AAPS Advances in the Pharmaceutical Sciences Series

FDA Bioequivalence Standards

Editors: Yu, Lawrence X., Li, Bing (Eds.)

  • Covers the fundamentals as well as the most up-to-date progress in bioequivalence standards, which are critical to new and generic development and regulation
  • Discusses the current best practices in bioanalytical method validation and conduct, introduces recent developments in bioanalysis, and highlights the challenges in bioanalysis
  • Introduces FDA approaches for highly variable drugs, the partial AUC concept, and narrow therapeutic index drugs
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eBook $159.00
price for USA (gross)
  • ISBN 978-1-4939-1252-0
  • Digitally watermarked, DRM-free
  • Included format: EPUB, PDF
  • ebooks can be used on all reading devices
  • Immediate eBook download after purchase
Hardcover $209.00
price for USA
  • ISBN 978-1-4939-1251-3
  • Free shipping for individuals worldwide
  • Usually dispatched within 3 to 5 business days.
Softcover $209.00
price for USA
  • ISBN 978-1-4939-5558-9
  • Free shipping for individuals worldwide
  • Usually dispatched within 3 to 5 business days.
About this book

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.

About the authors

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.

Table of contents (16 chapters)

  • Bioequivalence History

    Yu, Alex (et al.)

    Pages 1-27

  • Fundamentals of Bioequivalence

    Chen, Mei-Ling

    Pages 29-53

  • Basic Statistical Considerations

    Makhlouf, Fairouz T. (et al.)

    Pages 55-93

  • The Effects of Food on Drug Bioavailability and Bioequivalence

    DeHaven, Wayne I. (et al.)

    Pages 95-118

  • Biowaiver and Biopharmaceutics Classification System

    Uppoor, Ramana S. (et al.)

    Pages 119-137

Buy this book

eBook $159.00
price for USA (gross)
  • ISBN 978-1-4939-1252-0
  • Digitally watermarked, DRM-free
  • Included format: EPUB, PDF
  • ebooks can be used on all reading devices
  • Immediate eBook download after purchase
Hardcover $209.00
price for USA
  • ISBN 978-1-4939-1251-3
  • Free shipping for individuals worldwide
  • Usually dispatched within 3 to 5 business days.
Softcover $209.00
price for USA
  • ISBN 978-1-4939-5558-9
  • Free shipping for individuals worldwide
  • Usually dispatched within 3 to 5 business days.
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Bibliographic Information

Bibliographic Information
Book Title
FDA Bioequivalence Standards
Editors
  • Lawrence X. Yu
  • Bing Li
Series Title
AAPS Advances in the Pharmaceutical Sciences Series
Series Volume
13
Copyright
2014
Publisher
Springer-Verlag New York
Copyright Holder
The United States Government
eBook ISBN
978-1-4939-1252-0
DOI
10.1007/978-1-4939-1252-0
Hardcover ISBN
978-1-4939-1251-3
Softcover ISBN
978-1-4939-5558-9
Series ISSN
2210-7371
Edition Number
1
Number of Pages
XIII, 465
Number of Illustrations and Tables
32 b/w illustrations, 26 illustrations in colour
Topics