FDA Bioequivalence Standards

ISBN-13: 9781493912513 / Angielski / Twarda / 2014 / 465 str.

Lawrence X. Yu; Bing V. Li

Opis

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.

Spis treści

.- 1 Bioequivalence History

.- Alex Yu, Duxin Sun, Bing Li, and Lawrence X. Yu

.- 2 Fundamentals of Bioequivalence

.- Mei-Ling Chen

.- 3 Basic Statistical Considerations

.- Fairouz T. Makhlouf, Stella C. Grosser, Donald J. Schuirmann

.- 4 The Effects of Food on Drug Bioavailability and Bioequivalence

.- Wayne I. DeHaven and Dale P. Conner

.- 5 Biowaiver and Biopharmaceutics Classification System

.- Ramana S. Uppoor, Jayabharathi Vaidyanathan, Mehul Mehta, and Lawrence X. Yu

.- 6 Bioequivalence of Highly Variable Drugs

.- Barbara M. Davit and Devvrat T. Patel

.- 7 Partial Area under the Curve: An Additional Pharmacokinetic Metric for Bioavailability and Bioequivalence Assessments

.- Hao Zhu, Ramana Uppoor, Mehul Mehta, and Lawrence X. Yu         

.- 8 Bioequivalence for Narrow Therapeutic Index Drugs

.- Wenlei Jiang and Lawrence X. Yu

.- 9 Pharmacodynamic Endpoint-based Bioequivalence Studies

.- Peng Zou and Lawrence X. Yu

.- 10 Clinical Endpoint Bioequivalence Study

.- John R Peters

.- 11 Bioequivalence for Liposomal Drug Products

.- Nan Zheng, Wenlei Jiang, Robert Lionberger, and Lawrence X. Yu

.- 12 Bioequivalence for Drug Products Acting Locally within Gastrointestinal Tract

.- Xiaojian Jiang,, Yongsheng Yang, and Ethan Stier

.- 13 Bioequivalence for Topical Drug Products

.- April C. Braddy and Dale P. Conner

.- 14 Bioequivalence for Orally Inhaled and Nasal Drug Products

.- Bhawana Saluja, Bing V. Li and Sau L. Lee

.- 15 Bioequivalence: Modeling and Simulation

.- Xinyuan Zhang and Robert Lionberger

.- 16 Bioanalysis

.- Sriram Subramaniam.        

O autorze

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.