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