Utilize este identificador para referenciar este registo: http://hdl.handle.net/10451/8159
Título: Harmonization of Regulatory Approaches for Evaluating Therapeutic Equivalence and Interchangeability of Multisource Drug Products: Workshop Summary Report
Autor: 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, José A. G.
Ormsby, Eric
Thomas, Saji
Tsang, Yu Chung
Velagapudi, Raja
Yu, Lawrence X.
Palavras-chave: Harmonization
Interchangeability
Regulatory standards
Bioequivalence
Therapeutic equivalence
Biopharmaceutics classification system
Data: 20-Nov-2011
Citação: European Journal of Pharmaceutical Sciences 44 (2011) 506–513
Resumo: 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.
Peer review: yes
URI: http://dx.doi.org/10.1016/j.ejps.2011.09.010
http://hdl.handle.net/10451/8159
http://www.sciencedirect.com/science/article/pii/S0928098711003149
ISSN: 0928-0987
Versão do Editor: http://www.sciencedirect.com/science/article/pii/S0928098711003149
Aparece nas colecções:FF - Artigos em Revistas Internacionais

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