ADVISORY COMMITTEE FOR PHARMACEUTICAL SCIENCE
September 24, 1999
Background Information
Clinical Pharmacology Topices
Tab A: Exposure Response Document: Response Relationships:
Study Design, data Analysis, and Reglatory Applications, September 1, 1999
Tab B: Pharmacokinetic/Pharmacodynamic Modeling in Drug Development, Lewis B. Sheiner,
Jean-Louis Steimer *
Tab C: Guideline for Industry, Dose-Response Information to
Support Drug Registration, ICH-E4, November 1994
Tab D: Guidance for Industry, Providing
Clinical Evidence of Effectiveness for Human Drug and Biological Products, May 1998
Tab E: Guidance for Industry, Population
Pharmacokinetics, February 1999
Tab F: Drug-Drug Interactions, Discussion Topics
Tab G: Draft Guidance for Industry, In Vivo
Drug Metabolism/Drug Interaction Studies-Study Design, Data Analysis, and Recommendations
for Dosing and Labeling, November 1998
Nonclinical Studies Subcommittee
Tab H: Initial Planning Meeting of the Nonclinical Studies
Subcommittee Advisory Committee on Pharmaceutical Science, August 31, 1999
*Copyrighted material. Material maybe view at: Dockets Management Branch, Food and Drug
Administration, 5630 Fishers Lane, Rm 1061, Rockville, MD 20852