© 2017

Bioequivalence Requirements in Various Global Jurisdictions

  • Isadore Kanfer


  • Combines BE (bioequivalence) standards from across the world into a single reference source

  • Provides essential information for market approval of generic products

  • Attempts to harmonize country specific standards

  • Contributes to the cost-related benefits in the quest to make medicines more affordable and more accessible to the wider public around the world and, importantly, to ensure the necessary quality, safety and efficacy


Part of the AAPS Advances in the Pharmaceutical Sciences Series book series (AAPS, volume 28)

Table of contents

  1. Front Matter
    Pages i-x
  2. Rodrigo Cristofoletti, Margareth R. C. Marques, Sílvia Storpirtis
    Pages 1-20
  3. Iain J. McGilveray
    Pages 21-57
  4. Yuanchao (Derek) Zhang, Chun (Charlie) Xu, Zi Qiang Gu
    Pages 59-74
  5. Roger K. Verbeeck, Joëlle Warlin
    Pages 75-100
  6. Subhash C. Mandal
    Pages 101-125
  7. Juichi Riku, Noriyuki Muranushi
    Pages 127-158
  8. I. E. Shohin, D. A. Rozhdestvenskiy, V. Yu. Medvedev, T. N. Komarov, D. Yu. Grebenkin
    Pages 199-227
  9. Isadore Kanfer
    Pages 229-268
  10. Barbara M. Davit, Dale P. Conner
    Pages 269-305
  11. John Gordon, Henrike Potthast, Matthias Stahl, Lembit Rägo
    Pages 307-331
  12. Back Matter
    Pages 333-345

About this book


Although the Bioequivalence (BE) requirements in many global jurisdictions have much in common, differences in certain approaches and requirements such as definitions and terms, choice of comparator (reference) product, acceptance criteria, fasted and fed studies, single and multi-dose studies, biowaivers and products not intended for absorption into the systemic circulation (locally acting medicines and dosage forms), amongst others, provide food for thought that standardisation should be a high priority objective in order to result in a harmonized international process for the market approval of products using BE. An important objective of Bioequivalence Requirements in Various Global Jurisdictions is to attempt to gather the various  BE requirements used in different global jurisdictions to provide a single source of relevant information. This information from, Brazil, Canada, China, European Union, India, Japan, MENA, Russia South Africa, the USA and WHO will be of value to drug manufacturers, regulatory agencies, pharmaceutical scientists and related health organizations and governments around the world in the quest to harmonize regulatory requirements for the market approval of generic products.


Bioequivalence generic drug product development pharmaceutics global generic drug standards

Editors and affiliations

  • Isadore Kanfer
    • 1
  1. 1.Faculty of PharmacyRhodes UniversityGrahamstownSouth Africa

About the editors

Dr. Isadore Kanfer was appointed to the Chair as the first Professor of Pharmaceutics at Rhodes University in 1980 and served as Head of Pharmacy at Rhodes University and Dean of the Faculty from 1987-1989 and from 1999-2007. He established the Biopharmaceutics Research Institute (BRI) at Rhodes University and was its first Director. The BRI has successfully completed many bioequivalence studies on behalf of pharmaceutical companies. Professor Kanfer obtained his BSc (Pharmacy), BSc(Honours) and PhD in Pharmaceutics at Rhodes University and was Visiting Professor in Pharmaceutics at the University of California, San Francisco in 1980/81 and then in 1990 spent a year as Visiting Professor in the Division of Pharmaceutics at the University of North Carolina’s School of Pharmacy in Chapel Hill, in the USA. He subsequently spent several years in the Pharmaceutical Industry in Canada where he was Vice-President: Scientific Affairs. He is an Associate Editor of the Journal of Pharmacy & Pharmaceutical Sciences and a member of the Editorial Board of Encyclopedia of Pharmaceutical Science and Technology. 

Dr. Kanfer has supervised 51 postgraduate students (MSc & PhD) and post-doctoral fellows in Pharmaceutical Sciences. He has contributed to over 200 research publications and conference presentations and is co-editor of 4 books in the series, Generic Drug Product Development.

He was the recipient of the Rhodes University Vice Chancellor’s Distinguished Senior Research award for 2007. He is a Fellow of the Pharmaceutical Society of South Africa (PSSA) and was elected as a Fellow of the American Association of Pharmaceutical Scientists (AAPS) in 2010 and in 2013 as Fellow of the Canadian Society for Pharmaceutical Sciences and has served as Chair of the AAPS Bioequivalence Focus Group. In 2008, he was appointed as Dean/Professor Emeritus (Pharmacy), Rhodes University and in 2010 as Honorary Professor, KLE University, Belgaum, Kar


India. He is currently a Professor at the Leslie Dan Faculty of Pharmacy, University of Toronto, Canada.

Bibliographic information

  • Book Title Bioequivalence Requirements in Various Global Jurisdictions
  • Editors Isadore Kanfer
  • Series Title AAPS Advances in the Pharmaceutical Sciences Series
  • Series Abbreviated Title AAPS Adv. Pharmaceutical Sciences
  • DOI
  • Copyright Information American Association of Pharmaceutical Scientists 2017
  • Publisher Name Springer, Cham
  • eBook Packages Biomedical and Life Sciences Biomedical and Life Sciences (R0)
  • Hardcover ISBN 978-3-319-68077-4
  • Softcover ISBN 978-3-319-88542-1
  • eBook ISBN 978-3-319-68078-1
  • Series ISSN 2210-7371
  • Series E-ISSN 2210-738X
  • Edition Number 1
  • Number of Pages X, 345
  • Number of Illustrations 2 b/w illustrations, 15 illustrations in colour
  • Topics Pharmaceutical Sciences/Technology
  • Buy this book on publisher's site
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