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Tab G: Draft Guidance for Industry, In Vivo Drug Metabolism/Drug Interaction Studies-Study Design, Data Analysis, and Recommendations for Dosing and Labeling, November 1998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