Food and Drug Administration
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