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/métodosAsunto(s)
Biomarcadores/análisis , Técnicas de Química Analítica/normas , Preparaciones Farmacéuticas/análisis , Calibración , Técnicas de Química Analítica/métodos , Descubrimiento de Drogas/educación , Europa (Continente) , Humanos , Preparaciones Farmacéuticas/normas , Control de Calidad , Estándares de Referencia , Reproducibilidad de los Resultados , Sociedades Científicas , Estudios de Validación como Asunto , Recursos HumanosRESUMEN
The 3rd Global CRO Council Closed Forum was held on the 3rd and 4th July 2011 in Guildford, United Kingdom, in conjunction with the 19th International Reid Bioanalytical Forum. In attendance were 21 senior-level representatives from 19 CROs on behalf of nine European countries and, for many of the attendees, this occasion was the first time that they had participated in a GCC meeting. Therefore, this closed forum was an opportunity to increase awareness of the aim of the GCC and how it works, share information about bioanalytical regulations and audit findings from different agencies, their policies and procedures and also to discuss some topics of interest and aim to develop ideas and provide recommendations for bioanalytical practices at future GCC meetings in Europe.
Asunto(s)
Preparaciones Farmacéuticas/análisis , Tecnología Farmacéutica/organización & administración , Biomarcadores/análisis , Cromatografía Líquida de Alta Presión , Regulación Gubernamental , Hemólisis , Humanos , Espectrometría de Masas en TándemRESUMEN
"The Global CRO Council (GCC) for Bioanalysis was formed in an effort to bring together many CRO leaders to openly discuss bioanalysis and the regulatory challenges unique to the outsourcing industry"