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/methodsSubject(s)
Biomarkers/analysis , Chemistry Techniques, Analytical/standards , Pharmaceutical Preparations/analysis , Calibration , Chemistry Techniques, Analytical/methods , Drug Discovery/education , Europe , Humans , Pharmaceutical Preparations/standards , Quality Control , Reference Standards , Reproducibility of Results , Societies, Scientific , Validation Studies as Topic , WorkforceABSTRACT
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.