AAPS Advances in the Pharmaceutical Sciences Series

Bioequivalence Requirements in Various Global Jurisdictions

Editors: Kanfer, Isadore (Ed.)

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  • 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
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eBook 106,99 €
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  • ISBN 978-3-319-68078-1
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Hardcover 187,19 €
price for Spain (gross)
  • ISBN 978-3-319-68077-4
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Softcover 135,19 €
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  • ISBN 978-3-319-88542-1
  • Free shipping for individuals worldwide
  • Institutional customers should get in touch with their account manager
  • Shipping restrictions
  • Usually ready to be dispatched within 3 to 5 business days, if in stock
  • The final prices may differ from the prices shown due to specifics of VAT rules
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.

About the authors

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

nataka,

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

Table of contents (11 chapters)

Table of contents (11 chapters)
  • Brazil

    Pages 1-20

    Cristofoletti, Rodrigo (et al.)

  • Canada

    Pages 21-57

    McGilveray, Iain J.

  • China

    Pages 59-74

    Zhang, Yuanchao (Derek), PhD (et al.)

  • The European Union

    Pages 75-100

    Verbeeck, Roger K. (et al.)

  • India

    Pages 101-125

    Mandal, Subhash C., MPharm,PhD(Pharm),FIC,CC,FIPA

Buy this book

eBook 106,99 €
price for Spain (gross)
  • ISBN 978-3-319-68078-1
  • Digitally watermarked, DRM-free
  • Included format: PDF, EPUB
  • ebooks can be used on all reading devices
  • Immediate eBook download after purchase
Hardcover 187,19 €
price for Spain (gross)
  • ISBN 978-3-319-68077-4
  • Free shipping for individuals worldwide
  • Institutional customers should get in touch with their account manager
  • Shipping restrictions
  • Usually ready to be dispatched within 3 to 5 business days, if in stock
  • The final prices may differ from the prices shown due to specifics of VAT rules
Softcover 135,19 €
price for Spain (gross)
  • ISBN 978-3-319-88542-1
  • Free shipping for individuals worldwide
  • Institutional customers should get in touch with their account manager
  • Shipping restrictions
  • Usually ready to be dispatched within 3 to 5 business days, if in stock
  • The final prices may differ from the prices shown due to specifics of VAT rules
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Bibliographic Information

Bibliographic Information
Book Title
Bioequivalence Requirements in Various Global Jurisdictions
Editors
  • Isadore Kanfer
Series Title
AAPS Advances in the Pharmaceutical Sciences Series
Series Volume
28
Copyright
2017
Publisher
Springer International Publishing
Copyright Holder
American Association of Pharmaceutical Scientists
eBook ISBN
978-3-319-68078-1
DOI
10.1007/978-3-319-68078-1
Hardcover ISBN
978-3-319-68077-4
Softcover ISBN
978-3-319-88542-1
Series ISSN
2210-7371
Edition Number
1
Number of Pages
X, 345
Number of Illustrations
2 b/w illustrations, 15 illustrations in colour
Topics