November 16, 2000


An Update on the BCS Guidance, Ajaz S Hussain PhD   ppt   html   pdf

Bioavailability and Bioequivalence Studies for Orally Administered Drug Products - General Considerations, Vinod P Shah PhD   pdf

Guidance Update:  Average, Population, and Individual Approaches to Establishing Bioequivalence, Mei-Ling Chen, PhD   ppt   html

Clinical Pharmacology:  Modeling and Simulation (M&S), Lawrence J Lesko  ppt   html

Modeling and Simulation in Drug Development, Michael D Hale PhD  ppt   html

A Framework of Modeling and Simulation in Regulatory Decisions, Peter Lee, Stella Machado, Larry Lesko   ppt   html

Research Update:  Office of Testing and Research Product Quality Research Institute, Inc, Ajaz S Hussain PhD   ppt  html   pdf

ANDA Bioequivalence Studies That Fail to Meet FDA's Current Bioequivalence Criteria, Dale P Conner, PharmD   ppt   html