Recommendations on bioanalytical method stability implications of co-administered and co-formulated drugs by Global CRO Council for Bioanalysis (GCC)

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. In 2010, the global bioanalytical community learned of regulatory agency concern about the potential for co-administered compounds present in a bioanalytical matrix to impact the stability of analytes subject to bioanalytical measurement. This pertained to conducting frozen...