Bioequivalence requirements in various global jurisdictions

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...

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Bibliographic Details
Other Authors Kanfer, Isadore (Editor)
Format Electronic eBook
LanguageEnglish
Published Cham, Switzerland : Springer, [2017]
SeriesAAPS advances in the pharmaceutical sciences series ; v. 28.
Subjects
Drugs > Therapeutic equivalency.
elektronické knihy
electronic books
Online AccessFull text
ISBN9783319680781
9783319680774
Physical Description1 online resource

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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).

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