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1.
Eur J Pharm Sci ; 44(4): 506-13, 2011 Nov 20.
Artigo em Inglês | MEDLINE | ID: mdl-21946259

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.


Assuntos
Aprovação de Drogas/legislação & jurisprudência , Medicamentos Genéricos/farmacocinética , Equivalência Terapêutica , Canadá , Avaliação Pré-Clínica de Medicamentos/métodos , Europa (Continente) , Humanos , Internacionalidade , Estados Unidos , Organização Mundial da Saúde
2.
AAPS J ; 13(4): 556-64, 2011 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-21845486

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.


Assuntos
Equivalência Terapêutica , Aprovação de Drogas/legislação & jurisprudência , Humanos , Farmacocinética , Estados Unidos , United States Food and Drug Administration , Organização Mundial da Saúde
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