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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Hlavní autoři: 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.
Médium: Artigo
Jazyk:Inglês
Vydáno: Springer US 2011
Témata:
Meeting Report
On-line přístup:https://ncbi.nlm.nih.gov/pmc/articles/PMC3231855/
https://ncbi.nlm.nih.gov/pubmed/21845486
https://ncbi.nlm.nih.govhttp://dx.doi.org/10.1208/s12248-011-9294-5
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