; 2-DIMENSIONAL
ELECTROPHORESIS; PATTERNS; SERUM; MICROARRAYS
C1 NCI, Pathol Lab, Ctr Canc Res, Bethesda, MD 20892 USA.
Food & Drug Adm, Ctr Biol Evaluat & Res, Bethesda, MD USA.
Clin Proteom Program, Food & Drug Adm, NCI, Bethesda, MD USA.
RP Liotta, LA (reprint author), NCI, Pathol Lab, Ctr Canc Res, Room 2A33,10 Ctr Dr,Bldg 10, Bethesda, MD 20892 USA.
EM lance@helix.nih.gov
NR 26
TC 15
Z9 15
U1 0
U2 1
PU AMER ASSOC CANCER RESEARCH
PI PHILADELPHIA
PA 615 CHESTNUT ST, 17TH FLOOR, PHILADELPHIA, PA 19106-4404 USA
SN 1078-0432
J9 CLIN CANCER RES
JI Clin. Cancer Res.
PD FEB 1
PY 2004
VL 10
IS 3
BP 825
EP 827
DI 10.1158/1078-0432.CCR-1223-3
PG 3
WC Oncology
SC Oncology
GA 774MF
UT WOS:000188982700003
PM 14871957
ER
PT J
AU Grube, M
Rezvani, K
Wiestner, A
Fujiwara, H
Sconocchia, G
Melenhorst, JJ
Hensel, N
Marti, GE
Kwak, LW
Wilson, W
Barrett, JA
AF Grube, M
Rezvani, K
Wiestner, A
Fujiwara, H
Sconocchia, G
Melenhorst, JJ
Hensel, N
Marti, GE
Kwak, LW
Wilson, W
Barrett, JA
TI Autoreactive, cytotoxic T lymphocytes specific for peptides derived from
normal B-cell differentiation antigens in healthy individuals and
patients with B-cell malignancies
SO CLINICAL CANCER RESEARCH
LA English
DT Article
ID CHRONIC MYELOGENOUS LEUKEMIA; RECEPTOR TRANSGENIC MICE;
CANCER-IMMUNOTHERAPY; DENDRITIC CELLS; EXPRESSION; TOLERANCE;
VACCINATION; LYMPHOMA; INDUCTION; THERAPY
AB Purpose: To investigate potential immunotherapeutic strategies in B lymphocytic malignancies we looked for CTLs recognizing CD19 and CD20 epitopes.
Experimental Design: Three CD19 and CD20 peptides binding to HLA-A*0201 were identified and used to detect peptide specific CTLs by a quantitative real-time PCR to measure IFN-gamma mRNA expression in 23 healthy individuals and 28 patients (18 chronic lymphocytic leukemia (CLL), 7 follicular lymphoma, 2 acute lymphocytic leukemia, and 1 large cell lymphoma). Peptide-specific CTLs were expanded in culture with CD40-activated B cells to test lytic activity in three patients.
Results: In healthy individuals, CD8(+) T-cell responses were detected in one to CD19(74-82) in three to CD20(127-135), and three to CD20(188-196). Seven of 27 patients (6 with CLL) had CD8(+) T cells recognizing CD19(74-82). Seven patients responded to CD20(127-135) and three to CD20(188-196). All were CLL patients. CD1974-12-specific CTLs from three patients were expanded over 4 weeks. These cells were HLAA*0201 specific and lytic for peptide-loaded antigen-presenting cells but not to malignant or unpulsed B cells.
Conclusions: CTLs that recognize CD19 and CD20 epitopes exist in healthy individuals and may be increased in CLL patients. They are of low avidity and require high doses of peptide for activation. Strategies to increase T-cell avidity would be necessary for T-cell immunotherapeutic approaches using the peptides studied.
C1 NHLBI, NIH, Bethesda, MD 20892 USA.
NCI, NIH, Bethesda, MD 20892 USA.
US FDA, Bethesda, MD 20892 USA.
RP Barrett, JA (reprint author), NIH, Hematol Branch, Bldg 10,9000 Rockville Pike,Room 7C 103,, Bethesda, MD 20892 USA.
EM barrettj@nih.gov
NR 65
TC 12
Z9 12
U1 1
U2 1
PU AMER ASSOC CANCER RESEARCH
PI PHILADELPHIA
PA 615 CHESTNUT ST, 17TH FLOOR, PHILADELPHIA, PA 19106-4404 USA
SN 1078-0432
J9 CLIN CANCER RES
JI Clin. Cancer Res.
PD FEB 1
PY 2004
VL 10
IS 3
BP 1047
EP 1056
DI 10.1158/1078-0432.CCR-03-0075
PG 10
WC Oncology
SC Oncology
GA 774MF
UT WOS:000188982700030
PM 14871984
ER
PT J
AU Averbuch, M
Katzper, M
AF Averbuch, M
Katzper, M
TI Assessment of visual analog versus categorical scale for measurement of
osteoarthritis acute pain.
SO CLINICAL PHARMACOLOGY & THERAPEUTICS
LA English
DT Meeting Abstract
CT Annual Meeting of the
American-Society-for-Clinical-Pharmacology-and-Therapeutics
CY MAR 24-27, 2004
CL Miami Beach, FL
SP Amer Soc Clin Pharmacol Therapeut
C1 Tel Aviv Sourasky Med ctr, Tel Aviv, Israel.
US FDA, Rockville, MD 20857 USA.
NR 0
TC 0
Z9 0
U1 0
U2 1
PU MOSBY, INC
PI ST LOUIS
PA 11830 WESTLINE INDUSTRIAL DR, ST LOUIS, MO 63146-3318 USA
SN 0009-9236
J9 CLIN PHARMACOL THER
JI Clin. Pharmacol. Ther.
PD FEB
PY 2004
VL 75
IS 2
BP P4
EP P4
DI 10.1016/j.clpt.2003.11.012
PG 1
WC Pharmacology & Pharmacy
SC Pharmacology & Pharmacy
GA 774MA
UT WOS:000188982200011
ER
PT J
AU Coster, TS
Szarfman, A
AF Coster, TS
Szarfman, A
TI Data mining analysis of psychosis with mefloquine and other antimalarial
drugs.
SO CLINICAL PHARMACOLOGY & THERAPEUTICS
LA English
DT Meeting Abstract
CT Annual Meeting of the
American-Society-for-Clinical-Pharmacology-and-Therapeutics
CY MAR 24-27, 2004
CL Miami Beach, FL
SP Amer Soc Clin Pharmacol Therapeut
C1 Walter Reed Army Inst Res, Silver Spring, MD USA.
US FDA, Rockville, MD 20857 USA.
NR 0
TC 0
Z9 0
U1 0
U2 1
PU MOSBY, INC
PI ST LOUIS
PA 11830 WESTLINE INDUSTRIAL DR, ST LOUIS, MO 63146-3318 USA
SN 0009-9236
J9 CLIN PHARMACOL THER
JI Clin. Pharmacol. Ther.
PD FEB
PY 2004
VL 75
IS 2
BP P77
EP P77
DI 10.1016/j.clpt.2003.11.290
PG 1
WC Pharmacology & Pharmacy
SC Pharmacology & Pharmacy
GA 774MA
UT WOS:000188982200285
ER
PT J
AU James, AJ
Sun, H
Parekh, A
Doddapaneni, S
Zhao, H
Lee, P
Hunt, J
Malinowski, H
Huang, S
Lesko, L
AF James, AJ
Sun, H
Parekh, A
Doddapaneni, S
Zhao, H
Lee, P
Hunt, J
Malinowski, H
Huang, S
Lesko, L
TI Exposure-response relationship in adults and children for pediatric dose
adjustment.
SO CLINICAL PHARMACOLOGY & THERAPEUTICS
LA English
DT Meeting Abstract
CT Annual Meeting of the
American-Society-for-Clinical-Pharmacology-and-Therapeutics
CY MAR 24-27, 2004
CL Miami Beach, FL
SP Amer Soc Clin Pharmacol Therapeut
C1 US FDA, Rockville, MD 20857 USA.
NR 0
TC 0
Z9 0
U1 0
U2 0
PU MOSBY, INC
PI ST LOUIS
PA 11830 WESTLINE INDUSTRIAL DR, ST LOUIS, MO 63146-3318 USA
SN 0009-9236
J9 CLIN PHARMACOL THER
JI Clin. Pharmacol. Ther.
PD FEB
PY 2004
VL 75
IS 2
BP P75
EP P75
DI 10.1016/j.clpt.2003.11.284
PG 1
WC Pharmacology & Pharmacy
SC Pharmacology & Pharmacy
GA 774MA
UT WOS:000188982200279
ER
PT J
AU Kenna, LA
Parekh, A
Jarugula, V
Chatterjee, DJ
Sun, H
Kim, MJ
Ortiz, S
Hunt, JP
Malinowski, H
AF Kenna, LA
Parekh, A
Jarugula, V
Chatterjee, DJ
Sun, H
Kim, MJ
Ortiz, S
Hunt, JP
Malinowski, H
TI Experience evaluating QT prolongation data.
SO CLINICAL PHARMACOLOGY & THERAPEUTICS
LA English
DT Meeting Abstract
CT Annual Meeting of the
American-Society-for-Clinical-Pharmacology-and-Therapeutics
CY MAR 24-27, 2004
CL Miami Beach, FL
SP Amer Soc Clin Pharmacol Therapeut
C1 US FDA, Rockville, MD 20857 USA.
NR 0
TC 0
Z9 0
U1 0
U2 0
PU MOSBY, INC
PI ST LOUIS
PA 11830 WESTLINE INDUSTRIAL DR, ST LOUIS, MO 63146-3318 USA
SN 0009-9236
J9 CLIN PHARMACOL THER
JI Clin. Pharmacol. Ther.
PD FEB
PY 2004
VL 75
IS 2
BP P7
EP P7
DI 10.1016/j.clpt.2003.11.026
PG 1
WC Pharmacology & Pharmacy
SC Pharmacology & Pharmacy
GA 774MA
UT WOS:000188982200025
ER
PT J
AU Lee, SH
Sun, H
Chen, P
Doddapaneni, S
Hunt, J
Malinowski, H
AF Lee, SH
Sun, H
Chen, P
Doddapaneni, S
Hunt, J
Malinowski, H
TI Sensitivity/reliability of the time-matched baseline subtraction method
in assessment of QTc interval prolongation.
SO CLINICAL PHARMACOLOGY & THERAPEUTICS
LA English
DT Meeting Abstract
CT Annual Meeting of the
American-Society-for-Clinical-Pharmacology-and-Therapeutics
CY MAR 24-27, 2004
CL Miami Beach, FL
SP Amer Soc Clin Pharmacol Therapeut
C1 US FDA, Rockville, MD 20857 USA.
NR 0
TC 1
Z9 1
U1 0
U2 0
PU MOSBY, INC
PI ST LOUIS
PA 11830 WESTLINE INDUSTRIAL DR, ST LOUIS, MO 63146-3318 USA
SN 0009-9236
J9 CLIN PHARMACOL THER
JI Clin. Pharmacol. Ther.
PD FEB
PY 2004
VL 75
IS 2
BP P56
EP P56
DI 10.1016/j.clpt.2003.11.211
PG 1
WC Pharmacology & Pharmacy
SC Pharmacology & Pharmacy
GA 774MA
UT WOS:000188982200206
ER
PT J
AU Sun, H
Chen, P
Kenna, L
Lee, P
AF Sun, H
Chen, P
Kenna, L
Lee, P
TI The chaotic QT interval variabilities on risk assessment trial designs.
SO CLINICAL PHARMACOLOGY & THERAPEUTICS
LA English
DT Meeting Abstract
CT Annual Meeting of the
American-Society-for-Clinical-Pharmacology-and-Therapeutics
CY MAR 24-27, 2004
CL Miami Beach, FL
SP Amer Soc Clin Pharmacol Therapeut
C1 US FDA, CDER, OCPB, Rockville, MD 20857 USA.
NR 0
TC 0
Z9 0
U1 0
U2 0
PU MOSBY, INC
PI ST LOUIS
PA 11830 WESTLINE INDUSTRIAL DR, ST LOUIS, MO 63146-3318 USA
SN 0009-9236
J9 CLIN PHARMACOL THER
JI Clin. Pharmacol. Ther.
PD FEB
PY 2004
VL 75
IS 2
BP P55
EP P55
DI 10.1016/j.clpt.2003.11.210
PG 1
WC Pharmacology & Pharmacy
SC Pharmacology & Pharmacy
GA 774MA
UT WOS:000188982200205
ER
PT J
AU Sun, H
Chen, P
Hunt, J
Malinowski, H
AF Sun, H
Chen, P
Hunt, J
Malinowski, H
TI Frequency of QT recording and the reliability of QT prolongation
assessments.
SO CLINICAL PHARMACOLOGY & THERAPEUTICS
LA English
DT Meeting Abstract
CT Annual Meeting of the
American-Society-for-Clinical-Pharmacology-and-Therapeutics
CY MAR 24-27, 2004
CL Miami Beach, FL
SP Amer Soc Clin Pharmacol Therapeut
C1 US FDA, CDER, OCPB, Rockville, MD 20857 USA.
NR 0
TC 0
Z9 0
U1 0
U2 0
PU MOSBY, INC
PI ST LOUIS
PA 11830 WESTLINE INDUSTRIAL DR, ST LOUIS, MO 63146-3318 USA
SN 0009-9236
J9 CLIN PHARMACOL THER
JI Clin. Pharmacol. Ther.
PD FEB
PY 2004
VL 75
IS 2
BP P48
EP P48
DI 10.1016/j.clpt.2003.11.182
PG 1
WC Pharmacology & Pharmacy
SC Pharmacology & Pharmacy
GA 774MA
UT WOS:000188982200177
ER
PT J
AU Sun, H
Lau, SW
Louis, A
Lee, P
Hunt, J
Malinowski, H
Lesko, L
AF Sun, H
Lau, SW
Louis, A
Lee, P
Hunt, J
Malinowski, H
Lesko, L
TI Survey based FDA experience on submissions with population analysis
and/or studies.
SO CLINICAL PHARMACOLOGY & THERAPEUTICS
LA English
DT Meeting Abstract
CT Annual Meeting of the
American-Society-for-Clinical-Pharmacology-and-Therapeutics
CY MAR 24-27, 2004
CL Miami Beach, FL
SP Amer Soc Clin Pharmacol Therapeut
C1 US FDA, Rockville, MD 20857 USA.
NR 0
TC 0
Z9 0
U1 0
U2 2
PU MOSBY, INC
PI ST LOUIS
PA 11830 WESTLINE INDUSTRIAL DR, ST LOUIS, MO 63146-3318 USA
SN 0009-9236
J9 CLIN PHARMACOL THER
JI Clin. Pharmacol. Ther.
PD FEB
PY 2004
VL 75
IS 2
BP P8
EP P8
DI 10.1016/j.clpt.2003.11.031
PG 1
WC Pharmacology & Pharmacy
SC Pharmacology & Pharmacy
GA 774MA
UT WOS:000188982200029
ER
PT J
AU Petricoin, EF
Liotta, LA
AF Petricoin, EF
Liotta, LA
TI SELDI-TOF-based serum proteomic pattern diagnostics for early detection
of cancer
SO CURRENT OPINION IN BIOTECHNOLOGY
LA English
DT Review
ID MOLECULAR WEIGHT PROTEINS; PROSTATE-CANCER; IDENTIFICATION; DISCOVERY
AB Proteomics is more than just generating lists of proteins that increase or decrease in expression as a cause or consequence of pathology. The goal should be to characterize the information flow through the intercellular protein circuitry that communicates with the extracellular microenvironment and then ultimately to the serum/plasma macroenvironment. The nature of this information can be a cause, or a consequence, of disease and toxicity-based processes. Serum proteomic pattern diagnostics is a new type of proteomic platform in which patterns of proteomic signatures from high dimensional mass spectrometry data are used as a diagnostic classifier. This approach has recently shown tremendous promise in the detection of early-stage cancers. The biomarkers found by SELDI-TOF-based pattern recognition analysis are mostly low molecular weight fragments produced at the specific tumor microenvironment.
C1 US FDA, Ctr Biol Evaluat & Res, Off Cell & Gene Teherapies, FDA NCI Clin Proteom Program, Bethesda, MD 20892 USA.
NCI, Canc Res Ctr, Pathol Lab, FDA NCI Clin Proteom Program,NIH, Bethesda, MD 20892 USA.
RP Petricoin, EF (reprint author), US FDA, Ctr Biol Evaluat & Res, Off Cell & Gene Teherapies, FDA NCI Clin Proteom Program, Bethesda, MD 20892 USA.
EM petricoin@cber.fda.gov
NR 22
TC 228
Z9 255
U1 2
U2 10
PU CURRENT BIOLOGY LTD
PI LONDON
PA 84 THEOBALDS RD, LONDON WC1X 8RR, ENGLAND
SN 0958-1669
J9 CURR OPIN BIOTECH
JI Curr. Opin. Biotechnol.
PD FEB
PY 2004
VL 15
IS 1
BP 24
EP 30
DI 10.1016/j.copbio.2004.01.005
PG 7
WC Biochemical Research Methods; Biotechnology & Applied Microbiology
SC Biochemistry & Molecular Biology; Biotechnology & Applied Microbiology
GA 780EC
UT WOS:000189358300005
PM 15102462
ER
PT J
AU Ginsberg, G
Slikker, W
Bruckner, J
Sonawane, B
AF Ginsberg, G
Slikker, W
Bruckner, J
Sonawane, B
TI Incorporating children's toxicokinetics into a risk framework
SO ENVIRONMENTAL HEALTH PERSPECTIVES
LA English
DT Review
DE children; dosimetry; risk assessment; toxicokinetics
ID PHYSIOLOGICALLY-BASED MODELS; BONE-SEEKING ELEMENTS;
AGE-RELATED-CHANGES; HUMAN-LIVER; PLACENTAL-TRANSFER; RAT-LIVER;
DEVELOPMENTAL EXPRESSION; CLINICAL PHARMACOKINETICS; CYTOCHROME-P450
ENZYMES; POSTNATAL-DEVELOPMENT
AB Children's responses to environmental toxicants will be affected by the way in which their systems absorb, distribute, metabolize, and excrete chemicals. These toxicokinetic factors vary during development, from in utero where maternal and placental processes play a large role, to the neonate in which emerging metabolism and clearance pathways are key determinants. Toxicokinetic differences between neonates and adults lead to the potential for internal dosimetry differences and increased or decreased risk, depending on the mechanisms for toxicity and clearance of a given chemical. This article raises a number of questions that need to be addressed when conducting a toxicokinetic analysis of in utero or childhood exposures. These questions are organized into a proposed framework for conducting the assessment that involves problem formulation (identification of early life stage toxicokinetic factors and chemical-specific factors that may raise questions/concerns for children); data analysis (development of analytic approach, construction of child/adult or child/animal dosimetry comparisons); and risk characterization (evaluation of how children's toxicokinetic analysis can be used to decrease uncertainties in the risk assessment). The proposed approach provides a range of analytical options, from qualitative to quantitative, for assessing children's dosimetry. Further, it provides background information on a variety of toxicokinetic factors that can vary as a function of developmental stage. For example, the ontology of metabolizing systems is described via reference to pediatric studies involving therapeutic drugs and evidence from in vitro enzyme studies. This type of resource information is intended to help the assessor begin to address the issues raised in this paper.
C1 Connecticut Dept Publ Hlth, Hartford, CT 06134 USA.
US FDA, Natl Ctr Toxicol Res, Jefferson, AR 72079 USA.
Univ Georgia, Athens, GA 30602 USA.
US EPA, Natl Ctr Environm Assessment, Off Res & Dev, Washington, DC 20460 USA.
RP Ginsberg, G (reprint author), Connecticut Dept Publ Hlth, 410 Capitol Ave,Mail Stop 11CHA, Hartford, CT 06134 USA.
EM gary.ginsberg@po.state.ct.us
NR 156
TC 41
Z9 42
U1 1
U2 5
PU US DEPT HEALTH HUMAN SCIENCES PUBLIC HEALTH SCIENCE
PI RES TRIANGLE PK
PA NATL INST HEALTH, NATL INST ENVIRONMENTAL HEALTH SCIENCES, PO BOX 12233,
RES TRIANGLE PK, NC 27709-2233 USA
SN 0091-6765
J9 ENVIRON HEALTH PERSP
JI Environ. Health Perspect.
PD FEB
PY 2004
VL 112
IS 2
BP 272
EP 283
DI 10.1289/ehp.6013
PG 12
WC Environmental Sciences; Public, Environmental & Occupational Health;
Toxicology
SC Environmental Sciences & Ecology; Public, Environmental & Occupational
Health; Toxicology
GA 776ZQ
UT WOS:000189149800044
PM 14754583
ER
PT J
AU Baldwin, RL
Chelonis, JJ
Flake, RA
Edwards, MC
Feild, CR
Meaux, JB
Paule, MG
AF Baldwin, RL
Chelonis, JJ
Flake, RA
Edwards, MC
Feild, CR
Meaux, JB
Paule, MG
TI Effect of methylphenidate on time perception in children with
attention-deficit/hyperactivity disorder
SO EXPERIMENTAL AND CLINICAL PSYCHOPHARMACOLOGY
LA English
DT Article; Proceedings Paper
CT 28th Annual Meeting of the Association-for-Behavior-Analysis
CY MAY, 2002
CL TORONTO, CANADA
SP Assoc Behav Anal
ID DEFICIT HYPERACTIVITY DISORDER; BEHAVIORAL-TEST BATTERY; MEMORY; ADHD;
PERFORMANCE; ADOLESCENTS; AMPHETAMINE
AB The effects of methylphenidate (MPH) on performance of a time-production task were studied in 17 children with attention-deficit/hyperactivity disorder who participated in 1 test session on and 1 off MPH. Participants held a response lever down for at least 10 but no longer than 14 s. Administration of MPH had no effect on the number of correct responses or on the mean duration of lever holds. MPH administration significantly decreased timing response variability, increased holds of 10- to 11-s duration, and decreased lever holds of extremely short durations. These results indicate that administration of MPH resulted in more precise timing performance without changing the mean duration of lever holds, suggesting an enhancement in working memory.
C1 Univ Arkansas Med Sci, Arkansas Childrens Hosp, Dept Pediat, Little Rock, AR 72202 USA.
Univ Arkansas, Dept Psychol, Little Rock, AR 72204 USA.
Natl Ctr Toxicol Res, Div Neurotoxicol, Jefferson, AR 72079 USA.
Univ Cent Arkansas, Dept Nursing, Conway, AR 72035 USA.
RP Baldwin, RL (reprint author), Univ Arkansas Med Sci, Arkansas Childrens Hosp, Dept Pediat, 800 Marshall St, Little Rock, AR 72202 USA.
EM baldwinronaldL@uams.edu
NR 35
TC 28
Z9 29
U1 1
U2 2
PU AMER PSYCHOLOGICAL ASSOC
PI WASHINGTON
PA 750 FIRST ST NE, WASHINGTON, DC 20002-4242 USA
SN 1064-1297
J9 EXP CLIN PSYCHOPHARM
JI Exp. Clin. Psychopharmacol.
PD FEB
PY 2004
VL 12
IS 1
BP 57
EP 64
DI 10.1037/1064-1297.12.1.57
PG 8
WC Psychology, Biological; Psychology, Clinical; Pharmacology & Pharmacy;
Psychiatry
SC Psychology; Pharmacology & Pharmacy; Psychiatry
GA 770GB
UT WOS:000188713900010
PM 14769100
ER
PT J
AU Buchanan, RL
Edelson-Mammel, SG
Boyd, G
Marmer, BS
AF Buchanan, RL
Edelson-Mammel, SG
Boyd, G
Marmer, BS
TI Influence of acidulant identity on the effects of pH and acid resistance
on the radiation resistance of Escherichia coli O157 : H7
SO FOOD MICROBIOLOGY
LA English
DT Article
DE organic acids; cross-protection; acid tolerance; irradiation
ID STATIONARY-PHASE; ORGANIC-ACIDS; FRUIT JUICES; APPLE JUICE; REDUCED PH;
TOLERANCE; SURVIVAL; INACTIVATION; IRRADIATION; SALMONELLA
AB The effects of pH (4.0-5.5), acid identity (acetic, citric, lactic, malic, and hydrochloric), and the induction of pH-dependent stationary phase acid resistance on the radiation resistance of E. coli 0 1 57:H7 Ent-C9490 was studied using cells grown in Tryptic Soy Broth with and without dextrose (induced and non-induced to acid resistance) and then resuspended in brain-heart infusion broth containing 5 g/l of an organic acid and acidified with concentrated hydrochloric acid. After treatment with gamma radiation, the number of survivors was determined by plating on brain-heart infusion agar (injured and non-injured cells) and MacConkey agar (non-injured cells), and the data used to calculate radiation D-values. The induction of pH-dependent stationary phase acid resistance consistently provided the enterohemorrhagic E. coli strain cross-protection from subsequent irradiation, increasing radiation D-values by 1.2-3.3-fold, depending on the organic acid present. The radiation resistance of E. coli varied with acid identity, but was largely unaffected by pH within the range examined. The results indicate that induction of cross-protection resulting from induction of acid resistance is a factor that should be considered to accurately determine the radiation dose needed to inactivate enterohemorrhagic E. coli in foods. (C) 2003 Elsevier Ltd. All rights reserved.
C1 US FDA, Ctr Food Safety & Appl Nutr, College Pk, MD 20740 USA.
USDA ARS, ERRC, Wyndmoor, PA 19038 USA.
RP Buchanan, RL (reprint author), US FDA, Ctr Food Safety & Appl Nutr, 5100 Paint Branch Pkwy, College Pk, MD 20740 USA.
NR 14
TC 20
Z9 20
U1 0
U2 6
PU ACADEMIC PRESS LTD ELSEVIER SCIENCE LTD
PI LONDON
PA 24-28 OVAL RD, LONDON NW1 7DX, ENGLAND
SN 0740-0020
J9 FOOD MICROBIOL
JI Food Microbiol.
PD FEB
PY 2004
VL 21
IS 1
BP 51
EP 57
DI 10.1016/S0740-0020(03)00039-X
PG 7
WC Biotechnology & Applied Microbiology; Food Science & Technology;
Microbiology
SC Biotechnology & Applied Microbiology; Food Science & Technology;
Microbiology
GA 759WP
UT WOS:000187774400007
ER
PT J
AU Fleischman, GJ
Ravishankar, S
Balasubramaniam, VM
AF Fleischman, GJ
Ravishankar, S
Balasubramaniam, VM
TI The inactivation of Listeria monocytogenes by pulsed electric field
(PEF) treatment in a static chamber
SO FOOD MICROBIOLOGY
LA English
DT Article
DE gellan gum; gel; Listeria; pulsed electric field; static chamber; milk
ID ESCHERICHIA-COLI O157-H7; LACTOBACILLUS-BREVIS; SKIM MILK; KINETICS;
INNOCUA
AB An experimental analysis of the effect of pulsed electric field (PEF) energy on the inactivation of Listeria monocytogenes was conducted using a custom-designed static chamber and a gel suspension medium for treatment. This allowed PEF energy to be delivered to the suspension under near isothermal conditions. The effects of variations in the number of pulses (5-50 pulses), electric field strength (15-30 kV/cm), temperature (0-60degreesC) and media bases (water and skim milk) on the inactivation of L. monocytogenes were examined. At temperatures less than 50degreesC a maximum of I log reduction was obtained for L. monocytogenes regardless of pulse number or electric field strength within the ranges examined. In skim milk no reduction occurred. At 50degreesC and 55degreesC synergy between PEF and thermal energy was observed. The experimental approach separated the contribution of PEF and thermal energy to total kill and thus allowed this synergy to be quantified. At 55degreesC the kill due to PEF energy increased to 4.5 logs with another 4.5 logs reduction attributable to thermal energy. It appears that under the conditions of this study PEF alone has a very limited effect on the reduction of L. monocytogenes. However, the addition of thermal energy not only contributed to the kill, but also increased the susceptibility of L. monocytogenes to PEF energy. Published by Elsevier Science Ltd.
C1 US FDA, Natl Ctr Food Safety & Technol, Summit Argo, IL 60501 USA.
IIT, Natl Ctr Food Safety & Technol, Summit Argo, IL 60501 USA.
RP Fleischman, GJ (reprint author), US FDA, Natl Ctr Food Safety & Technol, 6502 S Archer Rd, Summit Argo, IL 60501 USA.
RI Balasubramaniam, VM Bala/A-2576-2008
OI Balasubramaniam, VM Bala/0000-0002-1540-4273
NR 12
TC 35
Z9 37
U1 2
U2 11
PU ACADEMIC PRESS LTD ELSEVIER SCIENCE LTD
PI LONDON
PA 24-28 OVAL RD, LONDON NW1 7DX, ENGLAND
SN 0740-0020
J9 FOOD MICROBIOL
JI Food Microbiol.
PD FEB
PY 2004
VL 21
IS 1
BP 91
EP 95
DI 10.1016/S0740-0020(03)00015-7
PG 5
WC Biotechnology & Applied Microbiology; Food Science & Technology;
Microbiology
SC Biotechnology & Applied Microbiology; Food Science & Technology;
Microbiology
GA 759WP
UT WOS:000187774400013
ER
PT J
AU Buntin, MB
Garber, AM
McClellan, M
Newhouse, JP
AF Buntin, MB
Garber, AM
McClellan, M
Newhouse, JP
TI The costs of decedents in the Medicare program: Implications for
payments to Medicare plus choice plans
SO HEALTH SERVICES RESEARCH
LA English
DT Article
DE Medicare; risk adjustment; managed care; end-of-life costs
ID FEE-FOR-SERVICE; LAST YEAR; DEATH; LIFE; BENEFICIARIES; HOSPICE; CANCER;
CARE; DIE; HMO
AB Objective. To discuss and quantify the incentives that Medicare managed care plans have to avoid (through selective enrollment or disenrollment) people who are at risk for very high costs, focusing on Medicare beneficiaries in the last year of life-a group that accounts for more than one-quarter of Medicare's annual expenditures.
Data Source. Medicare administrative claims for 1994 and 1995. Study Design. We calculated the payment a plan would have received under three risk-adjustment systems for each beneficiary in our 1995 sample based on his or her age, gender, county of residence, original reason for Medicare entitlement, and principal inpatient diagnoses received during any hospital stays in 1994. We compared these amounts to the actual costs incurred by those beneficiaries. We then looked for clinical categories that were predictive of costs, including costs in a beneficiary's last year of life, not accounted for by the risk adjusters.
Data Extraction Methods. The analyses were conducted using claims for a 5 percent random sample of Medicare beneficiaries who died in 1995 and a matched group of survivors.
Principal Findings. Medicare is currently implementing the Principal Inpatient Diagnostic Cost Groups (PIP-DCG) risk adjustment payment system to address the problem of risk selection in the Medicare+Choice program. We quantify the strong financial disincentives to enroll terminally ill beneficiaries that plans still have under this risk adjustment system. We also show that up to one-third of the selection observed between Medicare HMOs and the traditional fee-for-service system could be due to differential enrollment of decedents. A risk adjustment system that incorporated more of the available diagnostic information would attenuate this disincentive; however, plans could still use clinical information (not included in the risk adjustment scheme) to identify beneficiaries whose expected costs exceed expected payments.
Conclusions. More disaggregated prospective risk adjustment methods and alternative payment systems that compensate plans for delivering care to certain classes of patients should be considered to ensure access to high-quality managed care for all beneficiaries.
C1 RAND Hlth, Arlington, VA 22202 USA.
Dept Vet Affairs, Palo Alto, CA USA.
Stanford Univ, Stanford, CA 94305 USA.
Food & Drug Adm, Rockville, MD USA.
Harvard Univ, Dept Hlth Care Policy, Boston, MA 02115 USA.
RP Buntin, MB (reprint author), RAND Hlth, 1200 S Hayes St, Arlington, VA 22202 USA.
RI Garber, Alan/F-1476-2010
FU NIA NIH HHS [AG 17253, AG05842, P01 AG005842, P30 AG017253]
NR 22
TC 12
Z9 12
U1 0
U2 2
PU BLACKWELL PUBLISHING INC
PI MALDEN
PA 350 MAIN ST, MALDEN, MA 02148 USA
SN 0017-9124
J9 HEALTH SERV RES
JI Health Serv. Res.
PD FEB
PY 2004
VL 39
IS 1
BP 111
EP 130
PG 20
WC Health Care Sciences & Services; Health Policy & Services
SC Health Care Sciences & Services
GA 770YB
UT WOS:000188758000009
PM 14965080
ER
PT J
AU Kumar, S
Jones, TR
Oakley, MS
Zheng, H
Kuppusamy, SP
Taye, A
Krieg, AM
Stowers, AW
Kaslow, DC
Hoffman, SL
AF Kumar, S
Jones, TR
Oakley, MS
Zheng, H
Kuppusamy, SP
Taye, A
Krieg, AM
Stowers, AW
Kaslow, DC
Hoffman, SL
TI CpG oligodeoxynucleotide and montanide ISA 51 adjuvant combination
enhanced the protective efficacy of a subunit malaria vaccine
SO INFECTION AND IMMUNITY
LA English
DT Article
ID MEROZOITE SURFACE PROTEIN-1; CARBOXYL-TERMINAL FRAGMENT;
PLASMODIUM-FALCIPARUM; AOTUS MONKEYS; INTERFERON-GAMMA;
MONOCLONAL-ANTIBODIES; IMMUNE-RESPONSE; C-TERMINUS; NK CELLS; IN-VIVO
AB Unmethylated CpG dinucleotide motifs present in bacterial genomes or synthetic oligodeoxynucleotides (ODNs) serve as strong immunostimulatory agents in mice, monkeys and humans. We determined the adjuvant effect of murine CpG ODN 1826 on the immunogenicity and protective efficacy of the Saccharomyces cerevisiae-expressed 19-kDa C-terminal region of merozoite surface protein 1 (yMSP1(19)) of the murine malaria parasite Plasmodium yoelli. We found that in C57BL/6 mice, following sporozoite challenge, the degree of protective immunity against malaria induced by yMSP1(19) in a formulation of Montanide ISA 51 (ISA) plus CpG ODN 1826 was similar or superior to that conferred by yMSP1(19) emulsified in complete Freund's adjuvant (CFA/incomplete Freund's adjuvant). In total, among mice immunized with yMSP1(19), 22 of 32 (68.7%) with ISA plus CpG 1826, 0 of 4 (0%) with CFA/incomplete Freund's adjuvant, 0 of 4 (0%) with CpG 1826 mixed with ISA (no yMSP1(19)), and 0 of 11 (0%) with CpG 1826 alone were completely protected against development of erythrocytic stage infection after sporozoite challenge. The adjuvant effect of CpG ODN 1826 was manifested as both significantly improved complete protection from malaria (defined as the absence of detectable erythrocytic form parasites) (P = 0.007, chi square) and reduced parasite burden in infected mice. In vivo depletions of interleukin-12 and gamma interferon cytokines and CD4(+) and CD8(+) T cells in vaccinated mice had no significant effect on immunity. On the other hand, immunoglobulin G (IgG) isotype levels appeared to correlate with protection. Inclusion of CpG ODN 1826 in the yMSP1(19) plus ISA vaccine contributed towards the induction of higher levels of IgG2a and IgG2b (Th1 type) antibodies, suggesting that CpG ODN 1826 caused a shift towards a Th1 type of immune response that could be responsible for the higher degree of protective immunity. Our results indicate that this potent adjuvant formulation should be further evaluated for use in clinical trials of recombinant malarial vaccine candidates.
C1 Naval Med Res Ctr, Malaria Program, Silver Spring, MD 20910 USA.
Johns Hopkins Univ, Bloomberg Sch Hyg & Publ Hlth, Dept Microbiol & Immunol, Baltimore, MD 21205 USA.
Coley Pharmaceut Grp, Wellesley, MA 02481 USA.
Univ Iowa, Dept Internal Med, Iowa City, IA 52242 USA.
NIAID, Malaria Vaccine Dev Unit, Bethesda, MD 20892 USA.
RP Kumar, S (reprint author), US FDA, Bacterial & Parasit Dis Sect, Div Emerging & Transfus Transmitted Dis, Ctr Biol Evaluat & Res, HFM-313,1401 Rockville Pike, Rockville, MD 20852 USA.
EM kumarS@cber.fda.gov
NR 45
TC 45
Z9 48
U1 0
U2 2
PU AMER SOC MICROBIOLOGY
PI WASHINGTON
PA 1752 N ST NW, WASHINGTON, DC 20036-2904 USA
SN 0019-9567
J9 INFECT IMMUN
JI Infect. Immun.
PD FEB
PY 2004
VL 72
IS 2
BP 949
EP 957
DI 10.1128/IAI.72.2.949-957.2004
PG 9
WC Immunology; Infectious Diseases
SC Immunology; Infectious Diseases
GA 771BV
UT WOS:000188766400040
PM 14742540
ER
PT J
AU Debrabant, A
Joshi, MB
Pimenta, PFP
Dwyer, DM
AF Debrabant, A
Joshi, MB
Pimenta, PFP
Dwyer, DM
TI Generation of Leishmania donovani axenic amastigotes: their growth and
biological characteristics
SO INTERNATIONAL JOURNAL FOR PARASITOLOGY
LA English
DT Article; Proceedings Paper
CT Annual Meeting of the Australian-Society-for-Parasitology
CY 2003
CL Darwin, AUSTRALIA
DE trypanosomatid; leishmaniasis; parasite; culture system; infectivity;
virulence
ID PROTOZOAN PARASITE LEISHMANIA; SECRETORY ACID-PHOSPHATASES; PROGRAMMED
CELL-DEATH; FUNCTIONAL DOMAINS; GENE-EXPRESSION; PROMASTIGOTES;
IDENTIFICATION; TRANSPORTER; PROTEIN; FAMILY
AB In this report, we describe an in vitro culture system for the generation and propagation of axenic amastigotes from the well characterised 1S-CL2D line of Leishmania donovani. Fine structure analyses of these in vitro-grown amastigotes demonstrated that they possessed morphological features characteristic of L. donovani tissue-derived amastigotes. Further, these axenic amastigotes (LdAxAm) were shown to synthesise and release a secretory acid phosphatase isoform similar to that produced by intracellular amastigotes. Such LdAxAm also expressed surface membrane 3'-nucleotidase enzyme activity similar to that of tissue-derived amastigotes. Moreover, LdAxAm, in contrast to promastigotes, expressed significant levels of the amastigote-specific A2 proteins. In addition, LdAxAm, derived from long term cultures of Ld 1S-CL2D promastigotes, had significant infectivity for both human macrophages in vitro and for hamsters in vivo. Thus, the in vitro culture system described herein provides a useful tool for the generation of large quantities of uniform populations of axenic amastigotes of the L. donovani 1S-CL2D line. The availability of such material should greatly facilitate studies concerning the cell and molecular biology of this parasite developmental stage. (C) 2003 Australian Society for Parasitology Inc. Published by Elsevier Ltd. All rights reserved.
C1 NIAID, Cell Biol Sect, Parasit Dis Lab, Div Intramural Res,NIH, Bethesda, MD 20892 USA.
US FDA, Ctr Biol Evaluat & Res, Div Emerging & Transfus Transmitted Dis, Bethesda, MD USA.
Fdn Oswaldo Cruz, Ctr Pesquisas Rene Rachou, Lab Med Entomol, Belo Horizonte, MG, Brazil.
RP Dwyer, DM (reprint author), NIAID, Cell Biol Sect, Parasit Dis Lab, Div Intramural Res,NIH, Bldg 4,Room 126, Bethesda, MD 20892 USA.
EM ddwyer@niaid.nih.gov
NR 44
TC 131
Z9 137
U1 0
U2 5
PU PERGAMON-ELSEVIER SCIENCE LTD
PI OXFORD
PA THE BOULEVARD, LANGFORD LANE, KIDLINGTON, OXFORD OX5 1GB, ENGLAND
SN 0020-7519
J9 INT J PARASITOL
JI Int. J. Parasit.
PD FEB
PY 2004
VL 34
IS 2
BP 205
EP 217
DI 10.1016/j.ijpara.2003.10.011
PG 13
WC Parasitology
SC Parasitology
GA 801FU
UT WOS:000220082600008
PM 15037106
ER
PT J
AU Vann, WF
Daines, DA
Murkin, AS
Tanner, ME
Chaffin, DO
Rubens, CE
Vionnet, J
Silver, RP
AF Vann, WF
Daines, DA
Murkin, AS
Tanner, ME
Chaffin, DO
Rubens, CE
Vionnet, J
Silver, RP
TI The NeuC protein of Escherichia coli K1 is a UDP N-acetylglucosamine
2-epimerase
SO JOURNAL OF BACTERIOLOGY
LA English
DT Article
ID ACETYLNEURAMINIC ACID SYNTHETASE; POLYSACCHARIDE BIOSYNTHESIS;
POLYSIALIC ACID; SIALIC-ACID; 2-EPIMERASE/N-ACETYLMANNOSAMINE KINASE;
NEISSERIA-MENINGITIDIS; GENE-PRODUCT; RAT-LIVER; EXPRESSION; SEQUENCE
AB The K1 capsule is an essential virulence determinant of Escherichia coli strains that cause meningitis in neonates. Biosynthesis and transport of the capsule, an alpha-2,8-linked polymer of sialic acid, are encoded by the 17-kb kps gene cluster. We deleted neuC, a K1 gene implicated in sialic acid synthesis, from the chromosome of EV36, a K-12-K1 hybrid, by allelic exchange. Exogenously added sialic acid restored capsule expression to the deletion strain (DeltaneuC), confirming that NeuC is necessary for sialic acid synthesis. The deduced amino acid sequence of NeuC showed similarities to those of UDP-N-acetylglucosamine (GlcNAc) 2-epimerases from both prokaryotes and eukaryotes. The NeuC homologue from serotype III Streptococcus agalactiae complements DeltaneuC. We cloned the neuC gene into an intein expression vector to facilitate purification. We demonstrated by paper chromatography that the purified neuC gene product catalyzed the formation of [2-C-14]acetamidoglucal and [N-C-14]acetylmannosamine (ManNAc) from UDP-[C-14]GlcNAc. The formation of reaction intermediate 2-acetamidoglucal with the concomitant release of UDP was confirmed by proton and phosphorus nuclear magnetic resonance spectroscopy. NeuC could not use GlcNAc as a substrate. These data suggest that neuC encodes an epimerase that catalyzes the formation of ManNAc from UDP-GlcNAc via a 2-acetamidoglucal intermediate. The unexpected release of the glucal intermediate and the extremely low rate of ManNAc formation likely were a result of the in vitro assay conditions, in which a key regulatory molecule or protein was absent.
C1 US FDA, Ctr Biol Evaluat & Res, Lab Bacterial Toxins, Bethesda, MD 20892 USA.
Univ Rochester, Med Ctr, Dept Microbiol & Immunol, Rochester, NY 14642 USA.
Univ British Columbia, Dept Chem, Vancouver, BC V6T 1Z1, Canada.
Univ Washington, Childrens Hosp & Reg Med Ctr, Dept Pediat, Seattle, WA 98105 USA.
RP Vann, WF (reprint author), US FDA, Ctr Biol Evaluat & Res, Lab Bacterial Toxins, Bethesda, MD 20892 USA.
EM wvann@helix.nih.gov
RI Murkin, Andrew/K-3146-2012
OI Murkin, Andrew/0000-0002-2559-4605
FU NIAID NIH HHS [AI22498, AI25152, AI39615, AI07362, R01 AI022498, T32
AI007362]
NR 43
TC 25
Z9 26
U1 1
U2 6
PU AMER SOC MICROBIOLOGY
PI WASHINGTON
PA 1752 N ST NW, WASHINGTON, DC 20036-2904 USA
SN 0021-9193
J9 J BACTERIOL
JI J. Bacteriol.
PD FEB
PY 2004
VL 186
IS 3
BP 706
EP 712
DI 10.1128/JB.186.3.706-712.2004
PG 7
WC Microbiology
SC Microbiology
GA 766HU
UT WOS:000188371600014
PM 14729696
ER
PT J
AU Spencer, SE
Valentin-Bon, IE
Whaley, K
Jerse, AE
AF Spencer, SE
Valentin-Bon, IE
Whaley, K
Jerse, AE
TI Inhibition of Neisseria gonorrhoeae genital tract infection by
leading-candidate topical microbicides in a mouse model
SO JOURNAL OF INFECTIOUS DISEASES
LA English
DT Article; Proceedings Paper
CT 3rd Workshop on Topical Microbicides Pre-Clinical
CY JAN 31-FEB 01, 2001
CL BALTIMORE, MARYLAND
ID SEXUALLY-TRANSMITTED-DISEASES; HUMAN-IMMUNODEFICIENCY-VIRUS;
HERPES-SIMPLEX-VIRUS; CELLULOSE SULFATE; VAGINAL MICROBICIDES; BACTERIAL
VAGINOSIS; PRO 2000; PHASE-I; PREVENTION; TOLERANCE
AB The development of effective vaginal microbicides is paramount in the fight against the spread of sexually transmitted infections. Preclinical testing of candidate microbicides for the prevention of gonorrhea has been seriously hindered by the lack of an animal model. We assessed the efficacy of 7 promising formulated agents CarraGuard, Ushercell, [poly] sodium 4-styrene sulfonate (T-PSS), PRO 2000, ACIDFORM, cellulose acetate phthalate (CAP), and BufferGel - by use of a mouse model of Neisseria gonorrhoeae genital tract infection. Mice received test agent, relevant placebo, or no treatment, followed by intravaginal N. gonorrhoeae challenge. N. gonorrhoeae colonization was tested by vaginal culture. CarraGuard, Ushercell, and T-PSS demonstrated significant protection, compared with control agents and no treatment. PRO 2000, ACIDFORM, and CAP showed significant protection, compared with no treatment but not compared with respective control agents. Mice that received BufferGel were provided significant protection, compared with untreated control mice; no placebo was tested. The findings of the present study suggest that topical agents may effectively reduce N. gonorrhoeae infection and that further evaluation is warranted.
C1 Uniformed Serv Univ Hlth Sci, Dept Microbiol & Immunol, Bethesda, MD 20814 USA.
US FDA, Rockville, MD 20857 USA.
Johns Hopkins Univ, Dept Biophys, Baltimore, MD USA.
ReProtect, Baltimore, MD USA.
Walter Reed Army Med Ctr, Washington, DC 20307 USA.
Epicyte Pharmaceut, San Diego, CA USA.
RP Spencer, SE (reprint author), Uniformed Serv Univ Hlth Sci, Dept Microbiol & Immunol, 4301 Jones Bridge Rd, Bethesda, MD 20814 USA.
EM SSpencerMD@comcast.net; ajerse@usuhs.mil
FU NIAID NIH HHS [AI45967]
NR 60
TC 37
Z9 38
U1 0
U2 0
PU UNIV CHICAGO PRESS
PI CHICAGO
PA 1427 E 60TH ST, CHICAGO, IL 60637-2954 USA
SN 0022-1899
J9 J INFECT DIS
JI J. Infect. Dis.
PD FEB 1
PY 2004
VL 189
IS 3
BP 410
EP 419
DI 10.1086/381125
PG 10
WC Immunology; Infectious Diseases; Microbiology
SC Immunology; Infectious Diseases; Microbiology
GA 767TC
UT WOS:000188467900008
PM 14745698
ER
PT J
AU Sawant, SP
Dnyanmote, AV
Shankar, K
Limaye, PB
Latendresse, JR
Mehendale, HM
AF Sawant, SP
Dnyanmote, AV
Shankar, K
Limaye, PB
Latendresse, JR
Mehendale, HM
TI Potentiation of carbon tetrachloride hepatotoxicity and lethality in
type 2 diabetic rats
SO JOURNAL OF PHARMACOLOGY AND EXPERIMENTAL THERAPEUTICS
LA English
DT Article
ID THIOACETAMIDE HEPATOTOXICITY; CYTOCHROME-P450 2E1; INSULIN-RESISTANCE;
HEPATIC-FAILURE; TISSUE-REPAIR; LIVER; INJURY; MODEL; BIOTRANSFORMATION;
TOXICOLOGY
AB There is a need for well characterized and economical type 2 diabetic model that mimics the human disease. We have developed a type 2 diabetes rat model that closely resembles the diabetic patients and takes only 24 days to develop robust diabetes. Nonlethal doses of allyl alcohol (35 mg/kg i.p.), CCl4 (2 ml/kg i.p.), or thioacetamide (300 mg/kg i.p.) yielded 80 to 100% mortality in diabetic rats. The objective of the present study was to investigate two hypotheses: higher CCl4 bioactivation and/or inhibited compensatory tissue repair were the underlying mechanisms for increased CCl4 hepatotoxicity in diabetic rats. Diabetes was induced by feeding high fat diet followed by a single dose of streptozotocin on day 14 (45 mg/kg i.p.) and was confirmed on day 24 by hyperglycemia, normoinsulinemia, and oral glucose intolerance. Time course studies (0-96 h) of CCl4 (2 ml/kg i.p.) indicated that although initial liver injury was the same in nondiabetic and diabetic rats, it progressed only in the latter, culminating in hepatic failure, and death. Hepatomicrosomal CYP2E1 protein and activity, lipid peroxidation, glutathione, and (CCl4)-C-14 covalent binding to liver tissue were the same in both groups, suggesting that higher bioactivation-based injury is not the mechanism. Inhibited tissue repair resulted in progression of injury and death in diabetic rats, whereas in the nondiabetic rats robust tissue repair resulted in regression of injury and survival after CCl4 administration. These studies show high sensitivity of type 2 diabetes to model hepatotoxicants and suggest that CCl4 hepatotoxicity is potentiated due to inhibited tissue repair.
C1 Univ Louisiana, Sch Pharm, Dept Toxicol, Monroe, LA 71209 USA.
Pathol Associates Int, Natl Ctr Toxicol Res, Jefferson, AR USA.
RP Mehendale, HM (reprint author), Univ Louisiana, Sch Pharm, Dept Toxicol, 700 Univ Ave, Monroe, LA 71209 USA.
EM mehendale@ulm.edu
RI Latendresse, John/A-9215-2009
NR 40
TC 34
Z9 35
U1 1
U2 3
PU AMER SOC PHARMACOLOGY EXPERIMENTAL THERAPEUTICS
PI BETHESDA
PA 9650 ROCKVILLE PIKE, BETHESDA, MD 20814-3998 USA
SN 0022-3565
J9 J PHARMACOL EXP THER
JI J. Pharmacol. Exp. Ther.
PD FEB 1
PY 2004
VL 308
IS 2
BP 694
EP 704
DI 10.1124/jpet.103.058834
PG 11
WC Pharmacology & Pharmacy
SC Pharmacology & Pharmacy
GA 767TB
UT WOS:000188467800037
PM 14610242
ER
PT J
AU Uhl, K
Kennedy, DL
Gilliland, WR
AF Uhl, K
Kennedy, DL
Gilliland, WR
TI Disease modifying antirheumatic drugs and pregnancy
SO JOURNAL OF RHEUMATOLOGY
LA English
DT Letter
C1 US FDA, Pregnancy Labeling Task Force, Ctr Drug Evaluat & Res, Rockville, MD 20852 USA.
Uniformed Serv Univ Hlth Sci, Dept Rheumatol, Bethesda, MD 20814 USA.
RP Uhl, K (reprint author), US FDA, Pregnancy Labeling Task Force, Ctr Drug Evaluat & Res, 1451 Rockville Pike,HFD-020, Rockville, MD 20852 USA.
EM uhlk@cder.fda.gov
NR 6
TC 3
Z9 3
U1 0
U2 0
PU J RHEUMATOL PUBL CO
PI TORONTO
PA 920 YONGE ST, SUITE 115, TORONTO, ONTARIO M4W 3C7, CANADA
SN 0315-162X
J9 J RHEUMATOL
JI J. Rheumatol.
PD FEB
PY 2004
VL 31
IS 2
BP 400
EP 401
PG 2
WC Rheumatology
SC Rheumatology
GA 770MU
UT WOS:000188735200036
PM 14760818
ER
PT J
AU Anderson, JB
Shuster, TA
Hansen, KE
Levy, AS
Volk, A
AF Anderson, JB
Shuster, TA
Hansen, KE
Levy, AS
Volk, A
TI A camera's view of consumer food-handling behaviors
SO JOURNAL OF THE AMERICAN DIETETIC ASSOCIATION
LA English
DT Article
ID SAFETY; KNOWLEDGE; HOME
AB Objective To compare consumer food-handling behaviors with the Fight BAC! consumer food-safety recommendations.
Design Subjects were videotaped in their home while preparing a meal. Videotapes were coded according to Fight BAC! recommendations. A food-safety survey was administered and temperature data was collected.
Subjects/Setting A market research company randomly recruited subjects by telephone. Ninety-nine consumers participated (92 women, seven men).
Statistical Analysis Performed Descriptive statistics were used.
Results Overall, subjects did not follow the Fight BAC! recommendations for safe food handling. Handwashing,was inadequate. The average hand wash length was significantly lower than the 20-second recommendation. Only one-third of subjects' hand wash attempts were with soap. Surface cleaning was inadequate with only one-third of surfaces thoroughly cleaned. Moreover, one-third of subjects did not attempt to clean surfaces during food preparation. Nearly all subjects cross-contaminated raw meat, poultry, seafood, eggs, and/or unwashed vegetables with ready-to-eat foods multiple times during food preparation. Unwashed hands were the most common cross-contamination agent. Many subjects undercooked the meat and poultry entrees. Very few subjects used a food thermometer.
Applications /Conclusions Consumers make many food-handling errors during food preparation, increasing their risk of foodborne illness. Dietetics professionals need to familiarize themselves with the Fight BAC! consumer food-safety recommendations; understand where consumers are making food-handling errors; increase food safety awareness; and educate consumers, especially those in high-risk populations, about safe food handling at home.
C1 Utah State Univ, Logan, UT 84322 USA.
Spectrum Consulting, N Logan, UT USA.
Safe Food Inst, N Logan, UT USA.
US FDA, Consumers Studies Branch, Ctr Food Safety & Appl Nutr, College Pk, MD USA.
Volk Enterprises, Norcross, GA USA.
RP Hansen, KE (reprint author), 1770 N Res Pkwy, N Logan, UT 84341 USA.
EM hansen@safefoodinstitute.org
NR 15
TC 70
Z9 72
U1 2
U2 14
PU AMER DIETETIC ASSOC
PI CHICAGO
PA 216 W JACKSON BLVD #800, CHICAGO, IL 60606-6995 USA
SN 0002-8223
J9 J AM DIET ASSOC
JI J. Am. Diet. Assoc.
PD FEB
PY 2004
VL 104
IS 2
BP 186
EP 191
DI 10.1016/j.jada.2003.11.010
PG 6
WC Nutrition & Dietetics
SC Nutrition & Dietetics
GA 773ZX
UT WOS:000188956200008
PM 14760565
ER
PT J
AU Fishman, DA
Hao, ZQ
Pelt, V
Petricoin, EF
Liotta, LA
Wiggins, WS
Seshaiah, P
Coleman, TA
Hitt, BA
AF Fishman, DA
Hao, ZQ
Pelt, V
Petricoin, EF
Liotta, LA
Wiggins, WS
Seshaiah, P
Coleman, TA
Hitt, BA
TI High throughput multidimensional mass spectrometry analysis for the
detection of early stage epithelial ovarian cancer: A serum test for
ovarian cancer.
SO JOURNAL OF THE SOCIETY FOR GYNECOLOGIC INVESTIGATION
LA English
DT Meeting Abstract
CT 51st Annual Meeting of the Society-for-Gynecologic-Investigation
CY MAR 24-27, 2004
CL Houston, TX
SP Soc Gynecol Investigat
C1 Northwestern Univ, Chicago, IL 60611 USA.
Advion Biosci, Ithaca, NY USA.
NCI FDA, Clin Proteom Program, Bethesda, MD USA.
Correl Syst Inc, Bethesda, MD USA.
NR 0
TC 0
Z9 0
U1 0
U2 0
PU ELSEVIER SCIENCE INC
PI NEW YORK
PA 360 PARK AVE SOUTH, NEW YORK, NY 10010-1710 USA
SN 1071-5576
J9 J SOC GYNECOL INVEST
JI J. Soc. Gynecol. Invest.
PD FEB
PY 2004
VL 11
IS 2
SU S
MA 246
BP 154A
EP 154A
PG 1
WC Obstetrics & Gynecology
SC Obstetrics & Gynecology
GA 802SZ
UT WOS:000220184500245
ER
PT J
AU Pritchard, WF
Wray-Cahen, D
Karanian, JW
Hilbert, S
Wood, BJ
AF Pritchard, WF
Wray-Cahen, D
Karanian, JW
Hilbert, S
Wood, BJ
TI Radiofrequency cauterization with biopsy introducer needle
SO JOURNAL OF VASCULAR AND INTERVENTIONAL RADIOLOGY
LA English
DT Article
ID PERCUTANEOUS LIVER-BIOPSY; FIBRIN SEALANT; TRACT IMPLANTATION; CANINE
MODEL; EMBOLIZATION; HEMATOMAS
AB PURPOSE: The principal risks of needle biopsy are hemorrhage and implantation of tumor cells in the needle tract. This study compared hemorrhage after liver and kidney biopsy with and without radiofrequency (RF) ablation of the needle tract.
MATERIALS AND METHODS: Biopsies of liver and kidney were performed in swine through introducer needles modified to allow RF ablation with the distal 2 cm of the needle. After each biopsy, randomization determined whether the site was to undergo RF ablation during withdrawal of the introducer needle. Temperature was measured with a thermistor stylet near the needle tip, with a target temperature of 70 degrees C-100 degrees C with RF ablation. Blood loss was measured as grams of blood absorbed in gauze at the puncture site for 2 minutes after needle withdrawal. Selected specimens were cut for gross examination.
RESULTS: RF ablation reduced bleeding compared with absence of RF ablation in liver and kidney (P <.01), with mean blood loss reduced 63% and 97%, respectively. Mean amounts of blood loss (+/- SD) in the liver in the RF and no-RF groups were 2.03 g +/- 4.03 (CI, 0.53-3.54 g) and 5.50 g +/- 5.58 (CI, 3.33-7.66 g), respectively. Mean amounts of blood loss in the kidney in the RF and no-RF groups were 0.26 g +/- 0.32 (CI, -0.01 to 0.53 g) and 8.79 g +/- 7.72 (CI, 2.34-15.24 g), respectively. With RF ablation, thermal coagulation of the tissue surrounding the needle tract was observed.
CONCLUSION: RF ablation of needle biopsy tracts reduced hemorrhage after biopsy in the liver and kidney and may reduce complications of hemorrhage as well as implantation of tumor cells in the tract.
C1 US FDA, Ctr Devices & Radiol Hlth, Off Sci & Technol, Rockville, MD 20857 USA.
NIH, Warren Grant Magnuson Clin Ctr, Dept Diagnost Radiol, Special Procedures Div, Bethesda, MD 20892 USA.
RP Pritchard, WF (reprint author), US FDA, Ctr Devices & Radiol Hlth, Off Sci & Technol, Rockville, MD 20857 USA.
EM wfp@cdrh.fda.gov
FU Intramural NIH HHS [Z99 CL999999]
NR 17
TC 19
Z9 19
U1 0
U2 0
PU LIPPINCOTT WILLIAMS & WILKINS
PI PHILADELPHIA
PA 530 WALNUT ST, PHILADELPHIA, PA 19106-3621 USA
SN 1051-0443
J9 J VASC INTERV RADIOL
JI J. Vasc. Interv. Radiol.
PD FEB
PY 2004
VL 15
IS 2
BP 183
EP 187
DI 10.1097/01.RVI.000019398.74740.69
PN 1
PG 5
WC Radiology, Nuclear Medicine & Medical Imaging; Peripheral Vascular
Disease
SC Radiology, Nuclear Medicine & Medical Imaging; Cardiovascular System &
Cardiology
GA 919EF
UT WOS:000228600400011
PM 14963187
ER
PT J
AU Zha, HB
Raffeld, M
Charboneau, L
Pittaluga, S
Kwak, LW
Petricoin, E
Liotta, LA
Jaffe, ES
AF Zha, HB
Raffeld, M
Charboneau, L
Pittaluga, S
Kwak, LW
Petricoin, E
Liotta, LA
Jaffe, ES
TI Similarities of prosurvival signals in Bcl-2-positive and Bcl-2-negative
follicular lymphomas identified by reverse phase protein microarray
SO LABORATORY INVESTIGATION
LA English
DT Article
DE apoptosis; follicular lymphoma; Bcl-2; protein microarray; proteomics
ID LASER CAPTURE MICRODISSECTION; NON-HODGKINS-LYMPHOMA; B-CELL LYMPHOMA;
NF-KAPPA-B; BCL-2 FAMILY; CHROMOSOMAL-ABNORMALITIES; TRANSCRIPTION
FACTOR; UP-REGULATION; EXPRESSION; SURVIVAL
AB Overexpression of Bcl-2 protein has been known to play a role in the pathogenesis of follicular lymphoma (FL). However, 10-15% of FLs are negative for Bcl-2 by immunohistochemistry, raising the possibility that another gene product(s) may provide prosurvival signal(s). We used reverse phase protein microarray to analyze lysates of follicle center cells isolated by laser capture microdissection from: Bcl-2+ FL, Bcl-2- FL and reactive follicular hyperplasia (FH) (nine cases each group). TUNEL assay confirmed similar and reduced levels of apoptosis in Bcl-2+ FL and Bcl-2- FL, indicating the likelihood of Bcl-2-independent inhibition of apoptosis. Arrays were quantitatively analyzed with antibodies to proteins involved in the apoptotic pathway. As expected, Bcl-2 levels were up to eight-fold higher in Bcl-2+ FL than in FH and Bcl-2- FL. However, there was no difference in levels of Mcl-1 and survivin among these three groups. Bcl-X-L showed a trend for increased expression in Bcl-2- FL as compared with Bcl-2+ FL, although the differences did not reach statistical significance (P>0.1). The increase in Bcl-X-L may provide an alternative antiapoptotic signal in FL negative for Ill protein. Interestingly, Bax expression was higher in FL (Bcl-2+ or -) than in FH (P=0.001). Notably, phospho-Akt (Ser-473) was increased in FL (Bcl-2+ or -) (P<0.03) with increased phospho-Bad (Ser-136), as compared with levels in FH. The activation of the Akt/Bad pathway provides further evidence of prosurvival signals in FL, independent of Bcl-2 alone. These data suggest that nodal FL represents a single disease with a final common biochemical pathway.
C1 NCI, Pathol Lab, Ctr Canc Res, NIH, Bethesda, MD 20892 USA.
NCI, Expt Transplantat & Immunol Branch, Bethesda, MD 20892 USA.
US FDA, Ctr Biol Evaluat & Res, Bethesda, MD 20892 USA.
RP Jaffe, ES (reprint author), NCI, Pathol Lab, Ctr Canc Res, NIH, Bldg 10,Room 2N202,MSC-1500, Bethesda, MD 20892 USA.
EM ejaffe@mail.nih.gov
NR 66
TC 63
Z9 68
U1 0
U2 1
PU NATURE PUBLISHING GROUP
PI NEW YORK
PA 345 PARK AVE SOUTH, NEW YORK, NY 10010-1707 USA
SN 0023-6837
J9 LAB INVEST
JI Lab. Invest.
PD FEB
PY 2004
VL 84
IS 2
BP 235
EP 244
DI 10.1038/labinvest.3700051
PG 10
WC Medicine, Research & Experimental; Pathology
SC Research & Experimental Medicine; Pathology
GA 840BW
UT WOS:000222833000013
PM 14767488
ER
PT J
AU Delmonte, P
Roach, JAG
Mossoba, MM
Losi, G
Yurawecz, MP
AF Delmonte, P
Roach, JAG
Mossoba, MM
Losi, G
Yurawecz, MP
TI Synthesis, isolation, and GC analysis of all the 6,8-to 13,15-cis/trans
conjugated linoleic acid isomers
SO LIPIDS
LA English
DT Article
ID PERFORMANCE LIQUID-CHROMATOGRAPHY; OCTADECADIENOIC ACID; METHYL-ESTERS;
SEPARATION; IDENTIFICATION; CLA
AB Octadecadienoic acids with conjugated double bonds are often referred to as conjugated linoleic acid, or CLA. CLA is of considerable interest because of potentially beneficial effects reported from animal studies. Analysis of CLA is usually carried out by GC elution of FAME. If the presence of low-level isomers is of interest, a complementary technique such as silver-ion HPLC is also used. These analyses have been hindered by a lack of well-characterized commercially available reference materials. Described here are the synthesis and isolation of selected 6,8- through 13,15-positional CLA isomers, followed by isomerization of these CLA isomers with iodine to produce all the possible cis,cis, cis,trans, trans,cis, and trans,trans combinations. Also present are the GC retention times of the CLA FAME relative to gamma-linolenic acid (6c,9c,12c-octadecatrienoic acid) FAME using a 100-m CP Sil-88 capillary column (Varian Inc., Lake Forest, CA). These data include all the CLA isomers that have been identified thus far in foods and dietary supplements and should greatly aid in the future analysis of CLA in these products.
C1 US FDA, Ctr Food Safety & Appl Nutr, College Pk, MD 20740 USA.
Univ Bologna, DIPROVAL, Bologna, Italy.
RP Yurawecz, MP (reprint author), US FDA, Ctr Food Safety & Appl Nutr, 5100 Paint Branck Pkwy,HFS-840,Room IE009, College Pk, MD 20740 USA.
EM mpy@cfsan.fda.gov
NR 18
TC 33
Z9 34
U1 0
U2 10
PU AMER OIL CHEMISTS SOC A O C S PRESS
PI CHAMPAIGN
PA 221 W BRADLEY AVE, CHAMPAIGN, IL 61821-1827 USA
SN 0024-4201
J9 LIPIDS
JI Lipids
PD FEB
PY 2004
VL 39
IS 2
BP 185
EP 191
PG 7
WC Biochemistry & Molecular Biology; Nutrition & Dietetics
SC Biochemistry & Molecular Biology; Nutrition & Dietetics
GA 813FQ
UT WOS:000220893400012
PM 15134147
ER
PT J
AU Taitt, CR
Golden, JP
Shubin, YS
Shriver-Lake, LC
Sapsford, KE
Rasooly, A
Ligler, FS
AF Taitt, CR
Golden, JP
Shubin, YS
Shriver-Lake, LC
Sapsford, KE
Rasooly, A
Ligler, FS
TI A portable array biosensor for detecting multiple analytes in complex
samples
SO MICROBIAL ECOLOGY
LA English
DT Article; Proceedings Paper
CT International Workshop on Microbial Ecology and the Space Environment
CY NOV 18-19, 2002
CL Tokyo, JAPAN
SP Int Space Life Sci Working Grp
ID SALMONELLA-ENTERITIDIS INFECTION; FIBER-OPTIC BIOSENSOR;
LISTERIA-MONOCYTOGENES; RAPID DETECTION; FOODS; IDENTIFICATION;
IMMUNOSENSOR; IMMUNOASSAY; ANTIBODIES; SURFACES
AB The Multi-Analyte Array Biosensor (MAAB) has been developed at the Naval Research Laboratory (NRL) with the goal of simultaneously detecting and identifying multiple target agents in complex samples with minimal user manipulation. This paper will focus on recent improvements in the biochemical and engineering aspects of this instrument. These improvements have enabled the expansion of the repertoire of analytes detected to include Salmonella typhimurium and Listeria monocytogenes, and also expanded the different sample matrices tested. Furthermore, all components of the biochemical assays could be prepared well in advance of sample testing, resulting in a "plug-and-play" methodology. Simultaneous detection of three toxins (ricin, staphylococcal enterotoxin B, and cholera toxin) was demonstrated using a novel fluidics cube module that limits the number of manipulations to only the initial sample loading. This work demonstrates the utility of the MAAB for rapid analysis of complex samples with multianalyte capability, with a minimum of operator manipulations required for either sample preparation or final analysis.
C1 USN, Res Lab, Ctr Biomol Sci & Engn, Washington, DC 20375 USA.
Geocenters Inc, Suitland, MD USA.
George Mason Univ, Arlington, VA USA.
US FDA, CFSAN, College Pk, MD USA.
RP Taitt, CR (reprint author), USN, Res Lab, Ctr Biomol Sci & Engn, Washington, DC 20375 USA.
EM crtaitt@cbmse.nrl.navy.mil
NR 73
TC 66
Z9 70
U1 0
U2 9
PU SPRINGER-VERLAG
PI NEW YORK
PA 175 FIFTH AVE, NEW YORK, NY 10010 USA
SN 0095-3628
J9 MICROBIAL ECOL
JI Microb. Ecol.
PD FEB
PY 2004
VL 47
IS 2
BP 175
EP 185
DI 10.1007/s00248-003-1011-1
PG 11
WC Ecology; Marine & Freshwater Biology; Microbiology
SC Environmental Sciences & Ecology; Marine & Freshwater Biology;
Microbiology
GA 818CL
UT WOS:000221223100010
PM 14765282
ER
PT J
AU Kawakami, K
Kawakami, M
Puri, RK
AF Kawakami, K
Kawakami, M
Puri, RK
TI Specifically targeted killing of interleukin-13 (IL-13)
receptor-expressing breast cancer by IL-13 fusion cytotoxin in animal
model of human disease
SO MOLECULAR CANCER THERAPEUTICS
LA English
DT Article
ID CELL CARCINOMA-CELLS; PSEUDOMONAS EXOTOXIN; SIGNAL-TRANSDUCTION;
CHIMERIC PROTEIN; ALPHA-2 CHAIN; (IL)-13 BINDING; TUMOR
IMMUNOSURVEILLANCE; ANTITUMOR-ACTIVITY; SYSTEMIC DELIVERY; MALIGNANT
GLIOMA
AB Interleukin-13 receptor (IL-13R) alpha2 chain binds IL-13 with high affinity and can internalize after binding to ligand. We have exploited this property of IL-13Ralpha2 chain by receptortargeted breast cancer therapy. Previous studies have demonstrated that in vivo intraturnoral (i.t.) gene transfer of this chain followed by IL-13 cytotoxin [comprised of IL-13 and Pseudomonas exotoxin (IL13-PE38QQR)] therapy causes regression of established human tumors in xenografted models. Breast carcinoma cells do not express IL-13Ralpha2 chain and are resistant to the antitumor effect of IL-13 cytotoxin. To determine whether IL-13Ralpha2 chain can render sensitivity of breast cancer to IL-13 cytotoxin, we injected IL-13Ralpha2 plasmid in s.c. established tumors by i.t. route, followed by systemic or i.t. IL-13 cytotoxin administration. This combination approach showed profound antitumor activity against human breast tumors in xenografted immunodeficient mice. Interestingly, there was dominant infiltration of inflammatory cells in regressing tumors, which were identified to be macrophages producing nitric oxide (NO) and natural killer cells. The partial role of inducible nitric oxide synthase (iNOS)-positive macrophages was confirmed by in vivo macrophage depletion experiments. Serum chemistry, hematology, and organ histology from treated mice did not show any remarkable toxicity resulting from the combination therapy. Taken together, local gene transfer of IL-13Ralpha2 followed by receptor-targeted IL-13 cytotoxin therapy may be applied safely and effectively to the treatment of localized breast cancer.
C1 US FDA, Ctr Biol Evaluat & Res, Lab Mol Tumor Biol, Div Cellular & Gene Therapies, Bethesda, MD 20892 USA.
RP Puri, RK (reprint author), US FDA, Ctr Biol Evaluat & Res, Lab Mol Tumor Biol, Div Cellular & Gene Therapies, NIH Bldg 29B,Room 2NN10,29 Lincoln Dr,MSC 4555, Bethesda, MD 20892 USA.
EM puri@cber.fda.gov
NR 50
TC 16
Z9 19
U1 0
U2 1
PU AMER ASSOC CANCER RESEARCH
PI PHILADELPHIA
PA 615 CHESTNUT ST, 17TH FLOOR, PHILADELPHIA, PA 19106-4404 USA
SN 1535-7163
J9 MOL CANCER THER
JI Mol. Cancer Ther.
PD FEB
PY 2004
VL 3
IS 2
BP 137
EP 147
PG 11
WC Oncology
SC Oncology
GA 778ME
UT WOS:000189244700005
PM 14985454
ER
PT J
AU Alayash, AI
AF Alayash, AI
TI Oxygen therapeutics: Can we tame haemoglobin?
SO NATURE REVIEWS DRUG DISCOVERY
LA English
DT Review
ID CROSS-LINKED HEMOGLOBIN; CELL-FREE HEMOGLOBIN; TRAUMATIC
HEMORRHAGIC-SHOCK; MYOGLOBIN REDOX CYCLE; NITRIC-OXIDE; BLOOD
SUBSTITUTE; HYDROGEN-PEROXIDE; HEME DEGRADATION; POLYOXYETHYLENE
CONJUGATE; RECOMBINANT HEMOGLOBIN
AB Chemically modified or genetically engineered haemoglobins (Hbs) developed as oxygen therapeutics (often termed 'blood substitutes') are designed to correct oxygen deficit due to ischaemia in a variety of clinical settings. These modifications are intended to stabilize Hb outside its natural environment - red blood cells - in a functional tetrameric and/or polymeric form. Uncontrolled haem-mediated oxidative reactions of cell-free Hb and its reactions with various oxidant/antioxidant and cell signalling systems have emerged as an important pathway of toxicity. Current protective strategies designed to produce safe Hb-based products are focused on controlling or suppressing the 'radical' nature of Hb while retaining its oxygen-carrying function.
C1 US FDA, Lab Biochem & Vasc Biol, Div Hematol, Ctr Biol Evaluat & Res, Bethesda, MD 20892 USA.
RP Alayash, AI (reprint author), US FDA, Lab Biochem & Vasc Biol, Div Hematol, Ctr Biol Evaluat & Res, 8800 Rockville Pike,NIH Bldg 29,Room 112, Bethesda, MD 20892 USA.
EM alayash@cber.fda.gov
NR 85
TC 176
Z9 183
U1 2
U2 26
PU NATURE PUBLISHING GROUP
PI LONDON
PA MACMILLAN BUILDING, 4 CRINAN ST, LONDON N1 9XW, ENGLAND
SN 1474-1776
J9 NAT REV DRUG DISCOV
JI Nat. Rev. Drug Discov.
PD FEB
PY 2004
VL 3
IS 2
BP 152
EP 159
DI 10.1038/nrd1307
PG 8
WC Biotechnology & Applied Microbiology; Pharmacology & Pharmacy
SC Biotechnology & Applied Microbiology; Pharmacology & Pharmacy
GA 768ZP
UT WOS:000188601800013
PM 15043006
ER
PT J
AU Taylor, CL
AF Taylor, CL
TI Regulatory frameworks for functional foods and dietary supplements
SO NUTRITION REVIEWS
LA English
DT Review
DE regulations; foods; dietary supplements
AB An understanding of the legal and regulatory requirements for foods, including dietary supplements and so-called functional foods, helps to focus attention on the special challenges that exist, which range from safety determinations to claim substantiation and consumer understanding. This article provides an overview of the Food and Drug Administration's regulatory framework for these products, it also highlights issues that are emerging and will require consideration and dialog.
C1 US FDA, Ctr Food Safety & Appl Nutr, Off Nutrit Prod Labeling & Dietary Supplements, College Pk, MD 20704 USA.
RP Taylor, CL (reprint author), US FDA, Ctr Food Safety & Appl Nutr, Off Nutrit Prod Labeling & Dietary Supplements, 5100 Paint Branch Pkwy, College Pk, MD 20704 USA.
NR 3
TC 8
Z9 11
U1 2
U2 3
PU INT LIFE SCIENCES INST NORTH AMERICA
PI WASHINGTON
PA ONE THOMAS CIRCLE, N W, 9TH FLOOR, WASHINGTON, DC 20005 USA
SN 0029-6643
J9 NUTR REV
JI Nutr. Rev.
PD FEB
PY 2004
VL 62
IS 2
BP 55
EP 59
DI 10.1301/nr.2004.feb.55-59
PG 5
WC Nutrition & Dietetics
SC Nutrition & Dietetics
GA 903NU
UT WOS:000227433600001
PM 15080366
ER
PT J
AU Koller, EA
Cross, JT
Schneider, B
AF Koller, EA
Cross, JT
Schneider, B
TI Risperidone-associated diabetes mellitus in children
SO PEDIATRICS
LA English
DT Letter
ID ATYPICAL ANTIPSYCHOTIC-DRUGS; HYPERGLYCEMIA
C1 US FDA, Div Metab & Endocrine Drug Prod, Ctr Drug Evaluat & Review, Rockville, MD 20857 USA.
RP Koller, EA (reprint author), US FDA, Div Metab & Endocrine Drug Prod, Ctr Drug Evaluat & Review, Rockville, MD 20857 USA.
NR 6
TC 19
Z9 19
U1 0
U2 0
PU AMER ACAD PEDIATRICS
PI ELK GROVE VILLAGE
PA 141 NORTH-WEST POINT BLVD,, ELK GROVE VILLAGE, IL 60007-1098 USA
SN 0031-4005
J9 PEDIATRICS
JI Pediatrics
PD FEB 1
PY 2004
VL 113
IS 2
BP 421
EP 421
DI 10.1542/peds.113.2.421
PG 1
WC Pediatrics
SC Pediatrics
GA 769AK
UT WOS:000188603800046
PM 14754964
ER
PT J
AU Takeshita, F
Gursel, I
Ishii, KJ
Suzuki, K
Gursel, M
Klinman, DM
AF Takeshita, F
Gursel, I
Ishii, KJ
Suzuki, K
Gursel, M
Klinman, DM
TI Signal transduction pathways mediated by the interaction of CpG DNA with
Toll-like receptor 9
SO SEMINARS IN IMMUNOLOGY
LA English
DT Review
DE CpG DNA; TLR 9; PAMP; signal transduction
ID NF-KAPPA-B; ACTIVATED PROTEIN-KINASES; ANTIGEN-PRESENTING CELLS;
BACTERIAL-DNA; CUTTING EDGE; INTERFERON-GAMMA; GENE-EXPRESSION;
IFN-BETA; RECOGNITION; REQUIRES
AB Synthetic oligodeoxynucleotides (ODN) expressing non-methylated "CpG motifs" patterned after those present in bacterial DNA have characteristic immunomodulatory effects. CpG DNA is recognized as a pathogen-associated molecular pattern, and triggers a rapid innate immune response. CpG ODN are being harnessed for a variety of therapeutic uses, including as immune adjuvants, for cancer therapy, as anti-allergens, and as immunoprotective agents. The signal transduction pathway mediated by the engagement of CpG DNA with Toll-like receptor 9 (TLR9) is shared with other members of the TLR family. Recent studies demonstrate that formation and maturation of CpG DNA-containing endosomes are regulated by phosphatidylinositol 3 kinases and the Ras-associated GTP-binding protein, Rab5, which are essential for the initiation of TLR9-mediated signaling. (C) 2003 Elsevier Ltd. All rights reserved.
C1 CBER, FDA, Bethesda, MD 20892 USA.
RP Klinman, DM (reprint author), CBER, FDA, Bldg 29A,Rm 3D10, Bethesda, MD 20892 USA.
EM Klinman@cber.fda.gov
RI Gursel, Mayda /H-1812-2012; Ishii, Ken/B-1685-2012;
OI Ishii, Ken/0000-0002-6728-3872; Gursel, Ihsan/0000-0003-3761-1166;
Gursel, Mayda/0000-0003-0044-9054
NR 43
TC 115
Z9 120
U1 6
U2 20
PU ACADEMIC PRESS LTD ELSEVIER SCIENCE LTD
PI LONDON
PA 24-28 OVAL RD, LONDON NW1 7DX, ENGLAND
SN 1044-5323
J9 SEMIN IMMUNOL
JI Semin. Immunol.
PD FEB
PY 2004
VL 16
IS 1
BP 17
EP 22
DI 10.1016/j.smim.2003.10.009
PG 6
WC Immunology
SC Immunology
GA 774VC
UT WOS:000189005300004
PM 14751759
ER
PT J
AU MacDonald, J
French, JE
Gerson, RJ
Goodman, J
Inoue, T
Jacobs, A
Kasper, P
Keller, D
Lavin, A
Long, G
McCullough, B
Sistare, FD
Storer, R
van der Laan, JW
AF MacDonald, J
French, JE
Gerson, RJ
Goodman, J
Inoue, T
Jacobs, A
Kasper, P
Keller, D
Lavin, A
Long, G
McCullough, B
Sistare, FD
Storer, R
van der Laan, JW
TI The utility of genetically modified mouse assays for identifying human
carcinogens: A basic understanding and path forward
SO TOXICOLOGICAL SCIENCES
LA English
DT Article
DE carcinogenicity; p53(+/-) knockout mouse; regulatory perspective; risk
assessment; Tg.rasH2 transgenic mouse; genetically modified mice
ID TUMORS
AB The Alternatives to Carcinogenicity Testing Committee of the International Life Sciences Institute (ILSI) Health and Environmental Sciences Institute (HESI) conducted a large-scale, multinational collaborative research program to evaluate several genetically modified mouse assays for assessing the human carcinogenic potential of compounds. The data from this testing program have made an important contribution to the general understanding of how these models can be best applied in hazard identification; however, questions still exist regarding methodology and data interpretation. To address these issues, ILSI HESI hosted a February 2003 workshop on the Utility of Transgenic Assays for Risk Assessment. The purpose of this workshop was to reach an understanding of how data from genetically modified mouse models are viewed by different regulatory bodies in the pharmaceutical sector and, based on this understanding, to identify areas in which more experimental work may be needed to increase the utility of data derived from these assays. In the course of discussions, various data gaps related to model selection and protocol issues were identified. Based on the outcome of the workshop, various studies are proposed to provide data to improve the utility of currently available assays for cancer hazard identification and risk assessment purposes.
C1 ILSI HESI, Washington, DC 20005 USA.
Schering Plough Res Inst, Kenilworth, NJ 07033 USA.
NIEHS, Res Triangle Pk, NC 27709 USA.
Endo Pharmaceut, Chadds Ford, PA 19352 USA.
Michigan State Univ, E Lansing, MI 48824 USA.
Natl Inst Hlth Sci, Tokyo 1588501, Japan.
US FDA, Ctr Drug Evaluat & Res, Rockville, MD 20857 USA.
Fed Inst Drugs & Med Devices BfArM, D-53175 Berlin, Germany.
Sanofi Synthelabo Res, Malvern, PA 19355 USA.
Eli Lilly & Co, Greenfield, IN 46140 USA.
Aventis Pharmaceut Inc, Bridgewater, NJ 08807 USA.
Merck Res Labs, W Point, PA 19486 USA.
Natl Inst Publ Hlth & Environm RIVM, NL-3720 BA Bilthoven, Netherlands.
RP Lavin, A (reprint author), ILSI HESI, 1 Thomas Circle,9th Floor, Washington, DC 20005 USA.
EM alavin@ilsi.org
OI Keller, Douglas/0000-0002-6186-2881
NR 7
TC 43
Z9 45
U1 0
U2 0
PU OXFORD UNIV PRESS
PI OXFORD
PA GREAT CLARENDON ST, OXFORD OX2 6DP, ENGLAND
SN 1096-6080
J9 TOXICOL SCI
JI Toxicol. Sci.
PD FEB
PY 2004
VL 77
IS 2
BP 188
EP 194
DI 10.1093/toxsci/kfh037
PG 7
WC Toxicology
SC Toxicology
GA 774ML
UT WOS:000188987000003
PM 14657512
ER
PT J
AU Scofield, TL
Miller, JP
Storry, JR
Rios, M
Reid, ME
AF Scofield, TL
Miller, JP
Storry, JR
Rios, M
Reid, ME
TI Evidence that Hy-RBCs express weak Jo(a) antigen
SO TRANSFUSION
LA English
DT Article
ID BLOOD-GROUP ANTIGEN; GROUP SYSTEM; JOA; GLYCOPROTEIN; PHENOTYPES;
EXAMPLE; GY(A); GYA
AB BACKGROUND: RBCs of the Hy- phenotype have, in the past, been typed as Gy(a+(w)), Hy-, Jo(a-), and RBCs with the Jo(a-) phenotype type Gy(a+), Hy-(w), and Jo(a-). Anti-Hy and anti-Jo(a) are difficult to identify mainly because appropriate reagent R6Cs are poorly characterized. Historically, anti-Jo(a) has not reacted with RBCs with either phenotype. This report describes a case of an anti-Jo(a) that shows Hy- RBCs express some Jo(a) antigen, albeit weakly.
CASE REPORT: Anti-Jo(a) was identified in a serum sample of a 71-year-old woman. The antibody reacted 1+ to 2+ by the IAT with all untreated and ficin-treated panel RBCs and did not react with Gy(a-) RBCs and Jo(a-) RBCs. Unexpectedly, the serum sample reacted weakly with six of eight RBC samples with the Hy- phenotype. The anti_Jo(a) was adsorbed onto and eluted from Hy- RBCs, indicating the presence of weak Jo(a) antigen. The patient's RBCs typed Gy(a+), Hy+, Jo(a-). DNA studies using PCR-RFLP analysis showed the patient to be homozygous for the JO allele, which is consistent with the serologically determined Jo(a-) status.
CONCLUSION: The DNA and serologic evidence of this case show that Hy- RBCs may express low levels of Jo(a) antigen, which contradicts previously published data concerning the Jo(a) type of Hy- RBCs.
C1 Amer Red Cross, N Cent Blood Serv, St Paul, MN 55107 USA.
US FDA, Ctr Biol Evaluat & Res, Bethesda, MD USA.
Univ Hosp, Skane Blood Ctr, Lund, Sweden.
New York Blood Ctr, Immunohematol Lab, New York, NY 10021 USA.
RP Scofield, TL (reprint author), Amer Red Cross, N Cent Blood Serv, 100 S Robert St, St Paul, MN 55107 USA.
EM scofieldt@usa.redcross.org
FU NHLBI NIH HHS [HL54459]
NR 15
TC 2
Z9 2
U1 0
U2 0
PU BLACKWELL PUBLISHING INC
PI MALDEN
PA 350 MAIN ST, MALDEN, MA 02148 USA
SN 0041-1132
J9 TRANSFUSION
JI Transfusion
PD FEB
PY 2004
VL 44
IS 2
BP 170
EP 172
DI 10.1111/j.1537-2995.2004.00627.x
PG 3
WC Hematology
SC Hematology
GA 775RH
UT WOS:000189055900006
PM 14962307
ER
PT J
AU Orton, SL
Stramer, SL
Dodd, RY
Alter, MJ
AF Orton, SL
Stramer, SL
Dodd, RY
Alter, MJ
TI Risk factors for HCV infection among blood donors confirmed to be
positive for the presence of HCV RNA and not reactive for the presence
of anti-HCV
SO TRANSFUSION
LA English
DT Article
ID HEPATITIS-C VIRUS; NON-B HEPATITIS; UNITED-STATES; HEALTH-CARE; NON-A;
DISEASE; EPIDEMIOLOGY; POPULATION; IDENTIFY; VIREMIA
AB BACKGROUND: In 1999, NAT of blood donations was implemented to detect "window-period" infections. Blood donors who have confirmed NAT results positive for the presence of HCV in the absence of anti-HCV are likely to have been recently infected. Of over 26.8 million donations tested between March 3, 1999, and March 31, 2003, 810 were HCV-reactive by NAT. A subset of these donors was assessed for recent exposure risk.
STUDY DESIGN AND METHODS: All anti-HCV-blood donors with reactive, unconfirmed HCV NAT results were invited to participate in a study that included an extensive demographic and risk questionnaire. Confirmed HCV+ cases were compared to HCV- (falsely positive) controls for histories of potential risk factors during the 6 months before donation.
RESULTS: Recent injection drug use (IDU) was independently associated with HCV infection (29.2% vs. 0% of cases vs. controls, p < 0.001). In addition, likely sources were identified for three other cases (4.6%), including occupational exposure, sexual contact with an HCV-infected partner (who was an IDU), and perinatal exposure, none of which was known to the donors at the time of donation. Incarceration was independently associated with HCV infection among the group not reporting IDU and after removal of the three donors with likely sources of risk (14.6% vs. 1.3% of cases vs. controls, p < 0.001).
CONCLUSIONS: A likely risk, primarily IDU, was found for 43 percent of HCV+ donors whose infections were identified solely by NAT. Because the maximum efficiency of the donor history questions may have been reached, NAT will continue to be an important measure to interdict recently infected blood donors.
C1 Amer Red Cross, Gaithersburg, MD USA.
Amer Red Cross, Rockville, MD USA.
Ctr Dis Control & Prevent, Atlanta, GA USA.
RP Orton, SL (reprint author), CBER, OBRR, Div Blood Applicat, Rockville, MD 20852 USA.
EM Orton@cber.fda.gov
NR 22
TC 38
Z9 40
U1 0
U2 2
PU BLACKWELL PUBLISHING INC
PI MALDEN
PA 350 MAIN ST, MALDEN, MA 02148 USA
SN 0041-1132
J9 TRANSFUSION
JI Transfusion
PD FEB
PY 2004
VL 44
IS 2
BP 275
EP 281
DI 10.1111/j.1537-2995.2004.00623.x
PG 7
WC Hematology
SC Hematology
GA 775RH
UT WOS:000189055900019
PM 14962320
ER
PT J
AU Raker, CA
Tabor, E
Okayama, A
Yu, MYW
Kohara, M
Mueller, NE
Tsubouchi, H
Stuver, SO
AF Raker, CA
Tabor, E
Okayama, A
Yu, MYW
Kohara, M
Mueller, NE
Tsubouchi, H
Stuver, SO
TI HCV core antigen as an alternative to NAT to detect HCV viremia
SO TRANSFUSION
LA English
DT Letter
ID ENZYME-IMMUNOASSAY; INFECTION
C1 Harvard Univ, Sch Publ Hlth, Dept Epidemiol, Boston, MA 02115 USA.
US FDA, Ctr Biol Evaluat & Res, Bethesda, MD USA.
Miyazaki Med Coll, Dept Internal Med 2, Miyazaki 88916, Japan.
Tokyo Metropolitan Inst Med Sci, Dept Microbiol & Cell Biol, Tokyo 113, Japan.
Boston Univ, Sch Publ Hlth, Dept Epidemiol, Boston, MA USA.
RP Raker, CA (reprint author), Harvard Univ, Sch Publ Hlth, Dept Epidemiol, Boston, MA 02115 USA.
EM craker@hsph.harvard.edu
FU NCI NIH HHS [T32 CA09001-27, CA38450]
NR 5
TC 8
Z9 8
U1 0
U2 0
PU BLACKWELL PUBLISHING INC
PI MALDEN
PA 350 MAIN ST, MALDEN, MA 02148 USA
SN 0041-1132
J9 TRANSFUSION
JI Transfusion
PD FEB
PY 2004
VL 44
IS 2
BP 307
EP 308
DI 10.1111/j.1537-2995.2004.00649.x
PG 2
WC Hematology
SC Hematology
GA 775RH
UT WOS:000189055900024
PM 14962325
ER
PT J
AU Petricoin, EF
Liotta, LA
AF Petricoin, EF
Liotta, LA
TI Proteomic approaches in cancer risk and response assessment
SO TRENDS IN MOLECULAR MEDICINE
LA English
DT Article
ID PROTEIN IDENTIFICATION TECHNOLOGY; TYROSINE KINASE INHIBITOR;
IMMOBILIZED PH GRADIENTS; OVARIAN-CANCER; MASS-SPECTROMETRY;
BREAST-CANCER; 2-DIMENSIONAL ELECTROPHORESIS; TRASTUZUMAB HERCEPTIN;
CLINICAL PROTEOMICS; MYELOID-LEUKEMIA
AB Proteomics is more than just a list-generating exercise where increases or decreases in protein expression are identified. Proteomic technologies will ultimately characterize information-flow through the protein circuitry that interconnects the extracellular microenvironment to the serum or plasma macroenvironment through intracellular signaling systems and their control of gene transcription. The nature of this information can be a cause or a consequence of disease processes and how patients respond to therapy. Analysis of human cancer as a model for how proteomics can have an impact at the bedside can take advantage of several promising new proteomic technologies. These technologies are being developed for early detection and risk assessment, therapeutic targeting and patient-tailored therapy.
C1 NCI, FDA, Clin Proteom Program, Bethesda, MD 20892 USA.
NCI, Pathol Lab, Ctr Canc Res, NIH, Bethesda, MD 20892 USA.
RP Petricoin, EF (reprint author), NCI, FDA, Clin Proteom Program, Bldg 29A,Room 2D12,8800 Rockville Pike, Bethesda, MD 20892 USA.
EM petricoin@cber.fda.gov
NR 70
TC 40
Z9 41
U1 0
U2 1
PU ELSEVIER SCI LTD
PI OXFORD
PA THE BOULEVARD, LANGFORD LANE, KIDLINGTON, OXFORD OX5 1GB, OXON, ENGLAND
SN 1471-4914
J9 TRENDS MOL MED
JI Trends Mol. Med
PD FEB
PY 2004
VL 10
IS 2
BP 59
EP 64
DI 10.1016/j.molmed.2003.12.006
PG 6
WC Biochemistry & Molecular Biology; Cell Biology; Medicine, Research &
Experimental
SC Biochemistry & Molecular Biology; Cell Biology; Research & Experimental
Medicine
GA 780BE
UT WOS:000189350600004
PM 15102358
ER
PT J
AU Goldsmith, JC
Eller, N
Mikolajczyk, M
Manischewitz, J
Golding, H
Scott, DE
AF Goldsmith, JC
Eller, N
Mikolajczyk, M
Manischewitz, J
Golding, H
Scott, DE
TI Intravenous immunoglobulin products contain neutralizing antibodies to
vaccinia
SO VOX SANGUINIS
LA English
DT Article
DE anti-vaccinia virus antibodies; immune globulin (intravenous, human);
primary immune deficiency; smallpox vaccination
ID SMALLPOX VACCINATION; VIRUS; COMPLICATIONS
AB Background and Objectives Individuals with primary or secondary immune-deficiency diseases may be at risk for vaccinia infection if widespread smallpox-immunization programmes are implemented in the United States of America (USA) for bioterrorism preparedness. The objective of this study was to determine whether commercial immune globulin (intravenous, human) products contain biologically active antibodies to vaccinia that have the potential to protect people, with immune deficiencies, from complications of vaccinia.
Materials and Methods Eight currently United States (US)-licensed and two European intravenous immunoglobulin (IVIG) products were tested in a vaccinia plaque-reduction neutralization assay. The in vivo activity of five of these lots was assessed in severely immune-deficient mice.
Results All tested products contained neutralizing anti-vaccinia activity, in vitro and in vivo.
Conclusions The use of IVIG by individuals with inherited or acquired humoral immune deficiencies may provide some protection if they are inadvertently exposed to vaccinia.
C1 Immune Deficiency Fdn, Towson, MD USA.
US FDA, Ctr Biol Evaluat & Res, Bethesda, MD USA.
RP Goldsmith, JC (reprint author), 40 W Chesapeake Ave,Suitte 308, Towson, MD 21204 USA.
EM jgoldsmith@primaryimmune.org
NR 24
TC 12
Z9 13
U1 0
U2 0
PU BLACKWELL PUBLISHING LTD
PI OXFORD
PA 9600 GARSINGTON RD, OXFORD OX4 2DG, OXON, ENGLAND
SN 0042-9007
J9 VOX SANG
JI Vox Sang.
PD FEB
PY 2004
VL 86
IS 2
BP 125
EP 129
DI 10.1111/j.0042-9007.2004.00397.x
PG 5
WC Hematology
SC Hematology
GA 810HW
UT WOS:000220696400007
PM 15023182
ER
PT J
AU Rodrigues, A
Rios, M
Costa, FF
Saad, STO
Pellegrino, J
Castilho, L
AF Rodrigues, A
Rios, M
Costa, FF
Saad, STO
Pellegrino, J
Castilho, L
TI Weakened expression of 'e' owing to concomitant occurrence of Cys16 and
Val245 (VS antigen)
SO VOX SANGUINIS
LA English
DT Article
DE e antigen; RHCE ce; SCD patients; VS antigen
ID BLOOD-GROUP SYSTEM; MOLECULAR-BIOLOGY; BLACK INDIVIDUALS; RHCE GENE;
POLYMORPHISMS; POLYPEPTIDES; INSIGHTS
AB Background and Objectives The 48 G>C transversion in exon 1 of the RHCE gene leads to Trp16Cys, usually present in the conventional RHCE Ce, while Trp 16 is associated with RHCE ce. The presence of Cys16 in RHCE ce is associated with the R-0 (Dce) haplotype in Africans, leading to a weak 'e' antigen expression on red blood cells (RBCs). VS is a common red cell antigen in individuals of African descent and results from a single point mutation in exon 5 of the RHCE (733C>G), leading to Leu245Val substitution; VS positivity is also associated with weak expression of 'e'. This study investigated the association of Cys16 and/or VS with the RHCE ce alleles in a cohort of sickle cell disease (SCD) patients phenotyped as R(0)r or R0R0 and rr.
Materials and Methods DNA samples from 58 SCD patients were tested for the 48 G>C transversion, encoding Cys16, by allele-specific polymerase chain reaction (PCR). We also amplified exon 5 of the RHCE by PCR and subjected the amplified product to restriction fragment length polymorphism analysis, using BfaI, in order to determine the VS status. Further cDNA analysis was performed on three samples to verify whether the mutations were located on the same or on different alleles.
Results Fifty-six of the 58 SCD patients studied (97%) were heterozygous for 48G/48C (Cys16). Of these, 18 (32%) were also heterozygous for 733C/G (245Val). All of these 18 samples showed weak 'e' expression on RBCs when tested with at least one monoclonal antibody to e antigen. cDNA sequencing of three of 18 patient samples showed that the genes encoding Cys16 and Val245 (VS) were on different alleles.
Conclusions We found a high incidence of Cys16 associated with the RHCE ce in our SCD cohort. A high percentage of these patients were also found to be heterozygous for VS. cDNA analysis showed that, in at least three samples, the two mutations were on different alleles, with consequent weakening of expression of the e antigen on RBCs.
C1 UNICAMP, Hemoctr, BR-13081970 Campinas, SP, Brazil.
US FDA, CBER, DETTD, Rockville, MD 20857 USA.
RP Castilho, L (reprint author), UNICAMP, Hemoctr, Rua Carlos Chagas 480,Caixa Postal 6198, BR-13081970 Campinas, SP, Brazil.
EM castilho@unicamp.br
RI Costa, Fernando/D-1566-2012; Castilho, Lilian/F-6123-2012
OI Castilho, Lilian/0000-0002-3104-647X
NR 22
TC 5
Z9 5
U1 0
U2 1
PU BLACKWELL PUBLISHING LTD
PI OXFORD
PA 9600 GARSINGTON RD, OXFORD OX4 2DG, OXON, ENGLAND
SN 0042-9007
J9 VOX SANG
JI Vox Sang.
PD FEB
PY 2004
VL 86
IS 2
BP 136
EP 140
DI 10.1111/j.0042-9007.2004.00399.x
PG 5
WC Hematology
SC Hematology
GA 810HW
UT WOS:000220696400009
PM 15023184
ER
PT J
AU Sakamoto, S
Qin, JZ
Navarro, A
Gamero, A
Potla, R
Yi, TL
Zhu, W
Baker, DP
Feldman, G
Larner, AC
AF Sakamoto, S
Qin, JZ
Navarro, A
Gamero, A
Potla, R
Yi, TL
Zhu, W
Baker, DP
Feldman, G
Larner, AC
TI Cells previously desensitized to type 1 interferons display different
mechanisms of activation of stat-dependent gene expression from naive
cells
SO JOURNAL OF BIOLOGICAL CHEMISTRY
LA English
DT Article
ID PROTEIN-TYROSINE-PHOSPHATASE; STIMULATED JAK/STAT PATHWAY;
GAMMA-INTERFERON; TRANSCRIPTIONAL INDUCTION; BETA-INTERFERON;
PHOSPHORYLATED STAT1; BINDING PROTEIN; DNA; INHIBITION; ALPHA
AB Over the past decade, a wealth of knowledge has been obtained concerning the mechanisms by which interferons (IFNs) and other cytokines activate or down-regulate immediate early genes via the Jak/Stat pathway. In contrast, little information is available on interferon-activated gene expression in naive cells compared with cells that have been desensitized and subsequently resensitized to the actions of these cytokines. In naive cells, the ISG54 gene is activated via IFN beta-stimulated formation of ISGF3, a heterotrimeric DNA binding complex consisting of p48 (IRF9) and tyrosine-phosphorylated Stat1 and Stat2. In contrast, in previously desensitized cells IFNbeta weakly stimulates the assembly of an ISGF3-like complex that lacks Stat1, even though ISG54 mRNA induction is the same as in naive cells. The lack of Stat1 tyrosine phosphorylation and DNA binding is due to increased activity of a protein-tyrosine phosphatase. In cells that do not express the tyrosine phosphatase Tc-PTP, the rate of Stat1 dephosphorylation is the same in naive and previously desensitized cells. These results implicate Tc-PTP in a novel role in the regulation of type 1 interferon-stimulated gene expression.
C1 Lerner Res Inst, Dept Immunol, Cleveland, OH 44195 USA.
Cleveland Clin Fdn, Dept Canc Biol, Cleveland, OH 44195 USA.
Biogen Inc, Cambridge, MA 02142 USA.
US FDA, Div Monoclonal Antibodies, Ctr Biol Evaluat & Res, Bethesda, MD 20892 USA.
RP Larner, AC (reprint author), Lerner Res Inst, Dept Immunol, 9500 Euclid Ave, Cleveland, OH 44195 USA.
EM larnera@ccf.iorg
FU NCI NIH HHS [CA77366]
NR 44
TC 22
Z9 22
U1 0
U2 0
PU AMER SOC BIOCHEMISTRY MOLECULAR BIOLOGY INC
PI BETHESDA
PA 9650 ROCKVILLE PIKE, BETHESDA, MD 20814-3996 USA
SN 0021-9258
J9 J BIOL CHEM
JI J. Biol. Chem.
PD JAN 30
PY 2004
VL 279
IS 5
BP 3245
EP 3253
DI 10.1074/jbc.M309631200
PG 9
WC Biochemistry & Molecular Biology
SC Biochemistry & Molecular Biology
GA 766MF
UT WOS:000188379600015
PM 14600148
ER
PT J
AU Moody, TW
Dudek, J
Zakowicz, H
Walters, J
Jensen, RT
Petricoin, E
Couldrey, C
Green, JE
AF Moody, TW
Dudek, J
Zakowicz, H
Walters, J
Jensen, RT
Petricoin, E
Couldrey, C
Green, JE
TI VIP receptor antagonists inhibit mammary carcinogenesis in C3(1)SV40T
antigen mice
SO LIFE SCIENCES
LA English
DT Article
DE VIP receptor antagonist; mammary carcinogenesis; transgenic mice;
chemoprevention; proteomics
ID VASOACTIVE INTESTINAL POLYPEPTIDE; BREAST-CANCER-CELLS; FUNCTIONAL
EXPRESSION; PEPTIDE RECEPTORS; TRANSGENIC MICE; PACAP RECEPTOR; HUMAN
TUMORS; LUNG-CANCER; GROWTH; IDENTIFICATION
AB The effects of a vasoactive intestinal peptide (VIP) receptor antagonist on mammary carcinogenesis were investigated using the C3(1)SV40T antigen (ag) mice. Ten mug/day VIPhybrid (VIPhyb) administered daily subcutaneously increased significantly the survival of C3(1)SV40Tag mice. At 5.2 months, VIPhyb significantly reduced the mammary tumor burden in C3(1)SV40Tag mice relative to control animals. I-125-VIP bound with high affinity to mouse mammary tumor homogenate. Because (Lys(15), Arg(16), Leu(27))VIP(1-7)GRF(8-27) (VPAC(1) selective) but not Ro25-1553 (VPAC(2) selective) inhibited specific I-125-VIP binding to mammary tumor membranes with high affinity, VPAC(1) receptors predominate. By RT-PCR, VPAC(1) receptor mRNA was detected in mammary tumors. By Western blot, a major 60 Kdalton band was detected in mammary tumor extracts using VPAC(1) receptor antisera. By immunocytochemistry, VPAC(1)-R immunostaining was detected in the cytosol and plasma membrane but not the nucleus of fixed mammary tumor tissue. Using laser capture microdissected tumor cells and surface enhanced laser desorption/ionization (SELDI) techniques on mammary tumor cells, the proteomic profile was altered in mice treated with VIPhyb. Because VPAC(1) receptor antagonists increase the survival and reduce the tumor burden in C3(1)SV40Tag mice, they may function as chemopreventive agents in mammary cancer. (C) 2003 Elsevier Inc. All rights reserved.
C1 NCI, Dept Hlth & Human Serv, Ctr Canc Res, NIH, Bethesda, MD 20892 USA.
George Washington Univ, Genet Program, Washington, DC 20037 USA.
NIDDK, Digest Dis Branch, Bethesda, MD USA.
CBER FDA, Div Cytokine Biol, Bethesda, MD USA.
NCI, Lab Cell Regulat & Carcinogenesis, Bethesda, MD 20892 USA.
RP Moody, TW (reprint author), NCI, Dept Hlth & Human Serv, Ctr Canc Res, NIH, Bldg 31,Rm 3A34,31 Ctr Dr, Bethesda, MD 20892 USA.
EM moodyt@mail.nih.gov
NR 37
TC 17
Z9 18
U1 0
U2 0
PU PERGAMON-ELSEVIER SCIENCE LTD
PI OXFORD
PA THE BOULEVARD, LANGFORD LANE, KIDLINGTON, OXFORD OX5 1GB, ENGLAND
SN 0024-3205
J9 LIFE SCI
JI Life Sci.
PD JAN 30
PY 2004
VL 74
IS 11
BP 1345
EP 1357
DI 10.1016/j.lfs.2003.07.043
PG 13
WC Medicine, Research & Experimental; Pharmacology & Pharmacy
SC Research & Experimental Medicine; Pharmacology & Pharmacy
GA 763NJ
UT WOS:000188092000004
PM 14706566
ER
PT J
AU Ellenberg, SS
AF Ellenberg, SS
TI Analytical, practical and regulatory issues in prevention studies
SO STATISTICS IN MEDICINE
LA English
DT Article; Proceedings Paper
CT 2nd International Conference on Statistical Methodology on Alzheimers
Disease Research
CY MAY 10-12, 2002
CL LEXINGTON, KENTUCKY
DE disease prevention; clinical trials; surrogate endpoints; missing data;
safety monitoring
ID CLINICAL-TRIALS; CARDIOVASCULAR-DISEASE; SURROGATE MARKERS; RANDOMIZED
TRIALS; BETA-CAROTENE; LUNG-CANCER; HEART; ADHERENCE; HEALTH; DROPOUTS
AB Prevention studies, as distinguished from studies investigating treatments for established disease, present some distinct challenges. Perhaps the most extensive experience with preventive agents is in the area of infectious diseases; vaccines have been extremely effective in preventing many such diseases. Vaccines have been, and continue to be, studied in other disease areas such as certain cancers, but as yet have not achieved success outside of infectious disease prevention. One obvious and important feature of prevention studies is that they enrol healthy individuals; thus such studies require particularly high standards for the safety of those enrolled (and those who might ultimately receive the product being tested). Prevention studies often need to be quite large, as the types of diseases most important to prevent tend to be uncommon. Large studies usually require simplified approaches; to ensure high quality of data on the key variables it may be necessary to compromise on the amount of data collected, frequency of data collection, and other aspects of trial design. The reliability of randomization and blinding may be especially important in these large studies, as bias could easily overwhelm the small effects that are usually sought. Often, biomarkers thought to indicate developing but as yet subclinical disease, will be important to evaluate; whether such markers can serve as primary endpoints in prevention studies has been a contentious issue in many contexts. Studies in older populations, such as those at risk for Alzheimer's Disease, raise challenges such as accounting for competing risks, and considering potential interactions of preventive agents with multiple medications often used by the elderly. Published in 2004 by John Wiley Sons, Ltd.
C1 US FDA, Ctr Biol Evaluat & Res, Off Biostat & Epidemiol, Rockville, MD 20852 USA.
RP Ellenberg, SS (reprint author), US FDA, Ctr Biol Evaluat & Res, Off Biostat & Epidemiol, 1401 Rockville Pike,HFM-210, Rockville, MD 20852 USA.
EM ellenberg@cber.fda.gov
NR 34
TC 4
Z9 5
U1 0
U2 0
PU JOHN WILEY & SONS LTD
PI CHICHESTER
PA THE ATRIUM, SOUTHERN GATE, CHICHESTER PO19 8SQ, W SUSSEX, ENGLAND
SN 0277-6715
J9 STAT MED
JI Stat. Med.
PD JAN 30
PY 2004
VL 23
IS 2
BP 297
EP 303
DI 10.1002/sim.1717
PG 7
WC Mathematical & Computational Biology; Public, Environmental &
Occupational Health; Medical Informatics; Medicine, Research &
Experimental; Statistics & Probability
SC Mathematical & Computational Biology; Public, Environmental &
Occupational Health; Medical Informatics; Research & Experimental
Medicine; Mathematics
GA 763TW
UT WOS:000188117400013
PM 14716730
ER
PT J
AU Mani, RB
AF Mani, RB
TI The evaluation of disease modifying therapies in Alzheimer's disease: a
regulatory viewpoint
SO STATISTICS IN MEDICINE
LA English
DT Article; Proceedings Paper
CT 2nd International Conference on Statistical Methodology on Alzheimers
Disease Research
CY MAY 10-12, 2002
CL LEXINGTON, KY
DE Alzheimer's disease; prevention; drug; clinical trials; surrogate
markers; brain imaging
ID INTERNATIONAL WORKING GROUP; DEMENTIA DRUG GUIDELINES; SURROGATE
END-POINTS; CLINICAL-TRIALS; POSITION PAPER; PROGRESSION; HARMONIZATION;
VALIDATION; CRITERIA
AB Several drugs have received marketing approval in this country for the treatment of dementia of the Alzheimer's type. Their approval has been based on clinical trial designs that do not permit a distinction to be made between an effect of the drug on the symptoms of that disease, and an effect on the pathophysiological mechanisms that underlie that disorder. The latter effect has been referred to as 'disease-modifying.'
In recent years there has been considerable interest in developing disease-modifying treatments for Alzheimer's disease (AD), using either specific clinical designs, or surrogate markers, such as brain imaging modalities. This paper outlines the regulatory framework governing how the Food and Drug Administration addresses new drug claims, the current basis for approving drugs for the treatment of AD, clinical trial designs that have been proposed as a means of demonstrating disease-modifying effects, a general and regulatory background to the use of surrogate markers in drug development, and, finally, views about the possible role of surrogate markers, especially brain imaging, as outcome measures in clinical trials intended to produce disease-modifying effects in Alzheimer's Disease. Copyright (C) 2004 John Wiley Sons, Ltd.
C1 US FDA, Div Neuropharmacol Drug Prod, Rockville, MD 20852 USA.
RP Mani, RB (reprint author), US FDA, Div Neuropharmacol Drug Prod, HFD-120,1451 Rockville Pike,Room 4040, Rockville, MD 20852 USA.
EM manir@cder.fda.gov
NR 21
TC 49
Z9 49
U1 0
U2 2
PU WILEY-BLACKWELL
PI HOBOKEN
PA 111 RIVER ST, HOBOKEN 07030-5774, NJ USA
SN 0277-6715
EI 1097-0258
J9 STAT MED
JI Stat. Med.
PD JAN 30
PY 2004
VL 23
IS 2
BP 305
EP 314
DI 10.1002/sim.1718
PG 10
WC Mathematical & Computational Biology; Public, Environmental &
Occupational Health; Medical Informatics; Medicine, Research &
Experimental; Statistics & Probability
SC Mathematical & Computational Biology; Public, Environmental &
Occupational Health; Medical Informatics; Research & Experimental
Medicine; Mathematics
GA 763TW
UT WOS:000188117400014
PM 14716731
ER
PT J
AU Acheson, DWK
Fiore, AE
AF Acheson, DWK
Fiore, AE
TI Preventing foodborne disease - What clinicians can do
SO NEW ENGLAND JOURNAL OF MEDICINE
LA English
DT Editorial Material
C1 US FDA, Ctr Food Safety & Appl Nutr, College Pk, MD 20740 USA.
Ctr Dis Control & Prevent, Div Viral Hepatitis, Natl Ctr Infect Dis, Atlanta, GA USA.
RP Acheson, DWK (reprint author), US FDA, Ctr Food Safety & Appl Nutr, College Pk, MD 20740 USA.
NR 0
TC 17
Z9 17
U1 0
U2 0
PU MASSACHUSETTS MEDICAL SOC/NEJM
PI WALTHAM
PA WALTHAM WOODS CENTER, 860 WINTER ST,, WALTHAM, MA 02451-1413 USA
SN 0028-4793
J9 NEW ENGL J MED
JI N. Engl. J. Med.
PD JAN 29
PY 2004
VL 350
IS 5
BP 437
EP 440
DI 10.1056/NEJMp038213
PG 4
WC Medicine, General & Internal
SC General & Internal Medicine
GA 767QJ
UT WOS:000188463900004
PM 14749450
ER
PT J
AU Marcy, SM
Kohl, KS
Dagan, R
Nalin, D
Blum, M
Jones, MC
Hansen, J
Labadie, J
Lee, L
Martin, BL
O'Brien, K
Rothstein, E
Vermeer, P
AF Marcy, SM
Kohl, KS
Dagan, R
Nalin, D
Blum, M
Jones, MC
Hansen, J
Labadie, J
Lee, L
Martin, BL
O'Brien, K
Rothstein, E
Vermeer, P
CA Brighton Collaboration Fever Worki
TI Fever as an adverse event following immunization: case definition and
guidelines of data collection, analysis, and presentation
SO VACCINE
LA English
DT Article
DE fever; adverse events following immunization; case definition;
guidelines
ID TYMPANIC MEMBRANE TEMPERATURES; INFRARED EAR THERMOMETRY; RECTAL
TEMPERATURE; BODY-TEMPERATURE; NEWBORN-INFANTS; YOUNG-CHILDREN;
AXILLARY; PALPATION; DIFFERENCE; ACCURACY
C1 Ctr Dis Control & Prevent, Natl Immunizat Program, Atlanta, GA 30333 USA.
Harbor UCLA Med Ctr, Los Angeles, CA USA.
Soroka Med Ctr, IL-84101 Beer Sheva, Israel.
Merck & Co Inc, West Point, PA USA.
Wyeth Res, Collegeville, PA USA.
Calif DHS Immunizat Branch, Berkeley, CA USA.
Kaiser Permanente Hlth Care Program, Oakland, CA USA.
Netherlands Pharmacovigilance Ctr Lareb, sHertogenbosch, Netherlands.
US FDA, Rockville, MD 20857 USA.
Walter Reed Army Med Ctr, Washington, DC 20307 USA.
Johns Hopkins Univ, Bloomberg Sch Publ Hlth, Baltimore, MD USA.
Pennridge Pediat Associates, Sellersville, PA USA.
Natl Inst Publ Hlth & Environm, NL-3720 BA Bilthoven, Netherlands.
Ctr Dis Control & Prevent, Atlanta, GA USA.
Univ Basel, Childrens Hosp, Basel, Switzerland.
RP Kohl, KS (reprint author), Ctr Dis Control & Prevent, Natl Immunizat Program, 1600 Clifton Rd,Mailstop E-61, Atlanta, GA 30333 USA.
EM secretariat@brightoncollaboration.org
NR 62
TC 67
Z9 68
U1 0
U2 2
PU ELSEVIER SCI LTD
PI OXFORD
PA THE BOULEVARD, LANGFORD LANE, KIDLINGTON, OXFORD OX5 1GB, OXON, ENGLAND
SN 0264-410X
EI 1873-2518
J9 VACCINE
JI Vaccine
PD JAN 26
PY 2004
VL 22
IS 5-6
BP 551
EP 556
DI 10.1016/j.vaccine.2003.09.007
PG 6
WC Immunology; Medicine, Research & Experimental
SC Immunology; Research & Experimental Medicine
GA 775YB
UT WOS:000189087300002
PM 14741143
ER
PT J
AU Bonhoeffer, J
Gold, MS
Heijbel, H
Vermeer, P
Blumberg, D
Braun, M
de Souza-Brito, G
Davis, RL
Halperin, S
Heininger, U
Khuri-Bulos, N
Menkes, J
Nokleby, H
AF Bonhoeffer, J
Gold, MS
Heijbel, H
Vermeer, P
Blumberg, D
Braun, M
de Souza-Brito, G
Davis, RL
Halperin, S
Heininger, U
Khuri-Bulos, N
Menkes, J
Nokleby, H
CA Brighton Collaboration HHE Working
TI Hypotonic-Hyporesponsive Episode (HHE) as an adverse event following
immunization: case definition and guidelines for data collection,
analysis, and presentation
SO VACCINE
LA English
DT Article
ID ACELLULAR PERTUSSIS VACCINES; WHOLE-CELL; VACCINATION; CHILDREN;
DIPHTHERIA; INFANTS; EXPERIENCE
C1 Univ Basel, Childrens Hosp, Basel, Switzerland.
Univ Adelaide, Dept Paediat, Adelaide, SA, Australia.
Swedish Inst Infect Dis Control, Lund, Sweden.
Natl Inst Publ Hlth & Environm, NL-3720 BA Bilthoven, Netherlands.
Univ Calif Davis, Med Ctr, Sacramento, CA 95817 USA.
US FDA, Rockville, MD 20857 USA.
Univ Sao Paulo, Sch Med, Sao Paulo, Brazil.
Univ Washington, Seattle, WA 98195 USA.
Dalhousie Univ, Halifax, NS, Canada.
Jordan Univ Hosp, Amman, Jordan.
Cedars Sinai Med Ctr, Los Angeles, CA 90048 USA.
Natl Inst Publ Hlth, Oslo, Norway.
Ctr Dis Control & Prevent, Atlanta, GA USA.
RP Bonhoeffer, J (reprint author), Univ Basel, Childrens Hosp, Basel, Switzerland.
EM secretariat@brightoncollaboration.org
RI Bonhoeffer, Jan/E-5903-2014
NR 20
TC 13
Z9 13
U1 0
U2 1
PU ELSEVIER SCI LTD
PI OXFORD
PA THE BOULEVARD, LANGFORD LANE, KIDLINGTON, OXFORD OX5 1GB, OXON, ENGLAND
SN 0264-410X
J9 VACCINE
JI Vaccine
PD JAN 26
PY 2004
VL 22
IS 5-6
BP 563
EP 568
DI 10.1016/j.vaccine.2003.09.009
PG 6
WC Immunology; Medicine, Research & Experimental
SC Immunology; Research & Experimental Medicine
GA 775YB
UT WOS:000189087300004
PM 14741145
ER
PT J
AU Bines, JE
Kohl, KS
Forster, J
Zanardi, LR
Davis, RL
Hansen, J
Murphy, TM
Music, S
Niu, M
Varricchio, F
Vermeer, P
Wong, EJC
AF Bines, JE
Kohl, KS
Forster, J
Zanardi, LR
Davis, RL
Hansen, J
Murphy, TM
Music, S
Niu, M
Varricchio, F
Vermeer, P
Wong, EJC
CA Brighton Collaboration Intussuscep
TI Acute intussusception in infants and children as an adverse event
following immunization: case definition and guidelines of data
collection, analysis, and presentation
SO VACCINE
LA English
DT Article
DE intussusception; adverse events following immunization; care definition;
data guidelines
ID VACCINE
C1 Ctr Dis Control & Prevent, Natl Immunizat Program, Atlanta, GA 30333 USA.
Royal Childrens Hosp, Parkville, Vic 3052, Australia.
St Josefs Hosp, Freiburg, Germany.
Univ Washington, Seattle, WA 98195 USA.
Kaiser Permanente Hlth Care Program, Oakland, CA USA.
Merck Res Labs, W Point, PA USA.
US FDA, Rockville, MD 20857 USA.
Natl Inst Publ Hlth & Environm, NL-3720 BA Bilthoven, Netherlands.
Harbor UCLA Med Ctr, Torrance, CA 90509 USA.
Ctr Dis Control & Prevent, Atlanta, GA USA.
Univ Basel, Childrens Hosp, Basel, Switzerland.
RP Kohl, KS (reprint author), Ctr Dis Control & Prevent, Natl Immunizat Program, 1600 Clifton Rd,Mailstop E-61, Atlanta, GA 30333 USA.
EM secretariat@brightoncollaboration.org
NR 7
TC 100
Z9 105
U1 0
U2 0
PU ELSEVIER SCI LTD
PI OXFORD
PA THE BOULEVARD, LANGFORD LANE, KIDLINGTON, OXFORD OX5 1GB, OXON, ENGLAND
SN 0264-410X
J9 VACCINE
JI Vaccine
PD JAN 26
PY 2004
VL 22
IS 5-6
BP 569
EP 574
DI 10.1016/j.vaccine.2003.09.016
PG 6
WC Immunology; Medicine, Research & Experimental
SC Immunology; Research & Experimental Medicine
GA 775YB
UT WOS:000189087300005
PM 14741146
ER
PT J
AU Rothstein, E
Kohl, KS
Ball, L
Halperin, SA
Halsey, N
Hammer, SJ
Heath, PT
Hennig, R
Kleppinger, C
Labadie, J
Varricchio, F
Vermeer, P
Walop, W
AF Rothstein, E
Kohl, KS
Ball, L
Halperin, SA
Halsey, N
Hammer, SJ
Heath, PT
Hennig, R
Kleppinger, C
Labadie, J
Varricchio, F
Vermeer, P
Walop, W
CA Brighton Collaboration Local React
TI Nodule at injection site as an adverse event following immunization:
case definition and guidelines for data collection, analysis, and
presentation
SO VACCINE
LA English
DT Article
ID ACELLULAR PERTUSSIS-VACCINE; PNEUMOCOCCAL POLYSACCHARIDE VACCINE;
HEPATITIS-A VACCINE; DIPHTHERIA-TETANUS; HEALTHY-ADULTS; IMMUNOGENICITY;
ALUMINUM; SAFETY; CHILDREN; GRANULOMA
C1 Ctr Dis Control & Prevent, Natl Immunizat Program, Atlanta, GA 30333 USA.
Pennridge Pediatr Associates, Sellersville, PA USA.
US FDA, Rockville, MD 20857 USA.
Dalhousie Univ, Halifax, NS, Canada.
Johns Hopkins Bloomberg Sch Publ Hlth, Baltimore, MD USA.
Calif Dept Hlth Serv, Berkeley, CA 94704 USA.
St George Hosp, Sch Med, London, England.
Chiron Behring GmbH & Co, Marburg, Germany.
US FDA, Rockville, MD 20857 USA.
Netherlands Pharmacovigilance Ctr Lareb, sHertogenbosch, Netherlands.
Natl Inst Publ Hlth & Environm, NL-3720 BA Bilthoven, Netherlands.
Hlth Canada, Ottawa, ON K1A 0L2, Canada.
Univ Basel, Childrens Hosp, Basel, Switzerland.
RP Kohl, KS (reprint author), Ctr Dis Control & Prevent, Natl Immunizat Program, 1600 Clifton Rd,Mailstop E-61, Atlanta, GA 30333 USA.
EM secretariat@brightoncollaboration.org
NR 42
TC 28
Z9 28
U1 0
U2 0
PU ELSEVIER SCI LTD
PI OXFORD
PA THE BOULEVARD, LANGFORD LANE, KIDLINGTON, OXFORD OX5 1GB, OXON, ENGLAND
SN 0264-410X
J9 VACCINE
JI Vaccine
PD JAN 26
PY 2004
VL 22
IS 5-6
BP 575
EP 585
DI 10.1016/j.vaccine.2003.09.005
PG 11
WC Immunology; Medicine, Research & Experimental
SC Immunology; Research & Experimental Medicine
GA 775YB
UT WOS:000189087300006
PM 14741147
ER
PT J
AU Samore, MH
Evans, RS
Lassen, A
Gould, P
Lloyd, J
Gardner, RM
Abouzelof, R
Taylor, C
Woodbury, DA
Willy, M
Bright, RA
AF Samore, MH
Evans, RS
Lassen, A
Gould, P
Lloyd, J
Gardner, RM
Abouzelof, R
Taylor, C
Woodbury, DA
Willy, M
Bright, RA
TI Surveillance of medical device - Related hazards and adverse events in
hospitalized patients
SO JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION
LA English
DT Article
ID CLOSED CLAIMS ANALYSIS; INTENSIVE-CARE-UNIT; DRUG EVENTS; QUALITY
IMPROVEMENT; SAFETY; ANESTHESIA; DESIGN
AB Context Although adverse drug events have been extensively evaluated by computer-based surveillance, medical device errors have no comparable surveillance techniques.
Objectives To determine whether computer-based surveillance can reliably identify medical device-related hazards (no known harm to patient) and adverse medical device events (AMDEs; patient experienced harm) and to compare alternative methods of detection of device-related problems.
Design, Setting, and Participants This descriptive study was conducted from January through September 2000 at a 520-bed tertiary teaching institution in the United States with experience in using computer tools to detect and prevent adverse drug events. All 20441 regular and short-stay patients (excluding obstetric and newborn patients) were included.
Main Outcome Measures Medical device events as detected by computer-based flags, telemetry problem checklists, International Classification of Diseases, Ninth Revision (ICD-9) discharge code (which could include AMDEs present at admission), clinical engineering work logs, and patient survey results were compared with each other and with routine voluntary incident reports to determine frequencies, proportions, positive predictive values, and incidence rates by each technique.
Results Of the 7059 flags triggered, 552 (7.8%) indicate a device-related hazard or AMDE. The estimated 9-month incidence rates (number per 1000 admissions [95% confidence intervals]) for AMDEs were 1.6 (0.9-2.5) for incident reports, 27.7 (24.9-30.7) for computer flags, and 64.6 (60.4-69.1) for ICD-9 discharge codes. Few of these events were detected by more than 1 surveillance method, giving an overall incidence of AMDE detected by at least 1 of these methods of 83.7 per 1000 (95% confidence interval, 78.8-88.6) admissions. The positive predictive value of computer flags for detecting device-related hazards and AMDEs ranged from 0% to 38%.
Conclusions More intensive surveillance methods yielded higher rates of medical device problems than found with traditional voluntary reporting, with little overlap between methods. Several detection methods had low efficiency in detecting AMDEs. The high rite of AMDEs suggests that AMDEs are an important patient safety issue, but additional research is necessary to identify optimal AMIDE detection strategies.
C1 Univ Utah, Sch Med, Salt Lake City, UT 84132 USA.
LDS Hosp Intermt Hlth Care, Salt Lake City, UT USA.
Vet Affairs Salt Lake City Hlth Care Syst, Salt Lake City, UT USA.
US FDA, Ctr Drug Evaluat & Res, Rockville, MD 20857 USA.
US FDA, Ctr Devices & Radiol Hlth, Rockville, MD 20857 USA.
RP Samore, MH (reprint author), Univ Utah, Sch Med, 50 N Med Dr,Room AC104, Salt Lake City, UT 84132 USA.
RI Bright, Roselie/D-2240-2016
FU PHS HHS [223-99-6101]
NR 36
TC 62
Z9 62
U1 2
U2 10
PU AMER MEDICAL ASSOC
PI CHICAGO
PA 515 N STATE ST, CHICAGO, IL 60610 USA
SN 0098-7484
J9 JAMA-J AM MED ASSOC
JI JAMA-J. Am. Med. Assoc.
PD JAN 21
PY 2004
VL 291
IS 3
BP 325
EP 334
DI 10.1001/jama.291.3.325
PG 10
WC Medicine, General & Internal
SC General & Internal Medicine
GA 764ZZ
UT WOS:000188243100032
PM 14734595
ER
PT J
AU Keller, JE
Cai, F
Neale, EA
AF Keller, JE
Cai, F
Neale, EA
TI Uptake of botulinum neurotoxin into cultured neurons
SO BIOCHEMISTRY
LA English
DT Article
ID SYNAPTIC PROTEIN SNAP-25; E DERIVATIVE TOXIN; SPINAL-CORD CELLS;
CLOSTRIDIAL NEUROTOXINS; NEUROMUSCULAR-JUNCTION; TYROSINE
PHOSPHORYLATION; LIPID BILAYERS; ION CHANNELS; HEAVY-CHAIN; SEROTYPE-A
AB Botulinum neurotoxins (BoNTs) act within the synaptic terminal to block neurotransmitter release. The toxin enters the neuron by binding to neuronal membrane receptor(s), being taken up into an endosome-like compartment, and penetrating the endosome membrane via a pH-dependent translocation process. Once within the synaptic cytoplasm, BoNT serotypes A and E cleave separate sites on the C-terminus of the neuronal protein SNAP-25, one of the SNARE proteins required for synaptic vesicle fusion. In this study, we measured the effect of brief toxin exposure on SNAP-25 proteolysis in neuronal cell cultures as an indicator of toxin translocation. The results indicate that (1) uptake of both BoNT-A and -E is enhanced with synaptic activity induced by K+ depolarization in the presence of Ca2+ and (2) translocation of BoNT-A from the acidic endosomal compartment is slow relative to that of BoNT-E. Polyclonal antisera against each toxin protect cells when applied with the toxin during stimulation but has no effect when added immediately after toxin exposure, indicating that toxin endocytosis occurs with synaptic activity. Both serotypes cleave SNAP-25 at concentrations between 50 pM and 4 nM. IC50 values for SNAP-25 cleavage are approximately 0.5 nM for both serotypes. Inhibition of the pH-dependent translocation process by pretreating cultures with concanamycin A (Con A) prevents cleavage of SNAP-25 with IC50 values of similar to25 nM. Addition of Con A at times up to 15 min after toxin exposure abrogated BoNT-A action; however, addition of Con A after 40 min was no longer protective. In contrast, Con A inhibited, but did not prevent, translocation of BoNT-E even when added immediately after toxin exposure, indicating that pH-dependent translocation of BoNT-E is rapid relative to that of BoNT-A. This study demonstrates that uptake of both BoNT-A and -E is enhanced with synaptic activity and that translocation of the toxin catalytic moiety into the cytosol occurs at different rates for these two serotypes.
C1 US FDA, Ctr Biol Evaluat & Res, Lab Bacterial Toxins, Bethesda, MD 20892 USA.
NICHHD, Dev Neurobiol Lab, NIH, Bethesda, MD 20892 USA.
RP Keller, JE (reprint author), US FDA, Ctr Biol Evaluat & Res, Lab Bacterial Toxins, Bethesda, MD 20892 USA.
EM kellerj@cber.fda.gov
NR 50
TC 101
Z9 106
U1 0
U2 3
PU AMER CHEMICAL SOC
PI WASHINGTON
PA 1155 16TH ST, NW, WASHINGTON, DC 20036 USA
SN 0006-2960
J9 BIOCHEMISTRY-US
JI Biochemistry
PD JAN 20
PY 2004
VL 43
IS 2
BP 526
EP 532
DI 10.1021/bi0356698
PG 7
WC Biochemistry & Molecular Biology
SC Biochemistry & Molecular Biology
GA 763RH
UT WOS:000188113900027
PM 14717608
ER
PT J
AU Sapsford, KE
Rasooly, A
Taitt, CR
Ligler, FS
AF Sapsford, KE
Rasooly, A
Taitt, CR
Ligler, FS
TI Detection of Campylobacter and Shigella species in food samples using an
array biosensor
SO ANALYTICAL CHEMISTRY
LA English
DT Article
ID ENTEROINVASIVE ESCHERICHIA-COLI; LINKED-IMMUNOSORBENT-ASSAY;
POLYMERASE-CHAIN-REACTION; RAPID DETECTION; ENRICHMENT CULTURE;
ENZYME-IMMUNOASSAY; POULTRY SAMPLES; PCR ASSAY; JEJUNI; IDENTIFICATION
AB Campylobacter and Shigella bacteria are common causes of food- and water-borne illness worldwide. There is a current need in food, medical, environmental, and military markets for a rapid and user-friendly method of detecting such pathogens. The array biosensor developed at the NRL encompasses these qualities. In this study, 25-min, sandwich immunoassays were developed for the detection of Campylobacter and Shigella species in both buffer and a variety of food and beverage samples. The limit of detection for Shigella dysenteriae in buffer and chicken carcass wash was 4.9 x 10(4) cfu mL(-1), whereas Campylobacter jejuni could be measured at concentrations as low as 9.7 x 10(2) cfu mL(-1). The limits of detection and dynamic range were found to vary depending on the sample matrix, but could be improved by running the sample over the waveguide surface for longer periods of time. Samples were run with no preconcentration or enrichment steps and little-to-no sample pretreatment prior to analysis.
C1 USN, Res Lab, Ctr Biomol Sci & Engn, Washington, DC 20375 USA.
US FDA, College Pk, MD 20740 USA.
George Mason Univ, Manassas, VA USA.
RP Ligler, FS (reprint author), USN, Res Lab, Ctr Biomol Sci & Engn, Washington, DC 20375 USA.
EM fligler@cbmse.nrl.navy.mil
NR 28
TC 65
Z9 71
U1 2
U2 18
PU AMER CHEMICAL SOC
PI WASHINGTON
PA 1155 16TH ST, NW, WASHINGTON, DC 20036 USA
SN 0003-2700
J9 ANAL CHEM
JI Anal. Chem.
PD JAN 15
PY 2004
VL 76
IS 2
BP 433
EP 440
DI 10.1021/ac035122z
PG 8
WC Chemistry, Analytical
SC Chemistry
GA 764GJ
UT WOS:000188198800027
PM 14719894
ER
PT J
AU Powers, JH
Albrecht, R
AF Powers, JH
Albrecht, R
TI Lipid amphotericin B formulations as comparators in clinical trials
SO CLINICAL INFECTIOUS DISEASES
LA English
DT Letter
ID NEUTROPENIA; TIME
C1 US FDA, Ctr Drug Evaluat & Res, Div Special Pathogen & Immunol Drug Prod, Rockville, MD 20857 USA.
US FDA, Off Drug Evaluat IV, Rockville, MD 20857 USA.
RP Powers, JH (reprint author), 9201 Corp Blvd,HFD-104, Rockville, MD 20850 USA.
NR 7
TC 1
Z9 1
U1 0
U2 0
PU UNIV CHICAGO PRESS
PI CHICAGO
PA 1427 E 60TH ST, CHICAGO, IL 60637-2954 USA
SN 1058-4838
J9 CLIN INFECT DIS
JI Clin. Infect. Dis.
PD JAN 15
PY 2004
VL 38
IS 2
BP 305
EP 306
DI 10.1086/381269
PG 2
WC Immunology; Infectious Diseases; Microbiology
SC Immunology; Infectious Diseases; Microbiology
GA 757NN
UT WOS:000187568500023
PM 14699471
ER
PT J
AU Karginov, VA
Robinson, TM
Riemenschneider, J
Golding, B
Kennedy, M
Shiloach, J
Alibek, K
AF Karginov, VA
Robinson, TM
Riemenschneider, J
Golding, B
Kennedy, M
Shiloach, J
Alibek, K
TI Treatment of anthrax infection with combination of ciprofloxacin and
antibodies to protective antigen of Bacillus anthracis
SO FEMS IMMUNOLOGY AND MEDICAL MICROBIOLOGY
LA English
DT Article
DE anthrax treatment; anti-protective antigen antibody; ciprofloxacin;
mouse model
ID DELIVERED POLYCLONAL ANTIBODIES; PSEUDOMONAS-AERUGINOSA; GUINEA-PIGS;
IMMUNOGLOBULIN; PROPHYLAXIS; EFFICACY; SPORES; MICE
AB Currently there is no effective treatment for inhalational anthrax beyond administration of antibiotics shortly after exposure. There is need for new, safe and effective treatments to supplement traditional antibiotic therapy. Our study was based on the premise that simultaneous inhibition of lethal toxin action with antibodies and blocking of bacterial growth by antibiotics will be beneficial for the treatment of anthrax. In this study, we tested the effects of a combination treatment using purified rabbit or sheep anti-protective antigen (PA) antibodies and the antibiotic ciprofloxacin in a rodent anthrax model. In mice infected with a dose of Bacillus anthracis Sterne strain corresponding to 10 LD50, antibiotic treatment with ciprofloxacin alone only cured 50% of infected animals. Administration of anti-PA IgG in combination with ciprofloxacin produced 90-100% survival. These data indicate that a combination of antibiotic/immunoglobulin therapy is more effective than antibiotic treatment alone in a rodent anthrax model. (C) 2003 Federation of European Microbiological Societies. Published by Elsevier B.V. All rights reserved.
C1 Adv Biosyst Inc, Manassas, VA 20110 USA.
CBER, FDA, Bethesda, MD USA.
NIDDK, NIH, Bethesda, MD USA.
George Mason Univ, Ctr Biodef, Manassas, VA USA.
RP Karginov, VA (reprint author), Adv Biosyst Inc, 10900 Univ Blvd, Manassas, VA 20110 USA.
EM vladimir.karginov@analex.com
NR 14
TC 38
Z9 41
U1 1
U2 3
PU ELSEVIER SCIENCE BV
PI AMSTERDAM
PA PO BOX 211, 1000 AE AMSTERDAM, NETHERLANDS
SN 0928-8244
J9 FEMS IMMUNOL MED MIC
JI FEMS Immunol. Med. Microbiol.
PD JAN 15
PY 2004
VL 40
IS 1
BP 71
EP 74
DI 10.1016/S0928-8244(03)00302-X
PG 4
WC Immunology; Infectious Diseases; Microbiology
SC Immunology; Infectious Diseases; Microbiology
GA 769FL
UT WOS:000188615700009
PM 14734189
ER
PT J
AU Hampshire, V
AF Hampshire, V
TI Emerging issues regarding informed consent - Consumers calling hotline
with concerns
SO JAVMA-JOURNAL OF THE AMERICAN VETERINARY MEDICAL ASSOCIATION
LA English
DT News Item
C1 FDA Ctr Vet Med, Off Surveillance & Compliance, Rockville, MD 20857 USA.
RP Hampshire, V (reprint author), FDA Ctr Vet Med, Off Surveillance & Compliance, Rockville, MD 20857 USA.
EM VHampshi@CVM.FDA.GOV
NR 0
TC 0
Z9 0
U1 0
U2 2
PU AMER VETERINARY MEDICAL ASSOC
PI SCHAUMBURG
PA 1931 N MEACHAM RD SUITE 100, SCHAUMBURG, IL 60173-4360 USA
SN 0003-1488
J9 JAVMA-J AM VET MED A
JI JAVMA-J. Am. Vet. Med. Assoc.
PD JAN 15
PY 2004
VL 224
IS 2
BP 177
EP 177
PG 1
WC Veterinary Sciences
SC Veterinary Sciences
GA 802BP
UT WOS:000220139300006
PM 14736049
ER
PT J
AU McDermott, MK
Schroeder, LW
Balsis, SL
Paradiso, NA
Byrne, ML
Briber, RM
AF McDermott, MK
Schroeder, LW
Balsis, SL
Paradiso, NA
Byrne, ML
Briber, RM
TI Mechanical properties of polyurethane film exposed to solutions of
nonoxynol-9 surfactant and poly(ethylene glycol)
SO JOURNAL OF APPLIED POLYMER SCIENCE
LA English
DT Article
DE polyurethanes; mechanical properties; surfactants; swelling; thermal
properties
ID ORGANIC LIQUIDS; MULTICOMPONENT DIFFUSION; THERMAL TECHNIQUES; POLYMER
MEMBRANES; LATEX ALLERGENS; SORPTION; CONDOMS; RUBBER; DETERIORATION;
DISSOLUTION
AB Mechanical properties of two polyether urethane films (Estane and Tecoflex) were studied after exposure to solutions of nonoxynol 9 (N9) surfactant and poly(ethylene glycol) 400 (PEG) for various times. Large amounts of N9 were absorbed from N9/PEG solutions, resulting in soft-segment plasticization and lower mechanical properties. As the N9 concentration increased, Estane absorbed more liquid and its mechanical properties decreased more compared to Tecoflex, although the mechanical properties of Estane were higher than Tecoflex at low concentrations of N9. Hard-segment domain disruption is probably not occurring because the relationship between the elastic modulus and polymer volume fraction followed Flory's theory for swollen elastic rubber networks and the liquids do not fully dissolve the polymers. The diffusion behavior of N9 and PEG was observed to follow Fickian behavior. Most of the absorption and decrease in mechanical properties occurred within the first 20 h after soaking, implying that additional loss in strength over longer times would be minimal. Mechanical property anisotropy suggests that condoms should be cut from Estane film in an orientation that optimizes the property-orientation relationship for specific end uses. (C) 2003 Wiley Periodicals, Inc. J Appl Polym Sci 91: 1086-1096, 2004.
C1 US FDA, Div Mech & Mat Sci, Off Sci & Technol, Rockville, MD 20850 USA.
Marquette Univ, Dept Biomed Engn, Milwaukee, WI 53201 USA.
Univ Maryland, Dept Mat & Nucl Engn, College Pk, MD 20742 USA.
RP McDermott, MK (reprint author), US FDA, Div Mech & Mat Sci, Off Sci & Technol, 9200 Corp Blvd,HFZ-150, Rockville, MD 20850 USA.
RI Briber, Robert/A-3588-2012
OI Briber, Robert/0000-0002-8358-5942
NR 71
TC 7
Z9 7
U1 2
U2 16
PU JOHN WILEY & SONS INC
PI HOBOKEN
PA 111 RIVER ST, HOBOKEN, NJ 07030 USA
SN 0021-8995
J9 J APPL POLYM SCI
JI J. Appl. Polym. Sci.
PD JAN 15
PY 2004
VL 91
IS 2
BP 1086
EP 1096
DI 10.1002/app.13285
PG 11
WC Polymer Science
SC Polymer Science
GA 749JA
UT WOS:000186915200050
ER
PT J
AU Walsh, DL
Schwerin, MR
Kisielewski, RW
Kotz, RM
Chaput, MP
Varney, GW
To, TM
AF Walsh, DL
Schwerin, MR
Kisielewski, RW
Kotz, RM
Chaput, MP
Varney, GW
To, TM
TI Abrasion resistance of medical glove materials
SO JOURNAL OF BIOMEDICAL MATERIALS RESEARCH PART B-APPLIED BIOMATERIALS
LA English
DT Article
DE glove; abrasion; tear; viral penetration; durability
ID BIOMECHANICAL PERFORMANCE; CLINICAL SETTINGS; LATEX; VINYL; PENETRATION;
LEAKAGE; PERMEABILITY; INTEGRITY; FATIGUE
AB Due to the increasing demand for nonlatex medical gloves in the health-care community, there is a need to assess the durability of alternative glove materials. This study examines durability characteristics of various glove materials by abrasion resistance testing. Natural rubber latex (latex), polyvinyl chloride (vinyl), acrylonitrile butadiene (nitrile), polychloroprene (neoprene), and a styrene-ethylenetbutylene-styrene block copolymer (SEBS) were tested. All test specimens, with the exception of the vinyl, were obtained from surgical gloves. Unaged out-of-the-box specimens as well as those subjected to various degrees of artificial aging were included in the study. After the abrasion sequence, the barrier integrity of the material was assessed through the use of a static leak test. Other traditional tests performed on these materials were viral penetration to validate the abrasion data and tear testing for comparative purposes. The results indicate that specific glove-material performance is dependent upon the particular test under consideration. Most notably, abrasion, even in controlled nonsevere conditions, may compromise to varying degrees the barrier integrity of latex, vinyl, SEBS, nitrile, and neoprene glove materials. However, as evidenced by the results of testing three brands of neoprene gloves, the abrasion resistance of any one glove material may be significantly affected by variations in production processes. (C) 2003 Wiley Periodicals. Inc.
C1 US FDA, CDRH, OST, DMMS, Rockville, MD 20850 USA.
US FDA, Ctr Devices & Radiol Hlth, Off Surveillance & Biometr, HFZ 542, Rockville, MD 20852 USA.
US FDA, Off Regulat Affairs, Winchester Engn & Analyt Ctr, Winchester, MA 01890 USA.
RP Walsh, DL (reprint author), US FDA, CDRH, OST, DMMS, 9200 Corp Blvd,HFZ 150, Rockville, MD 20850 USA.
FU ODCDC CDC HHS [U60/CCU015989-01]
NR 27
TC 13
Z9 13
U1 1
U2 9
PU WILEY-LISS
PI NEW YORK
PA DIV JOHN WILEY & SONS INC, 605 THIRD AVE, NEW YORK, NY 10158-0012 USA
SN 0021-9304
J9 J BIOMED MATER RES B
JI J. Biomed. Mater. Res. Part B
PD JAN 15
PY 2004
VL 68B
IS 1
BP 81
EP 87
DI 10.1002/jbm.b.10055
PG 7
WC Engineering, Biomedical; Materials Science, Biomaterials
SC Engineering; Materials Science
GA 758UR
UT WOS:000187669200011
PM 14689500
ER
PT J
AU Feng, CG
Collazo-Custodio, CM
Eckhaus, M
Hieny, S
Belkaid, Y
Elkins, K
Jankovic, D
Taylor, GA
Sher, A
AF Feng, CG
Collazo-Custodio, CM
Eckhaus, M
Hieny, S
Belkaid, Y
Elkins, K
Jankovic, D
Taylor, GA
Sher, A
TI Mice deficient in LRG-47 display increased susceptibility to
mycobacterial infection associated with the induction of lymphopenia
SO JOURNAL OF IMMUNOLOGY
LA English
DT Article
ID NITRIC-OXIDE SYNTHASE; INDUCIBLY EXPRESSED GTPASE; INTERFERON-GAMMA;
IFN-GAMMA; AVIUM INFECTION; TUBERCULOSIS INFECTION; T-CELLS; RESISTANCE;
APOPTOSIS; IDENTIFICATION
AB Although IFN-gamma is essential for host control of mycobacterial infection, the mechanisms by which the cytokine restricts pathogen growth are only partially understood. LRG-47 is an IFN-inducible GTP-binding protein previously shown to be required for IFN-gamma-dependent host resistance to acute Listeria monocytogenes and Toxoplasma gondii infections. To examine the role of LRG-47 in control of mycobacterial infection, LRG-47(-/-) and wild-type mice were infected with Mycobacterium avium, and host responses were analyzed. LRG-47 protein was strongly induced in livers of infected wild-type animals in an IFN-gamma-dependent manner. LRG-47(-/-) mice were unable to control bacterial replication, but survived the acute phase, succumbing 11-16 wk postinfection. IFN-gamma-primed, bone marrow-derived macrophages from LRG-47(-/-) and wild-type animals produced equivalent levels of TNF and NO upon M. avium infection in vitro and developed similar intracellular bacterial loads. In addition, priming for IFN-gamma production was observed in T cells isolated from infected LRG-47(-/-) mice. Importantly, however, mycobacterial granulomas in LRG-47(-/-) mice showed a marked lymphocyte deficiency. Further examination of these animals revealed a profound systemic lymphopenia and anemia triggered by infection. As LRG47(-/-) T lymphocytes were found to both survive and confer resistance to M. avium in recipient recombinase-activating gene-2(-/-) mice, the defect in cellular response and bacterial control in LRG-47(-/-) mice may also depend on a factor(s) expressed in a nonlymphocyte compartment. These findings establish a role for LRG-47 in host control of mycobacteria and demonstrate that in the context of the IFN-gamma response to persistent infection, LRG-47 can have downstream regulatory effects on lymphocyte survival. The Journal of Immunology, 2004, 172: 1163-1168.
C1 NIAID, Immunol Sect, Parasit Dis Lab, NIH, Bethesda, MD 20892 USA.
NIH, Vet Resources Program, Off Res Serv, Bethesda, MD 20892 USA.
US FDA, Ctr Biol Evaluat & Res, Div Bacterial Allergen & Parasit Prod, Lab Mycobacterial Dis & Cellular Immun, Rockville, MD 20852 USA.
Duke Univ, Vet Affairs Med Ctr, Geriatr Res Educ & Clin Ctr, Durham, NC 27710 USA.
Duke Univ, Vet Affairs Med Ctr, Ctr Study Aging & Human Dev, Durham, NC 27710 USA.
Duke Univ, Vet Affairs Med Ctr, Dept Med, Durham, NC 27710 USA.
Duke Univ, Vet Affairs Med Ctr, Dept Immunol, Durham, NC 27710 USA.
RP Feng, CG (reprint author), NIAID, Immunol Sect, Parasit Dis Lab, NIH, Room 6148,Bldg 50,50 S Dr, Bethesda, MD 20892 USA.
EM cfeng@niaid.niti.gov
NR 33
TC 83
Z9 90
U1 1
U2 5
PU AMER ASSOC IMMUNOLOGISTS
PI BETHESDA
PA 9650 ROCKVILLE PIKE, BETHESDA, MD 20814 USA
SN 0022-1767
J9 J IMMUNOL
JI J. Immunol.
PD JAN 15
PY 2004
VL 172
IS 2
BP 1163
EP 1168
PG 6
WC Immunology
SC Immunology
GA 762WM
UT WOS:000188005200051
PM 14707092
ER
PT J
AU Wong-Chew, RM
Islas-Romero, R
Garcia-Garcia, MD
Beeler, JA
Audet, S
Santos-Preciado, JI
Gans, H
Lew-Yasukawa, L
Maldonado, YA
Arvin, AM
Valdespino-Gomez, JL
AF Wong-Chew, RM
Islas-Romero, R
Garcia-Garcia, MD
Beeler, JA
Audet, S
Santos-Preciado, JI
Gans, H
Lew-Yasukawa, L
Maldonado, YA
Arvin, AM
Valdespino-Gomez, JL
TI Induction of cellular and humoral immunity after aerosol or subcutaneous
administration of Edmonston-Zagreb measles vaccine as a primary dose to
12-month-old children
SO JOURNAL OF INFECTIOUS DISEASES
LA English
DT Article
ID RANDOMIZED-TRIAL; MMR VACCINATION; RESPONSES; ANTIBODY; INFANTS;
SCHOOLCHILDREN; ROUTES
AB Infants were immunized by aerosol (10(3.6) plaque-forming units [pfu]/dose) or subcutaneous (sc) (10(4.27) pfu/dose) administration of Edmonston-Zagreb measles vaccine. Measles-specific T cell proliferative responses with a stimulation index of greater than or equal to3 developed in 72% of children given aerosol-administered vaccine, compared with 87% given sc-administered vaccine (P = .06). Seroconversion rates were 90% after aerosol-administered vaccine and 100% after sc-administered vaccine (P = .01), and measles geometric mean titers were 237 milli-international units (mIU) (95% confidence interval [CI], 146-385 mIU) and 487 mIU (95% CI, 390-609 mIU) in each group, respectively (P = .01). Measles-specific T and B cell responses were weaker after aerosol than after sc vaccination, indicating a need to use a higher aerosol dose to achieve optimal immunogenicity.
C1 Univ Nacl Autonoma Mexico, Fac Med, Dept Expt Med, Mexico City 06726, DF, Mexico.
Ctr Nacl Salud Infancia & Adolescencia, Secretaria Salud, Mexico City, DF, Mexico.
Inst Nacl Salud Publ, Cuernavaca, Morelos, Mexico.
Stanford Univ, Sch Med, Stanford, CA 94305 USA.
US FDA, Rockville, MD 20857 USA.
RP Wong-Chew, RM (reprint author), Univ Nacl Autonoma Mexico, Fac Med, Dept Expt Med, Dr Balmis 148,Colonia Doctores, Mexico City 06726, DF, Mexico.
EM rmwong@correo.unam.mx
FU NICHD NIH HHS [HD01310, HD33698]; PHS HHS [A137127]
NR 18
TC 39
Z9 41
U1 0
U2 2
PU OXFORD UNIV PRESS INC
PI CARY
PA JOURNALS DEPT, 2001 EVANS RD, CARY, NC 27513 USA
SN 1537-6613
J9 J INFECT DIS
JI J. Infect. Dis.
PD JAN 15
PY 2004
VL 189
IS 2
BP 254
EP 257
DI 10.1086/380565
PG 4
WC Immunology; Infectious Diseases; Microbiology
SC Immunology; Infectious Diseases; Microbiology
GA 763QD
UT WOS:000188097900012
PM 14722890
ER
PT J
AU Rockett, JC
Burczynski, ME
Fornace, AJ
Herrmann, PC
Krawetz, SA
Dix, DJ
AF Rockett, JC
Burczynski, ME
Fornace, AJ
Herrmann, PC
Krawetz, SA
Dix, DJ
TI Surrogate tissue analysis: monitoring toxicant exposure and health
status of inaccessible tissues through the analysis of accessible
tissues and cells
SO TOXICOLOGY AND APPLIED PHARMACOLOGY
LA English
DT Article
DE disease states; genomics; hair follicles; ionizing radiation;
proteomics; peripheral blood lymphocytes; peripheral blood mononuclear
cells; renal cell carcinoma; sperm; STA, surrogate tissue analysis;
toxicity
ID GENE-EXPRESSION SIGNATURES; IONIZING-RADIATION; PREDICT SURVIVAL; STRESS
GENES; PROFILES; CANCER; BLOOD; DISEASE; IDENTIFICATION; MICROARRAY
AB Genomics and proteomics have made it possible to define molecular physiology in exquisite detail, when tissues are accessible for sampling. However, many tissues are not accessible for human diagnostic evaluations or experimental studies, creating the need for surrogates that afford insight into exposures and effects in such tissues. Surrogate tissue analysis (STA) incorporating contemporary genomic and proteomic technologies may be useful in determining toxicant exposure and effect, or disease state, in target tissues at the pre- or early clinical stage. We present here a discussion of STA based on presentations given at the Society of Toxicology's 2003 annual meeting's "Innovations in Applied Toxicology" symposium. Speakers at the symposium (Box 1) discussed various potential applications of STA, including the use of peripheral blood lymphocytes (PBLs) as a source of genetic biomarkers to monitor radiation exposure; the use of gene expression analysis of PBLs and hair follicles as a means to monitor the impact of toxicants on inaccessible organs; the characterization of disease-associated gene signatures in peripheral blood mononuclear cells (PBMCs) of renal cell carcinoma (RCC) patients; the use of sperm RNA to determine genetic and environmental effects on sperm development in the testis; and the use of serum protein profiles to monitor the development and progression of various cancers. Also discussed are some of the challenges that must be overcome if the utility of STA is to be proven, and thus permit researchers to move this concept from the laboratory to the clinical environment. Published by Elsevier Inc.
C1 US EPA, Off Res & Dev, Natl Hlth & Environm Res Lab, Reprod Toxicol Div, Res Triangle Pk, NC 27711 USA.
Wyeth Ayerst Res, Discovery Med, Andover, MA 01810 USA.
NCI, Ctr Canc Res, Bethesda, MD 20892 USA.
US FDA, Ctr Biol Evaluat & Res, Rockville, MD 20852 USA.
Wayne State Univ, Reprod Med Network, NICHD, Inst Comp Sci, Detroit, MI 48201 USA.
RP Rockett, JC (reprint author), US EPA, Off Res & Dev, Natl Hlth & Environm Res Lab, Reprod Toxicol Div, Res Triangle Pk, NC 27711 USA.
EM rockett.john@epa.gov
RI Fornace, Albert/A-7407-2008
OI Fornace, Albert/0000-0001-9695-085X
FU NICHD NIH HHS [HD36512]
NR 45
TC 48
Z9 51
U1 0
U2 4
PU ACADEMIC PRESS INC ELSEVIER SCIENCE
PI SAN DIEGO
PA 525 B ST, STE 1900, SAN DIEGO, CA 92101-4495 USA
SN 0041-008X
J9 TOXICOL APPL PHARM
JI Toxicol. Appl. Pharmacol.
PD JAN 15
PY 2004
VL 194
IS 2
BP 189
EP 199
DI 10.1016/j.taap.2003.09.005
PG 11
WC Pharmacology & Pharmacy; Toxicology
SC Pharmacology & Pharmacy; Toxicology
GA 777AV
UT WOS:000189152600009
PM 14736499
ER
PT J
AU Bos, J
Crutcher, JM
Cote, T
Greenwald, MA
Polder, J
Srinivasan, A
Arduino, M
Jernigan, DB
Beall, B
Elliott, JA
Facklam, RR
Schuchat, A
Van Beneden, C
Lee, E
Ferguson, D
AF Bos, J
Crutcher, JM
Cote, T
Greenwald, MA
Polder, J
Srinivasan, A
Arduino, M
Jernigan, DB
Beall, B
Elliott, JA
Facklam, RR
Schuchat, A
Van Beneden, C
Lee, E
Ferguson, D
TI Invasive Streptococcus pyogenes after allograft implantation - Colorado,
2003 (Reprinted from MMWR, vol 52, pg 1173-1176, 2003)
SO JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION
LA English
DT Reprint
ID DISEASE
C1 Oklahoma Dept Hlth, Oklahoma City, OK 73117 USA.
Colorado Dept Publ Hlth & Environm, Denver, CO 80246 USA.
US FDA, Ctr Biol Evaluat & Res, Rockville, MD 20857 USA.
CDC, Div Healthcare Qual Promot, Atlanta, GA 30333 USA.
CDC, Div Bacterial & Mycot Dis, Atlanta, GA 30333 USA.
CDC, Div Viral & Rickettsial Dis, Natl Ctr Infect Dis, Atlanta, GA 30333 USA.
RP Bos, J (reprint author), Oklahoma Dept Hlth, Oklahoma City, OK 73117 USA.
RI Arduino, Matthew/C-1461-2012
OI Arduino, Matthew/0000-0001-7072-538X
NR 10
TC 0
Z9 0
U1 0
U2 0
PU AMER MEDICAL ASSOC
PI CHICAGO
PA 515 N STATE ST, CHICAGO, IL 60610 USA
SN 0098-7484
J9 JAMA-J AM MED ASSOC
JI JAMA-J. Am. Med. Assoc.
PD JAN 14
PY 2004
VL 291
IS 2
BP 174
EP 176
PG 3
WC Medicine, General & Internal
SC General & Internal Medicine
GA 762YZ
UT WOS:000188040900009
ER
PT J
AU Kasim, NA
Whitehouse, M
Ramachandran, C
Bermejo, M
Lennernas, H
Hussain, AS
Junginger, HE
Stavchansky, SA
Midha, KK
Shah, VP
Amidon, GL
AF Kasim, Nehal A.
Whitehouse, Marc
Ramachandran, Chandrasekharan
Bermejo, Marival
Lennernas, Hans
Hussain, Ajaz S.
Junginger, Hans E.
Stavchansky, Salomon A.
Midha, Kamal K.
Shah, Vinod P.
Amidon, Gordon L.
TI Molecular properties of WHO essential drugs and provisional
biopharmaceutical classification
SO MOLECULAR PHARMACEUTICS
LA English
DT Article
DE BCS; solubility; dose number; permeability; partition coefficient; WHO
essential drugs; pK(a)
AB The purpose of this study is to provisionally classify, based on the Biopharmaceutics Classification System (BCS), drugs in immediate-release dosage forms that appear on the World Health Organization (WHO) Essential Drug List. The classification in this report is based on the aqueous solubility of the drugs reported in commonly available reference literature and a correlation of human intestinal membrane permeability for a set of 29 reference drugs with their calculated partition coefficients. The WHO Essential Drug List consists of a total of 325 medicines and 260 drugs, of which 123 are oral drugs in immediate-release (IR) products. Drugs with dose numbers less than or equal to unity [Do = (maximum dose strength/250 mL)/solubility :5 1] are defined as high-solubility drugs. Drug solubility for the uncharged, lowest-solubility form reported in the Merck Index or USP was used. Of the 123 WHO oral drugs in immediate-release dosage forms, 67% (82) were determined to be high-solubility drugs. The classification of permeability is based on correlations of human intestinal permeability of 29 reference drugs with the estimated log P or CLogP lipophilicity values. Metoprolol was chosen as the reference compound for permeability and log P or CLogP. Log P and CLogP were linearly correlated (r(2) = 0.78) for 104 drugs. A total of 53 (43.1%) and 62 (50.4%) drugs on the WHO list exhibited log P and CLogP estimates, respectively, that were greater than or equal to the corresponding metoprolol value and are classified as high-permeability drugs. The percentages of the drugs in immediate-release dosage forms that were classified as BCS Class 1, Class 2, Class 3, and Class 4 drugs using dose number and log P were as follows: 23.6% in Class 1, 17.1% in Class 2, 31.7% in Class 3, and 10.6% in Class 4. The remaining 17.1% of the drugs could not be classified because of the inability to calculate log P values because of missing fragments. The corresponding percentages in the various BCS classes with dose number and CLogP criteria were similar: 28.5% in Class 1, 19.5% in Class 2, 35.0% in Class 3, and 9.8% in Class 4. The remaining 7.3% of the drugs could not be classified since CLogP could not be calculated. These results suggest that a satisfactory bioequivalence (BE) test for more than 55% of the high-solubility Class 1 and Class 3 drug products on the WHO Essential Drug List may be based on an in vitro dissolution test. The use of more easily implemented, routinely monitored, and reliable in vitro dissolution tests can ensure the clinical performance of drug products that appear on the WHO Essential Medicines List.
C1 [Kasim, Nehal A.; Whitehouse, Marc; Ramachandran, Chandrasekharan; Amidon, Gordon L.] Univ Michigan, Coll Pharm, Ann Arbor, MI 48109 USA.
[Kasim, Nehal A.] Univ Alexandria, Coll Pharm, Alexandria, Egypt.
[Bermejo, Marival] Univ Valencia, Dept Pharm & Technol, Valencia, Spain.
[Lennernas, Hans] Uppsala Univ, BMC, Dept Pharm, SE-75123 Uppsala, Sweden.
[Hussain, Ajaz S.; Shah, Vinod P.] US FDA, Off Pharmaceut Sci, Ctr Drug Evaluat & Res, Rockville, MD 20857 USA.
[Junginger, Hans E.] Leiden Amsterdam Ctr Drug Res, Div Pharmaceut Technol, NL-2300 RA Leiden, Netherlands.
[Stavchansky, Salomon A.] Univ Texas Austin, Coll Pharm, Div Pharmaceut, Austin, TX 78712 USA.
[Midha, Kamal K.] PharmaLytics Inc, Saskatoon, SK S7N 3R2, Canada.
[Midha, Kamal K.] Univ Saskatchewan, Coll Med, Saskatoon, SK S7N 5E5, Canada.
[Midha, Kamal K.] Univ Saskatchewan, Coll Pharm & Nutr, Saskatoon, SK S7N 5C9, Canada.
RP Amidon, GL (reprint author), Univ Michigan, Coll Pharm, 428 Church St, Ann Arbor, MI 48109 USA.
EM glamidon@umich.edu
RI Bermejo, Marival/A-4163-2009
OI Bermejo, Marival/0000-0001-5022-0544
FU NASA [NAG5-3874]; NIH [R01-GM37188]
FX This work was supported in part by NASA Grant NAG5-3874 and NIH Grant
R01-GM37188.
NR 24
TC 418
Z9 437
U1 8
U2 68
PU AMER CHEMICAL SOC
PI WASHINGTON
PA 1155 16TH ST, NW, WASHINGTON, DC 20036 USA
SN 1543-8384
J9 MOL PHARMACEUT
JI Mol. Pharm.
PD JAN 12
PY 2004
VL 1
IS 1
BP 85
EP 96
DI 10.1021/mp034006h
PG 12
WC Medicine, Research & Experimental; Pharmacology & Pharmacy
SC Research & Experimental Medicine; Pharmacology & Pharmacy
GA V54FP
UT WOS:000203664900010
PM 15832504
ER
PT J
AU Yan, J
Wang, L
Fu, PP
Yu, HT
AF Yan, J
Wang, L
Fu, PP
Yu, HT
TI Photomutagenicity of 16 polycyclic aromatic hydrocarbons from the US EPA
priority pollutant list
SO MUTATION RESEARCH-GENETIC TOXICOLOGY AND ENVIRONMENTAL MUTAGENESIS
LA English
DT Article
DE polycyclic aromatic hydrocarbons; photomutagemcity; light irradiation;
Salmonella typhimurium TA102 and TA98
ID SINGLE-STRAND CLEAVAGE; INDUCED DNA CLEAVAGE; SKIN-CANCER;
ULTRAVIOLET-RADIATION; UVA; PHOTOTOXICITY; PHOTOCHEMISTRY; MUTAGENICITY;
GENOTOXICITY; ACTIVATION
AB The photomutagenicity of 16 polycyclic aromatic hydrocarbons (PAHs), all on the United States Environmental Protection Agency (US EPA) priority pollutant list, was studied. Concomitant exposing the Salmonella typhimurium bacteria strain TA 102 to one of the PAHs and light (I. I J/cm(2) UVA + 2.1 J/cm(2) visible) without the activation enzyme S9, strong photomutagenic response is observed for anthracene, benz[a]anthracene, benzo[ghi]perylene, benzo[alpha]pyrene, indeno[1,2,3-cd]pyrene, and pyrene. Under the same conditions, acenaphthene, acenaphthylene, benzo[k]fluoranthene, chrysene, and fluorene are weakly photomutagenic. Benzo[b]fluoranthene, fluoranthene, naphthalene, phenanthrene, and dibenz[a,h]anthracene are not photomutagenic. These results indicate that PAHs can be activated by light and become mutagenic in Salmonella TA102 bacteria. At the same time, the mutagenicity for all the 16 PAHs was examined with the standard mutagenicity test with 10% S9 as the activation system. Benzo[b]fluoranthene, benzo[k]fluoranthene, chrysene, acenaphthylene, and fluorene are weakly mutagenic, while the rest of the PAHs are not. In general, the photomutagenicity of PAHs in TA102 does not correlate with their S9-activated mutagenicity in either TA102 or TA98/TA100 since they involve different activation mechanisms. (C) 2003 Elsevier B.V. All rights reserved.
C1 Jackson State Univ, Dept Chem, Jackson, MS 39217 USA.
Natl Ctr Toxicol Res, Jefferson, AR 72079 USA.
RP Yu, HT (reprint author), Jackson State Univ, Dept Chem, Jackson, MS 39217 USA.
EM yu@ccaix.jsums.edu
FU NCRR NIH HHS [G12 RR013459, G12RR13459]; NIGMS NIH HHS [S06 GM008047,
S06 GM008047-290048, S06 GM08047]
NR 50
TC 97
Z9 110
U1 4
U2 26
PU ELSEVIER SCIENCE BV
PI AMSTERDAM
PA PO BOX 211, 1000 AE AMSTERDAM, NETHERLANDS
SN 1383-5718
J9 MUTAT RES-GEN TOX EN
JI Mutat. Res. Genet. Toxicol. Environ. Mutagen.
PD JAN 10
PY 2004
VL 557
IS 1
BP 99
EP 108
DI 10.1016/j.mrgentox.2003.10.004
PG 10
WC Biotechnology & Applied Microbiology; Genetics & Heredity; Toxicology
SC Biotechnology & Applied Microbiology; Genetics & Heredity; Toxicology
GA 768EM
UT WOS:000188530700010
PM 14706522
ER
PT J
AU Lague, P
Pastor, RW
Brooks, BR
AF Lague, P
Pastor, RW
Brooks, BR
TI Pressure-based long-range correction for Lennard-Jones interactions in
molecular dynamics simulations: Application to alkanes and interfaces
SO JOURNAL OF PHYSICAL CHEMISTRY B
LA English
DT Article
ID NUCLEAR MAGNETIC-RESONANCE; PARTICLE MESH EWALD; COMPUTER-SIMULATION;
PHOSPHOLIPID MONOLAYER; LIPID-BILAYERS; WATER; FORCES; MOTION;
GRAMICIDIN; DIFFUSION
AB A straightforward method that accounts for the long-range Lennard-Jones (LJ) terms in constant pressure molecular dynamics simulations is presented. This long-range correction (LRC) consists of an additional applied pressure tensor which is periodically calculated from the difference of instantaneous pressures at the selected cutoff and a very long cutoff. It provides results that are nearly independent of the LJ cutoff distance at negligible additional calculation costs, and is particularly suited for anisotropic systems such as liquid/ liquid interfaces or heterogeneous macromolecules where approximations based on spherically symmetric radial distribution functions are expected to fail. The utility of the method is demonstrated for a series of alkanes and water, and for interfaces including a lipid bilayer. The LRC increases densities and decreases isothermal compressibilities, with the changes larger for alkanes than for water (where the long-range interactions are dominated by electrostatic interactions). While implementation of the LRC will not necessarily improve agreement with a particular experiment, it will provide a baseline for improvements in a parameter set that are consistent with the long-range Lennard-Jones interactions.
C1 NIH, Struct Biol Lab, Div Comp Res & Technol, Bethesda, MD 20892 USA.
US FDA, Biophys Lab, Ctr Biol Evaluat & Res, Rockville, MD 20852 USA.
RP Brooks, BR (reprint author), NIH, Struct Biol Lab, Div Comp Res & Technol, Bldg 10, Bethesda, MD 20892 USA.
NR 28
TC 69
Z9 72
U1 1
U2 11
PU AMER CHEMICAL SOC
PI WASHINGTON
PA 1155 16TH ST, NW, WASHINGTON, DC 20036 USA
SN 1520-6106
J9 J PHYS CHEM B
JI J. Phys. Chem. B
PD JAN 8
PY 2004
VL 108
IS 1
BP 363
EP 368
DI 10.1021/jp030458y
PG 6
WC Chemistry, Physical
SC Chemistry
GA 760MW
UT WOS:000187838800049
ER
PT J
AU Meseda, CA
Schmeisser, F
Pedersen, R
Woerner, A
Weir, JP
AF Meseda, CA
Schmeisser, F
Pedersen, R
Woerner, A
Weir, JP
TI DNA immunization with a herpes simplex virus 2 bacterial artificial
chromosome
SO VIROLOGY
LA English
DT Article; Proceedings Paper
CT 28th International Herpesvirus Workshop
CY JUL 26-31, 2003
CL Madison, WI
DE herpes simplex virus 2; BAC; thymidine kinase
ID ESCHERICHIA-COLI; VIRUS GENOME; REPLICATION-COMPETENT; HERPESVIRUS
GENOME; MAMMALIAN-CELLS; VECTORS; CLONING; MANIPULATION; MUTAGENESIS;
SEQUENCES
AB Construction of a herpes simplex virus 2 (HSV-2) bacterial artificial chromosome (BAC) is described. BAC vector sequences were inserted into the thymidine kinase gene of HSV-2 by homologous recombination. DNA from cells infected with the resulting recombinant virus was transformed into E. coli, and colonies containing the HSV-2 BAC (HSV2-BAC) were isolated and analyzed for the expected genotype. HSV2-BAC DNA was infectious when transfected back into mammalian cells and the resulting virus was thymidine kinase negative. When used to immunize mice, the HSV2-BAC DNA elicited a strong HSV-2 specific antibody response that was equal to or greater than live virus immunization. Further, HSV2-BAC immunization was protective when animals were challenged with a lethal dose of virus. The utility of the HSV2-13AC for construction of recombinant virus genomes was demonstrated by elimination of the HSV-2 glycoprotein D (gD) gene. A recombinant HSV-2 BAC with the gD gene deleted was isolated and shown to be incapable of producing infectious virus following transfection unless an HSV gD gene was expressed in a complementing cell line. Immunization of mice with the HSV2 gD-BAC also elicited an HSV-2 specific antibody response and was protective. The results demonstrate the feasibility of DNA immunization with HSV-2 bacterial artificial chromosomes for replicating and nonreplicating candidate HSV-2 vaccines, as well as the utility of BAC technology for construction and maintenance of novel HSV-2 vaccines. The results further suggest that such technology will be a powerful tool for dissecting the immune response to HSV-2. (C) 2003 Elsevier Inc. All rights reserved.
C1 US FDA, Ctr Biol Evaluat & Res, Lab DNA Viruses, Bethesda, MD 20892 USA.
RP Weir, JP (reprint author), Ctr Biol Evaluat & Res, Div Viral Prod, HFM-457,1401 Rockville Pike, Rockville, MD 20852 USA.
EM weirj@cber.fda.gov
NR 23
TC 19
Z9 20
U1 1
U2 2
PU ACADEMIC PRESS INC ELSEVIER SCIENCE
PI SAN DIEGO
PA 525 B ST, STE 1900, SAN DIEGO, CA 92101-4495 USA
SN 0042-6822
J9 VIROLOGY
JI Virology
PD JAN 5
PY 2004
VL 318
IS 1
BP 420
EP 428
DI 10.1016/j.virol.2003.09.033
PG 9
WC Virology
SC Virology
GA 778LL
UT WOS:000189243000040
PM 14972567
ER
PT J
AU Kao, G
Tsai, CM
AF Kao, G
Tsai, CM
TI Quantification of O-acetyl, N-acetyl and phosphate groups and
determination of the extent of O-acetylation in bacterial vaccine
polysaccharides by high-performance anion-exchange chromatography with
conductivity detection (HPAEC-CD)
SO VACCINE
LA English
DT Article
DE bacterial polysaccharides; O-acetylation; HPLC-conductivity detection
ID PULSED-AMPEROMETRIC DETECTION; NUCLEAR-MAGNETIC-RESONANCE; MENINGITIDIS
SEROGROUP-A; PNEUMONIAE TYPE 9V; NEISSERIA-MENINGITIDIS; CAPSULAR
POLYSACCHARIDE; STRUCTURAL DETERMINATION; GROUP-B; ANTIGENS; RESPONSES
AB The O-acetyl groups in meningococcal A and typhoid Vi polysaccharides (PSs) are functional immunogenic epitopes in humans. To quantify and determine the extent of O-acetylation in these and other bacterial vaccine PSs, anion-exchange HPLC methods have been developed for quantification of O-acetyl, N-acetyl, and phosphate groups in the PSs after these groups were hydrolyzed into anions. The O-acetylation in meningococcal A, C, Y and W-135, pneumococcal 9V and 18C and typhoid Vi PSs were analyzed. The O-acetyl group was selectively released from a PS as acetate by mild alkaline hydrolysis in 10 or 20 mM NaOH at 37degreesC until maximum release. The acetate in the hydrolysate was then quantified by high-performance anion-exchange chromatography with conductivity detection (HPAEC-CD) after removal of the PS by filtration with a 10,000 molecular-weight-cut-off membrane. Since the extent of O-acetylation on the PSs depends on bacterial species, strains and growth conditions, the N-acetyl group of amino-sugars, phosphate or monosaccharide components of the PSs were also quantified using HPAEC with conductivity or amperometry detection to determine the molar ratios of the O-acetyl group to these components. The average numbers of O-acetyl molecules in one PS repeating unit of the PSs were obtained from the molar ratios. Besides the O-acetyl determination, the pyruvate component in non-O-acetylated pneumococcal type 4 PS was analyzed by the HPAEC method. The HPAEC method can quantify the O-acetyl content in 0.2 mug of the meningococcal C PS and has a sensitivity at least 10 times higher than that of the colorimetric Hestrin assay. The method can be used for routine analysis of O-acetylation of PSs for quality control of vaccine PSs. Published by Elsevier Ltd.
C1 US FDA, Ctr Biol Evaluat & Res, Div Bacterial Parasit & Allergen Prod, Off Vaccine Res & Review, Rockville, MD 20852 USA.
RP Tsai, CM (reprint author), US FDA, Ctr Biol Evaluat & Res, Div Bacterial Parasit & Allergen Prod, Off Vaccine Res & Review, 1401 Rockville Pike HFM-428, Rockville, MD 20852 USA.
EM tsai@cber.fda.gov
NR 24
TC 10
Z9 15
U1 1
U2 13
PU ELSEVIER SCI LTD
PI OXFORD
PA THE BOULEVARD, LANGFORD LANE, KIDLINGTON, OXFORD OX5 1GB, OXON, ENGLAND
SN 0264-410X
J9 VACCINE
JI Vaccine
PD JAN 2
PY 2004
VL 22
IS 3-4
BP 335
EP 344
DI 10.1016/j.vaccine.2003.08.008
PG 10
WC Immunology; Medicine, Research & Experimental
SC Immunology; Research & Experimental Medicine
GA 765UF
UT WOS:000188301600007
PM 14670314
ER
PT S
AU Ilev, IK
Waynant, RW
Gorman, E
AF Ilev, IK
Waynant, RW
Gorman, E
GP ieee
TI A simple all-hollow-waveguide concept for efflicient CO2 laser delivery
into precise tissue area
SO 2004 IEEE LEOS ANNUAL MEETING CONFERENCE PROCEEDINGS, VOLS 1 AND 2
SE IEEE Lasers and Electro-Optics Society (LEOS) Annual Meeting
LA English
DT Proceedings Paper
CT 17th Annual Meeting of the IEEE-Lasers-and-Electro-Optics-Society
CY NOV 07-11, 2004
CL Rio Grande, PR
SP IEEE Lasers & Electro Opt Soc, IEEE
DE fiber optics; mid-infrared laser delivery; light propagation in tissue
ID LASER DELIVERY; TAPER
AB A novel and simple all-hollow-waveguide lens-free system for mid-infrared CO2 laser (10.6 mum) delivery into precise tissue area is presented. It includes a grazing-incidence-based uncoated hollow glass taper for direct laser-to-waveguide coupling and a multilayer hollow delivery waveguide.
C1 US FDA, Ctr Devices & Radiol Hlth, Div Phys, Rockville, MD 20857 USA.
RP Ilev, IK (reprint author), US FDA, Ctr Devices & Radiol Hlth, Div Phys, Rockville, MD 20857 USA.
NR 4
TC 0
Z9 0
U1 0
U2 0
PU IEEE
PI NEW YORK
PA 345 E 47TH ST, NEW YORK, NY 10017 USA
SN 1092-8081
BN 0-7803-8557-8
J9 IEEE LEOS ANN MTG
PY 2004
BP 831
EP 832
PG 2
WC Optics
SC Optics
GA BBG19
UT WOS:000225390900414
ER
PT S
AU Pfefer, J
AF Pfefer, J
GP ieee
TI Depth-selective fluorescence spectroscopy
SO 2004 IEEE LEOS ANNUAL MEETING CONFERENCE PROCEEDINGS, VOLS 1 AND 2
SE IEEE Lasers and Electro-Optics Society (LEOS) Annual Meeting
LA English
DT Proceedings Paper
CT 17th Annual Meeting of the IEEE-Lasers-and-Electro-Optics-Society
CY NOV 07-11, 2004
CL Rio Grande, PR
SP IEEE Lasers & Electro Opt Soc, IEEE
AB Variations in the origin of detected fluorescence signals due to illumination/collection parameters were studied through Monte Carlo modeling. In many cases, proper design of normal- or oblique-incidence geometries may enable depth-selective interrogation of turbid media.
C1 US FDA, Ctr Devices & Radiol Hlth, Rockville, MD 20852 USA.
RP Pfefer, J (reprint author), US FDA, Ctr Devices & Radiol Hlth, 12725 Twinbrook Pkwy, Rockville, MD 20852 USA.
NR 3
TC 0
Z9 0
U1 0
U2 0
PU IEEE
PI NEW YORK
PA 345 E 47TH ST, NEW YORK, NY 10017 USA
SN 1092-8081
BN 0-7803-8557-8
J9 IEEE LEOS ANN MTG
PY 2004
BP 892
EP 893
PG 2
WC Optics
SC Optics
GA BBG19
UT WOS:000225390900445
ER
PT B
AU Bassen, H
Casamento, J
AF Bassen, H
Casamento, J
GP ieee
TI High resolution computations and measurements of potential EMI with
models of medical implants and radiating sources
SO 2004 INTERNATIONAL SYMPOSIUM ON ELECTROMAGNETIC COMPATIBILITY, SYMPOSIUM
RECORD 1-3
LA English
DT Proceedings Paper
CT IEEE International Symposium on Electromagnetic Compatibility (EMC 2004)
CY AUG 09-13, 2004
CL Santa Clara, CA
SP IEEE, EMC Soc, Rohde & Schwarz, AR Worldwide, Compliance Certificat Serv, ETS Lindgren, Murata Elect N A Inc, Sunol Sci, DLS Elect Syst Inc, Int Certificat Serv, Opt Filter, X-EMI
DE medical device; computation; finite difference time domain; FDTD;
measurement; pacemaker; defibrillator; cardiac; computer modeling
AB We used high resolution finite difference time domain (FDTD) computer modeling to evaluate the potential of cellular phones to cause interference in an implanted cardiac pacemaker-defibrillator. The model consisted of a combination of an 835 MHz source which was either (1) a special boat-mounted cellular phone antenna (a sleeve dipole fed by a 3W amplifier) or (2) a standard EMI test model of a cellular phone handset (a dipole antenna placed 8 mm from the victim). The victim was a simplified model of a pacemaker-defibrillator with one insulated sensing/stimulation lead in a torso simulator. The handset model and the victim conformed to the AAMI PC69 standard for pacemaker-defibrillator EMI testing. We compared the EMI-induced voltage in the victim from the sleeve dipole source with the induced voltage from a cellular phone handset model. We performed experimental comparisons of the computed results using the actual antennas. We used a fiber-optically linked pacemaker-defibrillator simulator to measure induced voltage at the junction between the lead and the box of the pacemaker-defibrillator model. Our conclusions were that the sleeve dipole at 15 cm, driven with a 3 waft amplifier, is less capable of causing potential interference than the handset. The sleeve dipole, with its companion 3-W amplifier, produced 12.7 dB less induced voltage in the victim than the phone handset model driven with 0.6 W. Our results were validated since measured values differed by 1.7 dB or less from computed values. This is well within the uncertainties of the measurements and computations.
C1 US FDA, Ctr Devices & Radiol Hlth, Rockville, MD 20857 USA.
RP Bassen, H (reprint author), US FDA, Ctr Devices & Radiol Hlth, Rockville, MD 20857 USA.
NR 4
TC 0
Z9 0
U1 1
U2 3
PU IEEE
PI NEW YORK
PA 345 E 47TH ST, NEW YORK, NY 10017 USA
BN 0-7803-8443-1
PY 2004
BP 75
EP 80
PG 6
WC Engineering, Electrical & Electronic
SC Engineering
GA BAU54
UT WOS:000223620100015
ER
PT J
AU Burgess, DJ
Duffy, E
Etzler, F
Hickey, AJ
AF Burgess, DJ
Duffy, E
Etzler, F
Hickey, AJ
TI Particle size analysis: AAPS workshop report, cosponsored by the food
and drug administration and the united states pharmacopeia
SO AAPS JOURNAL
LA English
DT Article
ID FAILURE INVESTIGATION TREE
C1 Univ Connecticut, Dept Pharmaceut Sci, Storrs, CT 06268 USA.
US FDA, Ctr Drug Evaluat & Res, Off Pharmaceut Sci, Rockville, MD 20857 USA.
Boehringer Ingelheim Pharmaceut Inc, Ridgefield, CT 06877 USA.
Univ N Carolina, Sch Pharm, Chapel Hill, NC 27599 USA.
RP Burgess, DJ (reprint author), Univ Connecticut, Dept Pharmaceut Sci, 372 Fairfield Rd, Storrs, CT 06268 USA.
NR 3
TC 1
Z9 1
U1 1
U2 1
PU AMER ASSOC PHARMACEUTICAL SCIENTISTS
PI ALEXANDRIA
PA 1650 KING ST, STE 200, ALEXANDRIA, VA 22314-2747 USA
SN 1550-7416
J9 AAPS J
PY 2004
VL 6
IS 3
PG 12
WC Pharmacology & Pharmacy
SC Pharmacology & Pharmacy
GA 005XI
UT WOS:000234859300004
ER
PT J
AU Shah, RB
Khan, MA
AF Shah, RB
Khan, MA
TI Regional permeability of salmon calcitonin in isolated rat
gastrointestinal tracts: Transport mechanism using Caco-2 cell monolayer
SO AAPS JOURNAL
LA English
DT Article
DE salmon calcitonin; regional permeability; stomach; duodenum; jejunum;
ileum; colon; Caco-2
ID ABSORPTION; DELIVERY; BIOAVAILABILITY; RECEPTOR; PEPTIDE; INSULIN; GENE
C1 US FDA, CDER, DPQR, Rockville, MD 20895 USA.
Texas Tech Univ, Hlth Sci Ctr, Sch Pharm, Amarillo, TX 79106 USA.
RP Khan, MA (reprint author), US FDA, CDER, DPQR, LS Bldg 64,HFD-940,5600 Fishers Lane, Rockville, MD 20895 USA.
EM Khanm@cder.fda.gov
NR 13
TC 2
Z9 2
U1 0
U2 1
PU AMER ASSOC PHARMACEUTICAL SCIENTISTS
PI ALEXANDRIA
PA 1650 KING ST, STE 200, ALEXANDRIA, VA 22314-2747 USA
SN 1550-7416
J9 AAPS J
PY 2004
VL 6
IS 4
PG 5
WC Pharmacology & Pharmacy
SC Pharmacology & Pharmacy
GA 006GQ
UT WOS:000234884900004
ER
PT J
AU Volpe, DA
AF Volpe, DA
TI Permeability classification of representative fluoroquinolones by a cell
culture method
SO AAPS PHARMSCI
LA English
DT Article
DE permeability; Caco-2; biopharmaceutics classification system;
fluoroquinolones
ID LINE CACO-2; IN-VITRO; CIPROFLOXACIN; SECRETION; GREPAFLOXACIN;
LEVOFLOXACIN
AB This study was undertaken to categorize representative fluoroquinolone drug substance permeability based on the methods outlined in the Food and Drug Administration's biopharmaceutic classification system (BCS) Guidance for Industry. The permeability of ciprofloxacin, levofloxacin, lomefloxaciri, and ofloxacin was measured in an in vitro Caco-2 assay with previously demonstrated method suitability. The permeability class and efflux potential were ascertained by comparing test drug results with standard compounds (metoprolol, atenolol, labetalol, and rhodamine-123). All 4 quinolones drugs demonstrated concentration-dependent permeability, indicating active drug transport. In comparing absorptive versus secretive in vitro transport, the tested fluoroquinolones were found to be subject to efflux in varying degrees (ciprofloxacin > lornefloxacin > rhodamine 123 > levofloxacin > ofloxacin). Based on comparison to labetalol, the high permeability internal standard, ciprofloxacin was classified as a low permeability drug, whereas lomefloxacin, levofloxacin, and ofloxacin were classified as high permeability drugs. The in vitro permeability results matched human in vivo data based on absolute bioavailabilities. This laboratory exercise demonstrated the applicability of an in vitro permeability method for classifying drugs as outlined in the BCS Guidance.
C1 US FDA, Div Prod Qual Res, Ctr Drug Evaluat & Res, Silver Spring, MD 20993 USA.
RP Volpe, DA (reprint author), US FDA, Div Prod Qual Res, Ctr Drug Evaluat & Res, LIfe Sci Bldg 64,HFD-940,10903 New Hampshire Ave, Silver Spring, MD 20993 USA.
EM volpe@cder.fda.gov
NR 19
TC 14
Z9 15
U1 0
U2 0
PU AMER ASSOC PHARMACEUTICAL SCIENTISTS
PI ALEXANDRIA
PA 1650 KING ST, STE 200, ALEXANDRIA, VA 22314-2747 USA
SN 1522-1059
J9 AAPS PHARMSCI
JI AAPS Pharmsci
PY 2004
VL 6
IS 2
AR 13
PG 6
WC Pharmacology & Pharmacy
SC Pharmacology & Pharmacy
GA 905ZZ
UT WOS:000227611600001
ER
PT J
AU Bansal, SK
Layloff, T
Bush, ED
Hamilton, M
Hankinson, EA
Landy, JS
Lowes, S
Nasr, MM
St Jean, PA
Shah, VP
AF Bansal, SK
Layloff, T
Bush, ED
Hamilton, M
Hankinson, EA
Landy, JS
Lowes, S
Nasr, MM
St Jean, PA
Shah, VP
TI Qualification of analytical instruments for use in the pharmaceutical
industry: A scientific approach
SO AAPS PHARMSCITECH
LA English
DT Article; Proceedings Paper
CT Workshop on A Scientific Approach to Analytical Instrument Validation
CY MAR 03-05, 2003
CL Arlington, VA
SP Amer Assoc Pharmaceut Sci, Int Pharmaceut Fed, Int Soc Pharmaceut Engn
C1 Hoffmann La Roche Inc, Nutley, NJ 07110 USA.
Management Sci Hlth, Granite City, IL 62040 USA.
OSI Pharmaceut Inc, Boulder, CO 80301 USA.
Bovis Lend Lease, Pharm Div, Surrey GU8 6LB, England.
Aventis, Bridgewater, NJ 08807 USA.
Advion BioSci, Ithaca, NY 14850 USA.
US FDA, Rockville, MD 20852 USA.
Waters Corp, Milford, MA 01757 USA.
RP Bansal, SK (reprint author), Hoffmann La Roche Inc, 340 Kingsland St, Nutley, NJ 07110 USA.
EM surendra.bansal@roche.com
NR 11
TC 1
Z9 1
U1 0
U2 2
PU AMER ASSOC PHARMACEUTICAL SCIENTISTS
PI ALEXANDRIA
PA 1650 KING ST, STE 200, ALEXANDRIA, VA 22314-2747 USA
SN 1530-9932
J9 AAPS PHARMSCITECH
JI AAPS PharmSciTech
PY 2004
VL 5
IS 1
PG 8
WC Pharmacology & Pharmacy
SC Pharmacology & Pharmacy
GA 881BJ
UT WOS:000225838100020
ER
PT J
AU Palamakula, A
Nutan, MTH
Khan, MA
AF Palamakula, A
Nutan, MTH
Khan, MA
TI Response surface methodology for optimization and characterization of
limonene-based Coenzyme Q10 self-nanoemulsified capsule dosage form
SO AAPS PHARMSCITECH
LA English
DT Article
DE response surface methodology; Box-Behnken design; coenzyme Q10;
R-limonene; statistical modeling
ID DRUG-DELIVERY SYSTEMS; STATISTICAL OPTIMIZATION; EXPERIMENTAL-DESIGN;
FORMULATIONS; VARIABLES; TABLETS
AB The aim of this study was to systematically obtain a model of factors that would yield an optimized self-nanoemulsified capsule dosage form (SNCDF) of a highly lipophilic model compound, Coenzyme Q10 (CoQ). Independent variables such as amount of R-(+)-limonene (X-1), surfactant (X-2), and cosurfactant (X-3), were optimized using a 3-factor, 3-level Box-Behnken statistical design. The dependent variables selected were cumulative percentage of drug released after 5 minutes (Y-1) with constraints on drug release in 15 minutes (Y-2), turbidity (Y-3), particle size (Y-4), and zeta potential (Y-5). A mathematical relationship obtained, Y-1 = 78.503 + 6.058X(1) + 13.738X(2) + 5.986X(3) - 25.831X(1)(2) + 9.12X(1)X(2) - 26.03 X1X3 - 38.67 X-2(2) + 11.02X(2)X(3) - 15.55 X-3(3) (r(2) = 0.97), explained the main and quadratic effects, and the interaction of factors that affected the drug release. Response surface methodology (RSM) predicted the levels of factors X-1, X-2, and X-3 (0.0344, 0.216, and 0.240, respectively), for a maximized response of Y-1 with constraints of >90% release on Y-2. The observed and predicted values of Y-1 were in close agreement. In conclusion, the Box-Behnken experimental design allowed us to obtain SNCDF with rapid (>90%) drug release within 5 minutes with desirable properties of low turbidity and particle size.
C1 Texas Tech Univ, Hlth Sci Ctr, Sch Pharm, Amarillo, TX 79106 USA.
RP Khan, MA (reprint author), US FDA, CDER, DPQR, White Oak,LS Bldg 64,HFD-940,5600 Fishers Lane, Rockville, MD 20895 USA.
EM Khanm@cder.fda.gov
RI Palamakula, Anitha/E-3741-2010
NR 20
TC 10
Z9 12
U1 0
U2 5
PU AMER ASSOC PHARMACEUTICAL SCIENTISTS
PI ALEXANDRIA
PA 1650 KING ST, STE 200, ALEXANDRIA, VA 22314-2747 USA
SN 1530-9932
J9 AAPS PHARMSCITECH
JI AAPS PharmSciTech
PY 2004
VL 5
IS 4
AR 66
PG 8
WC Pharmacology & Pharmacy
SC Pharmacology & Pharmacy
GA 902KV
UT WOS:000227356200017
ER
PT J
AU Gur, D
Wagner, RF
Chan, HP
AF Gur, D
Wagner, RF
Chan, HP
TI On the repeated use of databases for testing incremental improvement of
computer-aided detection schemes
SO ACADEMIC RADIOLOGY
LA English
DT Editorial Material
ID FINITE-SAMPLE SIZE; CLASSIFIERS; PERFORMANCE; DIAGNOSIS
C1 Univ Pittsburgh, Dept Radiol, Pittsburgh, PA 15213 USA.
US FDA, Off Sci & Technol, Ctr Devices & Radiol Hlth, Rockville, MD USA.
Univ Michigan, Dept Radiol, Ann Arbor, MI 48109 USA.
RP Gur, D (reprint author), Univ Pittsburgh, Dept Radiol, Suite 4200,300 Halket St, Pittsburgh, PA 15213 USA.
NR 7
TC 9
Z9 11
U1 0
U2 1
PU ASSOC UNIV RADIOLOGISTS
PI OAK BROOK
PA 820 JORIE BLVD, OAK BROOK, IL 60523-2251 USA
SN 1076-6332
J9 ACAD RADIOL
JI Acad. Radiol.
PD JAN
PY 2004
VL 11
IS 1
BP 103
EP 105
DI 10.1016/S1076-6332(03)00511-7
PG 3
WC Radiology, Nuclear Medicine & Medical Imaging
SC Radiology, Nuclear Medicine & Medical Imaging
GA 759CR
UT WOS:000187721200015
PM 14746409
ER
PT J
AU Shao, ZH
Vanden Hoek, TL
Li, CQ
Schumacker, PT
Becker, LB
Chan, KC
Qin, YM
Yin, JJ
Yuan, CS
AF Shao, ZH
Vanden Hoek, TL
Li, CQ
Schumacker, PT
Becker, LB
Chan, KC
Qin, YM
Yin, JJ
Yuan, CS
TI Synergistic effect of Scutellaria baicalensis and grape seed
proanthocyanidins on scavenging reactive oxygen species in vitro
SO AMERICAN JOURNAL OF CHINESE MEDICINE
LA English
DT Article
DE Scutellaria baicalensis; grape seed proanthocyanidins; herbal medicine;
hydroxyl radicals; suproxide; antioxidant; synergistic effect
ID ATTENUATES OXIDANT STRESS; OXIDATIVE STRESS; CARDIOMYOCYTES; EXTRACT;
INJURY; ANTIOXIDANT; REPERFUSION; FLAVONOIDS; ISCHEMIA; GEORGI
AB Scutellaria baicalensis (SbE) is a commonly used Chinese herb medicine and grape seed proanthocyanidins is a popular herbal supplement in the United States. Both herbs have been shown to possess potent antioxidant effects. Using an in vitro model to produce the reactive oxygen species (ROS) generation (H2O2/FeSO4 for hydroxyl radicals, xanthine/ xanthine oxidase for suproxide), we observed that Scutellaria baicalensis and grape seed proanthocyanidins acted synergistically to scavenge ROS. Our data suggest that a combination of these two herbs can potentially enhance their antioxidant efficacy, allowing lower dosages of each drug to be used. This has the advantage of avoiding possible side effects that may arise when higher doses of a single herb are used in an attempt to achieve a maximum degree of antioxidant activity.
C1 Univ Chicago, Pritzker Sch Med, Dept Anesthesia & Crit Care, Chicago, IL 60637 USA.
Univ Chicago, Pritzker Sch Med, Tang Ctr Herbal Med Res, Chicago, IL 60637 USA.
Univ Chicago, Pritzker Sch Med, Emergency Med & Emergency Resuscitat Ctr, Chicago, IL 60637 USA.
Univ Chicago, Pritzker Sch Med, Comm Clin Pharmacol & Pharmacogen, Chicago, IL 60637 USA.
Univ Chicago, Pritzker Sch Med, Dept Med, Chicago, IL 60637 USA.
US FDA, Ctr Food Safety & Appl Nutr, College Pk, MD USA.
RP Yuan, CS (reprint author), Univ Chicago, Pritzker Sch Med, Dept Anesthesia & Crit Care, 5841 S Maryland Ave,MC 4028, Chicago, IL 60637 USA.
EM cyuan@uchicago.edu
RI Yin, Jun Jie /E-5619-2014
FU NCCIH NIH HHS [AT00381, AT00563, AT01575]; NHLBI NIH HHS [HL03779,
HL35440]
NR 20
TC 26
Z9 33
U1 1
U2 7
PU WORLD SCIENTIFIC PUBL CO PTE LTD
PI SINGAPORE
PA JOURNAL DEPT PO BOX 128 FARRER ROAD, SINGAPORE 912805, SINGAPORE
SN 0192-415X
J9 AM J CHINESE MED
JI Am. J. Chin. Med.
PY 2004
VL 32
IS 1
BP 89
EP 95
DI 10.1142/S0192415X04001722
PG 7
WC Integrative & Complementary Medicine; Medicine, General & Internal
SC Integrative & Complementary Medicine; General & Internal Medicine
GA 813XD
UT WOS:000220938900009
PM 15154288
ER
PT J
AU Mehendale, SR
Aung, HH
Yin, JJ
Lin, E
Fishbein, A
Wang, CZ
Xie, JT
Yuan, CS
AF Mehendale, SR
Aung, HH
Yin, JJ
Lin, E
Fishbein, A
Wang, CZ
Xie, JT
Yuan, CS
TI Effects of antioxidant herbs on chemotherapy-induced nausea and vomiting
in a rat-pica model
SO AMERICAN JOURNAL OF CHINESE MEDICINE
LA English
DT Article
DE chemotherapy; cisplatin; nausea and vomiting; emesis; free radical;
antioxidant; Scutellaria baicalensis; american ginseng; ginseng berry;
kaolin; pica; rat
ID CISPLATIN-INDUCED EMESIS; ANTIEMETIC DRUGS; NK1 RECEPTOR;
NEUROPHARMACOLOGICAL MECHANISMS; ANIMAL-MODEL; SUBSTANCE-P; INVOLVEMENT;
RELEASE; EXTRACT; ANTAGONIST
AB Nausea and vomiting are significant adverse effects of chemotherapeutic agents like cisplatin, and cause significant patient morbidity. Cisplatin treatment results in oxidant gut injury, which is postulated to be the primary cause of nausea and vomiting. We evaluated the effects of two antioxidant herbs, Scutellaria baicalensis and American ginseng berry, on cisplatin-induced nausea and vomiting using a rat model. Rats react to emetic or nausea-producing stimuli, such as cisplatin, with altered feeding habits, manifested by increased kaolin consumption (pica). We measured pica in rats to quantify cisplatin-induced nausea. We observed that pretreatment of rats with S. baicalensis or ginseng berry extracts resulted in a significant reduction in cisplatin-induced pica. The in vitro free radical scavenging ability of the herbal extract observed in the study, further confirmed the antioxidant action of the herb. We conclude that herbal antioxidants may have a role in attenuating cisplatin-induced nausea and vomiting.
C1 Univ Chicago, Pritzker Sch Med, Tang Ctr Herbal Med Res, Chicago, IL 60637 USA.
Univ Chicago, Pritzker Sch Med, Dept Anesthesia & Crit Care, Chicago, IL 60637 USA.
US FDA, Ctr Food Safety & Appl Nutr, College Pk, MD USA.
RP Yuan, CS (reprint author), Univ Chicago, Pritzker Sch Med, Tang Ctr Herbal Med Res, 5841 S Maryland Ave,MC 4028, Chicago, IL 60637 USA.
EM cyuan@airway.uchicago.edu
RI Yin, Jun Jie /E-5619-2014
FU NCI NIH HHS [P30 CA14599]
NR 36
TC 14
Z9 15
U1 0
U2 3
PU WORLD SCIENTIFIC PUBL CO PTE LTD
PI SINGAPORE
PA 5 TOH TUCK LINK, SINGAPORE 596224, SINGAPORE
SN 0192-415X
J9 AM J CHINESE MED
JI Am. J. Chin. Med.
PY 2004
VL 32
IS 6
BP 897
EP 905
DI 10.1142/S0192415X04002508
PG 9
WC Integrative & Complementary Medicine; Medicine, General & Internal
SC Integrative & Complementary Medicine; General & Internal Medicine
GA 886VH
UT WOS:000226260400007
PM 15673195
ER
PT J
AU Mathews, F
Youngman, L
Neil, A
AF Mathews, F
Youngman, L
Neil, A
TI Maternal circulating nutrient concentrations in pregnancy: implications
for birth and placental weights of term infants
SO AMERICAN JOURNAL OF CLINICAL NUTRITION
LA English
DT Article
DE pregnancy; nutrition; birth weight; placenta; smoking; human
ID FETAL GROWTH; VITAMIN-A; HEMOGLOBIN CONCENTRATION; PROSPECTIVE COHORT;
SMOKING STATUS; NUTRITION; RETARDATION; VOLUME; WOMEN
AB Background: Compromised fetal growth may program chronic diseases of adulthood, and it has been suggested that maternal nutrition is a major determinant of fetal growth. We previously found no clinically significant associations between maternal diet and the size of the infant and placenta at birth in a large cohort of white women living in the United Kingdom.
Objective: The objective was to examine the relations between indexes of maternal nutritional status in pregnancy and the birth and placental weights of infants born at term.
Design: We conducted a prospective cohort study of 798 white nulliparous women with singleton pregnancies. Blood samples were obtained at approximate to 16 and 28 wk of gestation.
Results: The concentration of most nutrients was not associated with pregnancy outcome. High retinol and hemoglobin concentrations in late, but not in early, pregnancy were strongly and independently associated with lower birth weight and smaller placental size at birth. Each 0.1-mumol increase in retinol predicted a 20.8-g (95% CL 9.2, 32.5 g) decrease in birth weight (P < 0.001), and each 0.1-g/L increase in hemoglobin predicted a 61.5-g (95% CI: 28.5, 94.4 g) decrease in birth weight (P < 0.001).
Conclusions: We found negative associations between birth and placental weights and maternal retinol and hemoglobin concentrations. These relations may be causal or may reflect an underlying metabolic dysfunction, such as failure of plasma volume expansion. Our results provide no evidence that having high circulating nutrient concentrations, for example, through the use of supplements, would improve infant and placental growth.
C1 Univ Oxford, Dept Zool, Oxford OX1 3PS, England.
US FDA, Ctr Vet Med, Laurel, MD USA.
Univ Oxford, Div Publ Hlth & Primary Hlth Care, Inst Hlth Sci, Oxford, England.
RP Mathews, F (reprint author), Univ Oxford, Dept Zool, S Parks Rd, Oxford OX1 3PS, England.
NR 37
TC 27
Z9 29
U1 0
U2 0
PU AMER SOC CLINICAL NUTRITION
PI BETHESDA
PA 9650 ROCKVILLE PIKE, SUBSCRIPTIONS, RM L-3300, BETHESDA, MD 20814-3998
USA
SN 0002-9165
J9 AM J CLIN NUTR
JI Am. J. Clin. Nutr.
PD JAN
PY 2004
VL 79
IS 1
BP 103
EP 110
PG 8
WC Nutrition & Dietetics
SC Nutrition & Dietetics
GA 757NZ
UT WOS:000187569500017
PM 14684405
ER
PT J
AU Myers, MJ
Farrell, DE
Heller, DN
Yancy, HF
AF Myers, MJ
Farrell, DE
Heller, DN
Yancy, HF
TI Development of a polymerase chain reaction-based method to identify
species-specific components in dog food
SO AMERICAN JOURNAL OF VETERINARY RESEARCH
LA English
DT Article
ID BOVINE-DERIVED MATERIALS; MITOCHONDRIAL GENOME; SPECTROMETRY; SEQUENCE;
DNA
AB Objectives-To determine whether there is a relationship between species-specific mitochondrial DNA (mtDNA), especially canine and feline mtDNA, and detectable amounts of pentobarbital in previously analyzed dog food samples.
Sample Population-31 dog food samples previously analyzed for pentobarbital (limit of detection, 1 mug/kg).
Procedure-Polymerase chain reaction (PCR) analysis was performed on dog food samples by use of PCR primers specific for either canine, feline, equine, bovine, porcine, ovine, or poultry mtDNA:
Results-PCR amplicons specific for feline or canine mtDNA at a 0.007% (70 mug/g [wt/wt basis]) or 0.0007% (7 mug/g) level, respectively, were not found in the 31 dog food samples. Most of the 31 dog food samples had a PCR amplicon on PCR analysis when a PCR primer set capable of simultaneously detecting mtDNA of cows, pigs, sheep, goats, deer, elk, and horses was used. Results of PCR analysis by use of primers specific for bovine, swine, sheep and goat, or horse mtDNA revealed amplicons specific for bovine or swine mtDNA only in 27 of the 31 samples. Analysis of the remaining 4 samples failed to yield amplicons for any mammalian mtDNA. Pentobarbital was detected in 2 of these 4 samples. Results of PCR analysis correlated with the stated ingredient list for most, but not all samples.
Conclusions and Clinical Relevance-Because canine and feline mtDNA were not found in a set of retail dog food samples, these results indicate that the source of pentobarbital in dog food is something other than proteins from rendered pet remains.
C1 US FDA, Div Anim Res, Res Off, Ctr Vet Med, Laurel, MD 20708 USA.
RP Myers, MJ (reprint author), US FDA, Div Anim Res, Res Off, Ctr Vet Med, 8401 Muirkirk Rd, Laurel, MD 20708 USA.
NR 12
TC 12
Z9 12
U1 0
U2 11
PU AMER VETERINARY MEDICAL ASSOC
PI SCHAUMBURG
PA 1931 N MEACHAM RD SUITE 100, SCHAUMBURG, IL 60173-4360 USA
SN 0002-9645
J9 AM J VET RES
JI Am. J. Vet. Res.
PD JAN
PY 2004
VL 65
IS 1
BP 99
EP 103
DI 10.2460/ajvr.2004.65.99
PG 5
WC Veterinary Sciences
SC Veterinary Sciences
GA 756TW
UT WOS:000187500100016
PM 14719710
ER
PT S
AU Harris, GR
Maruvada, S
Gammell, PM
AF Harris, GR
Maruvada, S
Gammell, PM
BE Shaw, A
TI Two efficient methods for measuring hydrophone frequency response in the
100 kHz to 2 MHz range
SO AMUM 2004: Advanced Metrology for Ultrasound in Medicine 2004
SE JOURNAL OF PHYSICS CONFERENCE SERIES
LA English
DT Proceedings Paper
CT Conference on Advanced Metrology for Ultrasound in Medicine (AMUN 2004)
CY APR 27-28, 2004
CL Natl Phys Lab, Teddington, ENGLAND
HO Natl Phys Lab
AB As new medical applications of ultrasound emerge with operating frequencies in the hundreds of kilohertz to low megahertz region, it becomes more important to have convenient calibration methods for hydrophones in this frequency range. Furthermore, short diagnostic ultrasound pulses affected by finite amplitude distortion require that the hydrophone frequency response be known well below the center frequency. National standards laboratories can provide accurate calibration data at these frequencies, but the two methods now employed, laser interferometry and three-transducer reciprocity, are both single-frequency techniques, and they can be time-consuming procedures. Therefore, two efficient methods for generating a wideband acoustic pressure spectrum have been implemented to cover this frequency range. In one method a high-voltage pulse generator was used to excite a thick piezoelectric ceramic disk, producing a plane-wave acoustic pressure transient < 1 mu s in duration with peak amplitude of about 40 kPa. In the other technique, time delay spectrometry (TDS), a purpose-built 1-3 piezoelectric composite source transducer weakly focused at 20 cm was swept over the 0-2 MHz range. Its transmitting voltage response at 1 MHz was 11 kPa/V. The broadband pulse technique has the advantage of being simpler to implement, but TDS has a much greater signal-to-noise ratio because of the frequency-swept narrowband filter employed.
C1 US FDA, Ctr Devices & Radiol Hlth, Rockville, MD 20850 USA.
RP Harris, GR (reprint author), US FDA, Ctr Devices & Radiol Hlth, Rockville, MD 20850 USA.
NR 13
TC 8
Z9 8
U1 0
U2 1
PU IOP PUBLISHING LTD
PI BRISTOL
PA DIRAC HOUSE, TEMPLE BACK, BRISTOL BS1 6BE, ENGLAND
SN 1742-6588
J9 J PHYS CONF SER
PY 2004
VL 1
BP 26
EP 31
DI 10.1088/1742-6596/1/1/008
PG 6
WC Automation & Control Systems; Biophysics; Medicine, Research &
Experimental
SC Automation & Control Systems; Biophysics; Research & Experimental
Medicine
GA BCE10
UT WOS:000228811800008
ER
PT J
AU Pazdur, R
Williams, G
Johnson, J
Farrell, A
Dagher, R
AF Pazdur, Richard
Williams, Grant
Johnson, John
Farrell, Ann
Dagher, Ramzi
TI Approval and access to caner drugs - U.S. Food and Drug Administration
SO ANNALS OF ONCOLOGY
LA English
DT Meeting Abstract
C1 [Pazdur, Richard; Williams, Grant; Johnson, John; Farrell, Ann; Dagher, Ramzi] US FDA, Rockville, MD 20857 USA.
NR 0
TC 0
Z9 0
U1 0
U2 0
PU OXFORD UNIV PRESS
PI OXFORD
PA GREAT CLARENDON ST, OXFORD OX2 6DP, ENGLAND
SN 0923-7534
J9 ANN ONCOL
JI Ann. Oncol.
PY 2004
VL 15
SU 3
BP 9
EP 9
PG 1
WC Oncology
SC Oncology
GA V14FS
UT WOS:000207720900029
ER
PT J
AU Rosenblatt, KP
Bryant-Greenwood, P
Killian, JK
Mehta, A
Geho, D
Espina, V
Petricoin, EE
Liotta, LA
AF Rosenblatt, KP
Bryant-Greenwood, P
Killian, JK
Mehta, A
Geho, D
Espina, V
Petricoin, EE
Liotta, LA
TI Serum proteomics in cancer diagnosis and management
SO ANNUAL REVIEW OF MEDICINE
LA English
DT Review
DE proteomics; mass spectrometry; SELDI; protein profiling
ID FLIGHT-MASS-SPECTROMETRY; OVARIAN-CANCER; PROSTATE-CANCER;
IDENTIFICATION; BIOMARKERS; DISCOVERY; PATTERNS; CHALLENGES; INTERFACE;
TIME
AB Mass spectrometry-based diagnostics has the potential to revolutionize molecular medicine. Using modem mass-spectrometer technologies, clinical tests can be developed that are practical, robust, accurate, and inexpensive. Serum proteomic pattern profiling couples mass spectrometry with adaptive artificial-intelligence-based bioinformatics, which can now be employed to detect pathological states reflected in the serum proteome. With this approach, rapid and cost-effective tests with exquisite clinical sensitivity and specificity are emerging. These tools may dramatically change how disease is detected, monitored, and managed.
C1 NCI, Pathol Lab, Ctr Canc Res, Bethesda, MD 20892 USA.
Univ Hawaii, John A Burns Sch Med, Dept Pathol, Honolulu, HI 96822 USA.
NCI, Food & Drug Adm, Clin Prote Program, Ctr Biol Evaluat & Res, Bethesda, MD 20892 USA.
RP Rosenblatt, KP (reprint author), NCI, Pathol Lab, Ctr Canc Res, Bethesda, MD 20892 USA.
EM rosenblk@nihexchange2.nih.gov
OI Espina, Virginia/0000-0001-5080-5972
NR 46
TC 101
Z9 109
U1 2
U2 9
PU ANNUAL REVIEWS
PI PALO ALTO
PA 4139 EL CAMINO WAY, PO BOX 10139, PALO ALTO, CA 94303-0139 USA
SN 0066-4219
J9 ANNU REV MED
JI Annu. Rev. Med.
PY 2004
VL 55
BP 97
EP 112
DI 10.1146/annurev.med.55.091902.105237
PG 20
WC Medicine, General & Internal
SC General & Internal Medicine
GA 827RL
UT WOS:000221918000006
PM 14746511
ER
PT J
AU Lian, JP
Word, B
Taylor, S
Hammons, GJ
Lyn-Cook, BD
AF Lian, JP
Word, B
Taylor, S
Hammons, GJ
Lyn-Cook, BD
TI Modulation of the constitutive activated STAT3 transcription factor in
pancreatic cancer prevention: Effects of indole-3-carbinol (I3C) and
genistein
SO ANTICANCER RESEARCH
LA English
DT Article
DE pancreatic cancer; prevention; STAT3 transcription factor;
indole-3-carbinol; genistein
ID PROSTATE CARCINOMA; CELLS; RECEPTOR; PROTEIN; APOPTOSIS; INHIBITION;
EXPRESSION; RISK
AB Background: The signal transducer and activator of transcription 3 (STAT3) is a latent transcription factor required in proliferation and differentiation. STAT3 is activated constitutively in a number of cancers. Materials and Methods: This study was conducted to assess the possible involvement of STAT3 activation in pancreatic cancer and the potential for this pathway as a target in chemopreventive strategy. Results: STAT3 was shown for the first time to be constitutively activated in human pancreatic carcinoma specimens but not in normal pancreatic tissues. Constitutively activated STAT3 was also found in pancreatic tumor cell lines (Panc-1 and MIA PaCa-2) which could be modulated by indole-3-carbinol (I3C) and genistein. At concentrations higher than 10 muM, STAT3 constitutive activation is inhibited by both agents. Induction of apoptosis by I3C was also demonstrated. Conclusion: Given its critical role in tumorigenesis, our results suggest that STAT3 activation provides an important and appropriate target for chemoprevention in pancreatic cancer treatment.
C1 Natl Ctr Toxicol Res, Div Mol Epidemiol, Jefferson, AR 72079 USA.
RP Lyn-Cook, BD (reprint author), Natl Ctr Toxicol Res, Div Mol Epidemiol, HFT-100, Jefferson, AR 72079 USA.
EM Blyncook@nctr.fda.gov
NR 34
TC 22
Z9 22
U1 0
U2 3
PU INT INST ANTICANCER RESEARCH
PI ATHENS
PA EDITORIAL OFFICE 1ST KM KAPANDRITIOU-KALAMOU RD KAPANDRITI, PO BOX 22,
ATHENS 19014, GREECE
SN 0250-7005
J9 ANTICANCER RES
JI Anticancer Res.
PD JAN-FEB
PY 2004
VL 24
IS 1
BP 133
EP 137
PG 5
WC Oncology
SC Oncology
GA 778ZV
UT WOS:000189271900019
PM 15015587
ER
PT J
AU Chen, S
Zhao, SH
White, DG
Schroeder, CM
Lu, R
Yang, HC
McDermott, PF
Ayers, S
Meng, JH
AF Chen, S
Zhao, SH
White, DG
Schroeder, CM
Lu, R
Yang, HC
McDermott, PF
Ayers, S
Meng, JH
TI Characterization of multiple-antimicrobial-resistant Salmonella serovars
isolated from retail meats
SO APPLIED AND ENVIRONMENTAL MICROBIOLOGY
LA English
DT Article
ID SEROTYPE TYPHIMURIUM DT104; AMPC BETA-LACTAMASE; ANTIBIOTIC-RESISTANCE;
ESCHERICHIA-COLI; CLASS-1 INTEGRON; MOLECULAR CHARACTERIZATION;
MULTIDRUG-RESISTANCE; UNITED-STATES; GENE-CLUSTER; FOOD ANIMALS
AB A total of 133 Salmonella isolates recovered from retail meats purchased in the United States and the People's Republic of China were assayed for antimicrobial susceptibility, the presence of integrons and antimicrobial resistance genes, and horizontal transfer of characterized antimicrobial resistance determinants via conjugation. Seventy-three (82%) of these Salmonella isolates were resistant to at least one antimicrobial agent. Resistance to the following antibiotics was common among the United States isolates: tetracycline (68% of the isolates were resistant), streptomycin (61%), sulfamethoxazole (42%), and ampicillin (29%). Eight Salmonella isolates (6%) were resistant to ceftriaxone. Fourteen isolates (11%) from the People's Republic of China were resistant to nalidixic acid and displayed decreased susceptibility to ciprofloxacin. A total of 19 different antimicrobial resistance genes were identified in 30 multidrug-resistant Salmonella isolates. The bla(CMY-2) gene, encoding a class A AmpC beta-lactamase, was detected in all 10 Salmonella isolates resistant to extended-spectrum beta-lactams. Resistance to ampicillin was most often associated with a TEM-1 family beta-lactamase gene. Six aminoglycoside resistance genes, aadA1, aadA2, aacC2, Kn, aph(3)-IIa, and aac(3)-IVa, were commonly present in the Salmonella isolates. Sixteen (54%) of 30 Salmonella isolates tested had integrons ranging in size from 0.75 to 2.7 kb. Conjugation studies demonstrated that there was plasmid-mediated transfer of genes encoding CMY-2 and TEM-1-like beta-lactamases. These data indicate that Salmonella isolates recovered from retail raw meats are commonly resistant to multiple antimicrobials, including those used for treating salmonellosis, such as ceftriaxone. Genes conferring antimicrobial resistance in Salmonella are often carried on integrons and plasmids and could be transmitted through conjugation. These mobile DNA elements have likely played an important role in transmission and dissemination of antimicrobial resistance determinants among Salmonella strains.
C1 Univ Maryland, Dept Nutr & Food Sci, College Pk, MD 20742 USA.
US FDA, Ctr Vet Med, Off Res, Div Anim & Food Microbiol, Laurel, MD USA.
China Agr Univ, Beijing, Peoples R China.
RP Meng, JH (reprint author), Univ Maryland, Dept Nutr & Food Sci, 0112 Skinner Bldg, College Pk, MD 20742 USA.
EM jm332@umail.umd.edu
OI Chen, Sheng/0000-0003-3526-7808
NR 36
TC 219
Z9 249
U1 5
U2 43
PU AMER SOC MICROBIOLOGY
PI WASHINGTON
PA 1752 N ST NW, WASHINGTON, DC 20036-2904 USA
SN 0099-2240
J9 APPL ENVIRON MICROB
JI Appl. Environ. Microbiol.
PD JAN
PY 2004
VL 70
IS 1
BP 1
EP 7
DI 10.1128/AEM.70.1.1-7.2004
PG 7
WC Biotechnology & Applied Microbiology; Microbiology
SC Biotechnology & Applied Microbiology; Microbiology
GA 763RY
UT WOS:000188115300001
PM 14711619
ER
PT J
AU Moody, JD
Freeman, JP
Fu, PP
Cerniglia, CE
AF Moody, JD
Freeman, JP
Fu, PP
Cerniglia, CE
TI Degradation of benzo[a]pyrene by Mycobacterium vanbaalenii PYR-1
SO APPLIED AND ENVIRONMENTAL MICROBIOLOGY
LA English
DT Article
ID POLYCYCLIC AROMATIC-HYDROCARBONS; SP STRAIN PYR-1; STEREOSELECTIVE
METABOLISM; SELENASTRUM-CAPRICORNUTUM; PYRENE DEGRADATION; GREEN-ALGA;
BENZOPYRENE; IDENTIFICATION; BACTERIUM; BIOREMEDIATION
AB Metabolism of the environmental pollutant benzo[a]pyrene in the bacterium Mycobacterium vanbaalenii PYR-1 was examined. This organism initially oxidized benzo [a] pyrene with dioxygenases and monooxygenases at C-4,5, C-9,10, and C-11,12. The metabolites were separated by reversed-phase high-performance liquid chromatography (HPLC) and characterized by UV-visible, mass, nuclear magnetic resonance, and circular dichroism spectral analyses. The major intermediates of benzo[a]pyrene metabolism that had accumulated in the culture media after 96 h of incubation were cis-4,5-dihydro-4,5-dihydroxybenzo [a] pyrene (benzo [a] pyrene cis-4,5-dihydrodiol), cis-11,12-dihydro-11,12-dihydroxybenzo [a] pyrene (benzo[a]pyrene cis-11,12-dihydrodiol), trans-11,12-dihydro-11,12-dihydroxybenzo[a]pyrene (benzo[a]pyrene trans-11,12-dihydrodiol), 10-oxabenzo[def]chrysen-9-one, and hydroxymethoxy and dimethoxy derivatives of benzo[]pyrene. The ortho-ring fission products 4-formylchrysene-5-carboxylic acid and 4,5-chrysene-dicarboxylic acid and a monocarboxylated chrysene product were formed when replacement culture experiments were conducted with benzo[a]pyrene cis-4,5-dihydrodiol. Chiral stationary-phase HPLC analysis of the dihydrodiols indicated that benzo[a]pyrene cis-4,5-dihydrodiol had 30% 4S,5R and 70% 4R,5S absolute stereochemistry. Benzo[a]pyrene cis-11,12-dihydrodiol adopted an 11S,12R conformation with 100% optical purity. The enantiomeric composition of benzo[a] pyrene trans-11,12-dihydrodiol was an equal mixture of 11S,12S and 11R,12R molecules. The results of this study, in conjunction with those of previously reported studies, extend the pathways proposed for the bacterial metabolism of benzo[a]pyrene. Our study also provides evidence of the stereo- and regioselectivity of the oxygenases that catalyze the metabolism of benzo[a]pyrene in M. vanbaalenii PYR-1.
C1 US FDA, Natl Ctr Toxicol Res, Jefferson, AR 72079 USA.
US FDA, Div Microbiol, Jefferson, AR 72079 USA.
US FDA, Div Chem, Jefferson, AR 72079 USA.
US FDA, Div Biochem Toxicol, Jefferson, AR 72079 USA.
RP Cerniglia, CE (reprint author), US FDA, Natl Ctr Toxicol Res, HFT-250, Jefferson, AR 72079 USA.
EM ccerniglia@nctr.fda.gov
NR 33
TC 72
Z9 96
U1 7
U2 29
PU AMER SOC MICROBIOLOGY
PI WASHINGTON
PA 1752 N ST NW, WASHINGTON, DC 20036-2904 USA
SN 0099-2240
J9 APPL ENVIRON MICROB
JI Appl. Environ. Microbiol.
PD JAN
PY 2004
VL 70
IS 1
BP 340
EP 345
DI 10.1128/AEM.70.1.340-345.2004
PG 6
WC Biotechnology & Applied Microbiology; Microbiology
SC Biotechnology & Applied Microbiology; Microbiology
GA 763RY
UT WOS:000188115300043
PM 14711661
ER
PT J
AU Umehara, H
Bloom, ET
Okazaki, T
Nagano, Y
Yoshie, O
Imai, T
AF Umehara, H
Bloom, ET
Okazaki, T
Nagano, Y
Yoshie, O
Imai, T
TI Fractalkine in vascular biology - From basic research to clinical
disease
SO ARTERIOSCLEROSIS THROMBOSIS AND VASCULAR BIOLOGY
LA English
DT Review
DE fractalkine; endothelial cells; vascular biology; atherosclerosis;
inflammation
ID CD8(+) T-CELLS; RECEPTOR CX(3)CR1; CHEMOKINE RECEPTORS; CX3C CHEMOKINE;
CRESCENTIC GLOMERULONEPHRITIS; RHEUMATOID-ARTHRITIS;
CHLAMYDIA-PNEUMONIAE; ALLOGRAFT-REJECTION; LEUKOCYTE ADHESION;
ENDOTHELIAL-CELLS
AB Fractalkine (now also called CX3CL1) is a unique chemokine that functions not only as a chemoattractant but also as an adhesion molecule and is expressed on endothelial cells activated by proinflammatory cytokines, such as interferon-gamma and tumor necrosis factor-alpha. The fractalkine receptor, CX3CR1, is expressed on cytotoxic effector lymphocytes, including natural killer (NK) cells and cytotoxic T lymphocytes, which contain high levels of intracellular perforin and granzyme B, and on macrophages. Soluble fractalkine causes migration of NK cells, cytotoxic T lymphocytes, and macrophages, whereas the membrane-bound form captures and enhances the subsequent migration of these cells in response to secondary stimulation with other chemokines. Furthermore, stimulation through membrane-bound fractalkine activates NK cells, leading to increased cytotoxicity and interferon-gamma production. Recently, accumulating evidence has shown that fractalkine is involved in the pathogenesis of various clinical disease states or processes, such as atherosclerosis, glomerulonephritis, cardiac allograft rejection, and rheumatoid arthritis. In addition, polymorphisms in CX3CR1, which reduce its binding activity to fractalkine, have been reported to increase the risk of HIV disease and to reduce the risk of coronary artery disease. This review will examine new concepts underlying fractalkine-mediated leukocyte migration and tissue damage, focusing primarily on the pathophysiological roles of fractalkine in various clinical conditions, especially in atherosclerosis and vascular injury.
C1 Kyoto Univ, Grad Sch Med, Dept Rheumatol & Clin Immunol, Sakyo Ku, Kyoto 6068507, Japan.
Kyoto Univ, Grad Sch Med, Dept Hematol & Oncol, Kyoto 6068507, Japan.
US FDA, Div Cellular & Gene Therapies HFM518, Ctr Biol Evaluat & Res, Bethesda, MD 20014 USA.
Osaka Dent Univ, Dept Med, Osaka, Japan.
Kinki Univ, Sch Med, Dept Microbiol, Osaka 589, Japan.
Kan Res Inst, Kyoto, Japan.
RP Umehara, H (reprint author), Kyoto Univ, Grad Sch Med, Dept Rheumatol & Clin Immunol, Sakyo Ku, 54 Shogoin Kawahara Cho, Kyoto 6068507, Japan.
NR 84
TC 179
Z9 193
U1 1
U2 16
PU LIPPINCOTT WILLIAMS & WILKINS
PI PHILADELPHIA
PA 530 WALNUT ST, PHILADELPHIA, PA 19106-3621 USA
SN 1079-5642
J9 ARTERIOSCL THROM VAS
JI Arterioscler. Thromb. Vasc. Biol.
PD JAN
PY 2004
VL 24
IS 1
BP 34
EP 40
DI 10.1161/01.ATV.0000095360.62479.1F
PG 7
WC Hematology; Peripheral Vascular Disease
SC Hematology; Cardiovascular System & Cardiology
GA 760BV
UT WOS:000187791600007
PM 12969992
ER
PT J
AU Witter, J
Dionne, RA
AF Witter, J
Dionne, RA
TI What can chronic arthritis pain teach about developing new analgesic
drugs?
SO ARTHRITIS RESEARCH & THERAPY
LA English
DT Article
DE analgesics; chronic pain; drug development; individual responses; pain
mechanisms
AB Chronic pain remains an important public health need with greater impact on the US economy than most other chronic conditions. Current pain management is largely limited to opioids and non-steroidal anti-inflammatory drugs, indicating a gap in the translation of new knowledge to the development of improved pain treatments. Strategies suggested include the re-evaluation of current drug screening methods, a recognition that molecular-genetic events occurring acutely contribute to the development of pain chronicity, the validation of analgesic targets in the intended patient population, consideration of the unique genetic profile that varies between individuals, and the introduction of individual response measures to improve the capture of outcomes in clinical trials.
C1 Natl Inst Dent & Craniofacial Res, NIH, Bethesda, MD 20892 USA.
US FDA, Ctr Drug Evaluat & Res, Rockville, MD 20857 USA.
RP Dionne, RA (reprint author), Natl Inst Dent & Craniofacial Res, NIH, Bethesda, MD 20892 USA.
EM raymond.dionne@nih.gov
NR 6
TC 3
Z9 3
U1 0
U2 0
PU BIOMED CENTRAL LTD
PI LONDON
PA 236 GRAYS INN RD, FLOOR 6, LONDON WC1X 8HL, ENGLAND
SN 1478-6354
J9 ARTHRITIS RES THER
JI Arthritis Res. Ther.
PY 2004
VL 6
IS 6
BP 279
EP 281
DI 10.1186/ar1450
PG 3
WC Rheumatology
SC Rheumatology
GA 871US
UT WOS:000225160100005
PM 15535840
ER
PT J
AU Hingorani, SR
Petricoin, EF
Maitra, A
Rajapakse, V
King, C
Jacobetz, MA
Ross, S
Conrads, TP
Veenstra, TD
Hitt, BA
Kawaguchi, Y
Johann, D
Liotta, LA
Crawford, HC
Putt, ME
Jacks, T
Wright, CVE
Hruban, RH
Lowy, AM
Tuveson, DA
AF Hingorani, SR
Petricoin, EF
Maitra, A
Rajapakse, V
King, C
Jacobetz, MA
Ross, S
Conrads, TP
Veenstra, TD
Hitt, BA
Kawaguchi, Y
Johann, D
Liotta, LA
Crawford, HC
Putt, ME
Jacks, T
Wright, CVE
Hruban, RH
Lowy, AM
Tuveson, DA
TI Preinvasive and invasive ductal pancreatic cancer and its early
detection in the mouse (vol 4, pg 434, 2003)
SO CANCER CELL
LA English
DT Correction
C1 Univ Penn, Abramson Canc Ctr, Abramson Family Canc Res Inst, Dept Med, Philadelphia, PA 19104 USA.
Univ Penn, Abramson Canc Ctr, Abramson Family Canc Res Inst, Dept Canc Biol, Philadelphia, PA 19104 USA.
US FDA, Ctr Biol Evaluat & Res, NCI, Clin Proteom Program, Bethesda, MD 20892 USA.
Johns Hopkins Univ, Sidney Kimmel Canc Ctr, Dept Pathol, Baltimore, MD 21287 USA.
Johns Hopkins Univ, Sidney Kimmel Canc Ctr, Dept Oncol, Baltimore, MD 21287 USA.
NCI, US FDA, Clin Proteom Program,Lab Pathol, Canc Res Ctr, Bethesda, MD 20892 USA.
NCI, Biomed Proteom Program, Analyt Chem Lab,Mass Spectrometry Ctr, SAIC Frederick Inc, Frederick, MD 21702 USA.
Correlog Syst Inc, Bethesda, MD 20892 USA.
Vanderbilt Univ, Sch Med, Dept Cell & Dev Biol, Nashville, TN 37232 USA.
SUNY Stony Brook, Dept Pharmacol Sci, Stony Brook, NY 11794 USA.
Univ Penn, Dept Biostat & Epidemiol, Philadelphia, PA 19104 USA.
MIT, Dept Biol, Cambridge, MA 02139 USA.
Howard Hughes Med Inst, Ctr Canc Res, Cambridge, MA 02139 USA.
Univ Cincinnati, Coll Med, Dept Surg, Div Surg Oncol, Cincinnati, OH 45219 USA.
RP Tuveson, DA (reprint author), Univ Penn, Abramson Canc Ctr, Abramson Family Canc Res Inst, Dept Med, Philadelphia, PA 19104 USA.
EM tuvesond@mail.med.upenn.edu
RI Crawford, Howard/A-2874-2008
NR 1
TC 0
Z9 1
U1 2
U2 7
PU CELL PRESS
PI CAMBRIDGE
PA 1100 MASSACHUSETTS AVE, CAMBRIDGE, MA 02138 USA
SN 1535-6108
J9 CANCER CELL
JI Cancer Cell
PD JAN
PY 2004
VL 5
IS 1
BP 103
EP 103
DI 10.1016/S1535-6108(03)00335-0
PG 1
WC Oncology; Cell Biology
SC Oncology; Cell Biology
GA 766XH
UT WOS:000188400300013
ER
PT J
AU Wu, AH
Yu, MC
Tseng, CC
Twaddle, NC
Doerge, DR
AF Wu, AH
Yu, MC
Tseng, CC
Twaddle, NC
Doerge, DR
TI Plasma isoflavone levels versus self-reported soy isoflavone levels in
Asian-American women in Los Angeles County
SO CARCINOGENESIS
LA English
DT Article
ID BREAST-CANCER RISK; MASS-SPECTROMETRY; HUMAN URINE; PHYTOESTROGENS;
CHROMATOGRAPHY; METABOLITES; POPULATION; PHARMACOKINETICS;
QUESTIONNAIRE; FREQUENCY
AB In a case-control study conducted among Asian-American women in Los Angeles County, we reported that the risk of breast cancer was significantly reduced in association with soy intake [Wu,A.H., Wan,P., Hankin,J. et al. (2002) Carcinogenesis, 23, 1491-1496]. In a subset of cases (n = 97) and controls (n = 97) we investigated the relationship between self-reported usual adult intake of soy isoflavones which was determined from a food frequency questionnaire and levels of plasma isoflavones (genistein and daidzein) and isoflavone metabolites (equol, dihydrogenistein and dihydrodaidzein) from a randomly timed blood specimen. In analyses conducted in cases and controls separately, levels of plasma genistein, daidzein and total isoflavones increased with increasing levels of self-reported intake of soy isoflavones. Breast cancer cases and control subjects did not differ in their respective associations between total plasma isoflavone levels and self-reported intake (P = 0.48). Among all subjects, there was a 3-fold difference in geometric mean plasma levels of total isoflavones [81.8 (95% CI = 53.4, 125.1) versus 26.4 nmol/l (95% CI = 16.6, 41.8)] between women in the highest quartile of soy isoflavone intake (>12.68 mg isoflavones/1000 kcal) compared with those in the lowest quartile of intake (less than or equal to1.79 mg isoflavones/1000 kcal), a difference that was statistically significant (P = 0.002). The present study provides independent corroboration that breast cancer cases and control subjects can reliably recall their usual soy intake and that there is no evidence of selective recall biases between breast cancer cases and controls. These results further strengthen our previous observation of an inverse association between soy intake and breast cancer risk in the Los Angeles Asian Breast Cancer Study.
C1 Univ So Calif, Norris Comprehens Canc Ctr, Keck Sch Med, Dept Prevent Med, Los Angeles, CA 90089 USA.
Natl Ctr Toxicol Res, Jefferson, AR 72079 USA.
RP Wu, AH (reprint author), Univ So Calif, Norris Comprehens Canc Ctr, Keck Sch Med, Dept Prevent Med, 1441 Eastlake Ave,MC 9175, Los Angeles, CA 90089 USA.
EM annawu@hsc.usc.edu
FU NCI NIH HHS [N01CN25403]
NR 24
TC 37
Z9 39
U1 1
U2 3
PU OXFORD UNIV PRESS
PI OXFORD
PA GREAT CLARENDON ST, OXFORD OX2 6DP, ENGLAND
SN 0143-3334
J9 CARCINOGENESIS
JI Carcinogenesis
PD JAN
PY 2004
VL 25
IS 1
BP 77
EP 81
DI 10.1093/carcin/bgg189
PG 5
WC Oncology
SC Oncology
GA 762MG
UT WOS:000187975700009
PM 14555615
ER
PT J
AU Weber, DJ
AF Weber, DJ
TI FDA regulation of allogeneic islets as a biological product
SO CELL BIOCHEMISTRY AND BIOPHYSICS
LA English
DT Article; Proceedings Paper
CT 3rd Annual Rachmiel Levine Diabetes and Obesity Symposium
CY OCT, 2002
CL Anaheim, CA
DE somatic cell therapy; Food and Drug Administration; pancreatic islets;
biologics license application; investigational new drug application;
cGMP; comparability
AB This article describes the Food and Drug Administration's recent manufacturing review experience with investigational new drug applications submitted for allogeneic pancreatic islets of Langerhans for the treatment of type 1 diabetes mellitus. In addition, considerations of islet preparation issues that will need to be resolved before the submission of a biologics license application are discussed.
C1 US FDA, Ctr Biol Evaluat & Res, Off Cells Tissue & Gene Therapies, Div Celular & Gene Therapies, Rockville, MD 20857 USA.
RP Weber, DJ (reprint author), US FDA, Ctr Biol Evaluat & Res, Off Cells Tissue & Gene Therapies, Div Celular & Gene Therapies, Rockville, MD 20857 USA.
EM dweber@bcg-usa.com
NR 4
TC 4
Z9 4
U1 0
U2 0
PU HUMANA PRESS INC
PI TOTOWA
PA 999 RIVERVIEW DRIVE SUITE 208, TOTOWA, NJ 07512 USA
SN 1085-9195
J9 CELL BIOCHEM BIOPHYS
JI Cell Biochem. Biophys.
PY 2004
SU S
BP 19
EP 22
PG 4
WC Biochemistry & Molecular Biology; Biophysics; Cell Biology
SC Biochemistry & Molecular Biology; Biophysics; Cell Biology
GA 853SC
UT WOS:000223846900003
ER
PT J
AU [Anonymous]
AF [Anonymous]
TI Regulation of islets as a biological product: FDA update
SO CELL BIOCHEMISTRY AND BIOPHYSICS
LA English
DT Meeting Abstract
RP US FDA, CBER, OTRR, Div Cell & Gene Therapy, Rockville, MD USA.
NR 0
TC 0
Z9 0
U1 0
U2 0
PU HUMANA PRESS INC
PI TOTOWA
PA 999 RIVERVIEW DRIVE SUITE 208, TOTOWA, NJ 07512 USA
SN 1085-9195
J9 CELL BIOCHEM BIOPHYS
JI Cell Biochem. Biophys.
PY 2004
SU S
BP 233
EP 234
PG 2
WC Biochemistry & Molecular Biology; Biophysics; Cell Biology
SC Biochemistry & Molecular Biology; Biophysics; Cell Biology
GA 853SC
UT WOS:000223846900046
ER
PT J
AU Fang, GC
Wu, YS
Fu, PPC
Yang, IL
Chen, MH
AF Fang, GC
Wu, YS
Fu, PPC
Yang, IL
Chen, MH
TI Polycyclic aromatic hydrocarbons in the ambient air of suburban and
industrial regions of central Taiwan
SO CHEMOSPHERE
LA English
DT Article
DE BaP; industrial; suburban; T-test; ambient air; Taichung
ID SUSPENDED PARTICULATE; URBAN ATMOSPHERE; PARTICLES; INDOOR; PAHS
AB The concentrations of gas-phase and particle-bound polycyclic aromatic hydrocarbons (PAHs) were measured simultaneously at an industrial area (Taichung Industrial Park) and a suburban area (Tunghai University Campus) in Taichung, Taiwan. Twenty-four hours samplings for two consecutive days were performed between August and December 2002 at both sampling sites. Ambient air particle-bound PAHs were collected on quartz filters and gas-phase PAHs were collected on glass cartridges using a PUF Sampler, respectively. Both types of samples were extracted with a DCM/n-hexane mixture (50/50, v/v) for 24 h, then the extracts were subjected to gas chromatography-mass spectrometric (GC-MS) analysis. Total PAHs concentrations at the Taichung Industrial Park (TIP) sampling site and the Tunghai University Campus (THUC) sampling site were found to be 1232.3 +/- 963.6 and 609.8 +/- 356.3 ng/m(3), respectively. Stationary combustion processes were mainly responsible for PAHs sources at the TIP sampling site, while traffic vehicle exhaust was the largest contributor for PAHs sources at the THUC sampling site. (C) 2003 Elsevier Ltd. All rights reserved.
C1 Hungkuang Univ, Dept Environm Engn, Air Tox & Environm Anal Lab, Taichung 433, Taiwan.
Natl Ctr Toxicol Res, Div Biochem Toxicol, Jefferson, AR 72079 USA.
Tunghai Univ, Dept Environm Sci, Taichung 407, Taiwan.
RP Fang, GC (reprint author), Hungkuang Univ, Dept Environm Engn, Air Tox & Environm Anal Lab, Taichung 433, Taiwan.
NR 14
TC 40
Z9 41
U1 4
U2 9
PU PERGAMON-ELSEVIER SCIENCE LTD
PI OXFORD
PA THE BOULEVARD, LANGFORD LANE, KIDLINGTON, OXFORD OX5 1GB, ENGLAND
SN 0045-6535
J9 CHEMOSPHERE
JI Chemosphere
PD JAN
PY 2004
VL 54
IS 4
BP 443
EP 452
DI 10.1016/S0045-6535(03)00706-9
PG 10
WC Environmental Sciences
SC Environmental Sciences & Ecology
GA 759NX
UT WOS:000187744700001
PM 14581046
ER
PT J
AU Powers, JH
Cooper, CK
AF Powers, JH
Cooper, CK
TI Evaluating combination therapy in community-acquired pneumonia
SO CHEST
LA English
DT Letter
ID RANDOMIZED CONTROLLED TRIAL
C1 US FDA, Ctr Drug Evaluat & Res, Rockville, MD 20857 USA.
RP Powers, JH (reprint author), HFD-104,9201 Corp Blvd, Rockville, MD 20850 USA.
EM POWERSJOH@cder.fda.gov
NR 5
TC 2
Z9 2
U1 0
U2 0
PU AMER COLL CHEST PHYSICIANS
PI NORTHBROOK
PA 3300 DUNDEE ROAD, NORTHBROOK, IL 60062-2348 USA
SN 0012-3692
J9 CHEST
JI Chest
PD JAN
PY 2004
VL 125
IS 1
BP 353
EP 353
DI 10.1378/chest.125.1.353
PG 1
WC Critical Care Medicine; Respiratory System
SC General & Internal Medicine; Respiratory System
GA 764QN
UT WOS:000188217700067
PM 14718472
ER
PT S
AU Johann, DJ
McGuigan, MD
Patel, AR
Tomov, S
Ross, S
Conrads, TP
Veenstra, TD
Fishman, DA
Whiteley, GR
Petricoin, EF
Liotta, LA
AF Johann, DJ
McGuigan, MD
Patel, AR
Tomov, S
Ross, S
Conrads, TP
Veenstra, TD
Fishman, DA
Whiteley, GR
Petricoin, EF
Liotta, LA
BE Hoon, DSB
Taback, B
TI Clinical proteomics and biomarker discovery
SO CIRCULATING NUCLEIC ACIDS IN PLASMA/SERUM III AND SERUM PROTEOMICS
SE ANNALS OF THE NEW YORK ACADEMY OF SCIENCES
LA English
DT Article; Proceedings Paper
CT 3rd International Symposium on Circulating Nucleic Acids in Plasma/Serum
(CNAPS III) and Serum Proteomics
CY NOV 09-12, 2003
CL Santa Monica, CA
SP John Wayne Canc Inst, Dept Mol Oncol
DE proteomics; bioinformatics; mass spectroscopy
ID PROSTATE-CANCER; SERUM; PATTERNS
AB Early detection of disease generally provides much-improved outcomes by a definitive medical procedure or through lifestyle modification along with specific medical management strategies. For serum biomarkers, which are central to the diagnosis of many diseases, to become truly useful sentinels of pathogenesis, their sensitivity and specificity in both early detection and recurrence monitoring must be improved. Currently, the detection and monitoring of disease markers is based on solitary proteins, and this approach is not always reliable. New classes of biomarkers derived from mass spectroscopy analysis of the low molecular weight proteome have shown improved abilities in the early detection of disease and hence in patient risk stratification and outcome. The development of a modular platform technology with sufficient flexibility and design abstractions allowing for concurrent experimentation, test, and refinement will help speed the progress of mass spectroscopy-derived proteomic pattern-based diagnostics from the scientific laboratory to the medical clinic. For acceptance by scientists, physicians, and regulatory personnel, new bioinformatic tools are essential system components for data management, analysis, and intuitive display of these new and complex data. Clinically engineered mass spectroscopy systems are essential for the further development and validation of multiplexed biomarkers that have shown tremendous promise for the early detection of disease.
C1 NCI, NIH, Pathol Lab,Ctr Canc Res, FDA Clin Proteom Program, Bethesda, MD 20892 USA.
Brookhaven Natl Lab, Div Informat Technol, Upton, NY 11973 USA.
NCI, NIH,Summer Student Program, Pathol Lab, FDA Clin Proteom Program, Bethesda, MD 20892 USA.
SAIC Frederick Inc, Natl Canc Inst, Biomed Proteom Program, Analyt Chem Lab,Mass Spectrometry Ctr, Frederick, MD 21702 USA.
Northwestern Univ, Sch Med, Natl Ovarian Canc Early Detect Program, Chicago, IL 60611 USA.
SAIC Frederick, NCI, FDA Clin Proteom Program, Clin Proteom Reference Lab, Gaithersburg, MD USA.
NCI, FDA Clin Proteom Program, Off Director, Ctr Biol Evaluat & Res, Bethesda, MD 20892 USA.
RP Johann, DJ (reprint author), NCI, NIH, Pathol Lab,Ctr Canc Res, FDA Clin Proteom Program, 8800 Rockville Pike,Bldg 29A,Room 2A21, Bethesda, MD 20892 USA.
EM johannd@mail.nih.gov
NR 17
TC 57
Z9 57
U1 0
U2 2
PU NEW YORK ACAD SCIENCES
PI NEW YORK
PA 2 EAST 63RD ST, NEW YORK, NY 10021 USA
SN 0077-8923
BN 1-57331-551-6
J9 ANN NY ACAD SCI
JI Ann.NY Acad.Sci.
PY 2004
VL 1022
BP 295
EP 305
DI 10.1196/annals.1318.045
PG 11
WC Biochemistry & Molecular Biology; Oncology; Medical Laboratory
Technology; Medicine, Research & Experimental; Multidisciplinary
Sciences
SC Biochemistry & Molecular Biology; Oncology; Medical Laboratory
Technology; Research & Experimental Medicine; Science & Technology -
Other Topics
GA BAN78
UT WOS:000223005300044
PM 15251975
ER
PT J
AU Hassan, R
Williams-Gould, J
Watson, T
Pai-Scherf, L
Pastan, I
AF Hassan, R
Williams-Gould, J
Watson, T
Pai-Scherf, L
Pastan, I
TI Pretreatment with rituximab does not inhibit the human immune response
against the immunogenic protein LMB-1
SO CLINICAL CANCER RESEARCH
LA English
DT Article
ID MONOCLONAL-ANTIBODY THERAPY; B-CELLS; PHASE-I; DEPLETION; RICIN;
IMMUNOTOXIN; IDEC-C2B8; INFUSION; TRIAL
AB Purpose: Rituximab, a humanized monoclonal antibody directed to the CD20 antigen present on B lymphocytes, could potentially abrogate the humoral immune response to murine monoclonal antibodies or immunotoxins by depleting antibody-producing B cells.
Experimental Design: A Phase II study of LMB-1, an immunotoxin targeting the Lewis Y tumor antigen, in combination with rituximab was conducted to test the hypothesis that rituximab could abolish or diminish the development of human antibodies to LMB-1. Five patients were treated in this study and received 375 mg/m(2) rituximab on days 1 and 7 followed by 45 mug/kg/day LMB-1 on days 10, 12, and 14. The development of human antibodies against LMB-1 was detected using a serum neutralization and ELISA.
Results: All five of the patients had a total suppression of circulating CD20/CD19 B-cell population before the administration of the first dose of the immunotoxin. Before rituximab treatment, the mean percentage of CD20/CD19-positive B cells in the five treated patients was 19.8% (range, 4.5-29.8%) of the total peripheral lymphocytes. After two doses of rituximab, CD20/CD19-positive B lymphocytes constituted less than or equal to0.1% of the total peripheral lymphocytes. Despite absent circulating antibody-producing B cells, before and during LMB-1 treatment, all of the patients developed neutralizing antibodies to the immunotoxin by day 21 of drug administration, which prevented retreatment.
Conclusions: Even though rituximah caused complete depletion of circulating CD20/CD19-positive B cells, it had no effect in suppressing the human antibody response to LMB-1 and may be of limited utility in suppressing human antibody responses to other immunogenic proteins.
C1 NCI, Mol Biol Lab, NIH, Bethesda, MD 20892 USA.
NCI, Med Oncol Clin Res Unit, NIH, Bethesda, MD 20892 USA.
US FDA, Ctr Drug Evaluat & Res, Rockville, MD 20857 USA.
RP Hassan, R (reprint author), NCI, Mol Biol Lab, NIH, 37 Convent Dr,Room 5116, Bethesda, MD 20892 USA.
EM hassanr@mail.nih.gov
NR 16
TC 28
Z9 29
U1 0
U2 0
PU AMER ASSOC CANCER RESEARCH
PI PHILADELPHIA
PA 615 CHESTNUT ST, 17TH FLOOR, PHILADELPHIA, PA 19106-4404 USA
SN 1078-0432
J9 CLIN CANCER RES
JI Clin. Cancer Res.
PD JAN 1
PY 2004
VL 10
IS 1
BP 16
EP 18
DI 10.1158/1078-0432.CCR-1160-3
PN 1
PG 3
WC Oncology
SC Oncology
GA 765YM
UT WOS:000188318700004
PM 14734446
ER
PT J
AU Jackson, AJ
Robbie, G
Marroum, P
AF Jackson, AJ
Robbie, G
Marroum, P
TI Metabolites and bioequivalence - Past and present
SO CLINICAL PHARMACOKINETICS
LA English
DT Review
ID LINEAR PHARMACOKINETICS; ACTIVE METABOLITE; PARENT DRUG;
BIOAVAILABILITY; PHARMACODYNAMICS; ALLOPURINOL; GERMANY
AB Although it is widely recognised that measurement of metabolite concentrations is crucial to understanding the clinical pharmacology characteristics of a new molecular entity, a clear consensus on the role of metabolites in the assessment of bioequivalence has never been achieved within the scientific community. However, a regulatory policy for the role of metabolites in bioavailability and bioequivalence has been established by the US FDA. One school of thought believes that the parent drug alone is sensitive to picking up formulation differences, whereas another school of thought believes that establishing bioequivalence criteria on all the species that contribute to safety and efficacy is the only way to ensure the switchability of two products.
In this paper, a brief review of the pharmacokinetics of metabolites under different scenarios is presented and the history of the role of metabolites in the assessment of bioequivalence is summarised. Relevant examples from the literature illustrating conflicting opinions on the need for the measurement of metabolites in bioequivalence studies are given. Cases from the literature in which the parent drug is able to meet the 90% confidence intervals while the metabolite(s) fail to do so, and vice versa, are presented to illustrate the difficulty in choosing the pertinent entity to measure. The relevant current US FDA policy and guidelines related to bioavailability and bioequivalence are discussed and contrasted with the rules and regulations applicable in Canada and Europe.
C1 Off Clin Pharmacol & Biopharmaceut, Ctr Drug Evaluat & Res, Div Pharmaceut Evaluat, Rockville, MD 20852 USA.
RP Jackson, AJ (reprint author), Off Clin Pharmacol & Biopharmaceut, Ctr Drug Evaluat & Res, Div Pharmaceut Evaluat, Mailstop HFD 860, Rockville, MD 20852 USA.
EM jacksonan@cder.fda.gov
NR 39
TC 19
Z9 21
U1 0
U2 0
PU ADIS INT LTD
PI AUCKLAND
PA 41 CENTORIAN DR, PRIVATE BAG 65901, MAIRANGI BAY, AUCKLAND 1311, NEW
ZEALAND
SN 0312-5963
J9 CLIN PHARMACOKINET
JI Clin. Pharmacokinet.
PY 2004
VL 43
IS 10
BP 655
EP 672
DI 10.2165/00003088-200443100-00002
PG 18
WC Pharmacology & Pharmacy
SC Pharmacology & Pharmacy
GA 841PC
UT WOS:000222942100002
PM 15244496
ER
PT J
AU Huang, SM
Hall, SD
Watkins, P
Love, LA
Serabjit-Singh, C
Betz, JM
Hoffman, FA
Honig, P
Coates, PM
Bull, J
Chen, ST
Kearns, GL
Murray, MD
AF Huang, SM
Hall, SD
Watkins, P
Love, LA
Serabjit-Singh, C
Betz, JM
Hoffman, FA
Honig, P
Coates, PM
Bull, J
Chen, ST
Kearns, GL
Murray, MD
TI Drug interactions with herbal products and grapefruit juice: A
conference report
SO CLINICAL PHARMACOLOGY & THERAPEUTICS
LA English
DT Editorial Material
ID ST-JOHNS-WORT; ALTERNATIVE MEDICINE USE; HYPERICUM-PERFORATUM; ORAL
AVAILABILITY; UNITED-STATES; DIETARY-SUPPLEMENTS; BRUSSELS-SPROUTS;
PHARMACOKINETICS; COMPLEMENTARY; CYP3A4
C1 Purdue Univ, Regenstrief Inst, Indianapolis, IN 46202 USA.
US FDA, Ctr Drug Evaluat & Res, Rockville, MD 20857 USA.
US FDA, Off Regulatory Affairs, Rockville, MD 20857 USA.
Indiana Univ, Sch Med, Indianapolis, IN USA.
Univ N Carolina, Ctr Med, Chapel Hill, NC USA.
GlaxoSmithKline, Res Triangle Pk, NC USA.
NIH, Off Dietary Supplements, Bethesda, MD 20892 USA.
Pfizer Inc, Pfizer Consumer Hlth Care, Morris Plains, NJ USA.
Merck Res Labs, W Point, PA USA.
Childrens Mercy Hosp & Clin, Kansas City, MO USA.
RP Murray, MD (reprint author), Purdue Univ, Regenstrief Inst, 1050 Wishard Blvd,RG-6, Indianapolis, IN 46202 USA.
EM mmurray@regenstrief.org
NR 55
TC 54
Z9 58
U1 3
U2 7
PU MOSBY, INC
PI ST LOUIS
PA 11830 WESTLINE INDUSTRIAL DR, ST LOUIS, MO 63146-3318 USA
SN 0009-9236
J9 CLIN PHARMACOL THER
JI Clin. Pharmacol. Ther.
PD JAN
PY 2004
VL 75
IS 1
BP 1
EP 12
DI 10.1016/j.clpt.2003.07.002
PG 12
WC Pharmacology & Pharmacy
SC Pharmacology & Pharmacy
GA 765YJ
UT WOS:000188318400001
PM 14749688
ER
PT J
AU Gorski, JC
Huang, SM
Pinto, A
Hamman, MA
Hilligoss, JK
Zaheer, NA
Desai, M
Miller, M
Hall, SD
AF Gorski, JC
Huang, SM
Pinto, A
Hamman, MA
Hilligoss, JK
Zaheer, NA
Desai, M
Miller, M
Hall, SD
TI The effect of echinacea (Echinacea purpurea root) on cytochrome P450
activity in vivo
SO CLINICAL PHARMACOLOGY & THERAPEUTICS
LA English
DT Article
ID MENSTRUAL-CYCLE PHASE; ST-JOHNS-WORT; 3-MONTH INTRAINDIVIDUAL
VARIABILITY; ALTERNATIVE MEDICINE USE; DRUG-INTERACTIONS; CYP3A
ACTIVITY; HERBAL MEDICINES; XANTHINE-OXIDASE; HEPATIC CYP3A; METABOLISM
AB Background: Echinacea is a widely available over-the-counter herbal remedy. Tinctures of echinacea have been shown to inhibit cytochrome P450 (CYP) in vitro. The effect of echinacea (Echinacea purpurea root) on CYP activity in vivo was assessed by use of the CYP probe drugs caffeine (CYP1A2), tolbutamide (CYP2C9), dextromethorphan (CYP2D6), and midazolam (hepatic and intestinal CYP3A).
Methods: Twelve healthy subjects (6 men) completed this 2-period, open-label, fixed-schedule study. Caffeine, tolbutamide, dextromethorphan, and oral and intravenous midazolam were administered before and after a short course of echinacea (400 mg 4 times a day for 8 days) to determine in vivo CYP activities.
Results: Echinacea administration significantly increased the systemic clearance of midazolam. by 34%, from 32 +/- 7 L/h to 43 +/- 16 L/h (P = .003; 90% confidence interval [CI], 116%-150%), and significantly reduced the midazolam area under the concentration-time curve by 23%, from 127 +/- 36 mug (.) h/L to 102 +/- 43 mug h/L (P = .024; 90% CI, 63%-88%). In contrast, the oral clearance of midazolam was not significantly altered (P = .655; 90% CI, 75%-124%), 137 +/- 19 L/h compared with 146 +/- 71 L/h. The oral availability of midazolam after echinacea dosing was significantly increased (P = .028; 90% CI, 108%-153%), from 0.23 +/- 0.06 to 0.33 +/- 0.13. Hepatic availability (0.72 +/- 0.08 versus 0.61 +/- 0.16; P = .006; 90% CI, 73%-90%) and intestinal availability (0.33 +/- 0.11 versus 0.61 +/- 0.38; P = .015; 90% CI, 125%-203%) were significantly altered in opposite directions. Echinacea dosing significantly reduced the oral clearance of caffeine, from 6.6 +/- 3.8 L/h to 4.9 +/- 2.3 L/h (P = .049; 90% CI, 58%-96%). The oral clearance of tolbutamide was reduced by 11%, from 0.81 +/- 0.18 L/h to 0.72 +/- 0.19 L/h, but this change was not considered to be clinically relevant because the 90% CIs were within the 80% to 125% range. The oral clearance of dextromethorphan in 11 CYP2D6 extensive metabolizers was not affected by echinacea dosing (1289 +/- 414 L/h compared with 1281 +/- 483 L/h; P = .732; 90% CI, 89%-108%).
Conclusions: Echinacea (Epurpurea root) reduced the oral clearance of substrates of CYP1A2 but not the oral clearance of substrates of CYP2C9 and CYP2D6. Echinacea selectively modulates the catalytic activity of CYP3A at hepatic and intestinal sites. The type of drug interaction observed between echinacea and other CYP3A substrates will be dependent on the relative extraction of drugs at hepatic and intestinal sites. Caution should be used when echinacea is coadministered with drugs dependent on CYP3A or CYP1A2 for their elimination.
C1 Indiana Univ, Sch Med, Dept Med, Indianapolis, IN 46204 USA.
US FDA, Ctr Drug Evaluat & Res, Rockville, MD 20857 USA.
US FDA, Off Commissioner, Rockville, MD 20857 USA.
RP Gorski, JC (reprint author), Indiana Univ, Div Clin Pharmacol, Wishard Mem Hosp, Sch Med, WD Myers Bldg,W7123,1001 W 10th St, Indianapolis, IN 46202 USA.
EM jcgorski@iupui.edu
FU NCRR NIH HHS [M01-RR00750]; NIGMS NIH HHS [T32GM08425]
NR 67
TC 143
Z9 152
U1 2
U2 13
PU MOSBY, INC
PI ST LOUIS
PA 11830 WESTLINE INDUSTRIAL DR, ST LOUIS, MO 63146-3318 USA
SN 0009-9236
J9 CLIN PHARMACOL THER
JI Clin. Pharmacol. Ther.
PD JAN
PY 2004
VL 75
IS 1
BP 89
EP 100
DI 10.1016/j.clpt.2003.09.013
PG 12
WC Pharmacology & Pharmacy
SC Pharmacology & Pharmacy
GA 765YJ
UT WOS:000188318400008
PM 14749695
ER
PT J
AU Sun, DX
Yu, LX
Hussain, MA
Wall, DA
Smith, RL
Amidon, GL
AF Sun, DX
Yu, LX
Hussain, MA
Wall, DA
Smith, RL
Amidon, GL
TI In vitro testing of drug absorption for drug 'developability'
assessment: Forming an interface between in vitro preclinical data and
clinical outcome
SO CURRENT OPINION IN DRUG DISCOVERY & DEVELOPMENT
LA English
DT Review
DE biopharmaceutics classification system; fraction of drug absorbed; in
vitro/in vivo correlation; maximum absorbable dose; permeability;
prodrug
ID BIOPHARMACEUTICS CLASSIFICATION-SYSTEM; CACO-2 CELLS;
INTESTINAL-ABSORPTION; PERMEABILITY; BIOAVAILABILITY; DISSOLUTION;
PREDICTION; HUMANS; MODEL
AB Drug 'developability' assessment has become an increasingly important addition to traditional drug efficacy and toxicity evaluations, as pharmaceutical scientists strive to accelerate drug discovery and development processes in a time- and cost-effective manner. The fraction of drug absorbed and the maximum absorbable dose (MAD) can be estimated from in vivo clinical pharmacokinetics, mass balance studies or in vivo drug permeability in humans by different calculation methods. Unfortunately, in vivo data are usually unavailable at the early stages of drug discovery and development, and in vitro screening for the permeability, solubility, activity and toxicity of a drug has become a routine measurement in drug discovery and development. These in vitro data could be used to predict drug 'developability' with different calculation methods before selecting candidates for clinical evaluation. The fraction of drug absorbed in human could be predicted by in vivo human permeability or in vitro Caco2 permeability. For example, if drug permeability in Caco2 cells reaches 13.3 to 18.1 x 10(-6) cm/s, its predicted in vivo permeability in humans would reach 2 x 10(-4) cm/s, and its predicted fraction of drug absorbed would be > 90%, which is defined as highly permeable. The MAD could also be predicted with in vitro permeability, or calculated absorption rate constant. In addition, in vitro solubility and permeability data can also be used for the biopharmaceutics classification system (BCS) and, subsequently, to direct formulation optimization strategies. If drug 'developability' becomes an obstacle for drug delivery based on these in vitro data and predictions at the early stages of drug discovery and development, options such as prodrug approaches could be explored to enhance drug 'developability', in addition to different formulation methods. Therefore, in vitro absorption testing is a highly valuable tool in the decision-making process to select candidates for in vivo clinical studies at early-stage drug discovery and development.
C1 Ohio State Univ, Coll Pharm, Div Pharmaceut, Columbus, OH 43210 USA.
Off Genet Drug, Ctr Drug Evalut & Res, Food & Drug Adm, Rockville, MD 20857 USA.
Bristol Myers Squibb Co, Pharmaceut Res Inst, Exploratory Biopharmaceut & Stabil, New Brunswick, NJ 08903 USA.
Univ Michigan, Coll Pharm, Dept Pharmaceut Sci, Ann Arbor, MI 48109 USA.
RP Sun, DX (reprint author), Ohio State Univ, Coll Pharm, Div Pharmaceut, Columbus, OH 43210 USA.
EM sun.176@osu.edu
RI Yu, Lawrence/L-6280-2016
NR 18
TC 74
Z9 81
U1 0
U2 18
PU THOMSON SCIENTIFIC
PI LONDON
PA 34-42 CLEVELAND STREET, LONDON, W1T 4JE, ENGLAND
SN 1367-6733
J9 CURR OPIN DRUG DISC
JI Curr. Opin. Drug Discov. Dev.
PD JAN
PY 2004
VL 7
IS 1
BP 75
EP 85
PG 11
WC Pharmacology & Pharmacy
SC Pharmacology & Pharmacy
GA 869MB
UT WOS:000224986400007
PM 14982151
ER
PT J
AU Calderon, SN
Coop, A
AF Calderon, SN
Coop, A
TI SNC 80 and related delta opioid agonists
SO CURRENT PHARMACEUTICAL DESIGN
LA English
DT Review
ID RECEPTOR-MEDIATED PHENOMENA; DISPLAYS SELECTIVE BINDING; MESSAGE-ADDRESS
CONCEPT;
(+)-4-<(ALPHA-R)-ALPHA-((2S,5R)-4-ALLYL-2,5-DIMETHYL-1-PIPERAZINYL)-3-ME
THOXYBE SNC-80; PHARMACOLOGICAL CHARACTERIZATION; ANTAGONISTS; LIGANDS;
PROBES; PEPTIDES; PHARMACOPHORE
AB The discovery of the selective delta (delta) opioid agonists SNC 80 and BW373U86, which possess a diarylmethylpiperazine structure unique among opioids, was a major advance in the field of delta-opioid ligands. Much research has been performed to uncover the structure-activity relationships (SAR) of this class of ligands and also to compare the diarylmethylpiperazines with the traditional morphinan-based delta opioids. This review focuses on the development of the SAR of this unique series of ligands, and discusses questions which remain unanswered.
C1 US FDA, CDER, Rockville, MD 20857 USA.
Univ Maryland, Sch Pharm, Dept Pharmaceut Sci, Baltimore, MD 21201 USA.
RP Calderon, SN (reprint author), US FDA, CDER, 5600 Fishers Lane, Rockville, MD 20857 USA.
EM CALDERONS@cder.fda.gov
FU NIDA NIH HHS [DA 13583]
NR 54
TC 19
Z9 19
U1 1
U2 5
PU BENTHAM SCIENCE PUBL LTD
PI HILVERSUM
PA PO BOX 1673, 1200 BR HILVERSUM, NETHERLANDS
SN 1381-6128
J9 CURR PHARM DESIGN
JI Curr. Pharm. Design
PY 2004
VL 10
IS 7
BP 733
EP 742
DI 10.2174/1381612043453054
PG 10
WC Pharmacology & Pharmacy
SC Pharmacology & Pharmacy
GA 780MA
UT WOS:000189383400004
PM 15032699
ER
PT J
AU Anderson, HA
Shacter, E
AF Anderson, HA
Shacter, E
TI Natural anticoagulant proteins in the regulation of autoimmunity:
Potential role of protein S
SO CURRENT PHARMACEUTICAL DESIGN
LA English
DT Review
DE protein S; apoptosis; phagocytosis; autoimmunity; anticoagulant protein;
coagulation; protein C; activated protein C
ID HUMAN MONONUCLEAR PHAGOCYTES; RECEPTOR TYROSINE KINASE; TOLL-LIKE
RECEPTORS; APOPTOTIC CELLS; SEVERE SEPSIS; MACROPHAGE RECOGNITION;
BLOOD-COAGULATION; VITRONECTIN RECEPTOR; ACTIVATED RECEPTOR-1;
IMMUNE-RESPONSES
AB Autoimmunity results when the immune system fails to distinguish between self and non-self factors in the body. The cellular and biochemical mechanisms that underlie development of autoimmunity are only partly understood. One current theory is that autoimmunity can result when there is a failure to clear dying cells from a tissue before they undergo lysis of the plasma membrane. That is, cells that die by apoptosis are thought to be cleared from a tissue by neighboring phagocytic cells, such as macrophages, before the cells have lost their plasma membrane integrity. This rapid removal of early apoptotic cells is thought to prevent induction of an inflammatory response to intracellular macromolecules, thereby allowing for an immunologically silent removal of the dying cells. Hence, any factor or condition that inhibits phagocytosis of early apoptotic cells may trigger or promote an autoimmune response to intracellular components. Depletion of factors required for the efficient phagocytosis of dying cells would have a similar outcome. The recent discovery that the natural anticoagulant protein S is required for efficient uptake of apoptotic cells (Anderson, H.A., Maylock, C.A., Williams, J.A., Paweletz, C.P., Shu, H., and Shacter, E. (2003) Nature Immunology 4, 87-91) reveals a potential new linkage between autoimmunity and coagulation systems. This article will review the dual roles of protein S as an anticoagulant and in regulating phagocytosis of apoptotic cells, with emphasis on exposing a possible novel role in regulating autoimmunity.
C1 Ctr Drug Evaluat & Res, Food & Drug Adm, Biochem Lab, Div Therapeut Prot, Bethesda, MD 20892 USA.
RP Shacter, E (reprint author), 29 Lincoln Dr,Bldg 29A,Room 2A-11, Bethesda, MD 20892 USA.
EM emily.shacter@fda.gov
NR 98
TC 9
Z9 9
U1 0
U2 0
PU BENTHAM SCIENCE PUBL LTD
PI HILVERSUM
PA PO BOX 1673, 1200 BR HILVERSUM, NETHERLANDS
SN 1381-6128
J9 CURR PHARM DESIGN
JI Curr. Pharm. Design
PY 2004
VL 10
IS 8
BP 929
EP 937
DI 10.2174/1381612043452839
PG 9
WC Pharmacology & Pharmacy
SC Pharmacology & Pharmacy
GA 804BH
UT WOS:000220273700012
PM 15032696
ER
PT S
AU Itzhak, Y
Anderson, KL
Ali, SF
AF Itzhak, Y
Anderson, KL
Ali, SF
BE Ali, SF
Nabeshima, T
Yanagita, T
TI Differential response of nNOS knockout mice to MDMA ("ecstasy")- and
methamphetamine-induced psychomotor sensitization and neurotoxicity
SO CURRENT STATUS OF DRUG DEPENDENCE / ABUSE STUDIES: CELLULAR AND
MOLECULAR MECHANISMS OF DRUGS OF ABUSE AND NEUROTOXICITY
SE ANNALS OF THE NEW YORK ACADEMY OF SCIENCES
LA English
DT Article; Proceedings Paper
CT Conference on Current Status of Depedence and Abuse Studies
CY JUL 30-AUG 01, 2003
CL Kyoto, JAPAN
SP Int Soc Neurochem, Japanese Pharmacol Soc, Japanese Med Soc Alcohol& Drug Studies, Japanese Soc Neurochem, Japanese Soc Neuropsychopharmocol, Minist Educ, Culture, Sports, Sci & Technol, Nagoya Univ Fdn, Uehara Memorial Fdn, Sigma-Tau Hlth Sci, Natl Inst Drug Abuse, Natl Ctr Toxicol Res, US FDA
DE nitric oxide (NO); knockout mice; locomotor activity; neurotoxicity;
dopamine; serotonin
ID NITRIC-OXIDE SYNTHASE; INDUCED DOPAMINERGIC NEUROTOXICITY; BEHAVIORAL
SENSITIZATION; LOCOMOTOR-ACTIVITY; DEFICIENT MICE;
3,4-METHYLENEDIOXYMETHAMPHETAMINE; NEUROTRANSMISSION; 7-NITROINDAZOLE;
STIMULATION; INHIBITION
AB It has been shown that mice deficient in neuronal nitric oxide synthase (nNOS) gene are resistant to cocaine-induced psychomotor sensitization and methamphetamine (METH)-induced dopaminergic neurotoxicity. The present study was undertaken to investigate the hypothesis that nNOS has a major role in dopamine (DA)- but not serotonin (5-hydroxytryptamine; 5-HT)mediated effects of psychostimulants. The response of nNOS knockout (KO) and wild-type (WT) mice to the psychomotor-stimulating and neurotoxic effects of 3,4-methylenedioxymethamphetamine (MDMA; "Ecstasy") and METH were investigated. Repeated administration of MDMA for 5 days resulted in psychomotor sensitization in both WT and nNOS KO mice, while repeated administration of METH caused psychomotor sensitization in WT but not in KO mice. Sensitization to both MDMA and METH was persistent for 40 days in WT mice, but not in nNOS KO mice. These findings suggest that the induction of psychomotor sensitization to MDMA and METH is NO independent and NO dependent, respectively, while the persistence of sensitization to both drugs is NO dependent. For the neurochemical studies, a high dose of MDMA caused marked depletion of 5-HT in several brain regions of both WT and KO mice, suggesting that the absence of the nNOS gene did not afford protection against MDMA-induced depletion of 5-HT. Striatal dopaminergic neurotoxicity caused by high doses of MDMA and METH in WT mice was partially prevented in KO mice administered with MDMA, but it was fully precluded in KO mice administered with METH. The differential response of nNOS KO mice to the behavioral and neurotoxic effects of MDMA and METH suggests that the nNOS gene is required for the expression and persistence of DA-mediated effects of METH and MDMA, while 5-HT-mediated effects of MDMA (induction of sensitization and 5-HT depletion) are not dependent on nNOS.
C1 Univ Miami, Sch Med, Dept Psychiat & Behav Sci, Miami, FL 33136 USA.
US FDA, Natl Ctr Toxicol Res, Neurochem Lab, Div Neurotoxicol, Jefferson, AR 72079 USA.
RP Itzhak, Y (reprint author), Univ Miami, Sch Med, Dept Psychiat & Behav Sci, 1011 NW 15th St,Gautier Bldg 503, Miami, FL 33136 USA.
EM yitzhak@med.miami.edu
FU NIDA NIH HHS [R01 DA12867]
NR 29
TC 18
Z9 18
U1 0
U2 2
PU NEW YORK ACAD SCIENCES
PI NEW YORK
PA 2 EAST 63RD ST, NEW YORK, NY 10021 USA
SN 0077-8923
BN 1-57331-522-2
J9 ANN NY ACAD SCI
JI Ann.NY Acad.Sci.
PY 2004
VL 1025
BP 119
EP 128
DI 10.1196/annals.1316.015
PG 10
WC Biochemistry & Molecular Biology; Cell Biology; Substance Abuse;
Multidisciplinary Sciences; Neurosciences
SC Biochemistry & Molecular Biology; Cell Biology; Substance Abuse; Science
& Technology - Other Topics; Neurosciences & Neurology
GA BBP90
UT WOS:000226975200015
PM 15542708
ER
PT S
AU Virmani, A
Gaetani, F
Binienda, Z
Xu, A
Duhart, H
Ali, SF
AF Virmani, A
Gaetani, F
Binienda, Z
Xu, A
Duhart, H
Ali, SF
BE Ali, SF
Nabeshima, T
Yanagita, T
TI Role of mitochondrial dysfunction in neurotoxicity of MPP+ - Partial
protection of PC12 cells by acetyl-L-carnitine
SO CURRENT STATUS OF DRUG DEPENDENCE / ABUSE STUDIES: CELLULAR AND
MOLECULAR MECHANISMS OF DRUGS OF ABUSE AND NEUROTOXICITY
SE ANNALS OF THE NEW YORK ACADEMY OF SCIENCES
LA English
DT Article; Proceedings Paper
CT Conference on Current Status of Depedence and Abuse Studies
CY JUL 30-AUG 01, 2003
CL Kyoto, JAPAN
SP Int Soc Neurochem, Japanese Pharmacol Soc, Japanese Med Soc Alcohol& Drug Studies, Japanese Soc Neurochem, Japanese Soc Neuropsychopharmocol, Minist Educ, Culture, Sports, Sci & Technol, Nagoya Univ Fdn, Uehara Memorial Fdn, Sigma-Tau Hlth Sci, Natl Inst Drug Abuse, Natl Ctr Toxicol Res, US FDA
DE L-carnitine; acetyl-L-carnitine; mitochondria; methamphetamine; MPTP;
1-methyl-4-phenylpyridinium (MPP+); Parkinson's; apoptosis; oxidative
phosphorylation; respiratory chain mitochondrial permeability pores
ID INDUCED DOPAMINERGIC NEUROTOXICITY; 1-METHYL-4-PHENYLPYRIDINIUM
TOXICITY; PERMEABILITY TRANSITION; NEUROBLASTOMA-CELLS;
PARKINSONS-DISEASE; METHAMPHETAMINE; SYNAPTOSOMES; INHIBITION;
TRANSPORT; GLUTAMATE
AB The damage to the central nervous system that is observed after administration of either methamphetamine (METH) or 1-methyl-4-phenylpyridinium (MPP+), the neurotoxic metabolite of 1-methyl-4-phenyl-1,2,3,6-tetrahydropyridine (MPTP), is known to be linked to dopamine (DA). The underlying neurotoxicity mechanism for both METH and MPPI seem to involve free radical formation and impaired mitochondrial function. The MPP+ is thought to selectively kill nigrostriatal dopaminergic neurons by inhibiting mitochondrial complex 1, with cell death being attributed to oxidative stress damage to these vulnerable DA neurons. In the present study, MPP+ was shown to significantly inhibit the response to MTT by cultured PC12 cells. This inhibitory action of MPPI could be partially reversed by the co-incubation of the cells with the acetylated form of carnitine, acetyl-L-carnitine (ALC). Since at least part of the toxic action of MPP+ is related to mitochondrial inhibition, the partial reversal of the inhibition of MTT response by ALC could involve a partial restoration of mitochondrial function. The role carnitine derivatives, such as ALC, play in attenuating MPPI and METH-evoked toxicity is still under investigation to elucidate the contribution of mitochondrial dysfunction in mechanisms of neurotoxicity.
C1 Sigma Tau HealthSci SpA, Res & Dev, I-00040 Pomezia, Italy.
US FDA, Natl Ctr Toxicol Res, Div Neurotoxicol, Jefferson, AR 72079 USA.
RP Virmani, A (reprint author), Sigma Tau HealthSci SpA, Res & Dev, I-00040 Pomezia, Italy.
EM ashraf.virmani@st-hs.it
NR 24
TC 31
Z9 34
U1 2
U2 3
PU NEW YORK ACAD SCIENCES
PI NEW YORK
PA 2 EAST 63RD ST, NEW YORK, NY 10021 USA
SN 0077-8923
BN 1-57331-522-2
J9 ANN NY ACAD SCI
JI Ann.NY Acad.Sci.
PY 2004
VL 1025
BP 267
EP 273
DI 10.1196/annals.1316.033
PG 7
WC Biochemistry & Molecular Biology; Cell Biology; Substance Abuse;
Multidisciplinary Sciences; Neurosciences
SC Biochemistry & Molecular Biology; Cell Biology; Substance Abuse; Science
& Technology - Other Topics; Neurosciences & Neurology
GA BBP90
UT WOS:000226975200033
PM 15542726
ER
PT S
AU Pereira, FC
Santos, SD
Ribeiro, CF
Ali, SF
Macedo, TR
AF Pereira, FC
Santos, SD
Ribeiro, CF
Ali, SF
Macedo, TR
BE Ali, SF
Nabeshima, T
Yanagita, T
TI A single exposure to morphine induces long-lasting hyporeactivity of rat
caudate putamen dopaminergic nerve terminals
SO CURRENT STATUS OF DRUG DEPENDENCE / ABUSE STUDIES: CELLULAR AND
MOLECULAR MECHANISMS OF DRUGS OF ABUSE AND NEUROTOXICITY
SE ANNALS OF THE NEW YORK ACADEMY OF SCIENCES
LA English
DT Article; Proceedings Paper
CT Conference on Current Status of Depedence and Abuse Studies
CY JUL 30-AUG 01, 2003
CL Kyoto, JAPAN
SP Int Soc Neurochem, Japanese Pharmacol Soc, Japanese Med Soc Alcohol& Drug Studies, Japanese Soc Neurochem, Japanese Soc Neuropsychopharmocol, Minist Educ, Culture, Sports, Sci & Technol, Nagoya Univ Fdn, Uehara Memorial Fdn, Sigma-Tau Hlth Sci, Natl Inst Drug Abuse, Natl Ctr Toxicol Res, US FDA
DE morphine; single-injection; dopamine neurotransmission; caudate putamen;
neuroadaptation
ID DELTA-OPIOID RECEPTORS; SUBSTANTIA-NIGRA; OPIATE AGONISTS; LIMBIC
DOPAMINE; RHESUS-MONKEYS; IN-VIVO; TOLERANCE; MICE; METABOLISM; RELEASE
AB The long-lasting effects of exposure to drugs of abuse on the brain is a central theme in drug addiction research. This study was designed to evaluate whether enduring neurochemical adaptations within caudate putamen can be evoked by a single injection of a high dose of morphine. Rats were pretreated once with 10 mg/kg morphine. Seven days later the effect of another injection of 10 mg/kg morphine on total levels of dopamine (DA), 3,4-dihydroxyphenylacetic acid (DOPAC), and homovanilic acid (HVA) in caudate putamen was assessed in half the pretreated animals. An irreversible mu-opioid receptor antagonist, cloccinamox (C-CAM; 0.1 mg/kg), significantly antagonized the elevation of the HVA/DA ratio, but not the elevation of the DOPAC/DA ratio induced by morphine in the caudate putamen from drug-naive animals. Pretreatment with morphine blunted changes in the HVA/DA ratio induced by another morphine challenge, but it had no effect on the DOPAC/DA ratio within the caudate putamen. Therefore, a single dose of 10 mg/kg morphine hampered nigrostriatal DA release and extraneuronal metabolism, mu-opioid receptor mediated, on another 10 mg/kg morphine challenge. This confirms that the first exposure to morphine does not go without long-lasting neurochemical adaptations.
C1 Univ Coimbra, Sch Med, Inst Farmacol & Terapeut, P-3004504 Coimbra, Portugal.
US FDA, Natl Ctr Toxicol Res, Div Neurotoxicol, Neurochem Lab, Jefferson, AR 72079 USA.
RP Pereira, FC (reprint author), Univ Coimbra, Sch Med, Inst Farmacol & Terapeut, P-3004504 Coimbra, Portugal.
EM fredcp@ci.uc.pt
OI Pereira, Frederico/0000-0002-9381-3320; Fontes Ribeiro,
Carlos/0000-0002-9707-4895; santos, sandra/0000-0002-1871-3696
NR 37
TC 8
Z9 9
U1 0
U2 1
PU NEW YORK ACAD SCIENCES
PI NEW YORK
PA 2 EAST 63RD ST, NEW YORK, NY 10021 USA
SN 0077-8923
BN 1-57331-522-2
J9 ANN NY ACAD SCI
JI Ann.NY Acad.Sci.
PY 2004
VL 1025
BP 414
EP 423
DI 10.1196/annals.1316.051
PG 10
WC Biochemistry & Molecular Biology; Cell Biology; Substance Abuse;
Multidisciplinary Sciences; Neurosciences
SC Biochemistry & Molecular Biology; Cell Biology; Substance Abuse; Science
& Technology - Other Topics; Neurosciences & Neurology
GA BBP90
UT WOS:000226975200051
PM 15542744
ER
PT S
AU Dass, SB
Ali, SF
AF Dass, SB
Ali, SF
BE Ali, SF
Nabeshima, T
Yanagita, T
TI Evaluation of gamma-hydroxybutyric acid for genotoxicity in the mouse
micronucleus assay
SO CURRENT STATUS OF DRUG DEPENDENCE / ABUSE STUDIES: CELLULAR AND
MOLECULAR MECHANISMS OF DRUGS OF ABUSE AND NEUROTOXICITY
SE ANNALS OF THE NEW YORK ACADEMY OF SCIENCES
LA English
DT Article; Proceedings Paper
CT Conference on Current Status of Depedence and Abuse Studies
CY JUL 30-AUG 01, 2003
CL Kyoto, JAPAN
SP Int Soc Neurochem, Japanese Pharmacol Soc, Japanese Med Soc Alcohol& Drug Studies, Japanese Soc Neurochem, Japanese Soc Neuropsychopharmocol, Minist Educ, Culture, Sports, Sci & Technol, Nagoya Univ Fdn, Uehara Memorial Fdn, Sigma-Tau Hlth Sci, Natl Inst Drug Abuse, Natl Ctr Toxicol Res, US FDA
DE gamma-hydroxybutyric acid (GHB); drugs of abuse; micronucleus test;
genotoxicity; micronucleated polychromatic erythrocytes;
gamma-butyrolactone
ID PERIPHERAL-BLOOD; SODIUM-BUTYRATE; ABERRATIONS; BRAIN; DRUGS; MICE
AB gamma-Hydroxybutyric acid (GHB) is an endogenous compound found in the brain and other tissues of mammals. Neurotransmitter/neuromodulator functions have been ascribed to GHB, which has lately become a drug of abuse. In this study, we tested GHB for genotoxicity by measuring its ability to induce micronuclei in polychromatic erythrocytes (reticulocytes) in the peripheral blood of mice. Intraperitoneal injection with a dose of 25 mg/kg/day for 3 days or 50 mg/kg/day x 3 days resulted in a significant (by Donnell's test) increase of 1.9- to 2.1-fold in micronuclei. However, because increases were small and because no consistent dose-dependent increase in induced micronuclear frequency could be demonstrated, our results do not conclusively show that GHB is an in vivo genotoxicant in mammals.
C1 Natl Ctr Toxicol Res, Neurochem Lab, Div Neurotoxicol, Jefferson, AR 72079 USA.
RP Dass, SB (reprint author), Merck Res Labs, Mail Code RY34B-364,126 E Lincoln Ave, Rahway, NJ 07065 USA.
NR 18
TC 1
Z9 1
U1 0
U2 1
PU NEW YORK ACAD SCIENCES
PI NEW YORK
PA 2 EAST 63RD ST, NEW YORK, NY 10021 USA
SN 0077-8923
BN 1-57331-522-2
J9 ANN NY ACAD SCI
JI Ann.NY Acad.Sci.
PY 2004
VL 1025
BP 538
EP 542
DI 10.1196/annals.1316.066
PG 5
WC Biochemistry & Molecular Biology; Cell Biology; Substance Abuse;
Multidisciplinary Sciences; Neurosciences
SC Biochemistry & Molecular Biology; Cell Biology; Substance Abuse; Science
& Technology - Other Topics; Neurosciences & Neurology
GA BBP90
UT WOS:000226975200066
PM 15542759
ER
PT S
AU Riegel, AC
Ali, SF
Torinese, S
French, ED
AF Riegel, AC
Ali, SF
Torinese, S
French, ED
BE Ali, SF
Nabeshima, T
Yanagita, T
TI Repeated exposure to the abused inhalant toluene alters levels of
neurotransmitters and generates peroxynitrite in nigrostriatal and
mesolimbic nuclei in rat
SO CURRENT STATUS OF DRUG DEPENDENCE / ABUSE STUDIES: CELLULAR AND
MOLECULAR MECHANISMS OF DRUGS OF ABUSE AND NEUROTOXICITY
SE ANNALS OF THE NEW YORK ACADEMY OF SCIENCES
LA English
DT Article; Proceedings Paper
CT Conference on Current Status of Depedence and Abuse Studies
CY JUL 30-AUG 01, 2003
CL Kyoto, JAPAN
SP Int Soc Neurochem, Japanese Pharmacol Soc, Japanese Med Soc Alcohol& Drug Studies, Japanese Soc Neurochem, Japanese Soc Neuropsychopharmocol, Minist Educ, Culture, Sports, Sci & Technol, Nagoya Univ Fdn, Uehara Memorial Fdn, Sigma-Tau Hlth Sci, Natl Inst Drug Abuse, Natl Ctr Toxicol Res, US FDA
DE inhalant; toluene; neurotransmitter; dopamine; serotonin; oxidative
stress; peroxynitrite; 3-nitrosotyrosine; nigrostriatal and mesolimbic
nuclei; neurotoxicity
ID MEDIATED LOCOMOTOR-ACTIVITY; SUBACUTE EXPOSURE; NEURONAL-ACTIVITY;
DOPAMINE; BINDING; BRAIN
AB Toluene, a volatile hydrocarbon found in a variety of chemical compounds, is misused and abused by inhalation for its euphorigenic effects. Toluene's reinforcing properties may share a common characteristic with other drugs of abuse, namely, activation of the mesolimbic dopamine system. Prior studies in our laboratory found that acutely inhaled toluene activated midbrain dopamine neurons in the rat. Moreover, single systemic injections of toluene in rats produced a dose-dependent increase in locomotor activity which was blocked by depletion of nucleus accumbens dopamine or by pretreatment with a D2 dopamine receptor antagonist. Here we examined the effects of seven daily intraperitoneal injections of 600 mg/kg toluene on the content of serotonin and dopamine in the caudate nucleus (CN) and nucleus accumbens (NAC), substantia nigra, and ventral tegmental area at 2, 4, and 24 h after the last injection. Also, the roles of nitric oxide, peroxynitrite, and the production of 3-nitrosotyrosine (3-NT), in the CN and NAC were assessed at the same time points. Toluene treatments increased dopamine levels in the CN and NAC, and serotonin levels in CN, NAC, and ventral tegmental area. Measurements of the dopamine metabolite dihydroxyphenylacetic acid (DOPAC) further suggested a change in transmitter utilization in CN and NAC. Lastly, 3-NT levels also showed a differential change between CN and NAC, but at different time points post-toluene injection. These results point out the complexity of action of toluene on neurotransmitter function following a course of chronic exposure. Changes in the production of 3-NT also suggest that toluene-induced neurotoxicity may mediate via generation of peroxynitrite.
C1 Univ Arizona, Coll Med, Dept Pharmacol, Tucson, AZ 85724 USA.
US FDA, Natl Ctr Toxicol Res, Div Neurotoxicol, Neurochem Lab, Jefferson, AR 72079 USA.
RP French, ED (reprint author), Univ Arizona, Coll Med, Dept Pharmacol, Tucson, AZ 85724 USA.
EM efrench@email.arizona.edu
NR 17
TC 17
Z9 17
U1 1
U2 3
PU NEW YORK ACAD SCIENCES
PI NEW YORK
PA 2 EAST 63RD ST, NEW YORK, NY 10021 USA
SN 0077-8923
BN 1-57331-522-2
J9 ANN NY ACAD SCI
JI Ann.NY Acad.Sci.
PY 2004
VL 1025
BP 543
EP 551
DI 10.1196/annals.1316.079
PG 9
WC Biochemistry & Molecular Biology; Cell Biology; Substance Abuse;
Multidisciplinary Sciences; Neurosciences
SC Biochemistry & Molecular Biology; Cell Biology; Substance Abuse; Science
& Technology - Other Topics; Neurosciences & Neurology
GA BBP90
UT WOS:000226975200067
PM 15542760
ER
PT J
AU Schwartz, A
Gaigalas, AK
Wang, LL
Marti, GE
Vogt, RF
Fernandez-Repollet, E
AF Schwartz, A
Gaigalas, AK
Wang, LL
Marti, GE
Vogt, RF
Fernandez-Repollet, E
TI Formalization of the MESF unit of fluorescence intensity
SO CYTOMETRY PART B-CLINICAL CYTOMETRY
LA English
DT Article
DE MESF; Molecules of Equivalent Soluble Fluorochrome; quantitation;
fluorescence intensity
AB This report summarizes the work performed during the past two years at the National Institute of Standards and Technology (NIST) in the refinement and formal definition of the MESF unit of fluorescence intensity. In addition to the theory underlying the MESF unit, considerations of error analysis are also presented. The details of this work may be found in the three publications of the NIST Journal of Research (www.nist.gov) listed as the references 2-4. The use of the fluorescence intensity unit provides a tool to compare quantitative fluorescence intensity measurements over time and across platforms. (C) 2003 Wiley-Liss, Inc.
C1 Univ Puerto Rico, Sch Med, Dept Pharmacol, San Juan, PR 00936 USA.
Ctr Dis Control, Div Sci Lab, Atlanta, GA 30333 USA.
US FDA, Ctr Biol Evaluat & Res, Bethesda, MD USA.
NIST, Div Biotechnol, Gaithersburg, MD 20899 USA.
Ctr Quantitat Cytometry, San Juan, PR USA.
RP Schwartz, A (reprint author), POB 194344, San Juan, PR 00919 USA.
EM abe@quantcyte.org
NR 4
TC 61
Z9 62
U1 0
U2 5
PU WILEY-LISS
PI NEW YORK
PA DIV JOHN WILEY & SONS INC, 605 THIRD AVE, NEW YORK, NY 10158-0012 USA
SN 0196-4763
J9 CYTOM PART B-CLIN CY
JI Cytom. Part B-Clin. Cytom.
PD JAN
PY 2004
VL 57B
IS 1
BP 1
EP 6
DI 10.1002/cyto.b.10066
PG 6
WC Medical Laboratory Technology; Pathology
SC Medical Laboratory Technology; Pathology
GA 760XQ
UT WOS:000187860900001
PM 14696057
ER
PT J
AU Lunning, MA
Zenger, VE
Dreyfuss, R
Stetler-Stevenson, M
Rick, ME
White, TA
Wilson, WH
Marti, GE
AF Lunning, MA
Zenger, VE
Dreyfuss, R
Stetler-Stevenson, M
Rick, ME
White, TA
Wilson, WH
Marti, GE
TI Albumin enhanced morphometric image analysis in CLL
SO CYTOMETRY PART B-CLINICAL CYTOMETRY
LA English
DT Article
DE chronic lymphocytic leukemia; morphology; atypical morphology; atypical
chronic lymphocytic leukemia; morphometric analysis
ID CHRONIC LYMPHOCYTIC-LEUKEMIA; IN-SITU HYBRIDIZATION; B-CELL DISORDERS;
PROLYMPHOCYTIC LEUKEMIA; PROGNOSTIC-SIGNIFICANCE; SCORING SYSTEM;
NUCLEAR CLEFTS; LABORATORY FEATURES; LYMPHOID LEUKEMIAS; MORPHOLOGY
AB Background: The heterogeneity of lymphocytes from patients with chronic lymphocytic leukemia (CLL) and blood film artifacts make morphologic subclassification of this disease difficult.
Methods: We reviewed paired blood films prepared from ethylene-diamine-tetraacetic acid (ETDA) samples with and without bovine serum albumin (BSA) from 82 CLL patients. Group 1 adhered to NCCLS specifications for the preparations of EDTA blood films. Group 2 consisted of blood films containing EDTA and a 1:12 dilution of 22% BSA. Eight patients were selected for digital photomicroscopy and statistical analysis. Approximately 100 lymphocytes from each slide were digitally captured.
Results: The mean cell area +/- standard error was 127.8 muM(2) +/- 1.42 for (n = 793) for group 1 versus 100.7 muM(2) +/- 1.39 (n = 831) for group 2. The nuclear area was 88.9 muM(2) +/- 0.85 for group 1 versus 76.4 muM(2) 0.83 for group 2. For the nuclear transmittance, the values were 97.6 +/- 0.85 for group 1 and 104.1 +/- 0.83 for group 2. The nuclear:cytoplasmic ratios were 0.71 +/- 0.003 for group 1 and 0.78 +/- 0.003 for group 2. All differences were statistically significant (P < 0.001).
Conclusions: BSA addition results in the reduction of atypical lymphocytes and a decrease in smudge cells. BSA also decreases the lymphocyte area and nuclear area, whereas nuclear transmittance and nuclear:cytoplasmic ratio are increased. A standardized method of slide preparation would allow accurate interlaboratory comparison. The use of BSA may permit better implementation of the blood film-based subclassification of CLL and lead to a better correlation of morphology with cytogenetics and immunophenotyping. Published 2003 Wiley-Liss, Inc(dagger).
C1 US FDA, Flow & Image Cytometry Sect, Lab Stem Biol, DCGT,CBER, Bethesda, MD 20892 USA.
NCI, Expt Transplantat & Immunol Branch, NIH, Bethesda, MD 20892 USA.
NCI, Med Oncol Clin Res Unit, NIH, Bethesda, MD 20892 USA.
NIH, Hematol Serv, Ctr Clin, Bethesda, MD 20892 USA.
NIH, Clin Flow Cytometry Sect, Pathol Lab, Div Clin Sci, Bethesda, MD 20892 USA.
NIH, Med Arts Photog Branch, Bethesda, MD 20892 USA.
RP Marti, GE (reprint author), US FDA, Flow & Image Cytometry Sect, Lab Stem Biol, DCGT,CBER, NIH Bldg 29B,Room 2NN08,8800 Rockville Pike, Bethesda, MD 20892 USA.
EM gemarti@helix.nih.gov
NR 40
TC 6
Z9 6
U1 0
U2 0
PU WILEY-LISS
PI NEW YORK
PA DIV JOHN WILEY & SONS INC, 605 THIRD AVE, NEW YORK, NY 10158-0012 USA
SN 0196-4763
J9 CYTOM PART B-CLIN CY
JI Cytom. Part B-Clin. Cytom.
PD JAN
PY 2004
VL 57B
IS 1
BP 7
EP 14
DI 10.1002/cyto.b.10059
PG 8
WC Medical Laboratory Technology; Pathology
SC Medical Laboratory Technology; Pathology
GA 760XQ
UT WOS:000187860900002
PM 14696058
ER
PT J
AU Jackson, G
AF Jackson, G
TI Austria dances - Past and present
SO DANCE CHRONICLE
LA English
DT Book Review
C1 US FDA, Rockville, MD 20857 USA.
Univ Chicago, Chicago, IL 60637 USA.
Rockefeller Univ, New York, NY USA.
RP Jackson, G (reprint author), US FDA, Rockville, MD 20857 USA.
NR 1
TC 0
Z9 0
U1 0
U2 0
PU MARCEL DEKKER INC
PI NEW YORK
PA 270 MADISON AVE, NEW YORK, NY 10016 USA
SN 0147-2526
J9 DANCE CHRONICLE
JI Dance Chron.
PY 2004
VL 27
IS 1
BP 143
EP 145
DI 10.1081/DNC-120029930
PG 3
WC Dance
SC Dance
GA 823HO
UT WOS:000221601400006
ER
PT J
AU Alosh, M
Wilkin, J
AF Alosh, M
Wilkin, J
TI Assessing the relationship between investigator global evaluation and
acne lesion counts
SO DRUG INFORMATION JOURNAL
LA English
DT Article
DE acne trials; lesion counts; logistic regression
ID LOGISTIC-REGRESSION
AB Efficacy evaluation for acne clinical trials is usually based on analysis of: (1) change (or relative change) in lesion counts from baseline and (2) the investigator global evaluation (IGE) at the final study endpoint, usually dichotomized to treatment success or failure. As lesion counts provide a quantitative assessment of the subject's acne condition and the IGE reflects the dermatologist's visual evaluation of the same condition, one would expect the two evaluations to be related. In this article we investigate the relationship between the two assessments by fitting logistic regression models to three data sets with different features. The results of the analysis show that final lesion counts explain very well the variability in the IGE treatment success. However, changes in lesion counts per se do not fully explain the variability in IGE treatment success, as baseline lesion counts are still a significant covariate in the model. Finally, inflammatory lesions consistently have a much greater impact than nonin-inflammatory lesions on explaining the variability in the IGE treatment success. The findings of this study emphasize the importance of having an initial estimate of treatment effect before embarking on phase 3 trials. Such an estimate would be very useful in guiding the decision on whether to seek a lesion-specific or general acne indication, which, in turn, impacts the sample size required for establishing efficacy.
C1 US FDA, CDER, OB, Div Biometr 3, Rockville, MD 20850 USA.
US FDA, CDER, Off Durg Evaluat 5, Div Dermatol & Dent Drug Prod, Rockville, MD 20850 USA.
RP Alosh, M (reprint author), US FDA, CDER, OB, Div Biometr 3, HFD-725,S-128,9201 Corp Blvd, Rockville, MD 20850 USA.
EM aloshm@cder.fda.gov
NR 6
TC 2
Z9 2
U1 0
U2 0
PU DRUG INFORMATION ASSOCIATION
PI FORT WASHINGTON
PA 501 OFFICE CENTER DR, STE 450, FORT WASHINGTON, PA 19034-3212 USA
SN 0092-8615
J9 DRUG INF J
JI Drug Inf. J.
PY 2004
VL 38
IS 4
BP 343
EP 351
PG 9
WC Health Care Sciences & Services; Pharmacology & Pharmacy
SC Health Care Sciences & Services; Pharmacology & Pharmacy
GA 869OL
UT WOS:000224993800005
ER
PT J
AU Cui, YY
Ang, CYW
Beger, RD
Heinze, TM
Hu, LH
Leakey, J
AF Cui, YY
Ang, CYW
Beger, RD
Heinze, TM
Hu, LH
Leakey, J
TI In vitro metabolism of hyperforin in rat liver microsomal systems
SO DRUG METABOLISM AND DISPOSITION
LA English
DT Article
ID ST-JOHNS-WORT; PERFORMANCE LIQUID-CHROMATOGRAPHY; PREGNANE X-RECEPTOR;
HYPERICUM-PERFORATUM; PHENOBARBITAL-INDUCTION; DIETARY-SUPPLEMENTS;
GENE; ANTIDEPRESSANT; STABILITY; MACROMOLECULES
AB Hyperforin is an important active component of St. John's wort (Hypericum perforatum) that has been suggested to be responsible for the St. John's wort antidepressive effects and herbal-drug interactions. In this study, the in vitro metabolism profile of hyperforin was investigated using liver microsomes from male and female Sprague-Dawley rats, with or without induction by phenobarbital or dexamethasone. Four major Phase I metabolites, named 19-hydroxyhyperforin, 24-hydroxyhyperforin, 29-hydroxyhyperforin, and 34-hydroxyhyperforin, were isolated by high performance liquid chromatography and identified by mass spectrometry and NMR. Results suggest that hydroxylation is a major biotransformation of the hyperforin pathway in rat liver and that inducible cytochrome P450 3A (CYP450 3A) and/or CYP2B may be the major cytochrome P450 isoforms catalyzing these hydroxylation reactions.
C1 US FDA, Natl Ctr Toxicol Res, Div Chem, Jefferson, AR 72079 USA.
RP Ang, CYW (reprint author), US FDA, Natl Ctr Toxicol Res, Div Chem, HFT-230,3900 NCTR Rd, Jefferson, AR 72079 USA.
NR 43
TC 22
Z9 24
U1 0
U2 5
PU AMER SOC PHARMACOLOGY EXPERIMENTAL THERAPEUTICS
PI BETHESDA
PA 9650 ROCKVILLE PIKE, BETHESDA, MD 20814-3998 USA
SN 0090-9556
J9 DRUG METAB DISPOS
JI Drug Metab. Dispos.
PD JAN 1
PY 2004
VL 32
IS 1
BP 28
EP 34
DI 10.1124/dmd.32.1.28
PG 7
WC Pharmacology & Pharmacy
SC Pharmacology & Pharmacy
GA 760RJ
UT WOS:000187847900005
PM 14709617
ER
PT J
AU Wiener, D
Doerge, DR
Fang, JL
Upadhyaya, P
Lazarus, P
AF Wiener, D
Doerge, DR
Fang, JL
Upadhyaya, P
Lazarus, P
TI Characterization of N-glucuronidation of the lung carcinogen
4-(methylnitrosamino)-1-(3-pyridyl)-1-butanol (nnal) in human liver:
Importance of UDP-glucuronosyltransferase 1A4
SO DRUG METABOLISM AND DISPOSITION
LA English
DT Article; Proceedings Paper
CT 94th Annual Meeting of the American-Association-for-Cancer-Research
CY JUL 11-14, 2003
CL WASHINGTON, D.C.
SP Amer Assoc Canc Res
ID TOBACCO-SPECIFIC NITROSAMINES; STABLE EXPRESSION; SMOKERS URINE; F344
RATS; METABOLITES; MICROSOMES; INDUCTION; BENZOPYRENE; QUANTITATION;
XENOBIOTICS
AB The nicotine-derived tobacco-specific nitrosamine, 4-(methylnitrosamino)-1-(3- pyridyl)-1-butanone (NNK), is one of the most potent and abundant procarcinogens found in tobacco and tobacco smoke and is considered to be a causative agent for several tobacco-related cancers. Glucuronidation of the major metabolite of NNK, 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanol (NNAL), has been implicated as an important mechanism for NNK detoxification. To characterize NNAL metabolism by N-glucuronidation in humans, high-pressure liquid chromatography was used to detect glucuronide conjugates of NNAL formed in human liver microsomes in vitro. In addition to peaks corresponding to the O-glucuronides of NNAL (NNAL-O-Gluc), a second series of peaks were observed in human liver microsomes that were identified by liquid chromatography-mass spectrometry to be NNAL N-glucuronides (NNAL-N-Gluc). Microsomes prepared from liver specimens from individual subjects (n = 42) exhibited substantial variability in the levels of NNAL-N-Gluc (49-fold variability) and NNAL-O-Gluc (49-fold variability) formed in vitro. This variability was likely not due to differences in tissue quality, as substantial variability (5-fold) was also observed in the ratio of NNAL-N-Gluc/NNAL-O-Gluc formation, with a mean ratio of 1.7 in the 42 specimens. Liver microsomes from smokers (n = 14) exhibited no significant difference in the levels of either NNAL-N-Gluc or NNAL-O-Gluc formation, or in the ratio of NNAL-N-Gluc/NNAL-O-Gluc formation, as compared with liver microsomes from never smokers (n = 28). Overexpressed UDP-glucuronosyltransferase (UGT) 1A4 exhibited significant levels of N-glucuronidating activity (V-max/K-m = 3.11 mul . min(-1) . g(-1)) in vitro; no NNAL-N-glucuronide formation was detected for the 11 other overexpressed UGT enzymes tested in these studies. These results demonstrate the importance of N-glucuronidation in the metabolism of NNAL and the role of UGT1A4 in this pathway.
C1 Univ S Florida, Canc Epidemiol & Prevent Program, H Lee Moffitt Canc Ctr, Dept Interdisciplinary Oncol, Tampa, FL USA.
Natl Ctr Toxicol Res, Div Biochem Toxicol, Jefferson, AR 72079 USA.
Univ Minnesota, Ctr Canc, Minneapolis, MN USA.
RP Lazarus, P (reprint author), Penn State Coll, Dept Pharmacol, H078,500 Univ Dr, Hershey, PA 17033 USA.
RI Wiener, Doris/A-8825-2013
FU NCI NIH HHS [CA68384]; NIDCR NIH HHS [DE13158]
NR 38
TC 67
Z9 69
U1 0
U2 1
PU AMER SOC PHARMACOLOGY EXPERIMENTAL THERAPEUTICS
PI BETHESDA
PA 9650 ROCKVILLE PIKE, BETHESDA, MD 20814-3998 USA
SN 0090-9556
J9 DRUG METAB DISPOS
JI Drug Metab. Dispos.
PD JAN 1
PY 2004
VL 32
IS 1
BP 72
EP 79
DI 10.1124/dmd.32.1.72
PG 8
WC Pharmacology & Pharmacy
SC Pharmacology & Pharmacy
GA 760RJ
UT WOS:000187847900011
PM 14709623
ER
PT J
AU Fu, PP
Xia, QS
Lin, G
Chou, MW
AF Fu, PP
Xia, QS
Lin, G
Chou, MW
TI Pyrrolizidine alkaloids - Genotoxicity, metabolism enzymes, metabolic
activation, and mechanisms
SO DRUG METABOLISM REVIEWS
LA English
DT Review
DE genotoxicity; pyrrolizidine alkaloids; metabolism; enzymes; DNA adduct;
mechanism; metabolic activation
ID VENO-OCCLUSIVE DISEASE; PERFORMANCE LIQUID-CHROMATOGRAPHY; DNA ADDUCT
FORMATION; PERFUSED-RAT-LIVER; FLAVIN-CONTAINING MONOOXYGENASE; ALCOHOL
GLUTATHIONE CONJUGATE; HEPATIC-MICROSOMAL METABOLISM; RAGWORT
SENECIO-JACOBAEA; AGE-DEPENDENT EXPRESSION; SOLID-PHASE EXTRACTION
AB Pyrrolizidine alkaloid-containing plants are widely distributed in the world and are probably the most common poisonous plants affecting livestock, wildlife, and humans. Because of their abundance and potent toxicities, the mechanisms by which pyrrolizidine alkaloids induce genotoxicities, particularly carcinogenicity, were extensively studied for several decades but not exclusively elucidated until recently. To date, the pyrrolizidine alkaloid-induced genotoxicities were revealed to be elicited by the hepatic metabolism of these naturally occurring toxins. In this review, we present updated information on the metabolism, metabolizing enzymes, and the mechanisms by which pyrrolizidine alkaloids exert genotoxicity and tumorigenicity.
C1 Natl Ctr Toxicol Res, Jefferson, AR 72079 USA.
Chinese Univ Hong Kong, Dept Pharmacol, Shatin, Hong Kong, Peoples R China.
RP Fu, PP (reprint author), 3900 NCTR Rd,HFT-110, Jefferson, AR 72079 USA.
EM pfu@nctr.fda.gov
NR 290
TC 223
Z9 230
U1 10
U2 58
PU MARCEL DEKKER INC
PI NEW YORK
PA 270 MADISON AVE, NEW YORK, NY 10016 USA
SN 0360-2532
J9 DRUG METAB REV
JI Drug Metab. Rev.
PY 2004
VL 36
IS 1
BP 1
EP 55
DI 10.1081/DMR-120028426
PG 55
WC Pharmacology & Pharmacy
SC Pharmacology & Pharmacy
GA 807RQ
UT WOS:000220519000001
PM 15072438
ER
PT J
AU Kennedy, DL
Uhl, K
Kweder, SL
AF Kennedy, DL
Uhl, K
Kweder, SL
TI Pregnancy exposure registries
SO DRUG SAFETY
LA English
DT Article
ID SURVEILLANCE; DRUGS
AB dScientifically valid data on the safety of drug use during pregnancy are a significant public: health need. Data are rarely available on the fetal effects of in utero exposure in human pregnancies, particularly when a drug is first marketed. Data from animal reproductive toxicology studies, which function as a screen for potential human teratogenicity, are usually all that is available in a product's labelling. For practising clinicians, translating known animal risks into an accurate assessment of teratogenic risks in their patients is very difficult, if not impossible. Without human data on the effects of in utero drug exposure, it is difficult for physicians and other healthcare providers (e.g. genetic counsellors) to adequately counsel patients about fetal risks. Therefore, a pregnant woman may decide to unnecessarily terminate a wanted pregnancy or forego needed drug therapy. In spite of the lack of data on the safety of drug use during human pregnancies, pregnant women are exposed to drugs either as prescribed therapy or inadvertently before pregnancy is known (over one-half of pregnancies are unplanned). Because little is known about the teratogenic potential of a drug in humans before marketing, post-marketing surveillance of drug use in pregnancy is critical to the detection of drug-induced fetal effects. The existing passive mechanism of spontaneous reporting of adverse drug effects is inadequate to routinely detect drug-induced fetal risks or lack of such risks. Therefore, post-marketing pregnancy exposure registries are being increasingly used to proactively monitor for major fetal effects and to describe margins of safety associated with drug exposure during pregnancy. However, differing methodological rigour has been applied to the development of pregnancy exposure registries. It is important that all pregnancy registries develop epidemiologically sound written study protocols a priori. It is only through the use of rigourous methodology and procedures that data from pregnancy exposure registries will withstand scientific scrutiny. Successful recruitment of an adequate number of exposed pregnancies, aggressive follow-up, and complete and accurate ascertainment of pregnancy outcome are critical attributes of a well-designed registry.
C1 US FDA, Ctr Drug Evaluat & Res, Pregnancy Labeling Team, Pregnancy Labeling Task Force, Rockville, MD 20874 USA.
RP Kennedy, DL (reprint author), US FDA, Ctr Drug Evaluat & Res, Pregnancy Labeling Team, Pregnancy Labeling Task Force, HFD-020,5600 Fishers Lane, Rockville, MD 20874 USA.
EM kennedyd@cder.fda.gov
NR 44
TC 30
Z9 31
U1 0
U2 3
PU ADIS INTERNATIONAL LTD
PI AUCKLAND
PA 41 CENTORIAN DR, PRIVATE BAG 65901, MAIRANGI BAY, AUCKLAND 10, NEW
ZEALAND
SN 0114-5916
J9 DRUG SAFETY
JI Drug Saf.
PY 2004
VL 27
IS 4
BP 215
EP 228
DI 10.2165/00002018-200427040-00001
PG 14
WC Public, Environmental & Occupational Health; Pharmacology & Pharmacy;
Toxicology
SC Public, Environmental & Occupational Health; Pharmacology & Pharmacy;
Toxicology
GA 805EU
UT WOS:000220350400001
PM 15003034
ER
PT J
AU Brinker, A
Goldkind, L
Bonnel, R
Beitz, J
AF Brinker, A
Goldkind, L
Bonnel, R
Beitz, J
TI Spontaneous reports of hypertension leading to hospitalisation in
association with rofecoxib, celecoxib, nabumetone and oxaprozin
SO DRUGS & AGING
LA English
DT Article
ID NONSTEROIDAL ANTIINFLAMMATORY DRUGS; BLOOD-PRESSURE;
RHEUMATOID-ARTHRITIS; METAANALYSIS; INHIBITORS; CYCLOOXYGENASE-2;
OSTEOARTHRITIS; DICLOFENAC
AB Background and objective: Data on file with the US FDA, and other published studies, suggest that the selective cyclo-oxygenase (COX)-2 inhibitor NSAID rofecoxib has a greater hypertensive adverse effect than other NSAIDs, including celecoxib. In this study we describe a pharmacoepidemiologic analysis of spontaneous adverse event reports of acute, clinically serious hypertension (as defined by hospitalisation) reported in association with rofecoxib, celecoxib, nabumetone and oxaprozin. The objective of this analysis is to assess whether postmarketing data are consistent with results of clinical trials. We also collapse cases into series for the identification of possible risk factors for clinically severe, NSAID-associated hypertension.
Methods: Domestic (US) cases of apparently unconfounded, acute hypertension leading to hospitalisation were collected and reviewed from the spontaneous adverse events database of the FDA for rofecoxib, celecoxib, nabumetone and oxaprozin for the initial 3 years of marketing. Drug use data for the same intervals enabled calculation of reporting rates.
Results: In an analysis of reporting rates, hospitalisation for acute blood pressure (BP) elevation was reported more frequently (3.8-fold) for rofecoxib compared with celecoxib. A total of 34 cases are collapsed into case series. No cases were identified for either nabumetone or oxaprozin. Inspection of reviewed cases for celecoxib and rofecoxib suggest that these patients (average age 72 years) were potentially high-risk candidates for NSAID therapy.
Discussion and conclusion: During early marketing, hospitalisation for acute BP elevation appears to have been reported more frequently for rofecoxib compared with celecoxib. This is consistent with clinical trial data on file with the FDA, and other published studies that found rofecoxib to have a greater effect on BP than other NSAIDs, including celecoxib. This finding may be particularly relevant in older patients given the prevalence of hypertension and cardiovascular disease in this age group.
C1 US FDA, Ctr Drug Evaluat & Res, Div Risk Evaluat, Off Drug Safety, Rockville, MD 20857 USA.
US FDA, Ctr Drug Evaluat & Res, Div Anti Inflammatory, Off Drug Evaluat 5, Rockville, MD 20857 USA.
RP Brinker, A (reprint author), US FDA, Ctr Drug Evaluat & Res, Div Risk Evaluat, Off Drug Safety, 5600 Fishers Lane, Rockville, MD 20857 USA.
EM brinkera@cder.fda.gov
NR 23
TC 17
Z9 19
U1 0
U2 1
PU ADIS INTERNATIONAL LTD
PI AUCKLAND
PA 41 CENTORIAN DR, PRIVATE BAG 65901, MAIRANGI BAY, AUCKLAND 10, NEW
ZEALAND
SN 1170-229X
J9 DRUG AGING
JI Drugs Aging
PY 2004
VL 21
IS 7
BP 479
EP 484
DI 10.2165/00002512-200421070-00005
PG 6
WC Geriatrics & Gerontology; Pharmacology & Pharmacy
SC Geriatrics & Gerontology; Pharmacology & Pharmacy
GA 826FJ
UT WOS:000221814400005
PM 15132714
ER
PT J
AU Fraunfelder, FW
AF Fraunfelder, FW
TI Ocular side effects associated with isotretinoin
SO DRUGS OF TODAY
LA English
DT Review
ID THERAPY; ACNE
AB Isotretinoin is used for severe recalcitrant nodular acne and has a variety of associated ocular side effects. This review classifies these ocular side effects according to World Health Organization (WHO) criteria and reviews the existing literature as well as 2449 spontaneous case reports collected from around the world. Ocular sicca, decreased dark adaptation and intracranial hypertension are identified as "certain" side effects from isotretinoin and clinicians are provided guidelines for care and follow-up. (C) 2004 Prous Science. All rights reserved.
C1 Oregon Hlth Sci Univ, Casey Eye Inst, Natl Registry Drug Induces Ocular Side Effects, Portland, OR 97201 USA.
WHO, Collaborating Ctr Int Drug Monitoring, Uppsala, Sweden.
US FDA, Rockville, MD 20857 USA.
RP Fraunfelder, FW (reprint author), Oregon Hlth Sci Univ, Casey Eye Inst, Natl Registry Drug Induces Ocular Side Effects, 3375 SW Terwilliger Blvd, Portland, OR 97201 USA.
EM eyedrug@ohsu.edu
NR 12
TC 17
Z9 17
U1 0
U2 5
PU PROUS SCIENCE, SA
PI BARCELONA
PA PO BOX 540, PROVENZA 388, 08025 BARCELONA, SPAIN
SN 0025-7656
J9 DRUGS TODAY
JI Drugs Today
PD JAN
PY 2004
VL 40
IS 1
BP 23
EP 27
DI 10.1358/dot.2004.40.1.799435
PG 5
WC Pharmacology & Pharmacy
SC Pharmacology & Pharmacy
GA 780MP
UT WOS:000189385300003
PM 14988767
ER
PT J
AU Patrick, ME
Adcock, PM
Gomez, TM
Altekruse, SF
Holland, BH
Tauxe, RV
Swerdlow, DL
AF Patrick, ME
Adcock, PM
Gomez, TM
Altekruse, SF
Holland, BH
Tauxe, RV
Swerdlow, DL
TI Salmonella enteritidis infections, United States, 1985-1999
SO EMERGING INFECTIOUS DISEASES
LA English
DT Article
ID PHAGE TYPE-4; EGGS; OUTBREAKS; FLOCKS; HENS
AB Salmonella enterica serotype Enteritidis emerged as an important illness during the 1980s. Investigations showed that consumption of undercooked eggs was the major risk factor for disease, and a variety of prevention and control efforts were initiated during the 1990s. We describe sporadic infections and outbreaks of S. Enteritidis in the United States from 1985 through 1999 and discuss prevention and control efforts. After reaching a high of 3.9 per 100,000 population in 1995, S. Enteritidis infections declined to 1.98 per 100,000 in 1999. While the total number of outbreaks decreased by half, those in the western states tripled. Outbreaks of S. Enteritidis phage type 4 infections accounted for 49% of outbreaks in 1999. Outbreak-associated deaths in health facilities decreased from 14 in 1987 to 0 in 1999. Overall, rates of sporadic S. Enteritidis infection, outbreaks, and deaths have declined dramatically. For further reductions, control measures should continue to be applied along the entire farm-to-table continuum.
C1 Ctr Dis Control & Prevent, Atlanta, GA USA.
USDA, Atlanta, GA USA.
US FDA, Rockville, MD 20857 USA.
RP Patrick, ME (reprint author), Dekalb Cty Board Hlth, Div Hlth Assessment & Promot, Sakura, Ibaraki 30031, Japan.
EM mcevans@gdph.state.ga.us
NR 25
TC 163
Z9 171
U1 0
U2 7
PU CENTER DISEASE CONTROL
PI ATLANTA
PA ATLANTA, GA 30333 USA
SN 1080-6040
J9 EMERG INFECT DIS
JI Emerg. Infect. Dis
PD JAN
PY 2004
VL 10
IS 1
BP 1
EP 7
PG 7
WC Immunology; Infectious Diseases
SC Immunology; Infectious Diseases
GA 762GD
UT WOS:000187962800001
PM 15078589
ER
PT J
AU Raney, JL
Delongchamp, RR
Valentine, CR
AF Raney, JL
Delongchamp, RR
Valentine, CR
TI Spontaneous mutant frequency and mutation spectrum for gene A of Phi
X174 grown in E-coli
SO ENVIRONMENTAL AND MOLECULAR MUTAGENESIS
LA English
DT Article
DE single burst analysis; mutant spectra; spontaneous mutant frequency
ID LACZ-TRANSGENIC MOUSE; IN-VIVO; MOLECULAR NATURE; MICE; SPECIFICITY;
BACTERIOPHAGE-PHI-X174; SUPPRESSION; REVERTANTS; SEQUENCE; ORIGINS
AB The use of transgenic targets for measuring mutant frequencies in mammalian tissue requires an estimate of the mutant frequency that results from recovery of the transgene in bacterial recovery systems. In this study, we have determined the spontaneous mutant frequency, estimated the mutation rate, and ascertained the mutation spectrum for gene A of (I)X 174 grown in E. coli strain CQ2 from 156 small independent cultures. The mutant frequency of 12 of the 156 cultures was 17 +/- 1.0 x 10(-6) and the estimated mutation rate per gene replication was 7.4 +/- 2.3 x 10(-6). The mutant frequency and spectrum from E. coli were not significantly different from that of solvent-treated embryonic mouse cells in culture, 19 +/- 0.5 x 10(-6) (Valentine CR et al. [2002]: Environ Mal Mutagen 39:55-68), indicating that those spontaneous mutants were primarily derived from E. coli. The E. coli spectrum was heavily weighted toward two major target sites (hot spots), 4225A-->G (56%) and 421 8G-->A or C (20%). Four new target sites and one new mutational event were recovered by the gene A forward assay. A mutant spectrum from an expanded phage stock was also determined to assess the effects of propagating the virus. This mutant frequency was higher (6 x 10(-4)), contained more double mutants (15% compared to 0.6%), and had a significantly different spectrum from the spectrum for independent cultures (fewer A:T-G:C and G:C C:G changes and more G:C-A:T; P < 0.002). The E. coli mutation spectrum will be useful for determining the origin of gene A mutation in tissues of PhiX174 transgenic mice. Published 2004 Wiley-Liss, Inc.(dagger)
C1 Natl Ctr Toxicol Res, Div Genet & Reprod Toxicol, Jefferson, AR 72079 USA.
Natl Ctr Toxicol, Div Biometry & Risk Assessment, Jefferson, AR USA.
RP Valentine, CR (reprint author), Natl Ctr Toxicol Res, Div Genet & Reprod Toxicol, 3900 NCTR Rd,HFT-120, Jefferson, AR 72079 USA.
EM cvalentine@nctr.fda.gov
NR 36
TC 23
Z9 23
U1 0
U2 4
PU WILEY-LISS
PI HOBOKEN
PA DIV JOHN WILEY & SONS INC, 111 RIVER ST, HOBOKEN, NJ 07030 USA
SN 0893-6692
J9 ENVIRON MOL MUTAGEN
JI Environ. Mol. Mutagen.
PY 2004
VL 44
IS 2
BP 119
EP 127
DI 10.1002/em.20041
PG 9
WC Environmental Sciences; Genetics & Heredity; Toxicology
SC Environmental Sciences & Ecology; Genetics & Heredity; Toxicology
GA 845BS
UT WOS:000223211300005
PM 15278916
ER
PT J
AU Valentine, CR
Raney, JL
Shaddock, JG
Dobrovolsky, VN
Delongchamp, RR
AF Valentine, CR
Raney, JL
Shaddock, JG
Dobrovolsky, VN
Delongchamp, RR
TI In vivo mutation in gene A of splenic lymphocytes from 4 Phi Chi 174
transgenic mice
SO ENVIRONMENTAL AND MOLECULAR MUTAGENESIS
LA English
DT Article
DE Phi Chi 1 74; single-burst analysis; mutant spectra; ethylnitrosourea;
clonality; spontaneous; mutant frequency; transgenic; forward mutational
assay
ID ESCHERICHIA-COLI; MOLECULAR CHARACTERISTICS; ETHYLATING AGENTS;
MAMMALIAN-CELLS; GERM-CELLS; LACI GENE; BASE-PAIR; MUTAGENESIS;
PHI-X174; REPAIR
AB Single-burst analysis was applied to a forward assay for gene A mutation in splenic lymphocytes of PhiXI 74 transgenic mice for the purpose of optimizing analytical parameters for identifying in vivo mutations. The effect of varying the cutoff value for an in vivo burst on induced mutant frequency, fold increase, and the significance of the difference between control and N-ethyl-N-nitrosourea (ENU)treated mice was calculated by two different methods. The plating density was reduced to an average of less than 10 background mutant plaques per aliquot in order to separate in vitro bursts. The spectrum of mutations contributing < 60 plaques per aliquot from control animals was not significantly different from the control spectra from E. coli or transgenic PhiXI74 cells in culture. The mutant spectra from ENU-treated animals was highly different between mutant bursts of > 80 plaques per aliquot compared to mutations contributing < 60 plaques per aliquot (P < 0.000001), the former fitting the spectrum expected for ENU-induced mutations. The latter spectrum was also different from control animals and E. coli (P < 0.000001), suggesting the difference was caused by ex vivo mutation. With the mutations found in this study, the total number of reported target sites for gene A is now 33. The results support the interpretation that, in contrast to results for the lacl transgene, 100% of mutants isolated in gene A from control animals and cells were fixed in E. coli. We attribute the difference between the two genes to hot-spot sites for mutation in gene A and to a testable hypothesis that the mosaic plaque assay for the lacl transgene underestimates the frequency of ex vivo mutants. Published 2004 Wiley-Liss, Inc.(dagger)
C1 Natl Ctr Toxicol Res, Div Genet & Reprod Toxicol, Jefferson, AR 72079 USA.
Natl Ctr Toxicol Res, Div Biometry, Jefferson, AR USA.
RP Valentine, CR (reprint author), Natl Ctr Toxicol Res, Div Genet & Reprod Toxicol, HFT-120,3900 NCTR Rd, Jefferson, AR 72079 USA.
EM cvalentine@nctr.fda.gov
NR 47
TC 6
Z9 6
U1 0
U2 1
PU WILEY-LISS
PI HOBOKEN
PA DIV JOHN WILEY & SONS INC, 111 RIVER ST, HOBOKEN, NJ 07030 USA
SN 0893-6692
J9 ENVIRON MOL MUTAGEN
JI Environ. Mol. Mutagen.
PY 2004
VL 44
IS 2
BP 128
EP 150
DI 10.1002/em.20043
PG 23
WC Environmental Sciences; Genetics & Heredity; Toxicology
SC Environmental Sciences & Ecology; Genetics & Heredity; Toxicology
GA 845BS
UT WOS:000223211300006
PM 15278917
ER
PT J
AU Chen, L
Mei, N
Chen, T
AF Chen, L
Mei, N
Chen, T
TI Mutations induced by aristolochic acid in the kidney of big blue
transgenic rat
SO ENVIRONMENTAL AND MOLECULAR MUTAGENESIS
LA English
DT Meeting Abstract
CT 35th Annual Meeting of the Environmental-Mutagen-Society
CY OCT 02-06, 2004
CL Pittsburgh, PA
SP Environm Mutagen Soc
C1 US FDA, Natl Ctr Toxicol Res, Div Genet & Reprod Toxicol, Jefferson, AR 72079 USA.
Shanghai Jiao Tong Univ, Coll Life Sci & Technol, Shanghai 200240, Peoples R China.
NR 0
TC 0
Z9 0
U1 0
U2 1
PU WILEY-LISS
PI HOBOKEN
PA DIV JOHN WILEY & SONS INC, 111 RIVER ST, HOBOKEN, NJ 07030 USA
SN 0893-6692
J9 ENVIRON MOL MUTAGEN
JI Environ. Mol. Mutagen.
PY 2004
VL 44
IS 3
MA 26
BP 192
EP 192
PG 1
WC Environmental Sciences; Genetics & Heredity; Toxicology
SC Environmental Sciences & Ecology; Genetics & Heredity; Toxicology
GA 852MF
UT WOS:000223758700028
ER
PT J
AU Dobrovolsky, VN
Heflich, RH
McGarrity, LJ
VonTungeln, LS
Beland, FA
AF Dobrovolsky, VN
Heflich, RH
McGarrity, LJ
VonTungeln, LS
Beland, FA
TI Frequency of micronucleated erythroid cells in AZT-treated TK-proficient
and TK-deficient mice
SO ENVIRONMENTAL AND MOLECULAR MUTAGENESIS
LA English
DT Meeting Abstract
CT 35th Annual Meeting of the Environmental-Mutagen-Society
CY OCT 02-06, 2004
CL Pittsburgh, PA
SP Environm Mutagen Soc
C1 Natl Ctr Toxicol Res, Jefferson, AR 72079 USA.
NR 0
TC 0
Z9 0
U1 0
U2 1
PU WILEY-LISS
PI HOBOKEN
PA DIV JOHN WILEY & SONS INC, 111 RIVER ST, HOBOKEN, NJ 07030 USA
SN 0893-6692
J9 ENVIRON MOL MUTAGEN
JI Environ. Mol. Mutagen.
PY 2004
VL 44
IS 3
MA 40
BP 196
EP 196
PG 1
WC Environmental Sciences; Genetics & Heredity; Toxicology
SC Environmental Sciences & Ecology; Genetics & Heredity; Toxicology
GA 852MF
UT WOS:000223758700043
ER
PT J
AU Elespuru, RK
Jenning, SM
AF Elespuru, RK
Jenning, SM
TI Molecular epidemiology of human lung cancer: Analysis using the IARC
tp53 database
SO ENVIRONMENTAL AND MOLECULAR MUTAGENESIS
LA English
DT Meeting Abstract
CT 35th Annual Meeting of the Environmental-Mutagen-Society
CY OCT 02-06, 2004
CL Pittsburgh, PA
SP Environm Mutagen Soc
C1 US FDA, CDRH, OSEL, Div Biol, Silver Spring, MD 20903 USA.
NR 0
TC 0
Z9 0
U1 0
U2 1
PU WILEY-LISS
PI HOBOKEN
PA DIV JOHN WILEY & SONS INC, 111 RIVER ST, HOBOKEN, NJ 07030 USA
SN 0893-6692
J9 ENVIRON MOL MUTAGEN
JI Environ. Mol. Mutagen.
PY 2004
VL 44
IS 3
MA 47
BP 197
EP 197
PG 1
WC Environmental Sciences; Genetics & Heredity; Toxicology
SC Environmental Sciences & Ecology; Genetics & Heredity; Toxicology
GA 852MF
UT WOS:000223758700049
ER
PT J
AU Jacobson-Kram, D
AF Jacobson-Kram, D
TI The role of the SHE cell transformation assay in drug development
SO ENVIRONMENTAL AND MOLECULAR MUTAGENESIS
LA English
DT Meeting Abstract
CT 35th Annual Meeting of the Environmental-Mutagen-Society
CY OCT 02-06, 2004
CL Pittsburgh, PA
SP Environm Mutagen Soc
C1 US FDA, Off New Drugs, Ctr Drug Evaluat & Res, Rockville, MD 20852 USA.
NR 0
TC 0
Z9 0
U1 0
U2 1
PU WILEY-LISS
PI HOBOKEN
PA DIV JOHN WILEY & SONS INC, 111 RIVER ST, HOBOKEN, NJ 07030 USA
SN 0893-6692
J9 ENVIRON MOL MUTAGEN
JI Environ. Mol. Mutagen.
PY 2004
VL 44
IS 3
MA 85
BP 207
EP 207
PG 1
WC Environmental Sciences; Genetics & Heredity; Toxicology
SC Environmental Sciences & Ecology; Genetics & Heredity; Toxicology
GA 852MF
UT WOS:000223758700090
ER
PT J
AU Kovalchuk, OV
Raiche, JN
Slovack, MK
Pogribny, IP
AF Kovalchuk, OV
Raiche, JN
Slovack, MK
Pogribny, IP
TI Radiation-induced gemonic DNA methylation changes - The biological
significance and possible mechanisms
SO ENVIRONMENTAL AND MOLECULAR MUTAGENESIS
LA English
DT Meeting Abstract
CT 35th Annual Meeting of the Environmental-Mutagen-Society
CY OCT 02-06, 2004
CL Pittsburgh, PA
SP Environm Mutagen Soc
C1 Univ Lethbridge, Lethbridge, AB T1K 3M4, Canada.
US FDA, NCTR, Jefferson, AR USA.
NR 0
TC 0
Z9 0
U1 0
U2 4
PU WILEY-LISS
PI HOBOKEN
PA DIV JOHN WILEY & SONS INC, 111 RIVER ST, HOBOKEN, NJ 07030 USA
SN 0893-6692
J9 ENVIRON MOL MUTAGEN
JI Environ. Mol. Mutagen.
PY 2004
VL 44
IS 3
MA 99
BP 211
EP 211
PG 1
WC Environmental Sciences; Genetics & Heredity; Toxicology
SC Environmental Sciences & Ecology; Genetics & Heredity; Toxicology
GA 852MF
UT WOS:000223758700104
ER
PT J
AU MacGregor, J
Bishop, ME
Dertinger, S
McNamee, J
Harper, S
Hotchkiss, C
Hayashi, M
AF MacGregor, J
Bishop, ME
Dertinger, S
McNamee, J
Harper, S
Hotchkiss, C
Hayashi, M
TI Integration of chromosomal damage assessment with routine toxicity
testing using a flow cytometric assay for micronucleated reticulocytes.
SO ENVIRONMENTAL AND MOLECULAR MUTAGENESIS
LA English
DT Meeting Abstract
CT 35th Annual Meeting of the Environmental-Mutagen-Society
CY OCT 02-06, 2004
CL Pittsburgh, PA
SP Environm Mutagen Soc
C1 US FDA, Natl Ctr Toxicol Res, Rockville, MD 20857 USA.
Toxicol Consulting Serv, Arnold, MD USA.
US FDA, Natl Ctr Toxicol Res, Jefferson, AR 72079 USA.
Hlth Canada, Ottawa, ON K1A 0L2, Canada.
US FDA, Ctr Food Safety & Appl Nutr, Laurel, MD USA.
Natl Inst Hlth Sci, Tokyo 158, Japan.
NR 0
TC 0
Z9 0
U1 0
U2 1
PU WILEY-LISS
PI HOBOKEN
PA DIV JOHN WILEY & SONS INC, 111 RIVER ST, HOBOKEN, NJ 07030 USA
SN 0893-6692
J9 ENVIRON MOL MUTAGEN
JI Environ. Mol. Mutagen.
PY 2004
VL 44
IS 3
MA 107
BP 213
EP 213
PG 1
WC Environmental Sciences; Genetics & Heredity; Toxicology
SC Environmental Sciences & Ecology; Genetics & Heredity; Toxicology
GA 852MF
UT WOS:000223758700112
ER
PT J
AU Manjanatha, MG
Aidoo, A
Shelton, SD
Bishop, ME
McDaniel, LP
Doerge, DR
AF Manjanatha, MG
Aidoo, A
Shelton, SD
Bishop, ME
McDaniel, LP
Doerge, DR
TI Evaluation of mutagenicity in big blue (BB) mice administered acrylamide
(AA) and glycidamide (GA) in drinking water for 4 weeks.
SO ENVIRONMENTAL AND MOLECULAR MUTAGENESIS
LA English
DT Meeting Abstract
CT 35th Annual Meeting of the Environmental-Mutagen-Society
CY OCT 02-06, 2004
CL Pittsburgh, PA
SP Environm Mutagen Soc
C1 US FDA, Natl Ctr Toxicol Res, Div Genet & Reprod Toxicol, Jefferson, AR 72079 USA.
US FDA, Natl Ctr Toxicol Res, Div Biochem Toxicol, Jefferson, AR 72079 USA.
NR 0
TC 2
Z9 3
U1 0
U2 1
PU WILEY-LISS
PI HOBOKEN
PA DIV JOHN WILEY & SONS INC, 111 RIVER ST, HOBOKEN, NJ 07030 USA
SN 0893-6692
J9 ENVIRON MOL MUTAGEN
JI Environ. Mol. Mutagen.
PY 2004
VL 44
IS 3
MA 110
BP 214
EP 214
PG 1
WC Environmental Sciences; Genetics & Heredity; Toxicology
SC Environmental Sciences & Ecology; Genetics & Heredity; Toxicology
GA 852MF
UT WOS:000223758700115
ER
PT J
AU McKinzie, PB
Chen, T
Heflich, RH
Parsons, BL
AF McKinzie, PB
Chen, T
Heflich, RH
Parsons, BL
TI ACB-PCR measurement of rare K-ras codon 12 mutations in liver of
N-hydroxy-2-acetylaminofluorene-treated Big Blue rats.
SO ENVIRONMENTAL AND MOLECULAR MUTAGENESIS
LA English
DT Meeting Abstract
CT 35th Annual Meeting of the Environmental-Mutagen-Society
CY OCT 02-06, 2004
CL Pittsburgh, PA
SP Environm Mutagen Soc
C1 US FDA, Natl Ctr Toxicol Res, Div Genet & Reprod Toxicol, Jefferson, AR 72079 USA.
NR 0
TC 0
Z9 0
U1 0
U2 1
PU WILEY-LISS
PI HOBOKEN
PA DIV JOHN WILEY & SONS INC, 111 RIVER ST, HOBOKEN, NJ 07030 USA
SN 0893-6692
J9 ENVIRON MOL MUTAGEN
JI Environ. Mol. Mutagen.
PY 2004
VL 44
IS 3
MA 111
BP 214
EP 214
PG 1
WC Environmental Sciences; Genetics & Heredity; Toxicology
SC Environmental Sciences & Ecology; Genetics & Heredity; Toxicology
GA 852MF
UT WOS:000223758700116
ER
PT J
AU Mei, N
Heflich, RH
Chou, MW
Fu, PP
Chen, T
AF Mei, N
Heflich, RH
Chou, MW
Fu, PP
Chen, T
TI Riddelliine-induced mutations in the liver CII gene of transgenic Big
Blue rats.
SO ENVIRONMENTAL AND MOLECULAR MUTAGENESIS
LA English
DT Meeting Abstract
CT 35th Annual Meeting of the Environmental-Mutagen-Society
CY OCT 02-06, 2004
CL Pittsburgh, PA
SP Environm Mutagen Soc
C1 US FDA, Natl Ctr Toxicol Res, Div Genet & Reprod Toxicol, Jefferson, AR 72079 USA.
US FDA, Natl Ctr Toxicol Res, Div Biochem Toxicol, Jefferson, AR 72079 USA.
NR 0
TC 0
Z9 0
U1 0
U2 1
PU WILEY-LISS
PI HOBOKEN
PA DIV JOHN WILEY & SONS INC, 111 RIVER ST, HOBOKEN, NJ 07030 USA
SN 0893-6692
J9 ENVIRON MOL MUTAGEN
JI Environ. Mol. Mutagen.
PY 2004
VL 44
IS 3
MA 113
BP 214
EP 214
PG 1
WC Environmental Sciences; Genetics & Heredity; Toxicology
SC Environmental Sciences & Ecology; Genetics & Heredity; Toxicology
GA 852MF
UT WOS:000223758700118
ER
PT J
AU Mittelstaedt, RA
Mei, N
Shaddock, JG
Dobrovolsky, VN
McGarrity, LJ
Greenlees, KJ
Heflich, RH
AF Mittelstaedt, RA
Mei, N
Shaddock, JG
Dobrovolsky, VN
McGarrity, LJ
Greenlees, KJ
Heflich, RH
TI Liver CII mutant frequency correlates with tumorigenicity in female Big
Blue mice and rats fed malachite green and leucomalachite green.
SO ENVIRONMENTAL AND MOLECULAR MUTAGENESIS
LA English
DT Meeting Abstract
CT 35th Annual Meeting of the Environmental-Mutagen-Society
CY OCT 02-06, 2004
CL Pittsburgh, PA
SP Environm Mutagen Soc
C1 US FDA, Natl Ctr Toxicol Res, Div Genet & Reprod Toxicol, Jefferson, AR 72079 USA.
US FDA, Ctr Vet Med, Rockville, MD 20855 USA.
NR 0
TC 0
Z9 0
U1 0
U2 1
PU WILEY-LISS
PI HOBOKEN
PA DIV JOHN WILEY & SONS INC, 111 RIVER ST, HOBOKEN, NJ 07030 USA
SN 0893-6692
J9 ENVIRON MOL MUTAGEN
JI Environ. Mol. Mutagen.
PY 2004
VL 44
IS 3
MA 117
BP 215
EP 215
PG 1
WC Environmental Sciences; Genetics & Heredity; Toxicology
SC Environmental Sciences & Ecology; Genetics & Heredity; Toxicology
GA 852MF
UT WOS:000223758700122
ER
PT J
AU Torous, DK
Dertinger, SD
MacGregor, JT
Bishop, ME
Ponten, I
Chen, Y
Tometsko, CR
AF Torous, DK
Dertinger, SD
MacGregor, JT
Bishop, ME
Ponten, I
Chen, Y
Tometsko, CR
TI Flow cytometric analysis of micronuclei in rodent and human blood using
a newly developed three-color labeling method
SO ENVIRONMENTAL AND MOLECULAR MUTAGENESIS
LA English
DT Meeting Abstract
CT 35th Annual Meeting of the Environmental-Mutagen-Society
CY OCT 02-06, 2004
CL Pittsburgh, PA
SP Environm Mutagen Soc
C1 Litron Labs, Rochester, NY 14620 USA.
US FDA, Natl Ctr Toxicol Res, Rockville, MD 20857 USA.
US FDA, Natl Ctr Toxicol Res, Jefferson, AR 72079 USA.
AstraZeneca R&D, Sodertalje, Sweden.
Univ Rochester, Med Ctr, Rochester, NY 14642 USA.
NR 0
TC 0
Z9 0
U1 0
U2 1
PU WILEY-LISS
PI HOBOKEN
PA DIV JOHN WILEY & SONS INC, 111 RIVER ST, HOBOKEN, NJ 07030 USA
SN 0893-6692
J9 ENVIRON MOL MUTAGEN
JI Environ. Mol. Mutagen.
PY 2004
VL 44
IS 3
MA 179
BP 232
EP 232
PG 1
WC Environmental Sciences; Genetics & Heredity; Toxicology
SC Environmental Sciences & Ecology; Genetics & Heredity; Toxicology
GA 852MF
UT WOS:000223758700188
ER
PT J
AU Valentine, CR
Rainey, HF
Delongchamp, RR
AF Valentine, CR
Rainey, HF
Delongchamp, RR
TI Comparison of in vivo mutation in gene A of PHIX174 to lacl and cll of
lambda from splenic lymphocytes in transgenic mice
SO ENVIRONMENTAL AND MOLECULAR MUTAGENESIS
LA English
DT Meeting Abstract
CT 35th Annual Meeting of the Environmental-Mutagen-Society
CY OCT 02-06, 2004
CL Pittsburgh, PA
SP Environm Mutagen Soc
C1 Natl Ctr Toxicol Res, Div Genet Toxicol, Jefferson, AR 72079 USA.
Natl Ctr Toxicol Res, Div Biometry, Jefferson, AR 72079 USA.
NR 0
TC 0
Z9 0
U1 0
U2 1
PU WILEY-LISS
PI HOBOKEN
PA DIV JOHN WILEY & SONS INC, 111 RIVER ST, HOBOKEN, NJ 07030 USA
SN 0893-6692
J9 ENVIRON MOL MUTAGEN
JI Environ. Mol. Mutagen.
PY 2004
VL 44
IS 3
MA 183
BP 233
EP 233
PG 1
WC Environmental Sciences; Genetics & Heredity; Toxicology
SC Environmental Sciences & Ecology; Genetics & Heredity; Toxicology
GA 852MF
UT WOS:000223758700193
ER
PT J
AU Verkler, TL
Delongchamp, RR
Warbritton, A
Couch, LH
Miller, BJ
Howard, PC
Parsons, BL
AF Verkler, TL
Delongchamp, RR
Warbritton, A
Couch, LH
Miller, BJ
Howard, PC
Parsons, BL
TI Accumulation of simulated solar light-induced mouse p53 codon 270 CGT to
TGT mutation during skin tumor development
SO ENVIRONMENTAL AND MOLECULAR MUTAGENESIS
LA English
DT Meeting Abstract
CT 35th Annual Meeting of the Environmental-Mutagen-Society
CY OCT 02-06, 2004
CL Pittsburgh, PA
SP Environm Mutagen Soc
C1 US FDA, Div Genet & Reprod Toxicol, Natl Ctr Toxicol Res, Jefferson, AR 72079 USA.
US FDA, Div Biometry, Natl Ctr Toxicol Res, Jefferson, AR 72079 USA.
US FDA, Pathol Serv, Charles River Labs, Natl Ctr Toxicol Res, Jefferson, AR 72079 USA.
US FDA, Div Biochem Toxicol, Natl Ctr Toxicol Res, Jefferson, AR 72079 USA.
NR 0
TC 0
Z9 0
U1 0
U2 1
PU WILEY-LISS
PI HOBOKEN
PA DIV JOHN WILEY & SONS INC, 111 RIVER ST, HOBOKEN, NJ 07030 USA
SN 0893-6692
J9 ENVIRON MOL MUTAGEN
JI Environ. Mol. Mutagen.
PY 2004
VL 44
IS 3
MA 188
BP 234
EP 234
PG 1
WC Environmental Sciences; Genetics & Heredity; Toxicology
SC Environmental Sciences & Ecology; Genetics & Heredity; Toxicology
GA 852MF
UT WOS:000223758700198
ER
PT J
AU Huber, WW
Teitel, CH
Coles, BF
King, RS
Wiese, FW
Kaderlik, KR
Casciano, DA
Shaddock, JG
Mulder, GJ
Ilett, KF
Kadlubar, FF
AF Huber, WW
Teitel, CH
Coles, BF
King, RS
Wiese, FW
Kaderlik, KR
Casciano, DA
Shaddock, JG
Mulder, GJ
Ilett, KF
Kadlubar, FF
TI Potential chemoprotective effects of the coffee components kahweol and
cafestol palmitates via modification of hepatic N-acetyltransferase and
glutathione S-transferase activities
SO ENVIRONMENTAL AND MOLECULAR MUTAGENESIS
LA English
DT Article
DE chemoprotection; coffee;
2-amino-1-methyl-6-phenylimidazo-[4,5-b]pyridine (Ph IP);
N-acetyltransferase; glutathione-5-transferase; rat
ID DNA ADDUCT FORMATION; BORNE CARCINOGEN
2-AMINO-1-METHYL-6-PHENYLIMIDAZO<4,5-B>PYRIDINE; GAMMA-GLUTAMYLCYSTEINE
SYNTHETASE; HETEROCYCLIC AMINE CARCINOGENS; ACETYLATOR INBRED RATS;
RATE-LIMITING ENZYME; ABERRANT CRYPT FOCI; COLON-TUMOR CELLS;
COLORECTAL-CANCER; GENE-EXPRESSION
AB Coffee drinking has been associated with reduced incidence of colorectal cancer, possibly via chemoprotection/modification of the metabolism of dietary heterocyclic amine carcinogens such as 2-amino-1-methyl-6-phenylimidazo-[4,5-b]pyridine (PhIP) by kahweol and cafestol palmitates (K/C), two components of unfiltered coffee. Using the PhIP-exposed male Fisher F344 rat as a model, K/C have been shown to reduce colonic PhlP-DNA adducts by >50%. We have used the male F344 rat to investigate the effects of dietary K/C (0.02-0.2% as a 1:1 mixture) on the metabolism of PhIP by N-acetyltransferase- (NAT), sulfotransferose- (SULT), and glutathione-dependent pathways. K/C decreased hepatic NAT-dependent PhIP activation by up to 80% in a dose-dependent manner. Conversely, hepatic glutathione S-transferase (GST) activity/expression increased, e.g., 3-4 fold toward 1-chloro-2,4-dinitrobenzene (total activity), up to 23-fold toward 4-vinylpyridine (rGSTP1),Coffee drinking has been associated with reduced incidence of colorectal cancer, possibly via chemoprotection/modification of the metabolism of dietary heterocyclic amine carcinogens such as 2-amino-1-methyl-6 phenylimidazo-[4,5-b]pyridine (PhIP) by kahweol and cafestol palmitates (K/C), two components of unfiltered coffee. Using the PhIP-exposed male Fisher F344 rat as a model, K/C have been shown to reduce colonic PhIP-DNA adducts by > 50%. We have used the male F344 rat to investigate the effects of dietary K/C (0.02-0.2% as a 1:1 mixture) on the metabolism of PhIP by M-acetyltransferase- (NAT), sulfotransferose- (SULT), and glutathione-dependent pathways. K/C decreased hepatic NAT-dependent PhlP activation by up to 80% in a dose-dependent manner. Conversely, hepatic glutathione S-transferase (GST) activity/expression increased, e.g., 3-4 fold toward 1-chloro-2,4-dinitrobenzene (total activity), up to 23-fold toward 4-vinylpyridine (rGSTP1), and similar to7-fold for rGSTA2 protein. These effects had fully developed after 5 days of the test diet and persisted for at least 5 days after withdrawal of K/C. Hepatic glutathione increased two- to threefold and this increase was more short-lived than other changes. K/C did not modify hepatic SULT activity or colon NAT and GST activities. Benzylisothiocyanate and black tea, which have also been shown to reduce the formation of PhlP-DNA adducts in this model, had little effect on hepatic NAT, SULT, GST, or GSH. In primary culture of rat hepatocytes, both kahweol and cafestol palmitates reduced NAT activity by 80%. In summary, the unique potential of K/C to convert rapid acetylators to a slow acetylator phenotype, accompanied by GST induction, might contribute to chemoprevention against cancers associated with heterocyclic amines. (C) 2004 Wiley-Liss, Inc.
C1 Natl Ctr Toxicol Res, Div Mol Epidemiol, Jefferson, AR USA.
Natl Ctr Toxicol Res, Div Genet Toxicol, Jefferson, AR USA.
Amsterdam Ctr Drug Res, Dept Toxicol, Leiden, Netherlands.
Univ Western Australia, Sch Med & Pharmacol, Pharmacol Unit, Crawley, Australia.
RP Huber, WW (reprint author), Med Univ Vienna, Dept Toxicol, Inst Krebsforsch, Borschkegasse 8A, A-1090 Vienna, Austria.
EM wolfgang.huher@meduniwien.ac.at
RI King, Roberta/A-1749-2010; yang, min/G-3030-2011
OI King, Roberta/0000-0002-3550-4255;
NR 90
TC 25
Z9 28
U1 0
U2 6
PU WILEY-LISS
PI HOBOKEN
PA DIV JOHN WILEY & SONS INC, 111 RIVER ST, HOBOKEN, NJ 07030 USA
SN 0893-6692
J9 ENVIRON MOL MUTAGEN
JI Environ. Mol. Mutagen.
PY 2004
VL 44
IS 4
BP 265
EP 276
DI 10.1002/em.20052
PG 12
WC Environmental Sciences; Genetics & Heredity; Toxicology
SC Environmental Sciences & Ecology; Genetics & Heredity; Toxicology
GA 867LY
UT WOS:000224845300002
PM 15468054
ER
PT J
AU Dertinger, SD
Camphausen, K
MacGregor, JI
Bishop, ME
Torous, DK
Avlasevich, S
Cairns, S
Tometsko, CR
Menard, C
Muanza, T
Chen, YY
Miller, RK
Cederbrant, K
Sandelin, K
Ponten, I
Bolcsfoldi, G
AF Dertinger, SD
Camphausen, K
MacGregor, JI
Bishop, ME
Torous, DK
Avlasevich, S
Cairns, S
Tometsko, CR
Menard, C
Muanza, T
Chen, YY
Miller, RK
Cederbrant, K
Sandelin, K
Ponten, I
Bolcsfoldi, G
TI Three-color labeling method for flow cytometric measurement of
cytogenetic damage in rodent and human blood
SO ENVIRONMENTAL AND MOLECULAR MUTAGENESIS
LA English
DT Article
DE micronuclei; cytogenetic damage; DNA damage; reticulocytes; CD71 antigen
ID RAT PERIPHERAL-BLOOD; MICRONUCLEUS ASSAY; BONE-MARROW; RETICULOCYTES;
ERYTHROCYTES; ENUMERATION; CYCLOPHOSPHAMIDE; SUITABILITY
AB Experiments described herein were designed to evaluate the performance characteristics of a flow cytometry-based system that scores the incidence of peripheral blood micronucleated reticulocytes IMN-RETs). These procedures represent the continued refinement of a previously reported anti-CD71-based method (Dertinger et al. [1996]: Mutat Res 371:283-292), with the following modifications: incorporation of a third fluorescent label to exclude platelets from the MN-RET region, and use of a CD71 -associated fluorescence thresholding technique to increase data acquisition rates. Mouse, rat, and human blood samples were analyzed using both the previously described two-color procedure (anti-CD71-FITC and propidium iodide) and a newly developed three-color technique (which adds an antiplatelet-PE antibody). The rodent specimens were also evaluated by standard microscopy procedures (acridine orange staining). Mouse blood was collected via heart puncture of vehicle- and 5-fluorouracil-treated CD-1 mice; blood samples from saline-treated Sprague-Dawley rats were collected from the tail vein and via heart puncture. Rodent blood samples were analyzed by both the two- and three-color methods. Human blood specimens, obtained via arm venipuncture from cancer patients undergoing radiation therapy, were analyzed for MNRETs using the two-color method. Subsequently, blood samples from a single chemotherapy patient were analyzed by both the two- and three-color methods. Finally, the chemotherapy patient blood samples and blood samples from 15 healthy volunteers were evaluated at very high densities in conjunction with a CD71-associated fluorescence thresholding technique. Results of these investigations showed that data from mouse blood analyzed by the two- and threecolor procedures correlated well with microscopy data (r values = 0.917 and 0.937 for the two- and three-color methods, respectively); all three methods confirmed the genotoxicity of 5-FU. Data from rat tail vein samples showed improved reproducibility with the three-color technique, but no significant difference between the two techniques was seen with the heart puncture specimens. Human blood analyzed according to the two-color procedure produced unreliable results, as platelets and platelet aggregates impacted the rare MN-RET scoring region. The three-color technique effectively overcome this problem and produced reproducible measurements that fell within expected ranges. For human blood analyses, the high cell density/CD71 -thresholding technique provided significant improvements over the low-density technique, as it allowed data acquisition to occur approximately six times faster with no loss of sensitivity. (C) 2004 Wiley-Liss, Inc.
C1 Litron Labs, Rochester, NY 14620 USA.
NCI, Radiat Oncol Branch, Bethesda, MD 20892 USA.
US FDA, Natl Ctr Toxicol Res, Rockville, MD 20857 USA.
US FDA, Natl Ctr Toxicol Res, Jefferson, AR 72079 USA.
Univ Rochester, Dept Radiat Oncol, James P Wilmot Canc Ctr, Rochester, NY USA.
Univ Rochester, Med Ctr, Dept Obstet & Gynecol, Rochester, NY 14642 USA.
AstraZeneca Res & Dev, Sodertalje, Sweden.
RP Dertinger, SD (reprint author), Litron Labs, 1351 Mt Hope Ave, Rochester, NY 14620 USA.
EM sdertinger@litronlabs.com
OI Cederbrant, Karin/0000-0003-3341-5416
FU NIEHS NIH HHS [R44ES011244-03, R44ES010752-02]
NR 21
TC 47
Z9 50
U1 0
U2 6
PU WILEY-LISS
PI HOBOKEN
PA DIV JOHN WILEY & SONS INC, 111 RIVER ST, HOBOKEN, NJ 07030 USA
SN 0893-6692
J9 ENVIRON MOL MUTAGEN
JI Environ. Mol. Mutagen.
PY 2004
VL 44
IS 5
BP 427
EP 435
DI 10.1002/em.20075
PG 9
WC Environmental Sciences; Genetics & Heredity; Toxicology
SC Environmental Sciences & Ecology; Genetics & Heredity; Toxicology
GA 886MN
UT WOS:000226231600009
PM 15517570
ER
PT J
AU Chapin, RE
Robbins, WA
Schieve, LA
Sweeney, AM
Tabacova, SA
Tomashek, KM
AF Chapin, RE
Robbins, WA
Schieve, LA
Sweeney, AM
Tabacova, SA
Tomashek, KM
TI Off to a good start: The influence of pre- and periconceptional
exposures, parental fertility, and nutrition on children's health
SO ENVIRONMENTAL HEALTH PERSPECTIVES
LA English
DT Review
DE birth defects; chemical exposure; conception; fertilization; review
ID IN-VITRO FERTILIZATION; INTRACYTOPLASMIC SPERM INJECTION; NEURAL-TUBE
DEFECTS; ASSISTED REPRODUCTIVE TECHNOLOGY; DIOXIN-LIKE CHEMICALS;
GREAT-LAKES FISH; LOW-BIRTH-WEIGHT; FIRST CELL-CYCLE;
POLYCHLORINATED-BIPHENYLS; SEMINAL PLASMA
AB The scientific community is developing a compelling body of evidence that shows the importance of the in utero environment (including chemical and hormonal levels) to the ultimate health of the child and even of the aging adult. This article summarizes the evidence that shows this impact begins with conception. Only a full life-cycle evaluation will help us understand these impacts, and only such an understanding will produce logically prioritized mitigation strategies to address the greatest threats first. Clearly, the time for analysis begins when the next generation is but a twinkle in the eye.
C1 Pfizer R&D, Groton, CT 06340 USA.
Univ Calif Los Angeles, Ctr Environm & Occupat Hlth, Los Angeles, CA USA.
Ctr Dis Control & Prevent, Div Reprod Hlth, Atlanta, GA USA.
Texas A&M Univ, Syst Hlth Sci Ctr, Dept Epidemiol & Biostat, Sch Publ Hlth, College Stn, TX 77843 USA.
US FDA, Natl Ctr Toxicol Res, Rockville, MD 20857 USA.
Ctr Dis Control & Prevent, Maternal & Infant Hlth Branch, Atlanta, GA USA.
RP Chapin, RE (reprint author), Pfizer R&D, Eastern Point Rd,MS8274-1336, Groton, CT 06340 USA.
EM robert_e_chapin@groton.pfizer.com
OI Chapin, Robert/0000-0002-5997-1261
NR 211
TC 44
Z9 46
U1 1
U2 6
PU US DEPT HEALTH HUMAN SCIENCES PUBLIC HEALTH SCIENCE
PI RES TRIANGLE PK
PA NATL INST HEALTH, NATL INST ENVIRONMENTAL HEALTH SCIENCES, PO BOX 12233,
RES TRIANGLE PK, NC 27709-2233 USA
SN 0091-6765
J9 ENVIRON HEALTH PERSP
JI Environ. Health Perspect.
PD JAN
PY 2004
VL 112
IS 1
BP 69
EP 78
DI 10.1289/ehp.6261
PG 10
WC Environmental Sciences; Public, Environmental & Occupational Health;
Toxicology
SC Environmental Sciences & Ecology; Public, Environmental & Occupational
Health; Toxicology
GA 761NH
UT WOS:000187914500043
PM 14698934
ER
PT J
AU Garber, EAE
Erb, JL
Magner, J
Larsen, G
AF Garber, EAE
Erb, JL
Magner, J
Larsen, G
TI Low levels of sodium and potassium in the water from wetlands in
minnesota that contained malformed frogs affect the rate of Xenopus
development
SO ENVIRONMENTAL MONITORING AND ASSESSMENT
LA English
DT Article
DE frog embryo teratogenesis assay : xenopus (FETAX); frog malformations;
Minnesota; potassium; sodium
ID EMBRYO TERATOGENESIS ASSAY; LIMB MALFORMATIONS; RANA-PIPIENS; POPULATION
DECLINES; POND WATER; UV-B; LAEVIS; FETAX; METAMORPHOSIS; DEFORMITIES
AB Water samples were collected between 1999 and 2000 from wetlands in Minnesota that contained malformed frogs. The water samples were analyzed for 14 minerals/ions and screened for the presence of biologically active compounds using Xenopus laevis. Results indicated that water from two sites, CWB and ROI2, induced severe retardation with embryo lengths reduced 20% after 96 hr of development. The developmental delay observed with water from ROI2 was alleviated by supplementation with sodium, while both sodium and potassium alleviated the developmental delay observed with water whose mineral content mimicked that of CWB. Seasonal fluctuations in the sodium and potassium content at ROI2 and NEY correlated with changes in the rates of Xenopus development. Xenopus embryos reared on water from ROI2 for 120 hr displayed gut malformations not present in embryos reared on a synthetic media designed to mimic the mineral content of the water from ROI2. Embryos reared on water from ROI2 supplemented with minerals at levels comparable to that routinely employed in the rearing of Xenopus were neither retarded nor malformed. It is proposed that climate driven hydrology may influence the mineral composition at selected wetlands and delay development which may alter window(s) of susceptibility towards biologically active agents and the occurrence of malformed frogs.
C1 ARS, USDA, Biosci Res Lab, Fargo, ND USA.
ThreeFold Sensors, Ann Arbor, MI USA.
Minnesota Pollut Control Agcy, St Paul, MN USA.
RP Garber, EAE (reprint author), US FDA, Div Nat Prod, Ctr Food Safety & Appl Nutr, 5100 Paint Branch Pkwy,HFS-315, College Pk, MD 20740 USA.
NR 41
TC 5
Z9 5
U1 1
U2 6
PU KLUWER ACADEMIC PUBL
PI DORDRECHT
PA VAN GODEWIJCKSTRAAT 30, 3311 GZ DORDRECHT, NETHERLANDS
SN 0167-6369
J9 ENVIRON MONIT ASSESS
JI Environ. Monit. Assess.
PD JAN
PY 2004
VL 90
IS 1-3
BP 45
EP 64
DI 10.1023/B:EMAS.0000003565.25474.8f
PG 20
WC Environmental Sciences
SC Environmental Sciences & Ecology
GA 744CP
UT WOS:000186610600003
PM 15887362
ER
PT J
AU Buzatu, DA
Beger, RD
Wilkes, JG
Lay, JO
AF Buzatu, DA
Beger, RD
Wilkes, JG
Lay, JO
TI Predicting toxic equivalence factors from C-13 nuclear magnetic
resonance spectra for dioxins, furans, and polychlorinated biphenyls
using linear and nonlinear pattern recognition methods
SO ENVIRONMENTAL TOXICOLOGY AND CHEMISTRY
LA English
DT Article
DE dioxin; spectroscopic data-activity relationship
ID NMR; BINDING; MODELS; PCBS; DIBENZOFURANS; MIXTURES; SVALBARD
AB Two quantitative spectrometric data-activity relationships (QSDAR) models have been developed relating 29 dioxin or dioxin-like molecules to their toxic equivalence factors (TEFs). These models were based on patterns in simulated C-13 nuclear magnetic resonance (NMR) data with the patterns defined by comparative spectral analysis (CoSA). Two versions of CoSA multiple linear regression (MLR) models using 7 or 10 spectral bins had, respectively, explained variances (r(2)) of 0.88 and 0.95, and leave-one-out (LOO) cross-validated variances (q(2)) of 0.78 and 0.88. A third, artificial neural network model-using a feed forward, back propagating, three-layer neural network-produced an r(2) of 0.99, a LOO q(2) of 0.82, and a leave-three-out q(2) of 0.81. A postulated reason that the results of these QSDAR models are better than traditional quantitative structure-activity relationship QSAR) models is based on the difference in descriptors rather than on any differences in pattern recognition approach. Results suggest that the C-13 NMR spectral data contain molecular quantum mechanical information more reflective of each molecule's biochemical properties than do the calculated electrostatic potentials and molecular alignment assumptions used in developing QSAR models. The QSDAR models provide a rapid, simple way to model the toxicity of dioxin and dioxin-like compounds.
C1 US FDA, Natl Ctr Toxicol Res, Div Chem, Jefferson, AR 72079 USA.
RP Buzatu, DA (reprint author), US FDA, Natl Ctr Toxicol Res, Div Chem, Jefferson, AR 72079 USA.
EM dbuzatu@nctr.fda.gov
RI Lay, Jackson/G-1007-2011
OI Lay, Jackson/0000-0003-3789-2527
NR 37
TC 4
Z9 4
U1 0
U2 9
PU SETAC
PI PENSACOLA
PA 1010 NORTH 12TH AVE, PENSACOLA, FL 32501-3367 USA
SN 0730-7268
J9 ENVIRON TOXICOL CHEM
JI Environ. Toxicol. Chem.
PD JAN
PY 2004
VL 23
IS 1
BP 24
EP 31
DI 10.1897/02-516
PG 8
WC Environmental Sciences; Toxicology
SC Environmental Sciences & Ecology; Toxicology
GA 761JF
UT WOS:000187897200005
PM 14768863
ER
PT J
AU Roecklein, BA
Kupferburg, HJ
Mortko, H
Hartman, N
Strong, J
AF Roecklein, BA
Kupferburg, HJ
Mortko, H
Hartman, N
Strong, J
TI Metabolism of fluorofelbamate differs from that of felbamate
SO EPILEPSIA
LA English
DT Meeting Abstract
CT Annual Meeting of the American-Epilepsy-Society
CY DEC 03-07, 2004
CL New Orlands, LA
SP Amer Epilepsy Soc
C1 MedPointe Pharmaceut, Med Marketing, Somerset, NJ USA.
US FDA, CDER, Silver Spring, MD USA.
NR 0
TC 0
Z9 0
U1 0
U2 0
PU BLACKWELL PUBLISHING INC
PI MALDEN
PA 350 MAIN ST, MALDEN, MA 02148 USA
SN 0013-9580
J9 EPILEPSIA
JI Epilepsia
PY 2004
VL 45
SU 7
BP 135
EP 136
PG 2
WC Clinical Neurology
SC Neurosciences & Neurology
GA 861MG
UT WOS:000224420100398
ER
PT J
AU Zhang, W
Wang, TG
Qin, LY
Gao, HM
Wilson, B
Ali, SF
Zhang, WQ
Hong, JS
Liu, B
AF Zhang, W
Wang, TG
Qin, LY
Gao, HM
Wilson, B
Ali, SF
Zhang, WQ
Hong, JS
Liu, B
TI Neuroprotective effect of dextromethorphan in the MPTP Parkinson's
disease model: role of NADPH oxidase
SO FASEB JOURNAL
LA English
DT Article
DE reactive oxygen species; microglia; dopamine; substantia nigra;
morphinan
ID INJURY FOLLOWING TRANSIENT; DOPAMINERGIC-NEURONS; FOCAL ISCHEMIA;
NITRIC-OXIDE; MICROGLIAL ACTIVATION; SUPEROXIDE PRODUCTION; GLUTAMATE
TOXICITY; TETRAZOLIUM SALT; MOUSE MODEL; PROTECTS
AB Parkinson's disease (PD) is a neurodegenerative movement disorder characterized by a progressive loss of dopaminergic neurons in the substantia nigra and depletion of the neurotransmitter dopamine in the striatum. Progress in the search for effective therapeutic strategies that can halt this degenerative process remains limited. Mechanistic studies using animal systems such as the 1-methyl-4-phenyl-1,2,3,6-tetrahydropyridine (MPTP) rodent PD model have revealed the involvement of the brain's immune cells and free radical-generating processes. We recently reported that dextromethorphan (DM), a widely used anti-tussive agent, attenuated endotoxin-induced dopaminergic neurodegeneration in vitro. In the current study, we investigated the potential neuroprotective effect of DM and the underlying mechanism of action in the MPTP rodent PD model. Mice (C57BL/6J) that received daily MPTP injections (15 mg free base/kg body weight, s.c.) for 6 consecutive days exhibited significant degeneration of the nigrostriatal dopaminergic pathway. However, the MPTP-induced loss of nigral dopaminergic neurons was significantly attenuated in those mice receiving DM (10 mg/kg body weight, s.c.). In mesencephalic neuron-glia cultures, DM significantly reduced the MPTP-induced production of both extracellular superoxide free radicals and intracellular reactive oxygen species (ROS). Because NADPH oxidase is the primary source of extracellular superoxide and intracellular ROS, we investigated the involvement of NADPH oxidase in the neuroprotective effect of DM. Indeed, the neuroprotective effect of DM was only observed in the wild-type but not in the NADPH oxidase-deficient mice, indicating that NADPH oxidase is a critical mediator of the neuroprotective activity of DM. More importantly, due to its proven safety record of long-term clinical use in humans, DM may be a promising agent for the treatment of degenerative neurological disorders such as PD.
C1 Univ Florida, Coll Pharm, Dept Pharmacodynam, Gainesville, FL 32610 USA.
NIEHS, Lab Pharmacol & Chem, Res Triangle Pk, NC 27709 USA.
First Clin Hosp, Dept Neurol, Dalian, Peoples R China.
Dalian Med Univ, Dept Physiol, Dalian, Peoples R China.
US FDA, Neurochem Lab, Natl Ctr Toxicol Res, Jefferson, AR 72079 USA.
RP Liu, B (reprint author), Univ Florida, Coll Pharm, Dept Pharmacodynam, Box 100487 HSC, Gainesville, FL 32610 USA.
EM liu@cop.ufl.edu
RI gao, huiming/C-8454-2012; liu, Bin/A-7695-2009
NR 47
TC 116
Z9 120
U1 0
U2 8
PU FEDERATION AMER SOC EXP BIOL
PI BETHESDA
PA 9650 ROCKVILLE PIKE, BETHESDA, MD 20814-3998 USA
SN 0892-6638
EI 1530-6860
J9 FASEB J
JI Faseb J.
PD JAN
PY 2004
VL 18
IS 1
BP 589
EP +
DI 10.0983/fj.03-0983fje
PG 21
WC Biochemistry & Molecular Biology; Biology; Cell Biology
SC Biochemistry & Molecular Biology; Life Sciences & Biomedicine - Other
Topics; Cell Biology
GA 772EX
UT WOS:000188829300001
PM 14734632
ER
PT J
AU Kroes, R
Renwick, AG
Cheeseman, M
Kleiner, J
Mangelsdorf, I
Piersma, A
Schilter, B
Schlatter, J
van Schothorst, F
Vos, JG
Wurtzen, G
AF Kroes, R
Renwick, AG
Cheeseman, M
Kleiner, J
Mangelsdorf, I
Piersma, A
Schilter, B
Schlatter, J
van Schothorst, F
Vos, JG
Wurtzen, G
TI Structure-based thresholds of toxicological concern (TTC): guidance for
application to substances present at low levels in the diet
SO FOOD AND CHEMICAL TOXICOLOGY
LA English
DT Article
DE risk assessment; threshold of toxicological concern (TTC);
carcinogenicity; neurotoxicity; teratogenicity; exposure; de Minimis
Risk; toxicity; food safety
ID CARCINOGENIC POTENCY DATABASE; DEVELOPMENTAL TOXICITY; PRENATAL
TOXICITY; BORIC-ACID; CHOLINESTERASE INHIBITION; GENERAL LITERATURE;
LITHIUM-CARBONATE; WISTAR RAT; CD-1 MOUSE; TERATOGENICITY
AB The threshold of toxicological concern (TTC) is a pragmatic risk assessment tool that is based on the principle of establishing a human exposure threshold value for all chemicals, below which there is a very low probability of an appreciable risk to human health. The concept that there are levels of exposure that do not cause adverse effects is inherent in setting acceptable daily intakes (ADIs) for chemicals with known toxicological profiles. The TTC principle extends this concept by proposing that a de minimis value can be identified for many chemicals, in the absence of a full toxicity database, based on their chemical structures and the known toxicity of chemicals which share similar structural characteristics. The establishment and application of widely accepted TTC values would benefit consumers, industry and regulators. By avoiding unnecessary toxicity testing and safety evaluations when human intakes are below such a threshold, application of the TTC approach would focus limited resources of time, cost, animal use and expertise on the testing and evaluation of substances with the greatest potential to pose risks to human health and thereby contribute to a reduction in the use of animals. An Expert Group of the European branch of the International Life Sciences Institute-ILSI Europe-has examined the TTC principle for its wider applicability in food safety evaluation. The Expert Group examined metabolism and accumulation, structural alerts, endocrine disrupting chemicals and specific endpoints, such as neurotoxicity, teratogenicity, developmental toxicity, allergenicity and immunotoxicity, and determined whether such properties or endpoints had to be taken into consideration specifically in a step-wise approach. The Expert Group concluded that the TTC principle can be applied for low concentrations in food of chemicals that lack toxicity data, provided that there is a sound intake estimate. The use of a decision tree to apply the TTC principle is proposed, and this paper describes the step-wise process in detail. Proteins, heavy metals and polyhalogenated-dibenzodioxins and related compounds were excluded from this approach. When assessing a chemical, a review of prior knowledge and context of use should always precede the use of the TTC decision tree. The initial step is the identification and evaluation of possible genotoxic and/or high potency carcinogens. Following this step, non-genotoxic substances are evaluated in a sequence of steps related to the concerns that would be associated with increasing intakes. For organophosphates a TTC of 18mug per person per day (0.3 mug/kg bw/day) is proposed, and when the compound is not an OP, the TTC values for the Cramer structural classes III, II and I, with their respective TTC levels (e.g. 1800, 540 and 90 mug per person per day; or 30, 9 and 1.5 mug/kg bw /day), would be applied sequentially. All other endpoints or properties were shown to have a distribution of no observed effect levels (NOELs) similar to the distribution of NOELs for general toxicity endpoints in Cramer classes I, II and III. The document was discussed with a wider audience during a workshop held in March 2003 (see list of workshop participants). (C) 2003 Published by Elsevier Ltd.
C1 ILSI Europe, B-1200 Brussels, Belgium.
Univ Utrecht, Inst Risk Assessment Sci, Fac Med Vet, NL-3508 TD Utrecht, Netherlands.
Univ Southampton, Clin Pharmacol Grp, Sch Med, Southampton SO16 7PX, Hants, England.
Food & Drug Adm, Food Contact Div, Washington, DC 20204 USA.
Fraunhofer Inst Toxicol & Aerosol Res, Dept Chem Risk Assessment, D-30625 Hannover, Germany.
Natl Inst Publ Hlth & Environm, NL-3720 BA Bilthoven, Netherlands.
Nestle Res Ctr, CH-1000 Lausanne 26, Switzerland.
Swiss Fed Off Publ Hlth, Food Toxicol Sect, CH-8004 Zurich, Switzerland.
Coca Cola Nord & Balt Div, DK-2900 Hellerup, Denmark.
RP Kleiner, J (reprint author), ILSI Europe, Ave E Mounier 83,Box 6, B-1200 Brussels, Belgium.
EM publications@ilsieurope.be
NR 85
TC 290
Z9 304
U1 10
U2 58
PU PERGAMON-ELSEVIER SCIENCE LTD
PI OXFORD
PA THE BOULEVARD, LANGFORD LANE, KIDLINGTON, OXFORD OX5 1GB, ENGLAND
SN 0278-6915
J9 FOOD CHEM TOXICOL
JI Food Chem. Toxicol.
PD JAN
PY 2004
VL 42
IS 1
BP 65
EP 83
DI 10.1016/j.fct.2003.08.006
PG 19
WC Food Science & Technology; Toxicology
SC Food Science & Technology; Toxicology
GA 763XU
UT WOS:000188126400008
PM 14630131
ER
PT J
AU Basile, EM
Gross, M
AF Basile, EM
Gross, M
TI The First Amendment and federal court deference to the Food and Drug
Administration: The times they are a-changin
SO FOOD AND DRUG LAW JOURNAL
LA English
DT Article
C1 King & Spalding LLP, Washington, DC USA.
FDA Practice Grp, Washington, DC USA.
Howard Univ, Sch Law, Washington, DC USA.
RP Basile, EM (reprint author), King & Spalding LLP, Washington, DC USA.
NR 6
TC 1
Z9 1
U1 1
U2 1
PU FOOD DRUG LAW INST
PI WASHINGTON
PA 1000 VERMONT AVE NW, SUITE 1200, WASHINGTON, DC 20005-4903 USA
SN 1064-590X
J9 FOOD DRUG LAW J
JI Food Drug Law J.
PY 2004
VL 59
IS 1
BP 31
EP 44
PG 14
WC Food Science & Technology; Law; Nutrition & Dietetics; Pharmacology &
Pharmacy
SC Food Science & Technology; Government & Law; Nutrition & Dietetics;
Pharmacology & Pharmacy
GA 826EH
UT WOS:000221811600002
PM 15190924
ER
PT J
AU Crawford, LM
AF Crawford, LM
TI Remarks of the acting FDA commissioner: FDLI's 47th Annual Conference
SO FOOD AND DRUG LAW JOURNAL
LA English
DT Article
C1 US FDA, Rockville, MD 20857 USA.
RP Crawford, LM (reprint author), US FDA, Rockville, MD 20857 USA.
NR 2
TC 1
Z9 1
U1 0
U2 0
PU FOOD DRUG LAW INST
PI WASHINGTON
PA 1000 VERMONT AVE NW, SUITE 1200, WASHINGTON, DC 20005-4903 USA
SN 1064-590X
J9 FOOD DRUG LAW J
JI Food Drug Law J.
PY 2004
VL 59
IS 2
BP 201
EP 208
PG 8
WC Food Science & Technology; Law; Nutrition & Dietetics; Pharmacology &
Pharmacy
SC Food Science & Technology; Government & Law; Nutrition & Dietetics;
Pharmacology & Pharmacy
GA 843CF
UT WOS:000223052400001
PM 15318391
ER
PT J
AU Pape, SM
Rubin, PD
Kim, H
AF Pape, SM
Rubin, PD
Kim, H
TI Food security would be compromised by combining the food and drug
administration and the US department of agriculture into a single food
agency
SO FOOD AND DRUG LAW JOURNAL
LA English
DT Article
C1 Patton Boggs LLP, FDA Practice Grp, Washington, DC USA.
RP Pape, SM (reprint author), Patton Boggs LLP, FDA Practice Grp, Washington, DC USA.
NR 13
TC 1
Z9 2
U1 0
U2 1
PU FOOD DRUG LAW INST
PI WASHINGTON
PA 1000 VERMONT AVE NW, SUITE 1200, WASHINGTON, DC 20005-4903 USA
SN 1064-590X
J9 FOOD DRUG LAW J
JI Food Drug Law J.
PY 2004
VL 59
IS 3
BP 405
EP 416
PG 12
WC Food Science & Technology; Law; Nutrition & Dietetics; Pharmacology &
Pharmacy
SC Food Science & Technology; Government & Law; Nutrition & Dietetics;
Pharmacology & Pharmacy
GA 862UL
UT WOS:000224516500005
PM 15586990
ER
PT J
AU Klamt, F
Shacter, E
AF Klamt, F
Shacter, E
TI Taurine chloramine treatment activates mitochondria-dependent programmed
cell death in human B lymphoma cells
SO FREE RADICAL BIOLOGY AND MEDICINE
LA English
DT Meeting Abstract
CT 11th Annual Meeting of the Society-for-Free-Radical-Biology-and-Medicine
CY NOV 17-21, 2004
CL St Thomas, VI
SP Soc Free Rad Biol & Med
C1 US FDA, Ctr Drug Evaluat & Res, Rockville, MD 20857 USA.
NR 0
TC 0
Z9 0
U1 0
U2 1
PU PERGAMON-ELSEVIER SCIENCE LTD
PI OXFORD
PA THE BOULEVARD, LANGFORD LANE, KIDLINGTON, OXFORD OX5 1GB, ENGLAND
SN 0891-5849
J9 FREE RADICAL BIO MED
JI Free Radic. Biol. Med.
PY 2004
VL 37
SU 1
BP S126
EP S126
PG 1
WC Biochemistry & Molecular Biology; Endocrinology & Metabolism
SC Biochemistry & Molecular Biology; Endocrinology & Metabolism
GA 875YK
UT WOS:000225458900388
ER
PT J
AU Shabalina, SA
Spiridonov, NA
AF Shabalina, SA
Spiridonov, NA
TI The mammalian transcriptome and the function of non-coding DNA sequences
SO GENOME BIOLOGY
LA English
DT Editorial Material
ID MATRIX-ATTACHMENT REGIONS; RNA UNTRANSLATED REGIONS; PRE-MESSENGER-RNA;
INTERGENIC REGIONS; HUMAN GENOME; TRANSLATION INITIATION; SELECTIVE
CONSTRAINT; CONSERVED SEQUENCES; POLYADENYLATED RNA; EXPRESSED GENES
AB For decades, researchers have focused most of their attention on protein-coding genes and proteins. With the completion of the human and mouse genomes and the accumulation of data on the mammalian transcriptome, the focus now shifts to non-coding DNA sequences, RNA-coding genes and their transcripts. Many non-coding transcribed sequences are proving to have important regulatory roles, but the functions of the majority remain mysterious.
C1 NIH, Natl Ctr Biotechnol Informat, Natl Lib Med, Bethesda, MD 20894 USA.
US FDA, Div Therapeut Prot, Ctr Drug Evaluat & Res, Bethesda, MD 20892 USA.
RP Shabalina, SA (reprint author), NIH, Natl Ctr Biotechnol Informat, Natl Lib Med, Bethesda, MD 20894 USA.
EM shabalin@ncbi.nlm.nih.gov
RI Shabalina, Svetlana/N-8939-2013; Spiridonov, Nikolay/B-6287-2014
OI Shabalina, Svetlana/0000-0003-2272-7473;
NR 73
TC 76
Z9 86
U1 0
U2 5
PU BIOMED CENTRAL LTD
PI LONDON
PA 236 GRAYS INN RD, FLOOR 6, LONDON WC1X 8HL, ENGLAND
SN 1474-760X
J9 GENOME BIOL
JI Genome Biol.
PY 2004
VL 5
IS 4
AR 105
DI 10.1186/gb-2004-5-4-105
PG 8
WC Biotechnology & Applied Microbiology; Genetics & Heredity
SC Biotechnology & Applied Microbiology; Genetics & Heredity
GA 808QX
UT WOS:000220584700002
PM 15059247
ER
PT J
AU Kessler, L
Ramsey, SD
Tunis, S
Sullivan, SD
AF Kessler, L
Ramsey, SD
Tunis, S
Sullivan, SD
TI From the field - Clinical use of medical devices in the 'Bermuda
Triangle'
SO HEALTH AFFAIRS
LA English
DT Article
ID PULMONARY-ARTERY CATHETERIZATION; VOLUME-REDUCTION SURGERY;
CRITICALLY-ILL PATIENTS; LUNG-VOLUME; RANDOMIZED-TRIAL; SEVERE
EMPHYSEMA; CANCER; HEART; CARE
AB The pace of medical technological development shows no sign of abating. Analyzing the effect of major federal health agencies on the availability of such technology is critical. This paper describes functions of three government health agencies: the Centers for Medicare and Medicaid Services (CMS), the Food and Drug Administration (FDA), and the National Institutes of Health (NIH). Certain medical technologies fall into gaps between these agencies, which pose challenges in today's era of demand for evidence-based medicine. We suggest new policy and pragmatic strategies that can close the gaps and move decision making relevant to technology forward more rapidly than is now the case.
C1 US FDA, Off Sci & Technol, Rockville, MD 20857 USA.
Fred Hutchinson Canc Res Ctr, Seattle, WA 98104 USA.
Ctr Medicare & Medicaid Serv, Baltimore, MD USA.
Washington Univ, Pharm & Hlth Serv, Seattle, WA USA.
Washington Univ, Pharm Outcomes Res & Policy Program, Seattle, WA USA.
RP Kessler, L (reprint author), US FDA, Off Sci & Technol, Rockville, MD 20857 USA.
NR 34
TC 18
Z9 19
U1 1
U2 3
PU PROJECT HOPE
PI BETHESDA
PA 7500 OLD GEORGETOWN RD, STE 600, BETHESDA, MD 20814-6133 USA
SN 0278-2715
J9 HEALTH AFFAIR
JI Health Aff.
PD JAN-FEB
PY 2004
VL 23
IS 1
BP 200
EP 207
DI 10.1377/hlthaff.23.1.200
PG 8
WC Health Care Sciences & Services; Health Policy & Services
SC Health Care Sciences & Services
GA 761KH
UT WOS:000187907600025
PM 15002643
ER
PT S
AU Brackett, RE
AF Brackett, RE
BE Looney, NE
TI Safety of fresh produce: Why is this such an issue today?
SO HORTICULTURE: ART AND SCIENCE FOR LIFE
SE ACTA HORTICULTURAE
LA English
DT Proceedings Paper
CT 26th International Horticultural Congress
CY AUG 11-17, 2002
CL TORONTO, CANADA
SP Canadian Soc Hort Sci, Int Soc Hort Sci, Univ Guelph
DE good agricultural practices; food-borne disease; sources of
contamination; and factors associated with product source; distribution
and storage; life style and population demographics; pathogen virulence;
disease monitoring and reporting; and consumer awareness
AB Although some of the apparent increase in food-borne illnesses associated with fresh produce is likely a result of better surveillance and reporting, there does appear to be a real increase in the number of cases. However, this does not necessarily mean that there is an absolute increase in the likelihood of any individual fresh produce item causing illness. Rather, increased consumption of fresh produce, diverse sources and complex distribution systems, the sources and types of food-borne pathogens. and demographic and societal changes we are experiencing combine to increase the risk of encountering a food-borne disease. However, solutions do exist and fresh produce can be made safer with appropriate research, technology, and education.
C1 US FDA, Ctr Food Safety & Appl Nutr, College Pk, MD 20740 USA.
RP Brackett, RE (reprint author), US FDA, Ctr Food Safety & Appl Nutr, 5100 Paint Branch Pkwy,HFS-001, College Pk, MD 20740 USA.
NR 2
TC 0
Z9 0
U1 0
U2 1
PU INTERNATIONAL SOCIETY HORTICULTURAL SCIENCE
PI LEUVEN 1
PA PO BOX 500, 3001 LEUVEN 1, BELGIUM
SN 0567-7572
BN 90-6605-217-1
J9 ACTA HORTIC
PY 2004
IS 642
BP 137
EP 144
PG 8
WC Horticulture
SC Agriculture
GA BBM82
UT WOS:000226246800015
ER
PT J
AU Lee, SJ
Badano, A
Kanicki, J
AF Lee, SJ
Badano, A
Kanicki, J
TI Monte Carlo modeling of the light transport in polymer light-emitting
devices on plastic substrates
SO IEEE JOURNAL OF SELECTED TOPICS IN QUANTUM ELECTRONICS
LA English
DT Article
DE Monte Carlo simulation; out-coupling efficiency; plastic substrate;
polymer light-emitting devices
ID QUANTUM EFFICIENCY; EMISSION; DIODES
AB A Monte Carlo method for modeling the light transport phenomena organic polymer light-emitting devices (PLEDs) has been reported previously (Badano and Kanicki, 2001). The advantage of this simulation method is its ability to model bulk absorption, thin-film coatings, and uneven or irregular surfaces by tracking the photon polarization in realistic device structures. We have applied this method to analyze the PLEDs spectral outputs and out-coupling efficiencies. We have established that the calculated out-coupling efficiencies are approximately the same (eta(coup) similar to 0.2) for the red and green PLEDs. Using a description of uneven surfaces with Fresnel analysis, we showed that the nonsmooth interfaces (as modeled by the algorithm for uneven surfaces) between light-emitting polymer and hole transporting layer increase the probabilities of out-coupling and wave-guiding of the internally generated light. In this paper, we use this method to calculate the angular distribution of the PLED light-emission. We found that the Monte Carlo simulated PLED light-emission angular distribution shows better agreement with the experimental data than previously used models relying on standard refraction theory at one interface [2].
C1 Univ Michigan, Macromol Sci & Engn & Solid State Elect Lab, Coll Engn, Dept Elect Engn & Comp Sci, Ann Arbor, MI 48109 USA.
US FDA, Div Imaging & Appl Math, Off Sci & Engn Labs, Ctr Devices & Radiol Hlth, Rockville, MD 20857 USA.
Univ Calif Santa Barbara, Ctr Polymers & Organ Solids, Santa Barbara, CA 93106 USA.
RP Lee, SJ (reprint author), Univ Michigan, Macromol Sci & Engn & Solid State Elect Lab, Coll Engn, Dept Elect Engn & Comp Sci, Ann Arbor, MI 48109 USA.
EM kanicki@eecs.umich.edu
RI Kanicki, Jerzy/E-2753-2016;
OI Kanicki, Jerzy/0000-0002-3649-8360; badano, aldo/0000-0003-3712-6670
NR 25
TC 10
Z9 10
U1 1
U2 4
PU IEEE-INST ELECTRICAL ELECTRONICS ENGINEERS INC
PI PISCATAWAY
PA 445 HOES LANE, PISCATAWAY, NJ 08855 USA
SN 1077-260X
J9 IEEE J SEL TOP QUANT
JI IEEE J. Sel. Top. Quantum Electron.
PD JAN-FEB
PY 2004
VL 10
IS 1
BP 37
EP 44
DI 10.1109/JSTQE.2004.824073
PG 8
WC Engineering, Electrical & Electronic; Optics; Physics, Applied
SC Engineering; Optics; Physics
GA 813KI
UT WOS:000220905600007
ER
PT J
AU Jakubzick, C
Kunkel, SL
Puri, RK
Hogaboam, CM
AF Jakubzick, C
Kunkel, SL
Puri, RK
Hogaboam, CM
TI Therapeutic targeting of IL-4- and IL-13-responsive cells in pulmonary
fibrosis
SO IMMUNOLOGIC RESEARCH
LA English
DT Article
DE idiopathic pulmonary fibrosis; IL-13; IL-4; IL-13 receptor; IL-4
receptor
ID NONSPECIFIC INTERSTITIAL PNEUMONIA; MONOCYTE CHEMOATTRACTANT PROTEIN-1;
HUMAN LUNG FIBROBLASTS; INTERFERON GAMMA-1B; SIGNAL-TRANSDUCTION; SKIN
FIBROBLASTS; IMMUNE-RESPONSE; GENE-EXPRESSION; NECK-CANCER; IL-13
AB Severe forms of idiopathic interstitial pneumonia (IIP), such as usual interstitial pneumonia (UIP), can be impervious to modern steroid and immunosuppressive treatment regimens, thereby emphasizing the need for novel effective therapies. Understanding the cytokine networks that may affect immune and structural cell activation and, hence, the progression of these fatal fibrotic diseases, has been a focus in our research. In this regard, we have examined the role of interleukin (IL)-4 and IL-13 and their respective receptor subunits in this process. Examination of clinical surgical lung biopsies (SLBs) showed that IIP is characterized by the abnormal, heightened expression of the receptor subunits that bind IL-4 and IL-13. Specifically, IL-4Ralpha and IL-13Ralpha2 (the high-affinity IL-13 receptor subunit) was present in greater abundance in SLBs and fibroblasts from IIP patients compared with normal patients, who exhibited no evidence of pulmonary fibrosis. These clinical findings prompted us to investigate whether the targeting Of Pulmonary cell types that were highly responsive to IL-4 and IL-13 was a viable therapeutic option in IIP. Using a chimeric protein comprised of human IL-13 and a truncated version of an exotoxin from Pseudomonas (abbreviated IL13-PE), we observed that IL13-PE selectively targeted human pulmonary fibroblasts grown from IIP SLBs, whereas it had a minimal effect on fibroblasts grown from biopsies from normal patients. In murine models characterized by abnormal airway or interstitial fibrotic responses, the intranasal administration of IL13-PE significantly attenuated the fibrotic response through the targeting of IL-4Ralpha- and IL-13Ralpha2-expressing pulmonary cells, including monocytes, macrophages, and pulmonary fibroblasts. Together, these data demonstrate that IL-4 and IL-13 are required for the initiation and maintenance of pulmonary fibrosis, and highlight the importance of further investigation of anti-fibrotic therapeutics that prevent the action of both cytokines during clinical pulmonary fibrosis.
C1 Univ Michigan, Sch Med, Dept Pathol, Ann Arbor, MI 48109 USA.
US FDA, Lab Mol Tumor Biol, Div Cellular & Gene Therapies, Ctr Biol Evaluat & Res, Bethesda, MD 20014 USA.
RP Hogaboam, CM (reprint author), Univ Michigan, Sch Med, Dept Pathol, Rm 5216B,Med Sci 1,1303 Catherine Rd, Ann Arbor, MI 48109 USA.
EM Hogaboam@med.umich.edu
RI hogaboam, cory /M-3578-2014
FU NIAID NIH HHS [T32 AI007413]
NR 65
TC 48
Z9 53
U1 0
U2 3
PU HUMANA PRESS INC
PI TOTOWA
PA 999 RIVERVIEW DRIVE SUITE 208, TOTOWA, NJ 07512 USA
SN 0257-277X
J9 IMMUNOL RES
JI Immunol. Res.
PY 2004
VL 30
IS 3
BP 339
EP 349
DI 10.1385/IR:30:3:339
PG 11
WC Immunology
SC Immunology
GA 870TR
UT WOS:000225081700006
PM 15531774
ER
PT J
AU Coban, C
Ishii, KJ
Stowers, AW
Keister, DB
Klinman, DM
Kumar, N
AF Coban, C
Ishii, KJ
Stowers, AW
Keister, DB
Klinman, DM
Kumar, N
TI Effect of CpG oligodeoxynucleotides on the immunogenicity of Pfs25, a
Plasmodium falciparum transmission-blocking vaccine antigen
SO INFECTION AND IMMUNITY
LA English
DT Article
ID MEROZOITE SURFACE PROTEIN-1; IMMUNE-RESPONSES; SYNTHETIC
OLIGODEOXYNUCLEOTIDES; MALARIA VACCINE; BACTERIAL-DNA; CUTTING EDGE;
ANTIBODIES; ADJUVANTS; MOTIFS; MICE
AB Antibodies directed against Pfs25, a protein present on the surface of zygotes and ookinetes of Plasmodium falciparum, completely block pathogen transmission. We evaluated the immunomodulatory effect of CpG oligodeoxynucleotides (ODN) on the immunogenicity of recombinant Pfs25 (rPfs25) formulated in alum (A1). Immunization of mice with rPfs25 plus CpG ODN improved both the antibody titer (a 30-fold-higher antibody response than that with rPfs25-A1 alone) and avidity. Coadministration of CpG ODN dramatically enhanced the titer of immunoglobulin G2A (IgG2a) compared to the titer of the IgG1-dominant response caused by rPfs25-A1 alone, and the sera from the CpG ODN-coadministered group completely blocked the transmission of P. falciparum parasites to mosquitoes, as determined by membrane feeding assays. However, transmission-blocking experiments revealed that blocking efficacy was dependent on high-titer antibody levels, independent of isotypes. These results suggest that CpG ODN can be used as an adjuvant to enhance the immunogenicity of rPfs25 as a malaria transmission-blocking vaccine.
C1 Johns Hopkins Univ, Dept Mol Microbiol & Immunol, Bloomberg Sch Publ Hlth, Malaria Res Inst, Baltimore, MD 21205 USA.
US FDA, Div Viral Prod, Ctr Biol Evaluat & Res, Bethesda, MD 20014 USA.
NIAID, Malaria Vaccine Dev Unit, Parasit Dis Lab, NIH, Rockville, MD USA.
RP Kumar, N (reprint author), Johns Hopkins Univ, Dept Mol Microbiol & Immunol, Bloomberg Sch Publ Hlth, Malaria Res Inst, 615 N Wolfe St, Baltimore, MD 21205 USA.
RI Coban, Cevayir/B-2129-2012; Ishii, Ken/B-1685-2012
OI Ishii, Ken/0000-0002-6728-3872
FU NCRR NIH HHS [M01 RR000722]; NIAID NIH HHS [AI47089, R01 AI047089]
NR 37
TC 21
Z9 24
U1 0
U2 0
PU AMER SOC MICROBIOLOGY
PI WASHINGTON
PA 1752 N ST NW, WASHINGTON, DC 20036-2904 USA
SN 0019-9567
J9 INFECT IMMUN
JI Infect. Immun.
PD JAN
PY 2004
VL 72
IS 1
BP 584
EP 588
DI 10.1128/IAI.72.1.584-588.2004
PG 5
WC Immunology; Infectious Diseases
SC Immunology; Infectious Diseases
GA 758JR
UT WOS:000187631600067
PM 14688140
ER
PT J
AU Fang, GC
Wu, YS
Fu, PPC
Chang, CN
Ho, TT
Chen, MH
AF Fang, GC
Wu, YS
Fu, PPC
Chang, CN
Ho, TT
Chen, MH
TI The study of temple and pastureland particle-bound polycyclic aromatic
hydrocarbons concentrations in central Taiwan
SO INTERNATIONAL JOURNAL OF ENVIRONMENT AND POLLUTION
LA English
DT Article
DE PAH; pastureland; PM2.5; PM2.5-10; PM10; temple
ID PARTICULATE; ATMOSPHERE; AEROSOLS; INDOOR; AIR
AB The concentrations of polycyclic aromatic hydrocarbons in the atmosphere were measured simultaneously at Tzu Yun Yen temple and Tung Hai University pastureland in Taichung, central Taiwan. At both sites, 24 h samplings were performed between August 2001 and December 2001. The results indicated that high molecular mass polycyclic aromatic hydrocarbons are predominant at the Tzu Yun Yen temple sampling site. Moreover, the PM2.5 (fine particulate) fraction of total polycyclic aromatic hydrocarbons was higher than that of the PM2.5-10 (coarse particulate) fraction by a factor of about 1.48 at the temple sampling site. This ratio was 1.24 for the pastureland environment.
C1 Hungkuang Univ, Air Tox & Environm Anal Lab, Taichung 433, Taiwan.
Natl Ctr Toxicol Res, Div Biochem Toxicol, Jefferson, AR 72079 USA.
Tunghai Univ, Dept Environm Sci, Taichung 407, Taiwan.
RP Fang, GC (reprint author), Hungkuang Univ, Air Tox & Environm Anal Lab, Taichung 433, Taiwan.
EM gcfang@sunrise.hk.edu.tw
NR 12
TC 2
Z9 2
U1 0
U2 1
PU INDERSCIENCE ENTERPRISES LTD
PI GENEVA
PA WORLD TRADE CENTER BLDG, 29 ROUTE DE PRE-BOIS, CASE POSTALE 896, CH-1215
GENEVA, SWITZERLAND
SN 0957-4352
J9 INT J ENVIRON POLLUT
JI Int. J. Environ. Pollut.
PY 2004
VL 22
IS 6
BP 688
EP 700
DI 10.1504/IJEP.2004.006049
PG 13
WC Environmental Sciences
SC Environmental Sciences & Ecology
GA 893CF
UT WOS:000226696200004
ER
PT J
AU Fang, GC
Wu, YS
Huang, WJ
Lu, HC
Fu, PPC
Chen, YS
AF Fang, GC
Wu, YS
Huang, WJ
Lu, HC
Fu, PPC
Chen, YS
TI Short-term variations in ambient particulates and their sources in
Taichung, Taiwan
SO INTERNATIONAL JOURNAL OF ENVIRONMENT AND POLLUTION
LA English
DT Article
DE diurnal variation; fine and coarse particulates; PCA; short-term
variation; TSP
ID ATMOSPHERIC AEROSOL; SUSPENDED PARTICLES; SIZE DISTRIBUTION; COARSE
PARTICLES; COASTAL SITE; PM10; URBAN; CALIFORNIA; SUBURBAN; ELEMENTS
AB Ambient particulate measurements were carried out using TE-PUF sampling and a Universal Air Sampler between 8 March and 25 April 2001 at Taichung. Samples were collected every 6 hours beginning at 0100 LST (Local Standard Time) each day at two sites, one at a university campus and the other at a roadside. Chemical species (Cl-, NO3-, SO42-, Na+, NH4+, K+, MgZ(+), Ca2+, Fe, Zn, Pb, Ni) were analysed simultaneously. The main sources at the campus sampling site were identified as soil dust re-suspension, sea salt spray, secondary aerosols and zinc-related industry, and those at the traffic sampling site as soil dust re-suspension, sea salt spray, secondary aerosol and fuel combustion. The diurnal variation of all the chemical species' concentrations were also measured. The meteorological conditions and the pollutant emission sources near the sampling sites are likely impact factors. These results also showed that the short-term diurnal variation of the concentrations of chemical species in the ambient suspended particulates is useful to identify the sources and modes of formation of the particulates.
C1 Hungkuang Univ, Air Tox & Environm Anal Lab, Taichung 433, Taiwan.
Natl Ctr Toxicol Res, Div Biochem Toxicol, Jefferson, AR 72079 USA.
Hungkuang Univ, Dept Food Nutr, Taichung 433, Taiwan.
RP Fang, GC (reprint author), Hungkuang Univ, Air Tox & Environm Anal Lab, Sha Lu, Taichung 433, Taiwan.
EM gcfang@sunrise.hk.edu.tw
NR 23
TC 1
Z9 1
U1 3
U2 5
PU INDERSCIENCE ENTERPRISES LTD
PI GENEVA
PA WORLD TRADE CENTER BLDG, 29 ROUTE DE PRE-BOIS, CASE POSTALE 896, CH-1215
GENEVA, SWITZERLAND
SN 0957-4352
J9 INT J ENVIRON POLLUT
JI Int. J. Environ. Pollut.
PY 2004
VL 21
IS 4
BP 383
EP 399
DI 10.1504/IJEP.2004.005115
PG 17
WC Environmental Sciences
SC Environmental Sciences & Ecology
GA 823NA
UT WOS:000221618500006
ER
PT J
AU Wu, YS
Fang, GC
Chu, CC
Fu, PPC
Ji, DY
Chen, MH
Yang, IL
AF Wu, YS
Fang, GC
Chu, CC
Fu, PPC
Ji, DY
Chen, MH
Yang, IL
TI A study of polycyclic aromatic hydrocarbons in airborne particulate
matter in central Taiwan
SO INTERNATIONAL JOURNAL OF ENVIRONMENT AND POLLUTION
LA English
DT Article
DE coal combustion; PAH; TSP; vehicular emissions
ID CARBONYL-COMPOUNDS; PAHS; URBAN; DEPOSITION; SITES; KOREA; AIR
AB Two sampling sites in central Taiwan, at Hungkuang University (HKU) and Tunghai University (THU), were chosen to contrast the content of polycyclic aromatic hydrocarbons (PAHs) in the atmosphere from November 2000 to April 2001. PAHs that arise from incomplete combustion of organic materials, especially fossil fuels, are the major toxic pollutants in central Taiwan. This study aimed to analyse PAHs, by using a PS-1 sampler and a gas chromatograph/mass selective detector (GC/MSD), and to identify the major sources of PAHs. At the HKU sampling site, the primary emission sources are probably vehicles and coal burning, and vehicular emissions are the primary contributor at the THU sampling site.
C1 Hungkuang Univ, Air Tox & Environm Anal Lab, Taichung 433, Taiwan.
Chien Yu Reg Teaching Hosp, Dept Internal Med, Intens Care Unit, Kaohsiung 832, Taiwan.
Natl Ctr Toxicol Res, Div Biochem Toxicol, Jefferson, AR 72079 USA.
RP Fang, GC (reprint author), Hungkuang Univ, Air Tox & Environm Anal Lab, Taichung 433, Taiwan.
EM gcfang@sunrise.hk.edu.tw
NR 15
TC 0
Z9 0
U1 0
U2 2
PU INDERSCIENCE ENTERPRISES LTD
PI GENEVA
PA WORLD TRADE CENTER BLDG, 29 ROUTE DE PRE-BOIS, CASE POSTALE 896, CH-1215
GENEVA, SWITZERLAND
SN 0957-4352
J9 INT J ENVIRON POLLUT
JI Int. J. Environ. Pollut.
PY 2004
VL 21
IS 5
BP 471
EP 480
DI 10.1504/IJEP.2004.005121
PG 10
WC Environmental Sciences
SC Environmental Sciences & Ecology
GA 837BS
UT WOS:000222602000005
ER
PT J
AU Fang, GC
Wu, YS
Fu, PPC
AF Fang, GC
Wu, YS
Fu, PPC
TI Sampling errors in the study of acid gases and anion species in
atmospheric aerosols
SO INTERNATIONAL JOURNAL OF ENVIRONMENT AND POLLUTION
LA English
DT Article
DE acid aerosols; annular denuder; MOUDI; ions; size distribution
ID ANNULAR DENUDER SYSTEM; AIRBORNE PARTICLES; AIR-POLLUTION; SIZE; TAIWAN
AB Atmospheric acid aerosols were sampled by two annular denuder systems (ADS) and a micro-orifice uniform deposit impactor (MOUDI) at a traffic site in central Taiwan. Theoretical analysis showed that the relative artifact for HNO3 gas sampling was about 0.53 when the initial HNO3 concentration was under 0.2 mug/m(3) and should be considered carefully. The concentrations of gaseous acid at the traffic sampling site were higher than those in the other study. The size distributions of acid aerosols were unimodal for Cl-, NO2- and NO3-, and bimodal for SO42-. The dominant acid ions in particles less than 18 mum were SO42-, NO3-, NO2- and Cl-.
C1 Hungkuang Univ, Air Tox & Environm Anal Lab, Taichung 433, Taiwan.
Chien Yu Reg Teaching Hosp, Dept Internal Med, Kaohsiung 832, Taiwan.
Natl Ctr Toxicol Res, Div Biochem Toxicol, Jefferson, AR 72079 USA.
RP Fang, GC (reprint author), Hungkuang Univ, Air Tox & Environm Anal Lab, Sha Lu, Taichung 433, Taiwan.
NR 14
TC 0
Z9 0
U1 0
U2 1
PU INDERSCIENCE ENTERPRISES LTD
PI GENEVA
PA WORLD TRADE CENTER BLDG, 29 ROUTE DE PRE-BOIS, CASE POSTALE 896, CH-1215
GENEVA, SWITZERLAND
SN 0957-4352
J9 INT J ENVIRON POLLUT
JI Int. J. Environ. Pollut.
PY 2004
VL 21
IS 6
BP 566
EP 578
PG 13
WC Environmental Sciences
SC Environmental Sciences & Ecology
GA 841YZ
UT WOS:000222970100004
ER
PT J
AU Tonidandel, S
Overall, JE
Smith, F
AF Tonidandel, S
Overall, JE
Smith, F
TI Use of resampling to select among alternative error structure
specifications for GLMM analyses of repeated measurements
SO INTERNATIONAL JOURNAL OF METHODS IN PSYCHIATRIC RESEARCH
LA English
DT Article
DE clinical trials; repeated measures; mixed models; goodness of fit;
significance testing; type I errors; power
ID MODELS
AB Autocorrelated error and missing, data due to dropouts have fostered interest in the flexible general linear mixed model (GLMM) procedures for analysis of data from controlled clinical trials. The user of these adaptable statistical tools must, however, choose among, alternative structural models to represent the correlated repeated measurements. The fit of the error structure model specification is important for validity of tests for differences in patterns of treatment effects across time, particularly when maximum likelihood procedures are relied upon. Results can he affected significantly by the error specification that is selected, so a principled basis for selecting the specification is important. As no theoretical grounds are usually available to guide this decision, empirical criteria have been developed that focus on model fit. The current report proposes alternative empirical criteria that focus on bootstrap estimates of actual type I error and power of tests for treatment effects. Results for model selection before and after the blind is broken are compared. Goodness-of-fit statistics also compare favourably for models fitted to the blinded or unblinded data, although the correspondence to actual type I error and power depends on the particular fit statistic that is considered.
C1 Davidson Coll, Dept Psychol, Davidson, NC 28035 USA.
US FDA, Rockville, MD 20857 USA.
Univ Texas, Hlth Sci Ctr, Dept Psychiat, Houston, TX USA.
RP Tonidandel, S (reprint author), Davidson Coll, Dept Psychol, Box 7061, Davidson, NC 28035 USA.
EM sctonidandel@davidson.edu
FU NIMH NIH HHS [MH32457]
NR 21
TC 1
Z9 1
U1 0
U2 2
PU JOHN WILEY & SONS LTD
PI CHICHESTER
PA THE ATRIUM, SOUTHERN GATE, CHICHESTER PO19 8SQ, W SUSSEX, ENGLAND
SN 1049-8931
J9 INT J METH PSYCH RES
JI Int. J. Methods Psychiatr. Res.
PY 2004
VL 13
IS 1
BP 24
EP 33
DI 10.1002/mpr.161
PG 10
WC Psychiatry
SC Psychiatry
GA 826VE
UT WOS:000221856800003
PM 15181484
ER
PT J
AU Royce, ME
Rowinsky, EK
Hoff, PM
Coyle, J
DeJager, R
Pazdur, R
Saltz, LB
AF Royce, ME
Rowinsky, EK
Hoff, PM
Coyle, J
DeJager, R
Pazdur, R
Saltz, LB
TI A Phase II study of intravenous exatecan mesylate (DX-8951f)
administered daily for five days every three weeks to patients with
metastatic adenocarcinoma of the colon or rectum
SO INVESTIGATIONAL NEW DRUGS
LA English
DT Article
DE camptothecin; clinical trial; DX-8951f; exatecan mesylate;
topoisomerase-1 inhibitor
ID ADVANCED COLORECTAL-CANCER; POTENT ANTITUMOR-ACTIVITY; CAMPTOTHECIN
ANALOG; RANDOMIZED-TRIAL; CONTINUOUS-INFUSION; FLUOROURACIL FAILURE;
1ST-LINE TREATMENT; TOPOISOMERASE-I; HUMAN PLASMA; TUMOR-CELLS
AB Background: To evaluate the antitumor activity, toxicities, and pharmacokinetics (PK) of DX-895 If administered as a 30-min infusion daily for 5 days every 3 weeks in patients with fluorouracil-resistant metastatic colorectal carcinoma. Patients and methods: Sixteen patients were enrolled. All had metastatic colorectal carcinoma resistant to or progressing after chemotherapy containing 5-fluorouracil and no prior chemotherapy with camptothecin derivatives. DX-8951f was administered until disease progression or unacceptable toxicity. Responses were assessed after every two courses. Results: Fifteen patients were evaluable. Fifty-one courses of therapy were delivered (median 2). Responses were one minor response, six stable disease, and eight progressive disease. The principal adverse event was neutropenia, with grade 3 and 4 toxicities in three and eight patients, respectively. Non-hematologic toxicities were mild to moderate; the most common were fatigue, nausea, and diarrhea. Plasma concentrations of DX-8951 were well described using a linear two-compartment PK model. There was no evidence of nonlinearity in the elimination of PK or auto-inhibition or induction of DX-8951 clearance over the 5 days of administration. Conclusions: DX-8951f at this dose and schedule had no significant activity in this patient population. The toxicity profile, mainly hematologic, was consistent with previous reports. The clearance and volume of distribution were not different from those previously reported.
C1 Univ Texas, MD Anderson Canc Ctr, Houston, TX 77030 USA.
Canc Therapy & Res Ctr S Texas, Inst Drug Dev, San Antonio, TX 78229 USA.
Albert Einstein Hosp, Ctr Clin Studies Canc, Sao Paulo, Brazil.
Daiichi Pharmaceut Corp, Montvale, NJ USA.
US FDA, Div Oncol Drug Prod, Rockville, MD 20857 USA.
Mem Sloan Kettering Canc Ctr, New York, NY 10021 USA.
RP Royce, ME (reprint author), Univ Texas, MD Anderson Canc Ctr, 1515 Holcombe Blvd,Box 424, Houston, TX 77030 USA.
OI Saltz, Leonard/0000-0001-8353-4670
NR 39
TC 7
Z9 7
U1 0
U2 2
PU KLUWER ACADEMIC PUBL
PI DORDRECHT
PA VAN GODEWIJCKSTRAAT 30, 3311 GZ DORDRECHT, NETHERLANDS
SN 0167-6997
J9 INVEST NEW DRUG
JI Invest. New Drugs
PD JAN
PY 2004
VL 22
IS 1
BP 53
EP 61
DI 10.1023/B:DRUG.0000006174.87869.6b
PG 9
WC Oncology; Pharmacology & Pharmacy
SC Oncology; Pharmacology & Pharmacy
GA 749AC
UT WOS:000186895600005
PM 14707494
ER
PT S
AU Morehouse, KM
Komolprasert, V
AF Morehouse, KM
Komolprasert, V
BE Komolprasert, V
Morehouse, KM
TI Irradiation of food and packaging: An overview
SO IRRADIATION OF FOOD AND PACKAGING: RECENT DEVELOPMENTS
SE ACS SYMPOSIUM SERIES
LA English
DT Article; Proceedings Paper
CT Symposium on Food Irradiation and Packing for Irradiated Food
CY AUG 18-22, 2002
CL Boston, MA
SP Amer Chem Soc, Div Agr & Food Chem
ID DNA COMET ASSAY; UNITED-STATES; EUROPEAN-UNION; IDENTIFICATION;
ACCEPTANCE; RADIATION; CONSUMER
AB Ionizing radiation can extend shelf life and improve the quality and safety of foods. National and international organizations and regulatory agencies have concluded that irradiated food is safe and wholesome. A brief background of the food irradiation issues leading to these conclusions is given. Despite its limited use in the past, use of food irradiation is increasing as consumers are beginning to appreciate the benefits of irradiated food. Interest in the use of food irradiation increased following the 1997 US Food and Drug Administration approval of irradiation for pathogen control in unprocessed red meat and meat products. This approval led to numerous studies on a variety of food irradiation applications. Since food is usually prepackaged prior to irradiation, the possibility of radiolytic products being released from packaging materials into food requires a safety evaluation. Therefore, the use of these packaging materials is subject to regulatory review and approval prior to their use. U.S. government work. Published 2004 American Chemical Society.
C1 US FDA, Off Food Addit Safety, Div Chem Res & Environm Review, College Pk, MD 20740 USA.
US FDA, Off Plant Dairy Foods & Beverages, Div Food Proc & Packaging, Summit Argo, IL 60501 USA.
RP Morehouse, KM (reprint author), US FDA, Off Food Addit Safety, Div Chem Res & Environm Review, 5100 Paint Branch Pkwy, College Pk, MD 20740 USA.
NR 45
TC 19
Z9 19
U1 0
U2 6
PU AMER CHEMICAL SOC
PI WASHINGTON
PA 1155 SIXTEENTH ST NW, WASHINGTON, DC 20036 USA
SN 0097-6156
BN 0-8412-3869-3
J9 ACS SYM SER
PY 2004
VL 875
BP 1
EP 11
PG 11
WC Chemistry, Multidisciplinary; Food Science & Technology; Nuclear Science
& Technology; Polymer Science
SC Chemistry; Food Science & Technology; Nuclear Science & Technology;
Polymer Science
GA BY69K
UT WOS:000189440600001
ER
PT S
AU Paquette, KE
AF Paquette, KE
BE Komolprasert, V
Morehouse, KM
TI Irradiation of prepackaged food: Evolution of the US food and drug
administration's regulation of the packaging materials
SO IRRADIATION OF FOOD AND PACKAGING: RECENT DEVELOPMENTS
SE ACS SYMPOSIUM SERIES
LA English
DT Article; Proceedings Paper
CT Symposium on Food Irradiation and Packing for Irradiated Food
CY AUG 18-22, 2002
CL Boston, MA
SP Amer Chem Soc, Div Agr & Food Chem
ID CHROMATOGRAPHY-MASS SPECTROMETRY; VOLATILE RADIOLYSIS PRODUCTS;
ELECTRON-BEAM IRRADIATION; POLYETHYLENE FILM; RADIATION; POLYMERS;
POLYPROPYLENE; MIGRATION
AB The FDA approved the first materials intended for use as packaging for irradiated foods (polyolefin films, polystyrene, cellophane, vinylidene chloride copolymers, and others) in 1964. Several other materials were approved for this use during the next four years. Since then, only one material, ethylene vinyl acetate copolymer, was added to Title 21 of the Code of Federal Regulations, in 1989. The recent interest in irradiating meat to eliminate pathogens such as E. coli O157:H7 has resulted in several industry submissions to the Agency regarding new packaging materials, as well as the radiation sources, intended for use during the irradiation of prepackaged food. A brief history of FDA regulation of packaging materials irradiated in contact with food, including a discussion of human exposures to radiolysis products formed in irradiated polymers, will be presented. The evaluation of new packaging materials for irradiated foods will be discussed within the context of FDA's Food Contact Substance Notification Program. U.S. government work. Published 2004 American Chemical Society.
C1 US FDA, Off Food Addit Safety, College Pk, MD 20740 USA.
RP Paquette, KE (reprint author), US FDA, Off Food Addit Safety, 5100 Paint Branch Pkwy,MS HFS-275, College Pk, MD 20740 USA.
NR 37
TC 7
Z9 7
U1 1
U2 5
PU AMER CHEMICAL SOC
PI WASHINGTON
PA 1155 SIXTEENTH ST NW, WASHINGTON, DC 20036 USA
SN 0097-6156
BN 0-8412-3869-3
J9 ACS SYM SER
PY 2004
VL 875
BP 182
EP 202
PG 21
WC Chemistry, Multidisciplinary; Food Science & Technology; Nuclear Science
& Technology; Polymer Science
SC Chemistry; Food Science & Technology; Nuclear Science & Technology;
Polymer Science
GA BY69K
UT WOS:000189440600012
ER
PT S
AU Sadler, GD
AF Sadler, GD
BE Komolprasert, V
Morehouse, KM
TI Fate of energy absorbed by polymers during irradiation treatment
SO IRRADIATION OF FOOD AND PACKAGING: RECENT DEVELOPMENTS
SE ACS SYMPOSIUM SERIES
LA English
DT Article; Proceedings Paper
CT Symposium on Food Irradiation and Packing for Irradiated Food
CY AUG 18-22, 2002
CL Boston, MA
SP Amer Chem Soc, Div Agr & Food Chem
C1 US FDA, Natl Ctr Food Safety & Technol, Summit Argo, IL 60501 USA.
RP Sadler, GD (reprint author), US FDA, Natl Ctr Food Safety & Technol, 6502 S Archer Rd, Summit Argo, IL 60501 USA.
NR 7
TC 0
Z9 0
U1 0
U2 0
PU AMER CHEMICAL SOC
PI WASHINGTON
PA 1155 SIXTEENTH ST NW, WASHINGTON, DC 20036 USA
SN 0097-6156
BN 0-8412-3869-3
J9 ACS SYM SER
PY 2004
VL 875
BP 203
EP 213
PG 11
WC Chemistry, Multidisciplinary; Food Science & Technology; Nuclear Science
& Technology; Polymer Science
SC Chemistry; Food Science & Technology; Nuclear Science & Technology;
Polymer Science
GA BY69K
UT WOS:000189440600013
ER
PT S
AU McNeal, TP
Komolprasert, V
Buchalla, R
Olivo, C
Begley, TH
AF McNeal, TP
Komolprasert, V
Buchalla, R
Olivo, C
Begley, TH
BE Komolprasert, V
Morehouse, KM
TI Effects of ionizing radiation on food contact materials
SO IRRADIATION OF FOOD AND PACKAGING: RECENT DEVELOPMENTS
SE ACS SYMPOSIUM SERIES
LA English
DT Article; Proceedings Paper
CT Symposium on Food Irradiation and Packing for Irradiated Food
CY AUG 18-22, 2002
CL Boston, MA
SP Amer Chem Soc, Div Agr & Food Chem
ID PRODUCTS; POLYMERS
AB FDA's Office of Food Additive Safety is responsible for the evaluation of food additive petitions and pre-market notifications requesting approval of new food contact materials for irradiation. Our lab supports that review process by conducting research to identify and quantify the products formed in food contact polymers after exposure to ionizing radiation and then determining whether any of these compounds migrate into food. A major objective of this research is to assist in the development of guidance to manufacturers seeking FDA approval to irradiate their products.
Different polyesters, polyamides, a high-density polyethylene, and an ethylene vinyl alcohol copolymer were evaluated before and after exposure to different levels of gamma and electron-beam radiation. Volatile chemicals were isolated from the test materials using static headspace sampling and analyzed by gas chromatography with mass selective detection. Semi-volatile and non-volatile chemicals were extracted from the test materials using a variety of solvents including n-heptane, a fatty food simulating solvent, and the extracts were analyzed using high performance liquid chromatography with mass selective detection, The extracts containing semi-volatiles were also analyzed by gas chromatography with mass selective detection.
Most of the chemicals found are thought to be products of the polymerization process or conversion of the polymer(s) into a finished package, and breakdown products of polymer additives. Although exposure to ionizing radiation increases the concentration of some of these chemicals and decreases the concentration of other chemicals, few of the chemicals determined are thought to be chemicals specifically formed by ionizing radiation. Results of these analyses and data on the migration of some of the chemicals are presented.
C1 US FDA, Div Chem Res & Environm Review, Ctr Food Safety & Appl Nutr, College Pk, MD 20740 USA.
US FDA, Natl Ctr Food Safety & Technol, Div Food Proc & Packaging, Summit Argo, IL 60501 USA.
Virginia Polytech Inst & State Univ, Blacksburg, VA 24061 USA.
RP McNeal, TP (reprint author), US FDA, Div Chem Res & Environm Review, Ctr Food Safety & Appl Nutr, College Pk, MD 20740 USA.
NR 20
TC 3
Z9 3
U1 0
U2 0
PU AMER CHEMICAL SOC
PI WASHINGTON
PA 1155 SIXTEENTH ST NW, WASHINGTON, DC 20036 USA
SN 0097-6156
BN 0-8412-3869-3
J9 ACS SYM SER
PY 2004
VL 875
BP 214
EP 235
PG 22
WC Chemistry, Multidisciplinary; Food Science & Technology; Nuclear Science
& Technology; Polymer Science
SC Chemistry; Food Science & Technology; Nuclear Science & Technology;
Polymer Science
GA BY69K
UT WOS:000189440600014
ER
PT J
AU Pergantis, SA
Miguens-Rodriguez, M
Vela, NP
Heitkemper, DT
AF Pergantis, SA
Miguens-Rodriguez, M
Vela, NP
Heitkemper, DT
TI Investigating the non-enzymatic methylation of arsenite by
methylcobalamin B-12 using high-performance liquid chromatography
on-line with inductively coupled plasma-mass spectrometry
SO JOURNAL OF ANALYTICAL ATOMIC SPECTROMETRY
LA English
DT Article
ID MONOMETHYLARSONOUS ACID; HUMAN URINE; IN-VITRO; SPECIATION; GLUTATHIONE;
WATER; IDENTIFICATION; SEPARATION; TRIVALENT; ARSENATE
AB In this study, we have demonstrated the use of HPLC-ICP-MS as a powerful toot for studying the reaction of arsenite with methylcobalamin in the presence of glutathione. Even though this reaction has previously been investigated using radioactive As-73, HPLC-ICP-MS provides considerable advantages relating to sample throughput, sensitivity, and separation efficiency of the arsenic-containing reaction products. As a result of these advantages, kinetic studies were easily conducted, potentially providing valuable insight into the reaction itself. In addition, the HPLC-ICP-MS approach allowed for the tentative identification of methylarsonous acid, an arsenic species that had escaped detection in previous studies of the same reaction. Overall, this study confirmed that methylcobalamin acts as a methylating agent for arsenite in the presence of glutathione in an abiotic environment. A series of methylated arsenic species, identified as methylarsonic acid, dimethylarsinic acid and methylarsonous acid were detected.
C1 US FDA, Forens Chem Ctr, Cincinnati, OH 45237 USA.
Univ London, Birkbeck Coll, Sch Biol & Chem Sci, London WC1H 0PP, England.
RP Heitkemper, DT (reprint author), US FDA, Forens Chem Ctr, 6751 Steger Dr, Cincinnati, OH 45237 USA.
EM spergantis@chemistry.uoc.gr
RI Pergantis, Spiros/D-4022-2009;
OI Pergantis, Spiros A./0000-0002-9077-7870
NR 40
TC 10
Z9 10
U1 0
U2 1
PU ROYAL SOC CHEMISTRY
PI CAMBRIDGE
PA THOMAS GRAHAM HOUSE, SCIENCE PARK, MILTON RD, CAMBRIDGE CB4 0WF, CAMBS,
ENGLAND
SN 0267-9477
J9 J ANAL ATOM SPECTROM
JI J. Anal. At. Spectrom.
PD JAN
PY 2004
VL 19
IS 1
BP 178
EP 182
DI 10.1039/b306947h
PG 5
WC Chemistry, Analytical; Spectroscopy
SC Chemistry; Spectroscopy
GA 803TN
UT WOS:000220253500028
ER
PT J
AU Schlesser, J
AF Schlesser, J.
TI Survival of a five strain cocktail of Escherichia coli O157 : H7 during
thermalization and the 60 day aging period of hard cheese made from
unpasteurized milk
SO JOURNAL OF ANIMAL SCIENCE
LA English
DT Meeting Abstract
DE thermalization; Escherichia coli O157 : H7; raw milk cheese
C1 [Schlesser, J.] US FDA, NCFST, Summit Argo, IL USA.
NR 0
TC 1
Z9 1
U1 0
U2 0
PU AMER SOC ANIMAL SCIENCE
PI SAVOY
PA 1111 NORTH DUNLAP AVE, SAVOY, IL 61874 USA
SN 0021-8812
J9 J ANIM SCI
JI J. Anim. Sci.
PY 2004
VL 82
SU 1
BP 122
EP 123
PG 2
WC Agriculture, Dairy & Animal Science
SC Agriculture
GA V45UM
UT WOS:000203095200491
ER
PT J
AU Perfield, JW
Delmonte, P
Lock, AL
Yurawecz, MP
Baumani, DE
AF Perfield, J. W., II
Delmonte, P.
Lock, A. L.
Yurawecz, M. P.
Baumani, D. E.
TI Trans-10, trans-12 conjugated linoleic acid (CLA) reduces the
Delta(9)-desaturase index without affecting milk fat yield in lactating
dairy cows
SO JOURNAL OF ANIMAL SCIENCE
LA English
DT Meeting Abstract
DE conjugated linoleic acid; milk fat depression; StearoylCoA desaturase
C1 [Perfield, J. W., II; Lock, A. L.; Baumani, D. E.] Cornell Univ, Ithaca, NY 14853 USA.
[Delmonte, P.; Yurawecz, M. P.] Ctr Food Safety & Appl Nutr, College Pk, MD 20740 USA.
NR 0
TC 0
Z9 0
U1 0
U2 1
PU AMER SOC ANIMAL SCIENCE
PI SAVOY
PA 1111 NORTH DUNLAP AVE, SAVOY, IL 61874 USA
SN 0021-8812
J9 J ANIM SCI
JI J. Anim. Sci.
PY 2004
VL 82
SU 1
BP 128
EP 128
PG 1
WC Agriculture, Dairy & Animal Science
SC Agriculture
GA V45UM
UT WOS:000203095200513
ER
PT J
AU Schlesser, J
Gerdes, R
AF Schlesser, J.
Gerdes, R.
TI Incidence of Escherichia coli O157 : H7 in raw milk and survival of a
five strain cocktail of E. coli O157 : H7 during the 60 days aging
period of hard cheese made from unpasteurized milk
SO JOURNAL OF ANIMAL SCIENCE
LA English
DT Meeting Abstract
DE raw milk cheese; Escherichia coli O157 : H7; E. coli O157 : H7 in raw
milk
C1 [Schlesser, J.] NCFST, US FDA, Summit Argo, IL USA.
[Gerdes, R.] IIT, Summit Argo, IL USA.
NR 0
TC 0
Z9 0
U1 0
U2 2
PU AMER SOC ANIMAL SCIENCE
PI SAVOY
PA 1111 NORTH DUNLAP AVE, SAVOY, IL 61874 USA
SN 0021-8812
J9 J ANIM SCI
JI J. Anim. Sci.
PY 2004
VL 82
SU 1
BP 383
EP 384
PG 2
WC Agriculture, Dairy & Animal Science
SC Agriculture
GA V45UM
UT WOS:000203095201577
ER
PT J
AU Baumgard, LH
Sanders, SR
Mendivil, OB
Kay, JK
Marchello, JA
Delmonte, P
Griinari, JM
Yurawecz, MP
AF Baumgard, L. H.
Sanders, S. R.
Mendivil, O. B.
Kay, J. K.
Marchello, J. A.
Delmonte, P.
Griinari, J. M.
Yurawecz, M. P.
TI Subcutaneous and abdominal fatty acid composition and CLA profiles in
grain finished steers
SO JOURNAL OF ANIMAL SCIENCE
LA English
DT Meeting Abstract
DE beef; CLA; adipose depot
C1 [Baumgard, L. H.; Sanders, S. R.; Mendivil, O. B.; Kay, J. K.; Marchello, J. A.] Univ Arizona, Tucson, AZ USA.
[Delmonte, P.; Yurawecz, M. P.] US FDA, Washington, DC 20204 USA.
[Griinari, J. M.] Univ Helsinki, FIN-00014 Helsinki, Finland.
NR 0
TC 0
Z9 0
U1 0
U2 1
PU AMER SOC ANIMAL SCIENCE
PI SAVOY
PA 1111 NORTH DUNLAP AVE, SAVOY, IL 61874 USA
SN 0021-8812
J9 J ANIM SCI
JI J. Anim. Sci.
PY 2004
VL 82
SU 1
BP 422
EP 422
PG 1
WC Agriculture, Dairy & Animal Science
SC Agriculture
GA V45UM
UT WOS:000203095201731
ER
PT J
AU Vela, NP
Heitkemper, DT
AF Vela, NP
Heitkemper, DT
TI Total arsenic determination and speciation in infant food products by
ion chromatography-inductively coupled plasma-mass spectrometry
SO JOURNAL OF AOAC INTERNATIONAL
LA English
DT Article
ID PERFORMANCE LIQUID-CHROMATOGRAPHY; ATOMIC-ABSORPTION-SPECTROMETRY;
MICROWAVE DIGESTION; UNITED-STATES; BABY FOODS; TOTAL DIET; ICP-MS;
EXTRACTION; SAMPLES; RICE
AB Health risk associated with dietary arsenic intake may be different for infants and adults. Seafood is the main contributor to arsenic intake for adults while terrestrial-based food is the primary source for infants. Processed infant food products such as rice-based cereals, mixed rice/formula cereals, milk-based infant formula, applesauce and puree of peaches, pears, carrots, sweet potatoes, green beans, and squash were evaluated for total and speciated arsenic content. Arsenic concentrations found in rice-based cereals (63-320 ng/g dry weight) were similar to those reported for raw rice. Results for the analysis of powdered infant formula by inductively coupled plasma-mass spectrometry (ICP-MS) indicated a narrow and low arsenic concentration range (12 to 17 ng/g). Arsenic content in puree infant food products, including rice cereals, fruits, and vegetables, varies from <1 to 24 ng/g wet weight. Sample treatment with trifluoroacetic acid at 100degreesC were an efficient and mild method for extraction of arsenic species present in different food matrixes as compared to alternative methods that included sonication and accelerated solvent extraction. Extraction recoveries from 94 to 128% were obtained when the summation of species was compared to total arsenic. The ion chromatography (IC)-ICP-MS method selected for arsenic speciation allowed for the quantitative determination of inorganic arsenic [As(III) + As(V)], dimethylarsinic acid (DMA), and methylarsonic acid (MMA). Inorganic arsenic and DMA are the main species found in rice-based and mixed rice/formula cereals, although traces of MMA were also detected. Inorganic arsenic was present in freeze-dried sweet potatoes, carrots, green beans, and peaches. MMA and DMA were not detected in these samples. Arsenic species in squash, pears, and applesauce were not detected above the method detection limit [5 ng/g dry weight for As(III), MMA, and DMA and 10 ng/g dry weight for As(V)].
C1 US FDA, Forens Chem Ctr, Cincinnati, OH 45237 USA.
RP Vela, NP (reprint author), US FDA, Forens Chem Ctr, 6751 Steger Dr, Cincinnati, OH 45237 USA.
EM nohora.vela@fda.hhs.gov
NR 28
TC 32
Z9 36
U1 2
U2 28
PU AOAC INTERNATIONAL
PI GAITHERSBURG
PA 481 NORTH FREDRICK AVE, STE 500, GAITHERSBURG, MD 20877-2504 USA
SN 1060-3271
J9 J AOAC INT
JI J. AOAC Int.
PD JAN-FEB
PY 2004
VL 87
IS 1
BP 244
EP 252
PG 9
WC Chemistry, Analytical; Food Science & Technology
SC Chemistry; Food Science & Technology
GA 805KA
UT WOS:000220364000038
PM 15084107
ER
PT J
AU Hungerford, JM
AF Hungerford, JM
TI Committee on natural toxins and food allergens
SO JOURNAL OF AOAC INTERNATIONAL
LA English
DT Article
ID SHELLFISH POISONING TOXINS; LIQUID-CHROMATOGRAPHIC DETERMINATION;
RECEPTOR-BINDING ASSAY; CAPILLARY-ELECTROPHORESIS; DOMOIC ACID;
CYANOBACTERIAL TOXINS; MIST ALERT(TM); ALGAL TOXINS; AQUATIC
ENVIRONMENT; MASS-SPECTROMETRY
C1 US FDA, Seafood Prod Res Ctr, Bothell, WA 98021 USA.
RP Hungerford, JM (reprint author), US FDA, Seafood Prod Res Ctr, 22201 23rd Dr SE, Bothell, WA 98021 USA.
EM James.Hungerford@fda.gov
NR 52
TC 1
Z9 1
U1 0
U2 0
PU AOAC INTERNATIONAL
PI GAITHERSBURG
PA 481 NORTH FREDRICK AVE, STE 500, GAITHERSBURG, MD 20877-2504 USA
SN 1060-3271
J9 J AOAC INT
JI J. AOAC Int.
PD JAN-FEB
PY 2004
VL 87
IS 1
BP 270
EP 275
PG 6
WC Chemistry, Analytical; Food Science & Technology
SC Chemistry; Food Science & Technology
GA 805KA
UT WOS:000220364000042
PM 15084110
ER
PT J
AU Trucksess, MW
AF Trucksess, MW
TI Mycotoxins
SO JOURNAL OF AOAC INTERNATIONAL
LA English
DT Article
ID OCHRATOXIN-A; PENICILLIUM-EXPANSUM; AFLATOXIN B-1;
LIQUID-CHROMATOGRAPHY; MASS-SPECTROMETRY; FUMONISIN B-1; DEOXYNIVALENOL
VOMITOXIN; NATURAL COOCCURRENCE; CITRININ PRODUCTION; ASPERGILLUS-FLAVUS
C1 US FDA, College Pk, MD 20740 USA.
RP Trucksess, MW (reprint author), US FDA, 5100 Paint Branch Pkwy, College Pk, MD 20740 USA.
EM mtruckse@cfsan.fda.gov
NR 85
TC 3
Z9 3
U1 0
U2 0
PU AOAC INTERNATIONAL
PI GAITHERSBURG
PA 481 NORTH FREDRICK AVE, STE 500, GAITHERSBURG, MD 20877-2504 USA
SN 1060-3271
J9 J AOAC INT
JI J. AOAC Int.
PD JAN-FEB
PY 2004
VL 87
IS 1
BP 275
EP 284
PG 10
WC Chemistry, Analytical; Food Science & Technology
SC Chemistry; Food Science & Technology
GA 805KA
UT WOS:000220364000043
ER
PT J
AU Andrews, WH
AF Andrews, WH
TI Food microbiology, non-dairy
SO JOURNAL OF AOAC INTERNATIONAL
LA English
DT Article
C1 US FDA, College Pk, MD 20740 USA.
RP Andrews, WH (reprint author), US FDA, 5100 Paint Branch Pkwy, College Pk, MD 20740 USA.
EM wallace.andrews@cfsan.fda.gov
NR 7
TC 1
Z9 1
U1 0
U2 1
PU AOAC INTERNATIONAL
PI GAITHERSBURG
PA 481 NORTH FREDRICK AVE, STE 500, GAITHERSBURG, MD 20877-2504 USA
SN 1060-3271
J9 J AOAC INT
JI J. AOAC Int.
PD JAN-FEB
PY 2004
VL 87
IS 1
BP 296
EP 302
PG 7
WC Chemistry, Analytical; Food Science & Technology
SC Chemistry; Food Science & Technology
GA 805KA
UT WOS:000220364000049
PM 15084113
ER
PT J
AU Kim, PI
Bai, H
Bai, D
Chae, H
Chung, S
Kim, Y
Park, R
Chi, YT
AF Kim, PI
Bai, H
Bai, D
Chae, H
Chung, S
Kim, Y
Park, R
Chi, YT
TI Purification and characterization of a lipopeptide produced by Bacillus
thuringiensis CMB26
SO JOURNAL OF APPLIED MICROBIOLOGY
LA English
DT Article
DE Bacillus thuringiensis CMB26; biocontrol agent; Colletotrichum
gloeosporioides; fengycin; lipopeptide
ID BACILLUS-SUBTILIS; RHIZOCTONIA-SOLANI; ITURIN-A;
STRUCTURAL-CHARACTERIZATION; MASS-SPECTROMETRY; SURFACTANT;
BIOSURFACTANTS; PEPTIDE
AB Aims: To isolate an antagonist for use in the biological control of phytopathogenic fungi including Colletotrichum gloeosporioides, then to purify and characterize the biocontrol agent produced by the antagonist.
Methods and Results: Bacteria that exhibited antifungal activity against the causative agent pepper anthracnose were isolated from soil, with Bacillus thuringiensis CMB26 showing the strongest activity. A lipopeptide produced by B. thuringiensis CMB26 was precipitated by adjusting the pH 2 with 3 n HCl and extracted using chloroform/methanol (2 : 1, v/v) and reversed-phase HPLC. The molecular weight was estimated as 1447 Da by MALDI-TOF mass spectrometry. Scanning electron and optical microscopies showed that the lipopeptide has activity against Escherichia coli O157:ac88, larvae of the cabbage white butterfly (Pieris rapae crucivora) and phytopathogenic fungi. The lipopeptide had cyclic structure and the amino acid composition was l-Glu, d-Orn, l-Tyr, d-allo-Thr, d-Ala, d-Val, l-Pro, and l-Ile in a molar ratio of 3 : 1 : 2 : 1 : 1 : 2 : 1 : 1. The purified lipopeptide showed the same amino acid composition as fengycin, but differed slightly in fatty acid composition, in which the double bond was at carbons 13-14 (m/z 303, 316) and there was no methyl group.
Conclusion: A lipopeptide was purified and characterized from B. thuringiensis CMB26 and found to be similar to the lipopeptide fengycin. This lipopeptide can function as a biocontrol agent, and exhibits fungicidal, bactericidal, and insecticidal activity.
Significance and Impact of the Study: Compared with surfactin and iturin, the lipopeptide from B. thuringiensis CMB26 showed stronger antifungal activity against phytopathogenic fungi. This lipopeptide is a candidate for the biocontrol of pathogens in agriculture.
C1 Chonnam Natl Univ, Sch Biol Sci & Technol, Kwangju 500757, South Korea.
Chonnam Natl Univ, Biotechnol Res Inst, Kwangju 500757, South Korea.
Chonnam Natl Univ, Div Appl Plant Sci, Kwangju 500757, South Korea.
Korea Basic Sci Inst, Proteome Anal Team, Taejon, South Korea.
US FDA, Natl Ctr Toxicol Res, Div Microbiol, Jefferson, AR 72079 USA.
Chonnam Natl Univ, Div Appl Biosci & Biotechnol, Kwangju 500757, South Korea.
RP Chi, YT (reprint author), Chonnam Natl Univ, Sch Biol Sci & Technol, Kwangju 500757, South Korea.
EM ytchi@chonnam.chonnam.ac.kr
NR 39
TC 96
Z9 122
U1 4
U2 23
PU BLACKWELL PUBLISHING LTD
PI OXFORD
PA 9600 GARSINGTON RD, OXFORD OX4 2DG, OXON, ENGLAND
SN 1364-5072
J9 J APPL MICROBIOL
JI J. Appl. Microbiol.
PY 2004
VL 97
IS 5
BP 942
EP 949
DI 10.1111/j.1365-2672.2004.02356.x
PG 8
WC Biotechnology & Applied Microbiology; Microbiology
SC Biotechnology & Applied Microbiology; Microbiology
GA 861EN
UT WOS:000224399000008
PM 15479409
ER
PT J
AU Ge, H
Chuang, YYE
Zhao, SP
Tong, M
Tsai, MH
Temenak, JJ
Richards, AL
Ching, WM
AF Ge, H
Chuang, YYE
Zhao, SP
Tong, M
Tsai, MH
Temenak, JJ
Richards, AL
Ching, WM
TI Comparative genomics of Rickettsia prowazekii Madrid E and Breinl
strains
SO JOURNAL OF BACTERIOLOGY
LA English
DT Article
ID ESCHERICHIA-COLI; CELL-DIVISION; SACCHAROMYCES-CEREVISIAE; EPIDEMIC
TYPHUS; CYTOCHROME-C; AGROBACTERIUM-TUMEFACIENS; TRANSCRIPTIONAL
ANALYSIS; SEQUENCE-ANALYSIS; SPOTTED-FEVER; ATP SYNTHASE
AB Rickeusia prowazekii, the causative agent of epidemic typhus, has been responsible for millions of human deaths. Madrid E is an attenuated strain of R. prowazekii, while Breinl is a virulent strain. The genomic DNA sequence of Madrid E has recently been published. To study the genomic variations between Madrid E (reference) and Breinl (test) DNAs, cohybridization experiments were performed on a DNA microarray containing all 834 protein-coding genes of Madrid E. Of the 834 genes assessed, 24 genes showed 1.5- to 2.0-fold increases in hybridization signals in Breinl DNA compared to Madrid E DNA, indicating the presence of genomic variations in similar to3% of the total genes. Eighteen of these 24 genes are predicted to be involved in different functions. Southern blot analysis of five genes, virB4,ftsK, rfbE, lpx,4, and rpoH, suggested the presence of an additional paralog(s) in BreinI, which might be related to the observed increase in hybridization signals. Studies by real-time reverse transcription-PCR revealed an increase in expression of the above-mentioned five genes and five other genes. In addition to the elevated hybridization signals of 24 genes observed in the Breinl strain, one gene (rp084) showed only 1/10 the hybridization signal of Madrid E. Further analysis of this gene by PCR and sequencing revealed a large deletion flanking the whole rp084 gene and part of the rp083 gene in the virulent Breinl strain. The results of this first rickettsial DNA microarray may provide some important information for the elucidation of pathogenic mechanisms of R. prowazekii.
C1 USN, Med Res Ctr, Infect Dis Directorate, Rickettsial Dis Dept, Silver Spring, MD 20910 USA.
Uniformed Serv Univ Hlth Sci, Dept Prevent Med & Biometr, Bethesda, MD 20814 USA.
NCI, NIH, Radiat Oncol Sci Program, Microarray Lab, Gaithersburg, MD 20877 USA.
Ctr Biol Evaluat & Res, Food & Drug Adm, Div Vaccines & Related Prod Applicat, Off Vaccines Res & Review, Rockville, MD 20852 USA.
RP Ching, WM (reprint author), USN, Med Res Ctr, Infect Dis Directorate, Rickettsial Dis Dept, Silver Spring, MD 20910 USA.
EM chingw@nmrc.navy.mil
NR 52
TC 26
Z9 27
U1 0
U2 3
PU AMER SOC MICROBIOLOGY
PI WASHINGTON
PA 1752 N ST NW, WASHINGTON, DC 20036-2904 USA
SN 0021-9193
J9 J BACTERIOL
JI J. Bacteriol.
PD JAN
PY 2004
VL 186
IS 2
BP 556
EP 565
DI 10.1128/JB.186.2.556-565.2004
PG 10
WC Microbiology
SC Microbiology
GA 763GP
UT WOS:000188066800032
PM 14702324
ER
PT J
AU Choudhuri, S
AF Choudhuri, S
TI Microarrays in biology and medicine
SO JOURNAL OF BIOCHEMICAL AND MOLECULAR TOXICOLOGY
LA English
DT Review
DE microarray; genomics; proteomics; glycomics; molecular pathology; RNAi
ID LINKED IMMUNOSORBENT ASSAY; GENE-EXPRESSION PATTERNS; CARBOHYDRATE
MICROARRAYS; TISSUE MICROARRAYS; QUANTITATIVE ASSAY; PROTEIN;
HYBRIDIZATION; VARIANCE; OLIGONUCLEOTIDE; IMMUNOGLOBULIN
AB The remarkable speed with which biotechnology has become critical to the practice of life sciences owes much to a series of technological revolutions. Microarray is the latest invention in this ongoing technological revolution. This technology holds the promise to revolutionize the future of biology and medicine unlike any other technology that preceded it. Development of microarray technology has significantly changed the way questions about diseases and/or biological phenomena are addressed. This is because microarrays facilitate monitoring the expression of thousands of genes or proteins in a single experiment. This enormous power of microarrays has enabled scientists to monitor thousands of genes and their products in a given living organism in one experiment, and to understand how these genes function in an orchestrated manner. Obtaining such a global view of life at the molecular level was impossible using conventional molecular biological techniques. However, despite all the progress made in developing this technology, microarray is yet to reach a point where all data are obtained, analyzed, and shared in a standardized fashion. The present article is a brief overview of microarray technologies and their applications with an emphasis on DNA microarray. (c) 2004 Wiley Periodicals, Inc.
C1 US FDA, Ctr Food Safety & Appl Nutr, Div Biotechnol, College Pk, MD 20740 USA.
US FDA, Ctr Food Safety & Appl Nutr, GRAS Notice Review, College Pk, MD 20740 USA.
RP Choudhuri, S (reprint author), US FDA, Ctr Food Safety & Appl Nutr, Div Biotechnol, College Pk, MD 20740 USA.
EM Supratim.Choudhuri@cfsan.fda.gov
NR 42
TC 29
Z9 30
U1 0
U2 11
PU JOHN WILEY & SONS INC
PI HOBOKEN
PA 111 RIVER ST, HOBOKEN, NJ 07030 USA
SN 1095-6670
J9 J BIOCHEM MOL TOXIC
JI J. Biochem. Mol. Toxicol.
PY 2004
VL 18
IS 4
BP 171
EP 179
DI 10.1002/jbt.20023
PG 9
WC Biochemistry & Molecular Biology; Toxicology
SC Biochemistry & Molecular Biology; Toxicology
GA 912JR
UT WOS:000228074500001
PM 15452887
ER
PT J
AU Lange, BJ
Dinndorf, P
Smith, FO
Arndt, C
Barnard, D
Feig, S
Feusner, J
Seibel, N
Weiman, M
Aplenc, R
Gerbing, R
Alonzo, TA
AF Lange, BJ
Dinndorf, P
Smith, FO
Arndt, C
Barnard, D
Feig, S
Feusner, J
Seibel, N
Weiman, M
Aplenc, R
Gerbing, R
Alonzo, TA
TI Pilot study of idarubicin-based intensive-timing induction therapy for
children with previously untreated acute myeloid leukemia: Children's
Cancer Group Study 2941
SO JOURNAL OF CLINICAL ONCOLOGY
LA English
DT Article
ID ACUTE MYELOGENOUS LEUKEMIA; TRIAL COMPARING IDARUBICIN;
CANCER-STUDY-GROUP; BONE-MARROW TRANSPLANTATION; BRITISH COOPERATIVE
GROUP; CONSOLIDATION CHEMOTHERAPY; RANDOMIZED-TRIAL; ADULT PATIENTS;
DAUNORUBICIN; CYTARABINE
AB Purpose
Randomized comparisons of idarubicin (IDA) with daunorubicin (DNR) show that in adults with acute myeloid leukemia (AML), IDA achieves higher remission rates and longer remission durations. In Children's Cancer Group Pilot Study CCG-2941, we assessed toxicity and feasibility of substituting 4 mg of DNR with 1 mg of IDA in intensive-timing daunorubicin-based induction therapy (DNR/DNR) used in CCG-2891.
Patients and Methods
On days 1 through 3 and 10 through 14, patients received two courses of dexamethasone, cytarabine, 6-thioguanine, etoposide, and IDA (IDA/IDA). After enrollment of 65 patients, toxicity prompted replacement of IDA with DNR (IDA/DNR) on days 10 through 14 for the remaining 28 patients. Outcomes were compared with those of intensive timing in CCG-2891.
Results
Treatment-related mortality after two courses of induction was not significantly different among the three regimens: 14% with IDA/IDA, 7% with IDA/DNR, and 9% with DNR/DNR. In course I of CCG-2941 IDA/IDA, 11% of patients withdrew compared with 1.5% in CCG-2891 (P <.001) and 5% in CCG-2941 IDA/DNR (P = not significant). Compared with CCG-2891 DNR/DRN, CCG-2941 IDA/IDA increased days in hospital (43 v36 days; P =.007), mean duration of course I by a week (P =.002), and risk of grade 3 or 4 hyperbilirubinemia (18% v 5%; P =.02). Toxicity of IDA/DNR was not different from that of DNR/DNR in CCG-2891. The mean day 7 marrow blast percentage was 11.4% in CCG-2941 versus 21.1% in CCG-2891 (P =.004). Remission induction, survival, and event-free survival rates were not significantly different from those of CCG-2891.
Conclusion
In CCG-2941, excessive toxicity and withdrawals outweighed potential benefits of early response with IDA.
C1 Childrens Oncol Grp, Arcadia, CA 91066 USA.
Childrens Hosp Philadelphia, Philadelphia, PA 19104 USA.
US FDA, Cincinnati, OH USA.
Cincinnati Childrens Hosp Med Ctr, Cincinnati, OH USA.
Mayo Clin, Rochester, MN USA.
Univ Calif Los Angeles, Izaak Walton Killam Hosp Children, Sch Med, Los Angeles, CA USA.
Childrens Hosp Los Angeles, Los Angeles, CA 90027 USA.
Childrens Hosp Oakland, Oakland, CA USA.
Childrens Natl Med Ctr, Washington, DC 20010 USA.
RP Lange, BJ (reprint author), Childrens Oncol Grp, POB 60012, Arcadia, CA 91066 USA.
NR 29
TC 23
Z9 24
U1 0
U2 0
PU AMER SOC CLINICAL ONCOLOGY
PI ALEXANDRIA
PA 330 JOHN CARLYLE ST, STE 300, ALEXANDRIA, VA 22314 USA
SN 0732-183X
J9 J CLIN ONCOL
JI J. Clin. Oncol.
PD JAN 1
PY 2004
VL 22
IS 1
BP 150
EP 156
DI 10.1200/JCO.2004.04.016
PG 7
WC Oncology
SC Oncology
GA 760DL
UT WOS:000187796300023
PM 14701777
ER
PT J
AU Wang, SJ
Chen, JJ
AF Wang, SJ
Chen, JJ
TI Sample size for identifying differentially expressed genes in microarray
experiments
SO JOURNAL OF COMPUTATIONAL BIOLOGY
LA English
DT Article
DE standardized effect size; number of arrays; one- and two-sample t-tests;
power; replicate
ID STATISTICAL-METHODS; REPLICATION; ARRAYS
AB Microarray technology allows simultaneous comparison of expression levels of thousands of genes under each condition. This paper concerns sample size calculation in the identification of differentially expressed genes between a control and a treated sample. In a typical experiment, only a fraction of genes (altered genes) is expected to be differentially expressed between two samples. Sample size determination depends on a number of factors including the specified significance level (alpha), the desired statistical power (1 - beta), the fraction (eta) of truly altered genes out of the total g genes studied, and the effect sizes (A) for the altered genes. This paper proposes a method to calculate the number of arrays required to detect at least 100lambda % (where 0 < lambda <= 1) of the truly altered genes under the model of an equal effect size for all altered genes. The required numbers of arrays are tabulated for various values of alpha, beta, Delta, eta, and lambda for the one-sample and two-sample t-tests for g = 10,000. Based on the proposed approach, to identify up to 90% of truly altered genes among the unknown number of truly altered genes, the estimated numbers of arrays needed appear to be manageable. For instance, when the standardized effect size is at least 2.0, the number of arrays needed is less than or equal to 14 for the two-sample t-test and is less than or equal to 10 for the one-sample t-test. As the cost per array declines, such array numbers become practical. The proposed method offers a simple, intuitive, and practical way to determine the number of arrays needed in microarray experiments in which the true correlation structure among the genes under investigation cannot be reasonably assumed. An example dataset is used to illustrate the use of the proposed approach to plan microarray experiments.
C1 US FDA, Div Biometr 2, Off Biostat, Ctr Drug Evaluat & Res, Rockville, MD 20857 USA.
US FDA, Div Biometry & Risk Assessment, Natl Ctr Toxicol Res, Jefferson, AR 72079 USA.
RP Wang, SJ (reprint author), US FDA, Div Biometr 2, Off Biostat, Ctr Drug Evaluat & Res, HFD-715,5600 Fishers Lane, Rockville, MD 20857 USA.
EM wangs@cder.fda.gov
NR 18
TC 24
Z9 24
U1 0
U2 1
PU MARY ANN LIEBERT INC
PI NEW ROCHELLE
PA 140 HUGUENOT STREET, 3RD FL, NEW ROCHELLE, NY 10801 USA
SN 1066-5277
J9 J COMPUT BIOL
JI J. Comput. Biol.
PY 2004
VL 11
IS 4
BP 714
EP 726
PG 13
WC Biochemical Research Methods; Biotechnology & Applied Microbiology;
Computer Science, Interdisciplinary Applications; Mathematical &
Computational Biology; Statistics & Probability
SC Biochemistry & Molecular Biology; Biotechnology & Applied Microbiology;
Computer Science; Mathematical & Computational Biology; Mathematics
GA 855LL
UT WOS:000223974700011
PM 15579240
ER
PT J
AU Schlesser, J
AF Schlesser, J.
TI Survival of a five strain cocktail of Escherichia coli O157 : H7 during
thermalization and the 60 day aging period of hard cheese made from
unpasteurized milk
SO JOURNAL OF DAIRY SCIENCE
LA English
DT Meeting Abstract
DE thermalization; Escherichia coli O157 : H7; raw milk cheese
C1 [Schlesser, J.] US FDA, NCFST, Summit Argo, IL USA.
NR 0
TC 1
Z9 1
U1 0
U2 0
PU AMER DAIRY SCIENCE ASSOC
PI SAVOY
PA 1111 N DUNLAP AVE, SAVOY, IL 61874 USA
SN 0022-0302
J9 J DAIRY SCI
JI J. Dairy Sci.
PY 2004
VL 87
SU 1
BP 122
EP 123
PG 2
WC Agriculture, Dairy & Animal Science; Food Science & Technology
SC Agriculture; Food Science & Technology
GA V45UN
UT WOS:000203095300491
ER
PT J
AU Schlesser, J
Gerdes, R
AF Schlesser, J.
Gerdes, R.
TI Incidence of Escherichia coli O157 : H7 in raw milk and survival of a
five strain cocktail of E. coli O157 : H7 during the 60 days aging
period of hard cheese made from unpasteurized milk
SO JOURNAL OF DAIRY SCIENCE
LA English
DT Meeting Abstract
DE raw milk cheese; Escherichia coli O157 : 117; E. coli O157 : H7 in raw
C1 [Schlesser, J.] NCFST, Food & Drug Adm, Summit Argo, IL USA.
[Gerdes, R.] IIT, Chicago, IL 60616 USA.
NR 0
TC 0
Z9 0
U1 0
U2 1
PU AMER DAIRY SCIENCE ASSOC
PI SAVOY
PA 1111 N DUNLAP AVE, SAVOY, IL 61874 USA
SN 0022-0302
J9 J DAIRY SCI
JI J. Dairy Sci.
PY 2004
VL 87
SU 1
BP 383
EP 384
PG 2
WC Agriculture, Dairy & Animal Science; Food Science & Technology
SC Agriculture; Food Science & Technology
GA V45UN
UT WOS:000203095301577
ER
PT J
AU Baumgard, LH
Sanders, SR
Mendivill, OB
Kay, JK
Marchello, JA
Delmonte, P
Griinari, JM
Yurawecz, MP
AF Baumgard, L. H.
Sanders, S. R.
Mendivill, O. B.
Kay, J. K.
Marchello, J. A.
Delmonte, P.
Griinari, J. M.
Yurawecz, M. P.
TI Subcutaneous and abdominal fatty acid composition and CLA profiles in
grain finished steers
SO JOURNAL OF DAIRY SCIENCE
LA English
DT Meeting Abstract
DE beef; CLA; adipose depot
C1 [Baumgard, L. H.; Sanders, S. R.; Mendivill, O. B.; Kay, J. K.; Marchello, J. A.] Univ Arizona, Tucson, AZ USA.
[Delmonte, P.; Yurawecz, M. P.] US FDA, Washington, DC 20204 USA.
[Griinari, J. M.] Univ Helsinki, FIN-00014 Helsinki, Finland.
NR 0
TC 0
Z9 0
U1 0
U2 0
PU AMER DAIRY SCIENCE ASSOC
PI SAVOY
PA 1111 N DUNLAP AVE, SAVOY, IL 61874 USA
SN 0022-0302
J9 J DAIRY SCI
JI J. Dairy Sci.
PY 2004
VL 87
SU 1
BP 422
EP 422
PG 1
WC Agriculture, Dairy & Animal Science; Food Science & Technology
SC Agriculture; Food Science & Technology
GA V45UN
UT WOS:000203095301731
ER
PT J
AU Akhtar, S
Lee, VH
Florence, AT
Cho, MJ
Yokoyama, M
Wickstrom, E
Shoji, Y
Hughes, J
Mrsny, R
Akhtar, S
AF Akhtar, S
Lee, VH
Florence, AT
Cho, MJ
Yokoyama, M
Wickstrom, E
Shoji, Y
Hughes, J
Mrsny, R
Akhtar, S
TI In honour of Professor Rudy Juliano, winner of the 2004 life-time
achievement award from the Journal of Drug Targeting
SO JOURNAL OF DRUG TARGETING
LA English
DT Biographical-Item
C1 Cardiff Univ, Welsh Sch Pharm, Ctr Genome Based Therapeut, Cardiff CF10 3XF, S Glam, Wales.
US FDA, Rockville, MD 20857 USA.
Univ London, Sch Pharm, London WC1E 7HU, England.
Univ N Carolina, Sch Pharm, Chapel Hill, NC USA.
Tokyo Womens Med Univ, Tokyo, Japan.
Thomas Jefferson Univ, Philadelphia, PA 19107 USA.
St Marianna Univ, Kawasaki, Kanagawa, Japan.
Univ Florida, Gainesville, FL 32611 USA.
Cardiff Univ, Cardiff, S Glam, Wales.
RP Akhtar, S (reprint author), Cardiff Univ, Welsh Sch Pharm, Ctr Genome Based Therapeut, Redwood Bldg,King Edward VII Ave, Cardiff CF10 3XF, S Glam, Wales.
EM saghirakhtar@cf.ac.uk
RI Lee, Vincent/A-9439-2008
OI Lee, Vincent/0000-0001-7708-6269
NR 0
TC 0
Z9 0
U1 0
U2 0
PU INFORMA HEALTHCARE
PI LONDON
PA TELEPHONE HOUSE, 69-77 PAUL STREET, LONDON EC2A 4LQ, ENGLAND
SN 1061-186X
J9 J DRUG TARGET
JI J. Drug Target.
PY 2004
VL 12
IS 6
BP 309
EP 311
DI 10.1080/10611860400005697
PG 3
WC Pharmacology & Pharmacy
SC Pharmacology & Pharmacy
GA 858BE
UT WOS:000224164300001
PM 15545080
ER
PT J
AU Stockbridge, N
Throckmorton, DC
AF Stockbridge, N
Throckmorton, DC
TI Regulatory advice on evaluation of the proarrhythmic potential of drugs
SO JOURNAL OF ELECTROCARDIOLOGY
LA English
DT Article; Proceedings Paper
CT 29th Annual ISCE Conference on Research and Technology Transfer in
Computerized Elecrocardiology
CY APR 27-MAY 02, 2004
CL Hutchinson Isl, FL
SP ISCE, Datex-Ohmeda Gems-It, Draeger-Siemens Med Syst, GE Med Syst Inc, Inovise Med Inc, Medtron, Mortara Instrument Inc, NE Montoring Inc, Philips Med Syst, Quinton Instrument Inc, Rozinn Elect Inc, Shiller AG, Welch Allyn - Cardio Control NV, Welch Allyn Inc
C1 US FDA, Rockville, MD 20857 USA.
RP Stockbridge, N (reprint author), US FDA, 5600 Fishers Lane, Rockville, MD 20857 USA.
EM stockbridgen@cder.fda.gov
NR 0
TC 9
Z9 9
U1 0
U2 0
PU CHURCHILL LIVINGSTONE INC MEDICAL PUBLISHERS
PI PHILADELPHIA
PA CURTIS CENTER, INDEPENDENCE SQUARE WEST, PHILADELPHIA, PA 19106-3399 USA
SN 0022-0736
J9 J ELECTROCARDIOL
JI J. Electrocardiol.
PY 2004
VL 37
SU S
BP 40
EP 41
DI 10.1016/j.jelectrocard.2003.08.007
PG 2
WC Cardiac & Cardiovascular Systems
SC Cardiovascular System & Cardiology
GA 875XR
UT WOS:000225456400006
PM 15534791
ER
PT J
AU Stockbridge, N
Brown, BD
AF Stockbridge, N
Brown, BD
TI Annotated ECG waveform data at FDA
SO JOURNAL OF ELECTROCARDIOLOGY
LA English
DT Article; Proceedings Paper
CT 29th Annual ISCE Conference on Research and Technology Transfer in
Computerized Elecrocardiology
CY APR 27-MAY 02, 2004
CL Hutchinson Isl, FL
SP ISCE, Datex-Ohmeda Gems-It, Draeger-Siemens Med Syst, GE Med Syst Inc, Inovise Med Inc, Medtron, Mortara Instrument Inc, NE Montoring Inc, Philips Med Syst, Quinton Instrument Inc, Rozinn Elect Inc, Shiller AG, Welch Allyn - Cardio Control NV, Welch Allyn Inc
C1 US FDA, Rockville, MD 20857 USA.
RP Stockbridge, N (reprint author), US FDA, 5600 Fishers Lane, Rockville, MD 20857 USA.
NR 0
TC 9
Z9 9
U1 0
U2 0
PU CHURCHILL LIVINGSTONE INC MEDICAL PUBLISHERS
PI PHILADELPHIA
PA CURTIS CENTER, INDEPENDENCE SQUARE WEST, PHILADELPHIA, PA 19106-3399 USA
SN 0022-0736
J9 J ELECTROCARDIOL
JI J. Electrocardiol.
PY 2004
VL 37
SU S
BP 63
EP 64
DI 10.1016/j.jelectrocard.2004.08.018
PG 2
WC Cardiac & Cardiovascular Systems
SC Cardiovascular System & Cardiology
GA 875XR
UT WOS:000225456400012
PM 15534802
ER
PT J
AU Buckles, D
Aguel, F
Brockman, R
Cheng, J
Demian, C
Ho, C
Jensen, D
Mallis, E
AF Buckles, D
Aguel, F
Brockman, R
Cheng, J
Demian, C
Ho, C
Jensen, D
Mallis, E
TI Advances in ambulatory monitoring: Regulatory considerations
SO JOURNAL OF ELECTROCARDIOLOGY
LA English
DT Article; Proceedings Paper
CT 29th Annual ISCE Conference on Research and Technology Transfer in
Computerized Elecrocardiology
CY APR 27-MAY 02, 2004
CL Hutchinson Isl, FL
SP ISCE, Datex-Ohmeda Gems-It, Draeger-Siemens Med Syst, GE Med Syst Inc, Inovise Med Inc, Medtron, Mortara Instrument Inc, NE Montoring Inc, Philips Med Syst, Quinton Instrument Inc, Rozinn Elect Inc, Shiller AG, Welch Allyn - Cardio Control NV, Welch Allyn Inc
DE Holter; ambulatory monitoring; 12-lead ECG; S-T segment analysis;
regulatory
AB Conventional ambulatory electrocardiogram (ECG) (Holter) monitoring involves 2 or 3 surface leads recorded with electrode positions and signal characteristics that are different from diagnostic quality 12-lead ECGs due to the limitations imposed by technology on the ambulatory recorders. The rapid pace of technological development for medical devices, particularly electrocardiography, has now enabled the recording of diagnostic quality 12-lead ECG waveforms for extended time periods. This capability allows Holter recording to become another source for diagnostic 12-lead ECG records on a par with other modalities Such as resting ECG and exercise stress testing. Additionally, other diagnostic techniques such as S-T segment analysis and Q-T interval analysis that rely on diagnostic quality waveforms can now be applied. All of these enhancements to the traditional Holter modality have altered the regulatory perspective of these devices, since the enhancements may represent a new intended use for the device.
C1 US FDA, Cardiac Electrophysiol & Monitoring Branh, Ctr Devices & Radiol Hlth, Dept Hlth & Human Serv, Rockville, MD 20850 USA.
RP Mallis, E (reprint author), US FDA, Cardiac Electrophysiol & Monitoring Branh, Ctr Devices & Radiol Hlth, Dept Hlth & Human Serv, HFZ-450,9200 Corp Blvd, Rockville, MD 20850 USA.
EM eym@cdrh.fda.gov
NR 0
TC 8
Z9 9
U1 0
U2 0
PU CHURCHILL LIVINGSTONE INC MEDICAL PUBLISHERS
PI PHILADELPHIA
PA CURTIS CENTER, INDEPENDENCE SQUARE WEST, PHILADELPHIA, PA 19106-3399 USA
SN 0022-0736
J9 J ELECTROCARDIOL
JI J. Electrocardiol.
PY 2004
VL 37
SU S
BP 65
EP 67
DI 10.1016/j.jelectrocard.2004.08.048
PG 3
WC Cardiac & Cardiovascular Systems
SC Cardiovascular System & Cardiology
GA 875XR
UT WOS:000225456400013
PM 15534803
ER
PT J
AU Muni, NI
Ho, C
Mallis, E
AF Muni, NI
Ho, C
Mallis, E
TI Regulatory issues for computerized electrocardiographic devices
SO JOURNAL OF ELECTROCARDIOLOGY
LA English
DT Article; Proceedings Paper
CT 29th Annual ISCE Conference on Research and Technology Transfer in
Computerized Elecrocardiology
CY APR 27-MAY 02, 2004
CL Hutchinson Isl, FL
SP ISCE, Datex-Ohmeda Gems-It, Draeger-Siemens Med Syst, GE Med Syst Inc, Inovise Med Inc, Medtron, Mortara Instrument Inc, NE Montoring Inc, Philips Med Syst, Quinton Instrument Inc, Rozinn Elect Inc, Shiller AG, Welch Allyn - Cardio Control NV, Welch Allyn Inc
DE FDA; 510(k); ECG; regulation; classification; tool; clinical; claim
ID T-WAVE ALTERNANS; RISK STRATIFICATION
AB Computerized electrocardiogram (ECG) devices are regulated in the U.S. by the FDA Center for Devices and Radiological Health (CDRH). This article aims to highlight the salient points of the FDA regulatory review process, including the important distinction between a "tool" claim and a clinical" claim in the intended use of a computerized ECG device. Specifically, a tool claim relates to the ability of the device to accurately measure a certain ECG parameter, such as T-wave alternans (TWA), while a clinical claim imputes a particular health hazard associated with the identified parameter, such as increased risk of ventricular tachyarrhythmia or sudden death. Given that both types of claims are equally important and receive the same regulatory scrutiny, the manufacturer of a new ECG diagnostic device should consider the distinction and regulatory pathways for approval between the two types of claims discussed in this paper.
C1 US FDA, Dept Hlth & Human Serv, Ctr Devices & Radiol Hlth, Rockville, MD 20850 USA.
RP Muni, NI (reprint author), US FDA, Dept Hlth & Human Serv, Ctr Devices & Radiol Hlth, HFZ-450,9200 Corp Blvd, Rockville, MD 20850 USA.
EM neal.muni@fda.hhs.gov
NR 3
TC 2
Z9 2
U1 0
U2 0
PU CHURCHILL LIVINGSTONE INC MEDICAL PUBLISHERS
PI PHILADELPHIA
PA CURTIS CENTER, INDEPENDENCE SQUARE WEST, PHILADELPHIA, PA 19106-3399 USA
SN 0022-0736
J9 J ELECTROCARDIOL
JI J. Electrocardiol.
PY 2004
VL 37
SU S
BP 74
EP 77
DI 10.1016/j.jelectrocard.2004.08.021
PG 4
WC Cardiac & Cardiovascular Systems
SC Cardiovascular System & Cardiology
GA 875XR
UT WOS:000225456400016
PM 15534806
ER
PT J
AU Kim, YH
Heinze, TM
Kim, SJ
Cerniglia, CE
AF Kim, YH
Heinze, TM
Kim, SJ
Cerniglia, CE
TI Adsorption and clay-catalyzed degradation of erythromycin A on homoionic
clays
SO JOURNAL OF ENVIRONMENTAL QUALITY
LA English
DT Article
ID ANTIBIOTIC-RESISTANCE; ACID DEGRADATION; PHARMACEUTICALS; DECOMPOSITION;
MECHANISMS; SORPTION; SOILS
AB Erythromycin has been widely used in food-producing animals and in humans, and is frequently detected as an organic pollutant in U.S. streams. In batch experiments with homoionic clays, the Freundlich isotherms were determined at 10 and 25degreesC. The adsorption of erythromycin A was strongly influenced by clay type, exchanged cations, the pH of the bulk solutions, and the acidity of clay surfaces. The formation of clay-erythromycin A complexes was thermodynamically favorable except for K+- and Fe3+-exchanged montmorillonites, since the reactions were exothermic (DeltaHdegrees > 0) and the systems became stable (DeltaSdegrees > 0). Clays catalyzed the erythromycin A degradation by the hydrolysis of the neutral sugar and the multiple dehydrations. The surface acidity of clay surface enhanced the rate of clay-catalyzed degradation of erythromycin A. In addition, the Fe3+-exchanged clay minerals seemed to have an electrostatic interaction with the erythromycin A molecule, by which the hydrolysis of the neutral sugar was influenced.
C1 US FDA, Natl Ctr Toxicol Res, Div Microbiol, Jefferson, AR 72079 USA.
US FDA, Natl Ctr Toxicol Res, Div Chem, Jefferson, AR 72079 USA.
RP Cerniglia, CE (reprint author), US FDA, Natl Ctr Toxicol Res, Div Microbiol, Jefferson, AR 72079 USA.
EM ccerniglia@nctr.fda.gov
NR 27
TC 25
Z9 28
U1 5
U2 39
PU AMER SOC AGRONOMY
PI MADISON
PA 677 S SEGOE RD, MADISON, WI 53711 USA
SN 0047-2425
J9 J ENVIRON QUAL
JI J. Environ. Qual.
PD JAN-FEB
PY 2004
VL 33
IS 1
BP 257
EP 264
PG 8
WC Environmental Sciences
SC Environmental Sciences & Ecology
GA 767WP
UT WOS:000188497100028
PM 14964380
ER
PT J
AU Chen, JJZ
Kadlubar, FF
AF Chen, JJZ
Kadlubar, FF
TI Mitochondrial mutagenesis and oxidative stress in human prostate cancer
SO JOURNAL OF ENVIRONMENTAL SCIENCE AND HEALTH PART C-ENVIRONMENTAL
CARCINOGENESIS & ECOTOXICOLOGY REVIEWS
LA English
DT Review
DE mitochondrial DNA; mutation; prostate cancer; oxidative stress
ID LASER CAPTURE MICRODISSECTION; DNA MUTATIONS; CARCINOMA-CELLS;
HIGH-FREQUENCY; TUMORS; PROGRESSION; POLYMERASE; SEQUENCE; DAMAGE;
ADENOCARCINOMA
AB Prostate cancer is the most common cancer diagnosed in men in the United States, but the primary cause and the molecular events leading to prostate carcinogenesis are poorly understood. Using the approach of laser capture microdissection, we revealed extensive somatic mitochondrial DNA (mtDNA) mutations in prostatic neoplastic lesions. Inspection of the lesion associated Mutations not only provided new insights into the genetics of prostate cancer, but also revealed new patterns of mtDNA mutation in prostate carcinogenesis. Further analysis on a high frequency of multiple mutational events observed in the same neoplastic lesion revealed an unusually rapid process in mitochondrial mutagenesis, suggesting a new process of mitochondrial hyper-mutagenesis in cancer cells, likely mediated by cellular oxidative stress. Thus, active mitochondrial mutagenesis in prostate cancer suggests a prominent role of increased cellular oxidative stress in neoplastic transformation and the increased susceptibility of neoplastic cells to oxidative damage.
C1 Natl Ctr Toxicol Res, Div Mol Epidemiol, Jefferson, AR 72079 USA.
RP Chen, JJZ (reprint author), Natl Ctr Toxicol Res, Div Mol Epidemiol, 3900 NCTR Rd, Jefferson, AR 72079 USA.
EM jjchen@nctr.fda.gov
FU PHS HHS [E07113.01]
NR 40
TC 53
Z9 54
U1 0
U2 5
PU MARCEL DEKKER INC
PI NEW YORK
PA 270 MADISON AVE, NEW YORK, NY 10016 USA
SN 1059-0501
J9 J ENVIRON SCI HEAL C
JI J. Environ. Sci. Health Pt. C-Environ. Carcinog. Ecotoxicol. Rev.
PY 2004
VL 22
IS 1
BP 1
EP 12
DI 10.1081/GNC-120037931
PG 12
WC Oncology; Environmental Sciences; Toxicology
SC Oncology; Environmental Sciences & Ecology; Toxicology
GA 832MA
UT WOS:000222270400001
PM 15845219
ER
PT J
AU Edelson-Mammel, SG
Buchanan, RL
AF Edelson-Mammel, SG
Buchanan, RL
TI Thermal inactivation of Enterobacter sakazakii in rehydrated infant
formula
SO JOURNAL OF FOOD PROTECTION
LA English
DT Article
ID NEONATAL MENINGITIS; POWDERED MILK; BACTEREMIA; CONTAMINATION;
INFECTIONS; RESISTANCE; OUTBREAK
AB The presence of low levels of Enterobacter sakazakii in dried infant formula have been linked to outbreaks of meningitis, septicemia, and necrotizing enterocolitis in neonates, particularly those who are premature or immunocompromised. In the current study, the ability of 12 strains of E. sakazakii to survive heating in rehydrated infant formula was determined at 58degreesC with a submerged coil apparatus. The observed D-58-values ranged from 30.5 to 591.9 s, with the strains appearing to fall into two distinct heat resistance phenotypes. The z-value of the most heat-resistant strain was 5.6degreesC. When dried infant formula containing this strain was rehydrated with water preequilibrated to various temperatures, a more than 4-log reduction in E sakazakii levels was achieved by preparing the formula with water at 70degreesC or greater.
C1 US FDA, Dept Hlth & Human Serv, Ctr Food Safety & Appl Nutr, College Pk, MD 20740 USA.
RP Buchanan, RL (reprint author), US FDA, Dept Hlth & Human Serv, Ctr Food Safety & Appl Nutr, 510 Paint Branch Pkwy, College Pk, MD 20740 USA.
EM robert.buchanan@cfsan.fda.gov
NR 27
TC 80
Z9 84
U1 0
U2 6
PU INT ASSOC FOOD PROTECTION
PI DES MOINES
PA 6200 AURORA AVE SUITE 200W, DES MOINES, IA 50322-2863 USA
SN 0362-028X
J9 J FOOD PROTECT
JI J. Food Prot.
PD JAN
PY 2004
VL 67
IS 1
BP 60
EP 63
PG 4
WC Biotechnology & Applied Microbiology; Food Science & Technology
SC Biotechnology & Applied Microbiology; Food Science & Technology
GA 761XB
UT WOS:000187939800009
PM 14717352
ER
PT J
AU Benner, RA
Staruszkiewicz, WF
Otwell, WS
AF Benner, RA
Staruszkiewicz, WF
Otwell, WS
TI Putrescine, cadaverine, and indole production by bacteria isolated from
wild and aquacultured penaeid shrimp stored at 0, 12, 24, and 36 degrees
C
SO JOURNAL OF FOOD PROTECTION
LA English
DT Article
ID POND-REARED SHRIMP; SHELF-LIFE; CHEMICAL CHARACTERISTICS; DIFFERENT
TEMPERATURES; MICROBIAL-FLORA; STORAGE
AB Putrescine, cadaverine, and indole production capabilities of bacteria isolated from wild domestic and aquacultured Nicaraguan penaeid shrimp in progressive decomposition states were evaluated. The numbers and types of microorganisms responsible for the production of putrescine, cadaverine, and indole in wild and aquacultured shrimp increased with increasing decomposition temperature and time. Throughout the storage experiments, mean aerobic plate counts (log/g) ranged from 4.5 to 9.7 and 4.5 to 9.0 for domestic and Nicaraguan shrimp, respectively. Vibrio spp. were more prominent in Nicaraguan shrimp (Litopenaeus vannamei) than in domestic shrimp (Litopenaeus setiferus and Litopenaeus brasiliensis). The only amine-producing (putrescine) microorganism isolated from wild and aquacultured shrimp at all temperatures of decomposition (0, 12, 24, and 36degreesC) was Shewanella putrefaciens. On the basis of putrescine production by S. putrefaciens at 0 and 12degreesC and putrescine production by S. putrefaciens, Vibrio spp., and Morganella morganii at 24 and 36degreesC, putrescine should be considered a potential chemical indicator of decomposition in shrimp.
C1 US FDA, Off Seafood, Washington Seafood Lab, Laurel, MD 20708 USA.
Univ Florida, Dept Food Sci & Human Nutr, Aquat Food Prod Lab, Gainesville, FL 32611 USA.
RP Benner, RA (reprint author), US FDA, Off Seafood, Washington Seafood Lab, HFS-426,8501 Muirkirk Rd, Laurel, MD 20708 USA.
EM rbenner@cfsan.fda.gov
NR 21
TC 11
Z9 12
U1 0
U2 2
PU INT ASSOC FOOD PROTECTION
PI DES MOINES
PA 6200 AURORA AVE SUITE 200W, DES MOINES, IA 50322-2863 USA
SN 0362-028X
J9 J FOOD PROTECT
JI J. Food Prot.
PD JAN
PY 2004
VL 67
IS 1
BP 124
EP 133
PG 10
WC Biotechnology & Applied Microbiology; Food Science & Technology
SC Biotechnology & Applied Microbiology; Food Science & Technology
GA 761XB
UT WOS:000187939800019
PM 14717362
ER
PT J
AU Staruszkiewicz, WF
Barnett, JD
Rogers, PL
Benner, RA
Wong, LL
Cook, J
AF Staruszkiewicz, WF
Barnett, JD
Rogers, PL
Benner, RA
Wong, LL
Cook, J
TI Effects of on-board and dockside handling on the formation of biogenic
amines in mahimahi (Coryphaena hippurus), skipjack tuna (Katsuwonus
pelamis), and yellowfin tuna (Thunnus albacares)
SO JOURNAL OF FOOD PROTECTION
LA English
DT Article
ID HISTAMINE FORMATION; ELEVATED-TEMPERATURES; DECOMPOSITION; CADAVERINE;
QUALITY; PUTRESCINE; FISH
AB Consumer illnesses by scombroid poisonings have been a continuing problem for many years. The intoxications follow the ingestion of fish such as tuna and mahimahi that have undergone bacterial decomposition, leading to the formation of biogenic amines. Research studies have concluded that histamine is one of the indicators of scombrotoxic fish and that other amines, such as cadaverine, could be involved in the illnesses. Guidance for the handling of fish on board fishing vessels to prevent the production of scombrotoxic fish has been limited by a lack of data addressing changes that occur in fish from the water to delivery at dockside. In this study, the changes in selected biogenic amines were determined in mahimahi and tuna, which were captured and held in seawater at 25 to 35degreesC for incubation times up to 18 h. The fillets from the treated fish were sectioned by transverse cuts and analyzed for histamine, cadaverine, and putrescine. Results showed that at 26degreesC, more than 12 h of incubation were required before a histamine concentration of 50 ppm was reached in mahimahi. At 35degreesC, 50 ppm histamine formed within 9 h. Similar results were found for skipjack and yellowfin tuna. Histamine concentrations exceeded 500 ppm within an additional 3 h of incubation in mahimahi. At both temperatures, an increase in the concentration of cadaverine preceded an increase in histamine levels. Changes in putrescine concentrations in the fish were less pronounced. The study also demonstrated that histidine decarboxylase activity was retained in some frozen samples of fish and could result in further increases in histamine on thawing.
C1 US FDA, Washington Seafood Lab, Laurel, MD 20708 USA.
US FDA, Seattle Reg Lab, Bothell, WA 98021 USA.
US FDA, Honolulu, HI 96850 USA.
RP Staruszkiewicz, WF (reprint author), US FDA, Washington Seafood Lab, 8301 Muirkirk Rd, Laurel, MD 20708 USA.
EM wstarusz@cfsan.fda.gov
NR 20
TC 25
Z9 26
U1 1
U2 6
PU INT ASSOC FOOD PROTECTION
PI DES MOINES
PA 6200 AURORA AVE SUITE 200W, DES MOINES, IA 50322-2863 USA
SN 0362-028X
J9 J FOOD PROTECT
JI J. Food Prot.
PD JAN
PY 2004
VL 67
IS 1
BP 134
EP 141
PG 8
WC Biotechnology & Applied Microbiology; Food Science & Technology
SC Biotechnology & Applied Microbiology; Food Science & Technology
GA 761XB
UT WOS:000187939800020
PM 14717363
ER
PT J
AU Penteado, AL
Eblen, BS
Miller, AJ
AF Penteado, AL
Eblen, BS
Miller, AJ
TI Evidence of Salmonella internalization into fresh mangos during
simulated postharvest insect disinfestation procedures
SO JOURNAL OF FOOD PROTECTION
LA English
DT Article
AB A recent U.S. salmonellosis outbreak was epidemiologically associated with consumption of imported fresh mangos. Studies were conducted to simulate the commercial heat disinfestation method used to eliminate tephritid fly larvae from mangos, as well as subsequent product cooling procedures, to assess whether this process promotes internalization of Salmonella into mangos. The experimental parameters were chosen to mimic the disinfestation method used by the South American producer/packer implicated in the recent outbreak. Untreated domestically grown immature and ripened Tommy Atkins variety mangos were immersed in water at 47degreesC for 90 min and then immersed in 21degreesC water containing brilliant blue FD&C no. 1 dye for 10 min. After dye internalization potential was established (67%), the same experiment was performed using 21degreesC water containing 10(7) CFU/ml Salmonella Enteritidis expressing constitutive green fluorescent protein. Fruit was then stored at 10, 20, or 30degreesC for up to 1 week. Immature and ripened mangos were positive for Salmonella internalization at a frequency of 80 and 87%, respectively. Internalization frequency into the stem-end segment (83%) was significantly higher (P < 0.05) than internalization into the middle-side (19%) or blossom-end (9%) segments of the fruit. Salmonella was detected in the mango pulp after 1 week of incubation. The degree of fruit ripeness, posttreatment holding temperature, or duration of storage had no significant effect (P > 0.05) on internalization frequency or survival of Salmonella inside mangos. This study illustrates the high potential for pathogen internalization if heat-disinfested mangos are cooled using contaminated water.
C1 Univ Estadual Campinas, Fac Engn Alimentos, Dept Tecnol Alimentos, Sao Paulo, Brazil.
US FDA, Ctr Food Safety & Appl Nutr, College Pk, MD 20740 USA.
RP Miller, AJ (reprint author), Univ Estadual Campinas, Fac Engn Alimentos, Dept Tecnol Alimentos, Cidade Univ,Zeferino Vaz Caixa Postal 6121, Sao Paulo, Brazil.
EM amiller@cfsan.fda.gov
NR 6
TC 47
Z9 50
U1 1
U2 6
PU INT ASSOC FOOD PROTECTION
PI DES MOINES
PA 6200 AURORA AVE SUITE 200W, DES MOINES, IA 50322-2863 USA
SN 0362-028X
J9 J FOOD PROTECT
JI J. Food Prot.
PD JAN
PY 2004
VL 67
IS 1
BP 181
EP 184
PG 4
WC Biotechnology & Applied Microbiology; Food Science & Technology
SC Biotechnology & Applied Microbiology; Food Science & Technology
GA 761XB
UT WOS:000187939800028
PM 14717371
ER
PT J
AU Ferreira, JL
Eliasberg, SJ
Edmonds, P
Harrison, MA
AF Ferreira, JL
Eliasberg, SJ
Edmonds, P
Harrison, MA
TI Comparison of the mouse bioassay and enzyme-linked immunosorbent assay
procedures for the detection of type A botulinal toxin in food
SO JOURNAL OF FOOD PROTECTION
LA English
DT Article
ID ELISA
AB Samples of chili linked to a foodborne illness outbreak of type A botulism were examined for preformed type A botulinal toxin using two enzyme-linked immunosorbent assay (ELISA) procedures and the mouse bioassay. One of the samples was positive for type A botulinal toxin and three of the samples were negative for type A, B, E, and F botulinal toxins using the three methods. The mouse bioassay indicated that type A toxin was present at the 10,000 minimal lethal dose per gram (MLD per g) of product. The ELISA tests indicated a toxicity of 7,650 MLD per g with one method and 8,350 MLD per g with the other method. The sample toxicity determined by the ELISA was estimated by comparing samples to a standard curve generated with standard type A neurotoxin in casein buffer. The ELISA methods are more rapid than the mouse bioassay, since the toxin type can be determined in I day. The mouse bioassay is more sensitive than the ELISA but usually requires multiple assays to obtain the toxin type and toxicity. Type A culture isolates from the sample were also verified using one ELISA method.
C1 US FDA, Atlanta, GA 30309 USA.
Georgia Inst Technol, Sch Biol, Atlanta, GA 30332 USA.
Univ Georgia, Dept Food Sci & Technol, Athens, GA 30602 USA.
RP Ferreira, JL (reprint author), US FDA, 60 8th St NE, Atlanta, GA 30309 USA.
EM jfeffeir@ora.fda.gov
NR 8
TC 40
Z9 42
U1 1
U2 7
PU INT ASSOC FOOD PROTECTION
PI DES MOINES
PA 6200 AURORA AVE SUITE 200W, DES MOINES, IA 50322-2863 USA
SN 0362-028X
J9 J FOOD PROTECT
JI J. Food Prot.
PD JAN
PY 2004
VL 67
IS 1
BP 203
EP 206
PG 4
WC Biotechnology & Applied Microbiology; Food Science & Technology
SC Biotechnology & Applied Microbiology; Food Science & Technology
GA 761XB
UT WOS:000187939800033
PM 14717376
ER
PT J
AU Lineback, DR
AF Lineback, DR
TI Globalization and food security - Plenary discussion session 1
SO JOURNAL OF FOOD SCIENCE
LA English
DT Editorial Material
C1 Univ Maryland, Joint Inst Food Safety & Appl Nutr, College Pk, MD 20742 USA.
RP Lineback, DR (reprint author), Univ Maryland, Joint Inst Food Safety & Appl Nutr, College Pk, MD 20742 USA.
NR 0
TC 0
Z9 0
U1 0
U2 0
PU INST FOOD TECHNOLOGISTS
PI CHICAGO
PA 525 WEST VAN BUREN, STE 1000, CHICAGO, IL 60607-3814 USA
SN 0022-1147
J9 J FOOD SCI
JI J. Food Sci.
PD JAN-FEB
PY 2004
VL 69
IS 1
BP R2
EP R3
PG 2
WC Food Science & Technology
SC Food Science & Technology
GA 802CR
UT WOS:000220142100004
ER
PT J
AU Argaw, T
Colon-Moran, W
Wilson, CA
AF Argaw, T
Colon-Moran, W
Wilson, CA
TI Limited infection without evidence of replication by porcine endogenous
retrovirus in guinea pigs
SO JOURNAL OF GENERAL VIROLOGY
LA English
DT Article
ID ANTIBODY-DEPENDENT ENHANCEMENT; IN-VIVO; CLINICAL XENOTRANSPLANTATION;
VIRUS-INFECTION; GENE-TRANSFER; HUMAN-CELLS; HOST-RANGE; LIVER;
TRANSMISSION; TISSUE
AB Porcine endogenous retrovirus (PERV) may potentially be transmitted through porcine xenotransplantation products administered to humans. This study examined the feasibility of using guinea pigs as a model to characterize the in vivo infectivity of PERV. To enhance the susceptibility of guinea pigs to retroviral infection or genomic integration, moderate physiological or immunological changes were induced prior to exposing the animals to PERV. Quantitative PERV-specific PCR performed on all tested samples resulted in either undetectable or very low copy numbers of proviruses, even in animals possessing PERV-specific antibody responses. The low copy number of viral DNA detected suggests that PERV infected a limited number of cells. However, PERV DNA levels did not increase over time, suggesting no virus replication occurred. These results in the guinea pig are similar to previous observations of non-human primate cells that allow PERV infection but do not support PERV replication in vitro.
C1 US FDA, Ctr Biol Evaluat & Res, Div Cellular & Gene Therapies, Lab Immunol & Virol, Bethesda, MD 20892 USA.
RP Wilson, CA (reprint author), US FDA, Ctr Biol Evaluat & Res, Div Cellular & Gene Therapies, Lab Immunol & Virol, 8800 Rockville Pike,HFM-725, Bethesda, MD 20892 USA.
EM wilsonc@cber.fda.gov
NR 30
TC 16
Z9 18
U1 0
U2 0
PU SOC GENERAL MICROBIOLOGY
PI READING
PA MARLBOROUGH HOUSE, BASINGSTOKE RD, SPENCERS WOODS, READING RG7 1AG,
BERKS, ENGLAND
SN 0022-1317
J9 J GEN VIROL
JI J. Gen. Virol.
PD JAN
PY 2004
VL 85
BP 15
EP 19
DI 10.1099/vir.0.19495-0
PN 1
PG 5
WC Biotechnology & Applied Microbiology; Virology
SC Biotechnology & Applied Microbiology; Virology
GA 770BT
UT WOS:000188703900002
PM 14718614
ER
PT J
AU Xu, LL
Heinze, T
Pogge, A
Slikker, W
Schmued, L
AF Xu, LL
Heinze, T
Pogge, A
Slikker, W
Schmued, L
TI Isolation and characterization of Fluoro-Jade B, a selective
histochemical stain for neuronal degeneration
SO JOURNAL OF LIQUID CHROMATOGRAPHY & RELATED TECHNOLOGIES
LA English
DT Article
DE fluorescent dye; Fluoro-Jade B components; neuronal degeneration;
derivatives of carboxyfluorescein
ID LOCALIZATION; FLUORESCEIN; CELLS; PH
AB Fluoro-Jade B is a novel fluorescent dye, and since its introduction in 1999 it has been widely used in neuroscience research for selectively staining degenerating neurons in brain tissue sections. However, the chemical composition of Fluoro-Jade B has not been previously resolved. We here report successful separation and identification of eight isomers and structural analogues of Fluoro-Jade B. Two analytical HPLC methods, consisting of a reversed-phase C18 column and a mobile phase with either a pH gradient or an acetonitrile gradient, were developed. A quantitative separation was performed by a semi-preparative reversed phase C-18 HPLC column. Each individual component was characterized by LC/ESI mass spectrometry and NMR spectroscopy. The compounds 5-(6'-hydroxy-3'-oxo-3H-xanthen-9'-yl)benzene-1,2,4-tricarboxylic acid, 2-(6-hydroxy-3-oxo-3H-xanthen-9-yl)-5-(2,4-dihydroxybenzoyl)terephthalic acid, and 4-(6-hydroxy-3-oxo-3H-xanthen-9-yl)-6-(2,4-dihydroxybenzoyl)isophthalic acid represent three new fluorescent compounds discovered in Fluoro-Jade B. They are, presumably, responsible for the dye's ability to detect degenerating neurons.
C1 US FDA, Natl Ctr Toxicol Res, USA, Div Neurotoxicol, Jefferson, AR 72079 USA.
US FDA, Natl Ctr Toxicol Res, USA, Div Chem, Jefferson, AR 72079 USA.
RP Schmued, L (reprint author), US FDA, Natl Ctr Toxicol Res, USA, Div Neurotoxicol, HFT132,3900 NCTR Rd, Jefferson, AR 72079 USA.
EM lschmued@nctr.fda.gov
NR 22
TC 5
Z9 5
U1 0
U2 1
PU MARCEL DEKKER INC
PI NEW YORK
PA 270 MADISON AVE, NEW YORK, NY 10016 USA
SN 1082-6076
J9 J LIQ CHROMATOGR R T
JI J. Liq. Chromatogr. Relat. Technol.
PY 2004
VL 27
IS 10
BP 1627
EP 1640
DI 10.1081/JLC-120034096
PG 14
WC Biochemical Research Methods; Chemistry, Analytical
SC Biochemistry & Molecular Biology; Chemistry
GA 827WR
UT WOS:000221934900012
ER
PT J
AU Mahmood, I
AF Mahmood, I
TI Interspecies scaling of protein drugs: Prediction of clearance from
animals to humans
SO JOURNAL OF PHARMACEUTICAL SCIENCES
LA English
DT Article
DE interspecies scaling; protein drugs; clearance; two versus three species
ID ATRIAL-NATRIURETIC-PEPTIDE; ENDOTHELIAL GROWTH-FACTOR; RECOMBINANT
FACTOR-IX; DIGOXIN-SPECIFIC FAB; METABOLIC-CLEARANCE; EPOETIN-BETA;
FACTOR-VIII; PHARMACOKINETICS; DOGS; ERYTHROPOIETIN
AB The objective of this study was to evaluate the interspecies scaling for therapeutic protein drugs to predict the systemic clearance in humans from animal data. This study was undertaken to examine whether the rule of exponents of Mahmood and Balian for the prediction of clearance of nonprotein drugs can also be extended to macromolecules. Three different methods were used to predict clearance in humans: (1) clearance versus body weight (simple allometry), (2) the product of clearance and maximum life-span potential (MLP) versus body weight, and (3) the product of clearance and brain weight versus body weight. Data from 15 therapeutic proteins were analyzed, and the results indicated that the clearance of protein drugs can be predicted accurately using simple allometry or brain weight depending on the exponents of the simple allometry. Furthermore, these 15 drugs were scaled up using two species and the predicted clearance was compared with the predicted clearance obtained from more than two species. It was found that more than two species are needed for a reliable prediction of clearance. (C) 2004 Wiley-Liss, Inc.
C1 US FDA, Div Clin Trial Design & Anal, Off Therapeut Res & Review,Ctr Biol Evaluat & Res, Clin Pharmacol & Toxicol Branch HFD579, Rockville, MD 20852 USA.
RP Mahmood, I (reprint author), US FDA, Div Clin Trial Design & Anal, Off Therapeut Res & Review,Ctr Biol Evaluat & Res, Clin Pharmacol & Toxicol Branch HFD579, Woodmont Off Ctr 1,Suite 200N,1401 Rockville Pike, Rockville, MD 20852 USA.
NR 36
TC 43
Z9 43
U1 0
U2 3
PU JOHN WILEY & SONS INC
PI HOBOKEN
PA 111 RIVER ST, HOBOKEN, NJ 07030 USA
SN 0022-3549
J9 J PHARM SCI-US
JI J. Pharm. Sci.
PD JAN
PY 2004
VL 93
IS 1
BP 177
EP 185
DI 10.1002/jps.10531
PG 9
WC Chemistry, Medicinal; Chemistry, Multidisciplinary; Pharmacology &
Pharmacy
SC Pharmacology & Pharmacy; Chemistry
GA 758UH
UT WOS:000187668400019
PM 14648647
ER
PT J
AU Wear, KA
AF Wear, KA
TI Measurement of dependence of backscatter coefficient from cylinders on
frequency and diameter using focused transducers - with applications in
trabecular bone
SO JOURNAL OF THE ACOUSTICAL SOCIETY OF AMERICA
LA English
DT Article
ID ULTRASONIC BACKSCATTER; SCATTERING; TISSUES; ECHOES
AB A theory for the elastic scattering response from a cylinder insonified by a plane wave was previously derived by Faran. In the present paper, the empirical relationship between Faran's theory and measurements of backscatter coefficient from cylindrical targets using focused transducers is investigated. Experimental measurements of dependence of backscatter coefficient on frequency and diameter for nylon wires are reported. It is found that, under certain conditions (including weak, incoherent scattering), backscatter coefficient measurements from collections of cylindrical scatterers may be meaningfully compared with Faran's model predictions. At low frequencies, the theory and experimental measurements exhibit similar dependences on frequency and diameter, provided that the scatterers are not too densely packed. At higher frequencies, the fine structure of Faran's predictions becomes difficult to reproduce experimentally with a focused transducer. Implications regarding applications to characterization of trabecular bone are discussed. (C) 2004 Acoustical Society of America.
C1 US FDA, Ctr Devices & Radiol Hlth, Rockville, MD 20852 USA.
RP Wear, KA (reprint author), US FDA, Ctr Devices & Radiol Hlth, HFZ-142,12720 Twinbrook Pkwy, Rockville, MD 20852 USA.
EM kaw@cdrh.fda.gov
NR 25
TC 30
Z9 30
U1 0
U2 0
PU ACOUSTICAL SOC AMER AMER INST PHYSICS
PI MELVILLE
PA STE 1 NO 1, 2 HUNTINGTON QUADRANGLE, MELVILLE, NY 11747-4502 USA
SN 0001-4966
J9 J ACOUST SOC AM
JI J. Acoust. Soc. Am.
PD JAN
PY 2004
VL 115
IS 1
BP 66
EP 72
DI 10.1121/1.1631943
PG 7
WC Acoustics; Audiology & Speech-Language Pathology
SC Acoustics; Audiology & Speech-Language Pathology
GA 765CJ
UT WOS:000188249300006
PM 14758996
ER
EF