FDA Bioequivalence Standards / AAPS Advances in the Pharmaceutical Sciences Series Bd.13 (PDF)
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This comprehensive reference provides an in-depth discussion on state-of-the-art regulatory science in bioequivalence. In sixteen chapters, the volume explores a broad range of topics pertaining to bioequivalence, including its origin and principles, statistical considerations, food effect studies, conditions for waivers of bioequivalence studies, Biopharmaceutics Classification Systems, Biopharmaceutics Drug Disposition Classification System, bioequivalence modeling/simulation, and best practices in bioanalysis. It also discusses bioequivalence studies with pharmacodynamic and clinical endpoints as well as bioequivalence approaches for highly variable drugs, narrow therapeutic index drugs, liposomes, locally acting gastrointestinal drug products, topical products, and nasal and inhalation products.
FDA Bioequivalence Standards is written by FDA regulatory scientists who develop regulatory policies and conduct regulatory assessment of bioequivalence. As such, both practical case studies and fundamental science are highlighted in these chapters. The book is a valuable resource for scientists who work in the pharmaceutical industry, regulatory agencies, and academia as well as undergraduate and graduate students looking to expand their knowledge about bioequivalence standards.
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.
- 2014, 2014, 465 Seiten, Englisch
- Herausgegeben: Lawrence X. Yu, Bing V. Li
- Verlag: Springer-Verlag GmbH
- ISBN-10: 1493912526
- ISBN-13: 9781493912520
- Erscheinungsdatum: 05.09.2014
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