2009 White Paper on Recent Issues in Regulated Bioanalysis from The 3rd Calibration and Validation Group Workshop

The 3rd Calibration and Validation Group Workshop on Recent Issues in Regulated Bioanalysis was organized by the Calibration and Validation Group as a 1.5-day full immersion workshop for contract research organizations, pharmaceutical companies and regulatory agencies to discuss several ‘hot’ topics concerning bioanalytical issues and regulatory challenges. A consensus was reached among panelists and attendees on many points regarding method validation of small molecules. The Calibration and Validation Group (CVG) is a Canadian-based, nonprofit scientific organization that partners with industrial, academic and regulatory bodies to provide education and forums for discussion on calibration and validation practices within the pharmaceutical community...