Harmonization of Regulatory Approaches for Evaluating Therapeutic Equivalence and Interchangeability of Multisource Drug Products: Workshop Summary Report

Regulatory approaches for evaluating therapeutic equivalence of multisource (or generic) drug products vary among different countries and/or regions. Harmonization of these approaches may decrease the number of in vivo bioequivalence studies and avoid unnecessary drug exposure to humans. Global harm...

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Bibliographic Details
Published in:The AAPS journal 2011-12, Vol.13 (4), p.556-564
Main Authors: Chen, Mei-Ling, Shah, Vinod P., Crommelin, Daan J., Shargel, Leon, Bashaw, Dennis, Bhatti, Masood, Blume, Henning, Dressman, Jennifer, Ducharme, Murray, Fackler, Paul, Hyslop, Terry, Lutter, Lorelei, Morais, Jose, Ormsby, Eric, Thomas, Saji, Tsang, Yu Chung, Velagapudi, Raja, Yu, Lawrence X.
Format: Article
Language:English
Subjects:
Biochemistry
Biomedical and Life Sciences
Biomedicine
Biotechnology
Drug Approval - legislation & jurisprudence
Humans
Meeting Report
Pharmacokinetics
Pharmacology/Toxicology
Pharmacy
Therapeutic Equivalency
United States
United States Food and Drug Administration
World Health Organization
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Summary:Regulatory approaches for evaluating therapeutic equivalence of multisource (or generic) drug products vary among different countries and/or regions. Harmonization of these approaches may decrease the number of in vivo bioequivalence studies and avoid unnecessary drug exposure to humans. Global harmonization for regulatory requirements may be promoted by a better understanding of factors underlying product performance and expectations from different regulatory authorities. This workshop provided an opportunity for pharmaceutical scientists from academia, industry and regulatory agencies to have open discussions on current regulatory issues and industry practices, facilitating harmonization of regulatory approaches for establishing therapeutic equivalence and interchangeability of multisource drug products.
ISSN:1550-7416
1550-7416
DOI:10.1208/s12248-011-9294-5