Bioequivalence Requirements in Various Global Jurisdictions

An important objective of Bioequivalence Requirements in Various Global Jurisdictions is to attempt to gather current and updated information, collated in a single source, regarding the various bioequivalence and related requirements to satisfy the regulatory requirements for the market approval of multi-source (generic) drug products in various global jurisdictions.

In view of the dynamic nature of regulatory requirements which are usually regularly updated, updating these requirements to remain current is an important necessity to provide such information 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. The revised volume includes updated information based on recent guidances and guidelines from the respective regulatory agencies as well as important trends and descriptions relating to innovative approaches for bioequivalence assessment.

Combines BE (bioequivalence) standards from across the world into a single reference source-harmonize standards Provides updated information on regulatory guidances for the market approval of generic products Describes and explains the various procedures, protocols, and statistical requirements for bioequivalence studies

Autorentext

Dr. Isadore Kanfer is an Emeritus Professor, Rhodes University in South Africa where he served as Head and Dean of the Faculty of Pharmacy from 1999- 2007 and is currently Professor at the Leslie Dan Faculty of Pharmacy, University of Toronto, Canada.

His research interests involve bioavailability and bioequivalence and in particular, topical products for local action. He has over 40 years' experience with the FDA's human vasoconstrictor assay (VCA) for topical corticosteroid products and is currently focusing on the development of new methods for the bioequivalence assessment of other topical dermatological dosage forms where the drug is not intended to be absorbed into the systemic circulation.

During his more than 45-year career in the pharmaceutical sciences he has had extensive academic and also industrial working experience. He served as the Canadian representative of the International Generic Pharmaceutical Alliances (IGPA) on the World Health Organization's (WHO) Committee on Multisource (generic) Pharmaceutical Products: Guidelines on registration requirements to establish interchangeability. Dr. Kanfer also served as Chair of the Bioequivalence Focus Group of the American Association of Pharmaceutical Scientists (AAPS) and was appointed as a Member of Health Canada's Scientific Advisory Committee on Pharmaceutical Sciences & Clinical Pharmacology (SAC-PSCP). He is an Honorary Life Member of the South African Academy of Pharmaceutical Sciences and a Fellow of the American Association of Pharmaceutical Scientists (FAAPS), Fellow of the Pharmaceutical Society of South Africa (FPS) and Fellow of the Canadian Society for Pharmaceutical Sciences (CSPS).

Dr. Kanfer has supervised over 50 postgraduate students (MSc & PhD) and post-doctoral fellows in Pharmaceutical Sciences. He has contributed to over 200 research publications including 23 book chapters, 187 conference presentations, 61 invited speaking engagements, 3 radio interviews and served as editor and co-editor of 6 books in the series, Generic Drug Product Development. He is the editor of the initial version of the book entitled "Bioequivalence Requirements in Various Global Jurisdictions", published in 2017.

Inhalt

Brazil.- Canada.- The European Union (EU).- India.- Japan.- The United States of America.- World Health Organization (WHO).