FDA Bioequivalence Standards

Dr. Lawrence X. Yu is the acting director of the Office of Pharmaceutical Science, Center for Drug Evaluation and Research (CDER), FDA, in Maryland, USA, where he oversees new, generic, and biotechnology product quality review functions as well as the FDA CDER quality labs. Dr. Yu is an adjunct professor at the University of Michigan, a fellow of the American Association of Pharmaceutical Scientists (AAPS) and an associate editor of The AAPS Journal. Dr. Yu received an M.S. in Chemical Engineering from Zhejiang University in Hangzhou, China; an M.S. in Pharmaceutics from the University of Cincinnati in Cincinnati, Ohio, USA; and a Ph.D. in Pharmaceutics from the University of Michigan in Ann Arbor, Michigan, USA. He is also the author/co-author of more than 100 papers, abstracts and book chapters and co-editor of Biopharmaceutics Applications in Drug Development.Dr. Bing V. Li is a team leader in the Division of Bioequivalence I, Office of Generic Drugs, Center for Drug Evaluation and Research (CDER), FDA, in Maryland, USA. Her current responsibility is to review drug products submitted in Abbreviated New Drug Applications (ANDAs) to determine the adequacy of the data from bioequivalence studies based on study design, analytical methodology and statistical analysis. Dr. Li received her Ph.D. in Pharmaceutical Sciences from the University of Wisconsin in Madison, Wisconsin, USA. She has chaired numerous FDA working groups, including the bioequivalence “For-Cause” Inspection, bioequivalence for nasal product review template and population bioequivalence of inhalation products. Dr. Li is also the author/coauthor of 40 papers, abstracts, and book chapters and winner of the Thomas Alva Edison Patent Award.

• 1 Bioequivalence History.- 2 Fundamentals of Bioequivalence.- 3 Basic Statistical Considerations.- 4 The Effects of Food on Drug Bioavailability and Bioequivalence.- 5 Bio waiver and Biopharmaceutics Classification System.- 6 Bioequivalence of Highly Variable Drugs.- 7 Partial Area under the Curve: An Additional Pharmacokinetic Metric for Bioavailability and Bioequivalence Assessments.- 8 Bioequivalence for Narrow Therapeutic Index Drugs.- 9 Pharmacodynamic Endpoint-based Bioequivalence Studies.- 10 Clinical Endpoint Bioequivalence Study.- 11 Bioequivalence for Liposomal Drug Products.- 12 Bioequivalence for Drug Products Acting Locally within Gastrointestinal Tract.- 13 Bioequivalence for Topical Drug Products.- 14 Bioequivalence for Orally Inhaled and Nasal Drug Products.- 15 Bioequivalence: Modeling and Simulation.- 16 Bioanalysis.