论文信息 - 2009 White Paper on recent issues in regulated bioanalysis from the 3rd Calibration and Validation Group Workshop.

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.

[1] Magnus Knutsson,et al. Incurred sample reproducibility: views and recommendations by the European Bioanalysis Forum. , 2009, Bioanalysis.

[2] Fabio Garofolo,et al. Impact of plasma and whole-blood anticoagulant counter ion choice on drug stability and matrix effects during bioanalysis. , 2009, Bioanalysis.

[3] Herman Lam,et al. Society spotlight: Spotlight on the calibration and validation group. , 2009, Bioanalysis.

[4] Anthony J. DeStefano,et al. Workshop Report and Follow-Up—AAPS Workshop on Current Topics in GLP Bioanalysis: Assay Reproducibility for Incurred Samples—Implications of Crystal City Recommendations , 2009, The AAPS Journal.

[5] Fabio Garofolo,et al. The 2nd Calibration and Validation Group workshop on recent issues in good laboratory practice bioanalysis. , 2009, Bioanalysis.

[6] C. T. Viswanathan,et al. Workshop/conference report—Quantitative bioanalytical methods validation and implementation: Best practices for chromatographic and ligand binding assays , 2007, The AAPS Journal.

[7] Walter A. Korfmacher,et al. Investigation of matrix effects in bioanalytical high-performance liquid chromatography/tandem mass spectrometric assays: application to drug discovery. , 2003, Rapid communications in mass spectrometry : RCM.