ABSTRACT
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.
Subject(s)
Drug Combinations , Pharmaceutical Preparations/analysis , Technology, Pharmaceutical/standards , Biomarkers/analysis , Chromatography, High Pressure Liquid/methods , Drug Stability , Government Regulation , Guidelines as Topic , Humans , Tandem Mass Spectrometry/methodsABSTRACT
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.
Subject(s)
Chemistry Techniques, Analytical/standards , Guidelines as Topic , Organizations, Nonprofit/standards , United States Food and Drug Administration/standards , Analytic Sample Preparation Methods , Calibration , Chemistry, Pharmaceutical , Documentation , Drug Combinations , Drug Stability , Europe , Reference Standards , Reproducibility of Results , United StatesABSTRACT
"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"