RESUMEN
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.
Asunto(s)
Combinación de Medicamentos , Preparaciones Farmacéuticas/análisis , Tecnología Farmacéutica/normas , Biomarcadores/análisis , Cromatografía Líquida de Alta Presión/métodos , Estabilidad de Medicamentos , Regulación Gubernamental , Guías como Asunto , Humanos , Espectrometría de Masas en Tándem/métodosRESUMEN
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.
Asunto(s)
Técnicas de Química Analítica/normas , Guías como Asunto , Organizaciones sin Fines de Lucro/normas , United States Food and Drug Administration/normas , Métodos Analíticos de la Preparación de la Muestra , Calibración , Química Farmacéutica , Documentación , Combinación de Medicamentos , Estabilidad de Medicamentos , Europa (Continente) , Estándares de Referencia , Reproducibilidad de los Resultados , Estados UnidosRESUMEN
Bioanalytical methods used to support the drug development process are validated to ensure that they function in the manner in which they are intended. "Incurred" or study samples can vary in their composition when compared with the standards and quality control samples used to validate the method and analyze these samples. During the 3rd American Association of Pharmaceutical Scientists(AAPS)/Food and Drug Administration(FDA) Bioanalytical Workshop, it was suggested that the reproducibility in the analysis of incurred samples be evaluated in addition to the usual prestudy validation activities performed. This manuscript provides recommendations concerning the number and types of samples that should be analyzed in such an evaluation, as well as the manner in which the resultant data should be analyzed. Suggestions as to follow-up activities and data reporting are also discussed. This approach is at best a beginning and is offered as a platform for future discussion, comments, and revision.
