ADVISORY COMMTTEE FOR PHARMACEUTICAL SCIENCE

September 23, 1999

Slides

Introduction, Average and Individual BE Criteria to Compare BE Measures; and Replicate and Non-Replicate Data Sets; and Introduction to Discussion Topics, Roger L. Williams, MD, Deputy Center Director for Pharmaceutical Science, CDER

Report of Expert Panel: Update and Perspectives, Leslie Z Benet, PhD

Motivation and Principles of Individual and Population Bioequivalence, Walter W. Hauck, PhD

Criteria and Update of Guidance, Mei-Ling Chen, PhD, Director, Division of Pharmaceutical Evaluation II, Office of Clinical Pharmacology and Biopharmaceutics, FDA

Mechanistic Understanding of Subject-by-Formulation Interactions, Lawrence J. Lesko, PhD, Office of Clinical Pharmacology and Biopharmaceutics, CDER, FDA

General BA/BE Guidance Orally Administered Drugs, Vinod P. Shah, PhD, Office of Pharmaceutical Science, CDER, FDA

Testimony of the Epilepsy Foundation, Steven C. Schachter, MD

A Practical Alternative Method for Assessing Individual and Population Bioequivalence, A. Lawrence Gould, Merck Research Laboratories

IGPA Position Paper on Individual Bioequivalence, Michael Spino, Pharm.D., International Generic Pharmaceutical Alliance

FDA Primary Motivations in the Presence of Estimated Variabilities, Laszlo Endrnyl, University of Toronto, Department of Pharmacology

Individual Bioequivalence Are we ready for it? Russell J. Rackley, PhD

Individual Bioequivalence - clinical Significance, Ethical and Cost Considerations, Leon Shargel, PhD, National Association of Pharmaceutical Manufacturers

PhRMA Perspective, Nevine Zariffa, Mmath, Biostatistics and Data Sciences, SmithKline Beecham Pharmaceuticals

Population and Individual Bioequivalence, AAPS Bioequivalence Focus Group 1, Position Paper