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2009 White Paper on recent issues in regulated bioanalysis from the 3rd Calibration and Validation Group Workshop.
Savoie, Natasha; Garofolo, Fabio; van Amsterdam, Peter; Booth, Brian P; Fast, Douglas M; Lindsay, Michael; Lowes, Steve; Masse, Robert; Mawer, Louise; Ormsby, Eric; Phull, Rupinder; Rocci, Mario L; Vallano, Patrick T; Yin, Xia.
Affiliation
  • Savoie N; Algorithme Pharma Inc., Laval (Montreal) QC, Canada.
Bioanalysis ; 2(1): 53-68, 2010 Jan.
Article in En | MEDLINE | ID: mdl-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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Full text: 1 Database: MEDLINE Main subject: Pharmaceutical Preparations / Chemistry Techniques, Analytical Type of study: Prognostic_studies Limits: Humans Language: En Year: 2010 Type: Article
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Full text: 1 Database: MEDLINE Main subject: Pharmaceutical Preparations / Chemistry Techniques, Analytical Type of study: Prognostic_studies Limits: Humans Language: En Year: 2010 Type: Article