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AASLD-FDA-NIH-PhRMA Hepatotoxicity
Steering Group Meeting
2006 Presentations
Session I. Non-Clinical Prediction (Patrick Wier, Moderator)
Can pre/non-clinical studies really predict that a drug will be hepatotoxic to people?
- Patrick J. Wier, PhD, GlaxoSmithKline,
Integrating liver toxicogenomics with clinical pathology, histopathology and drug metabolism data in preclinical studies – GSK perspective
- Donald G. Robertson, PhD, DABT, Pfizer,
Metabonomics in Preclinical Assessment of Hepatic Toxicity
- Craig E. Thomas, PhD, Lilly Research Laboratories,
Metabonomics: Using biofluid metabolite profiling to assess pre-clinical hepatotoxicity
- James E. Sanders, DVM, PhD, DABT, Johnson and Johnson,
New developments in preclinical prediction of human hepatotoxicity
- Robert N. McBurney, PhD, BG Medicine, Inc.,
The Liver Toxicity Biomarkers Study CRADA
- Yvonne P Dragan, PhD, Food and Drug Administration,
The critical path to new medical products
Session I Questions and Answers [PDF]
Session II. Liver Adaptation to Injury (Paul Watkins, Moderator)
How does the liver adapt to xenobiotic injury and become tolerant?
- John R. Senior, MD, Food and Drug Administration,
Adaptation to Liver Injury: Tacrine, Isoniazid, Ethanol, Experimental Drugs
- Lance R. Pohl, Pharm.D., PhD, NHLBI, NIH,
Role of cytokines and other factors in protecting the liver from drug-induced disease
- Harihara M. Mehendale, PhD, University of Louisiana,
Liver tissue repair, survival factors, and adaptation to injury
- Rebecca Taub, MD, Hoffmann- La Roche,
Interplay Between Liver Regeneration and Hepatoprotection
- Jack Uetrecht, MD, PhD, University of Toronto
Tolerance
- Paul B. Watkins, MD, University of North Carolina, Chapel Hill,
The way forward toward improved biomarkers
- Daniel K. Burns, PhD, GlaxoSmithKline,
Investigating the role of inheritance in drug induced hepatotoxicity
Session II Questions and Answers [PDF] Session III. Attribution of Causality (Len Seeff, Moderator)
How likely is it that a drug really caused the injury, and if so which drug?
- Leonard B. Seeff, MD, NIDDK, NIH,
The Problems of Establishing Causality
- James Freston, MD, PhD, University of Connecticut School of Medicine,
Use and limitations of the RUCAM
- Don Rockey, MD, University of Texas Southwestern,
Method of DILIN in establishing causality
- William M. Lee, MD, University of Texas,
Criteria for Causality Assessment in Drug-Induced Liver Injury (DILI): Results from the Acute Liver Failure (ALF) Study Group
- Herbert L. Bonkovsky, MD, University of Connecticut,
Immunological Tests for Improving Causality Assessment
- Tim Davern, MD, University of
California San Francisco,
Can we replace opinion consensus with a Bayesian process?
- Mark Avigan, MD CM, Food and Drug Administration,
Characterization of risk for drug-induced serious liver injury prompted by a series of spontaneously reported post-marketing cases
- Naga Chalasani, MD, Indiana University,
Update on the DILIN
Session III Summary [PDF]
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Date created: April 4, 2006 |
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