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Bioequivalence Requirements in Various Global Jurisdictions


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Table of Contents

Brazil.- Canada.- China.- The European Union.- India.- Bioequivalence Studies in Japan.- Middle East and North Africa (MENA) Bioequivalence Requirements.- Russia.- South Africa.- The United States of America.- World Health Organization (WHO).

About the Author

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.

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