Food and Drug Administration

Advisory Committee for Pharmaceutical Science

April 14, 2004


Why Bioequivalence of Highly Variable Drugs is an Issue, Charles DiLiberti, Barr Laboratories, Inc. (HTM) (PPT)

Sources of Variability: Physicochemical and Gastrointestinal, Gordon Amidon, University of Michigan (HTM) (PPT)

Bioequivalence of Highly Variable (HV) Drugs: Clinical Implications Why HV Drugs are Safer, Dr. Leslie Benet, PhD, University of California San Francisco (HTM) (PPT)

Evaluation of Bioequivalence for Highly-Variable Drugs and Drug Products, Laszlo Endrenyi, University of Toronto and Laszlo Tothfalusi, Semmelweiss University of Budapest (HTM) (PPT)

Highly Variable Drugs FDA Case Studies, Dr. Barabara Davit, PhD, FDA (HTM) (PPT)

Bioequivalence of Highly Variable Drugs: Regulatory Perspectives, Dr. Sam Haidar, RPh, PhD, FDA (HTM) (PPT)

Questions: Bioequivalence - Highly Variable Products (HTM) (PPT)

BioINequivalence: Concept and Definition, Dr. Lawrence Yu, PhD, FDA (HTM) (PPT)

Statistical Criteria for Establishing Bio-Inequivalence Among Drug Products, Qian Li,, FDA (HTM) (PPT)

Questions: BioINequivalence - Concept and Definition (HTM) (PPT)

Topical Bioequivalence Update, Dr. Robert Lionberger, PhD, FDA (HTM) (PPT)

Nanotechnology: An Awareness Topic, Dr. Nakissa Sadrieh, PhD (HTM) (PPT)