ADVISORY COMMTTEE FOR PHARMACEUTICAL SCIENCE

September 24, 1999

Slides

Exposure-Response Introduction/Overview, Roger L Williams, MD, Deputy Center Director for Pharmaceutical Science, CDER, FDA

Exposure-Response (PK/PD), Lawrence J. Lesko, PhD, Office of Clinical Pharmacology and Biopharmaceutics, CDER, FDA

Exposure-Response Document Expert Panel Review Report, Don Stanski, MD

Drug-Drug Interaction Introduction, Roger L Williams, MD, Deputy Center Director for Pharmaceutical Science, CDER, FDA

In Vivo Drug-Drug Interactions, Shiew-Mei Huang, PhD, Associate Director, Science & Regulatory Policy, Office of Clinical Pharmacology and Biopharmaceutics, OPS, CDER, FDA

ACPS Nonclinical Studies Subcommittee

Nonclinical Studies Subcommittee Report, Jack A. Reynolds, Subcommittee Chairperson