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.

List of contents

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

Product details

• Assisted by: Isadore Kanfer (Editor)
• Publisher: Springer, Berlin
• Languages: English
• Product format: Hardback
• Released: 26.12.2024
• EAN: 9783031767739
• ISBN: 978-3-0-3176773-9
• No. of pages: 237
• Dimensions: 155 mm x 17 mm x 235 mm
• Weight: 491 g
• Illustrations: XIII, 237 p. 24 illus., 16 illus. in color.
• Series: AAPS Advances in the Pharmaceutical Sciences Series
• Subjects: Natural sciences, medicine, IT, technology > Biology > Biochemistry, biophysics; Pharmakologie, Pharmacology, Pharmaceutics, Drug Safety and Pharmacovigilance, Regulatory Harmonization of Bioequivalence Requirements, Market Approval of Generic Drug Products, Bioequivalence Guidances and Guidelines, Bioequivalence, Generic Drug Products