Food and Drug Administration

Advisory Committee for Pharmaceutical Science

October 20, 2004

Slides

Science in Regulation: A Visionary Overview, Arthur Kibbe, Ph.D. ppt htm

Organizational Gaps in Reaching the "Desired State," Helen Winkle ppt htm

Moving Toward the "Desired State": Scientific Gap Analysis, Ajaz S. Hussain, Ph.D., CDER, FDA ppt htm

Policy Development and Guidance, Jon Clark, FDA ppt htm

FDA Critical Path Initiative: A Generic Industry Perspective, Shahid Ahmed, Generic Pharmaceutical Association ppt htm

PhRMA Perspective on FDA Final Report, G. P Migliaccio, Pfizer, Inc. ppt htm

BioINequivalence: Concept and Definition Lawrence X. Yu, Ph.D., CDER, FDA ppt htm

Criteria for Evaluating Bio-inequivalence among Drug Products Using Multiple PK Endpoints, Qian H. Li, CDER, FDA ppt htm

Questions -- The Concept and Criteria of Bioinequivalence ppt htm

Bioequivalence Testing for Locally Acting Gastrointestinal Drugs: Scientific Principles, Gordon L. Amidon, Ph.D., College of Pharmacy, The University of Michigan ppt htm

Bioequivalence of Locally Acting GI Drugs, Robert lionberger, CDER, FDA ppt htm

Questions -- Bioequivalence Testing for Locally Acting Gastrointestinal Drugs ppt htm