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  • Title: 2009 White Paper on recent issues in regulated bioanalysis from the 3rd Calibration and Validation Group Workshop.
    Author: Savoie N, Garofolo F, van Amsterdam P, Booth BP, Fast DM, Lindsay M, Lowes S, Masse R, Mawer L, Ormsby E, Phull R, Rocci ML, Vallano PT, Yin X.
    Journal: Bioanalysis; 2010 Jan; 2(1):53-68. PubMed ID: 21083120.
    Abstract:
    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.
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