Bioequivalence Requirements in Various Global Jurisdictions

A Guide to Bioequivalence Requirements Around the World

This book is a comprehensive resource that gathers bioequivalence (BE) requirements from various global jurisdictions into a single, accessible source. It highlights the differences and commonalities in approaches, such as definitions, comparator product choice, acceptance criteria, and study types, to emphasize the need for a harmonized international process for the market approval of generic products. The information is valuable for drug manufacturers, regulatory agencies, pharmaceutical scientists, and health organizations globally.

Key Features

• Global Overview: Gathers BE requirements from diverse jurisdictions, including Brazil, Canada, China, European Union, India, Japan, MENA, Russia, South Africa, the USA, and the WHO.
• Detailed Comparisons: Provides in-depth comparisons of different approaches, including definitions, choice of reference products, acceptance criteria, and study requirements (fasted, fed, single, and multi-dose).
• Harmonization Focus: The information aims to assist in the quest to harmonize regulatory requirements for the market approval of generic products.
• Broad Relevance: Serves as a valuable source for drug manufacturers, regulatory agencies, pharmaceutical scientists, and related health organizations and governments worldwide.