RESUMO
An open letter written by the Global CRO Council for Bioanalysis (GCC) describing the GCC survey results on stability data from co-administered and co-formulated drugs was sent to multiple regulatory authorities on 14 December 2011. This letter and further discussions at different GCC meetings led to subsequent recommendations on this topic of widespread interest within the bioanalytical community over the past 2 years.
Assuntos
Combinação de Medicamentos , Preparações Farmacêuticas/análise , Tecnologia Farmacêutica/normas , Biomarcadores/análise , Cromatografia Líquida de Alta Pressão/métodos , Estabilidade de Medicamentos , Regulamentação Governamental , Guias como Assunto , Humanos , Espectrometria de Massas em Tandem/métodosRESUMO
The Global CRO Council for Bioanalysis (GCC) was formed in September 2010. Since then, the representatives of the member companies come together periodically to openly discuss bioanalysis and the regulatory challenges unique to the outsourcing industry. The 4th GCC Closed Forum brought together experts from bioanalytical CROs to share and discuss recent issues in regulated bioanalysis, such as the impact of coadministered drugs on stability, some differences between European Medicines Agency and US FDA bioanalytical guidance documents and lessons learned following recent Untitled Letters. Recent 483s and agency findings, as well as issues on method carryover, were also part of the topics discussed.
Assuntos
Técnicas de Química Analítica/normas , Guias como Assunto , Organizações sem Fins Lucrativos/normas , United States Food and Drug Administration/normas , Métodos Analíticos de Preparação de Amostras , Calibragem , Química Farmacêutica , Documentação , Combinação de Medicamentos , Estabilidade de Medicamentos , Europa (Continente) , Padrões de Referência , Reprodutibilidade dos Testes , Estados UnidosRESUMO
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 SaúdeRESUMO
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.