Bioequivalence Requirements in Various Global Jurisdictions

• Corporate Author: SpringerLink (Online service)
• Other Authors: Kanfer, Isadore (Editor)
• Format: Electronic eBook
• Language: English
• Published: Cham : Springer International Publishing : Imprint: Springer, 2017.
• Series: AAPS Advances in the Pharmaceutical Sciences Series, 28
• Subjects: Medicine.; Pharmaceutical technology.; Biomedicine.; Pharmaceutical Sciences/Technology.

Although the Bioequivalence (BE) requirements in many global jurisdictions have much in common, differences in certain approaches and requirements such as definitions and terms, choice of comparator (reference) product, acceptance criteria, fasted and fed studies, single and multi-dose studies, biow...

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).