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
Regulatory approaches for evaluating therapeutic equivalence of multisource (or generic) drug products vary among different countries and/or regions. Harmonization of these approaches may decrease the number of in vivo bioequivalence studies and avoid unnecessary drug exposure to humans. Global harmonization for regulatory requirements may be promoted by a better understanding of factors underlying product performance and expectations from different regulatory authorities. This workshop provided an opportunity for pharmaceutical scientists from academia, industry and regulatory agencies to have open discussions on current regulatory issues and industry practices, facilitating harmonization of regulatory approaches for establishing therapeutic equivalence and interchangeability of multisource drug products.
Subject(s)
Drug Approval/legislation & jurisprudence , Drugs, Generic/pharmacokinetics , Therapeutic Equivalency , Canada , Drug Evaluation, Preclinical/methods , Europe , Humans , Internationality , United States , World Health OrganizationABSTRACT
Regulatory approaches for evaluating therapeutic equivalence of multisource (or generic) drug products vary among different countries and/or regions. Harmonization of these approaches may decrease the number of in vivo bioequivalence studies and avoid unnecessary drug exposure to humans. Global harmonization for regulatory requirements may be promoted by a better understanding of factors underlying product performance and expectations from different regulatory authorities. This workshop provided an opportunity for pharmaceutical scientists from academia, industry and regulatory agencies to have open discussions on current regulatory issues and industry practices, facilitating harmonization of regulatory approaches for establishing therapeutic equivalence and interchangeability of multisource drug products.
