ADVISORY COMMITTEE FOR PHARMACEUTICAL SCIENCE
November 16, 2000
Slides
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