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Bioequivalence Requirements in Various Global Jurisdictions

  • Isadore Kanfer

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

Introduction

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.

Keywords

Bioequivalence generic drug product development pharmaceutics global generic drug standards

Editors and affiliations

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

Bibliographic information

  • DOI https://doi.org/10.1007/978-3-319-68078-1
  • Copyright Information American Association of Pharmaceutical Scientists 2017
  • Publisher Name Springer, Cham
  • eBook Packages Biomedical and Life Sciences
  • Print ISBN 978-3-319-68077-4
  • Online ISBN 978-3-319-68078-1
  • Series Print ISSN 2210-7371
  • Series Online ISSN 2210-738X
  • Buy this book on publisher's site
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