Bioequivalence Requirements in Various Global Jurisdictions (AAPS Advances in the Pharmaceutical Sciences Series Book 28) (English Edition) - Erstausgabe

EAN (ISBN-13): 9783319680781
ISBN (ISBN-10): 3319680781
Erscheinungsjahr: 2017
Herausgeber: Springer International Publishing

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ISBN/EAN: 9783319680781

ISBN - alternative Schreibweisen:
3-319-68078-1, 978-3-319-68078-1
Alternative Schreibweisen und verwandte Suchbegriffe:
Autor des Buches: kanfer

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Daten vom Verlag:

Autor/in: Isadore Kanfer
Titel: AAPS Advances in the Pharmaceutical Sciences Series; Bioequivalence Requirements in Various Global Jurisdictions
Verlag: Springer; Springer International Publishing; American Association of Pharmaceutical Scientists
345 Seiten
Erscheinungsjahr: 2017-12-05
Cham; CH
Sprache: Englisch
223,63 € (DE)
229,90 € (AT)
260,00 CHF (CH)
Available
X, 345 p. 17 illus., 15 illus. in color.

EA; E107; eBook; Nonbooks, PBS / Biologie/Biochemie, Biophysik; Medizinische Chemie, Pharmazeutische Chemie; Verstehen; Bioequivalence; generic; drug product development; pharmaceutics; global; generic drug standards; B; Pharmaceutics; Biomedical and Life Sciences; BB

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

Bioequivalence Requirements

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

Bioequivalence Requirements
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;