The 2nd Calibration and Validation Group Workshop on recent issues in Good Laboratory Practice bioanalysis

This event was organized by the Calibration and Validation Group (a scientific nonprofit organization based in Toronto, Canada) as a 1.5-day workshop for contract research organizations and pharmaceutical companies involved in providing bioanalytical data for bioavailability, bioequivalence, pharmacokinetic and comparability studies. The reliable reporting of data from the quantitative analysis of drugs and their metabolites is the backbone of bioavailability, bioequivalence, pharmacokinetic (PK) and comparability studies. The regulatory agencies of different countries have their respective guidance documents describing the requirements for bioanalytical method validation and the application of these methods to routine drug analysis. Bioanalytical method validation is a process...