Summary report of second EUFEPS/AAPS conference on global harmonization in bioequivalence-Reference-Cited by-同舟云学术

Summary report of second EUFEPS/AAPS conference on global harmonization in bioequivalence

Published:2019-01 Issue: Volume:127 Page:24-28
ISSN:0928-0987
Container-title:European Journal of Pharmaceutical Sciences
language:en
Short-container-title:European Journal of Pharmaceutical Sciences

Author:

Chen Mei-Ling,Blume Henning,Beuerle Gerald,Mehta Mehul,Potthast Henrike,Brandt Andreas,Schug Barbara S.,Ducharme Murray,Endrenyi Laszlo,Gallicano Keith,Schuirmann Donald,Welink Jan

Publisher

Elsevier BV

Subject

Pharmaceutical Science

Reference25 articles.

1. ANVISA Resolution RDC No. 1170/2006;Brazilian Health Agency (ANVISA),2006

2. The Global Bioequivalence Harmonization Initiative: summary report for EUFEPS international conference;Chen;Eur. J. Pharm. Sci.,2018

3. Implementation of a reference-scaled average bioequivalence approach for highly variable generic drug products by the US Food and Drug Administration;Davit;AAPS J.,2012

4. Regulatory conditions for the determination of bioequivalence of highly variable drugs;Endrenyi;J. Pharm. Pharm. Sci.,2009

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