FDA Bioequivalence Standards

  • Lawrence X. Yu
  • Bing V. Li

Part of the AAPS Advances in the Pharmaceutical Sciences Series book series (AAPS, volume 13)

Table of contents

  1. Front Matter
    Pages i-xiii
  2. Alex Yu, Duxin Sun, Bing V. Li, Lawrence X. Yu
    Pages 1-27
  3. Mei-Ling Chen
    Pages 29-53
  4. Fairouz T. Makhlouf, Stella C. Grosser, Donald J. Schuirmann
    Pages 55-93
  5. Wayne I. DeHaven, Dale P. Conner
    Pages 95-118
  6. Ramana S. Uppoor, Jayabharathi Vaidyanathan, Mehul Mehta, Lawrence X. Yu
    Pages 119-137
  7. Barbara M. Davit, Devvrat T. Patel
    Pages 139-164
  8. Wenlei Jiang, Lawrence X. Yu
    Pages 191-216
  9. Peng Zou, Lawrence X. Yu
    Pages 217-241
  10. John R. Peters
    Pages 243-274
  11. Nan Zheng, Wenlei Jiang, Robert Lionberger, Lawrence X. Yu
    Pages 275-296
  12. Xiaojian Jiang, Yongsheng Yang, Ethan Stier
    Pages 297-334
  13. April C. Braddy, Dale P. Conner
    Pages 335-367
  14. Bhawana Saluja, Bing V. Li, Sau L. Lee
    Pages 369-394
  15. Xinyuan Zhang
    Pages 395-417
  16. Sriram Subramaniam
    Pages 419-458
  17. Back Matter
    Pages 459-465

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.


ANDA bioequivalence narrow therapeutic window index drugs regulations simulation

Editors and affiliations

  • Lawrence X. Yu
    • 1
  • Bing V. Li
    • 2
  1. 1.Office of Pharmaceutical ScienceU.S. Food and Drug Administration, Center for Drug Evaluation and Research, Office of Pharmaceutical ScienceSilver SpringUSA
  2. 2.U.S. Food and Drug Administration, Center for Drug Evaluation and Research, Office of Generic DrugsSilver SpringUSA

Bibliographic information

Industry Sectors
Health & Hospitals
Consumer Packaged Goods