The Role of Model-Based Drug Development in Paving the Critical Path [PDF]
AAPS Workshop on Quantitative Clinical Pharmacology
AAPS Annual Meeting
San Diego, California
November 10, 2007
Lawrence J. Lesko, Ph.D., FCP
Director of the Office of Clinical Pharmacology
Center for Drug Evaluation and Research
Food and Drug Administration
Clinical Trial Simulations in the Critical Path Initiative and Regulatory Decision-Making [PDF]
Clinical Trial Simulations: Many Questions, Few Answers
AAPS Annual Meeting
San Diego, California
November 12, 2007
Lawrence J. Lesko, Ph.D., FCP
Director of the Office of Clinical Pharmacology
Center for Drug Evaluation and Research
Food and Drug Administration