Page 1. Hepatotoxicity Steering Committee Meeting Rockville Civic Center Rockville, Maryland February 5, 2004 8:00 AM Continental Breakfast All ...
Center for Drug Evaluation (CDER)
FDA-PhRMA-AASLD Hepatotoxicity Steering Committee Meeting Rockville Civic Center (�The Mansion�), Rockville, Maryland Friday, January 28 ...
... Although this scale is felt to yield a valid assessment of hepatotoxicity, it is complex, and therefore is also believed to be difficult to use clinical ...
... hepatotoxicity. Unfortunately, this model has not been investigated enough to find what we can learn from the mouse about survival strategies. ...
... Edwin J. Matthews, Ph.D., FDA MCASE Prediction of Hepatotoxicity Using Post-Market ... Paul B. Watkins, University of North Carolina, Chapel Hill, NC Identifying ...
... at Harvard University and the Massachusetts General Hospital (1959-62), where he worked out the mechanisms of intestinal absorption of fats ...
... Logic in 1998, Dr. Mendrick was a Group Leader in ... of Regulatory in the company and focused on the ... in the best practices of other companies, thought leaders in ...
... In fact, the Drug Induced Liver Injury Network (DILIN) utilizes such a process currently for causality assessment in both retrospective and prospective studies ...
... reaction. Rarely, such reactions may go on to self-sustaining hepatitis or other organ damage with hallmarks of autoimmune disease. ...
... the three expert reviewers who adjudicate each case of suspected DILI collected from the DILIN centers and presented to the reviewers in a standardized fashion ...
... led to an inhibition of the immune system that is ... chemistry from the University of California Medical Center ... Current studies deal with the role of cytokines and ...
... this afternoon upon some of these resistance-repair-regeneration processes in seeking to understand better their diversity, and how we may learn to use these ...
... the technology in assessment of hepatic toxicity including necessary caveats, learnings from the COMET metabonomics consortium and real-world applications of ...
... a �routine� toxicology testing protocol by creating a facile data generation/reporting process, providing sufficient reference knowledge (and processes to ...
... A potential collaboration to perform a high density scan on ... utilizing molecular biology techniques to investigate the structure function relationship of ...
... urine and serum specimens from people who begin treatment with isoniazid ... by the National Institute for Diabetes Digestive and Kidney Diseases. ...
... Group; Herbert L. Bonkovsky, MD, University of Connecticut, Immunological tests for improving causality assessment; Tim ...
... 28 January 2005. FDA/CDER-AASLD-PhRMA HepTox Steering Group. 4. Rules of the Game (1). ... FDA/CDER-AASLD-PhRMA HepTox Steering Group. 5. Rules of the Game (2). ...
... Judith Racoosin CDER 301-796-1135 Judith.racoosin@fda.hhs.gov Glenn Sipes (AASLD) University Of Arizona 520-626-7123 520-626-2466 sipes@email.arizona.edu ...
... loss (Kg) for combined (capsule and tablet) high dose groups. ... FDA/CDER-AASLD-PhRMA HepTox Steering Group. 22. ... to rapidly explore; 'One at a time' thinking is the ...
... DDIILLII �� WWHHEERREE DDOO WWEE GGOO FFRROOMM HHEERREE?? January 25, 2006 8:00 AM CHECK-IN and CONTINENTAL BREAKFAST 8:30 AM Welcome John Senior (FDA) ...
... is the distribution of clinical severity of liver injury among the post-marketing cases ... In addition, he was the principal investigator of NIH funded R-29 and R0 ...
... to study viral hepatitis, conducting a number of long-term natural history studies of ... on Treatment of Hepatitis C and participated in writing AASLD Guidelines ...
... than seems possible for the half-life of the ... his Ph.D. in Organic Chemistry from Cornell ... Societies and Activities: Chair, Pharmaceutical Sciences grant review ...
... Drugs. ... the academic book award there in 1978, was awarded post-doctoral research fellowships from the Damon Runyon-Walter Winchell Cancer Foundation and the ...
... Yvonne Dragan received her Ph.D. in Pharmacology and Toxicology from the Medical College of ... She was a member of the School of Public Health faculty at the Ohio ...
... and metabolomic methods for blood plasma; and, metabolomic methods for urine ... of CeNeS Pharmaceuticals, Inc., and from 1990-2000 was Chief Scientific Officer and ...
... analysis. Biographical Sketch. Dr. James. E. Sanders joined J&J PRD in 2005 as a Preclinical Development Team Leader. In addition ...
... Craig was then granted an NIEHS Research Service Award to conduct postdoctoral work at Oregon State where he investigated mechanisms of calcium-dependent ...
... 81) and the Kakatiya Medical College (MB, BS 1988), after which he served as an internal medical resident at Emory University in Atlanta (1991-4 ...
... one of the 10 sites participating in the NIH HALT-C study, a long-term treatment program for patients who are non-responders to interferon therapy. ...
... ' Page 2. THE MOLECULAR ANATOMY OF PFDA HEPATOTOXICITY AS STUDIED BY TWO- DIMENSIONAL ELECTROPHORESIS ...
DTIC Science & Technology
