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