2009 White Paper on Recent Issues in Regulated Bioanalysis from The 3rd Calibration and Validation Group Workshop
2009; Future Science Ltd; Volume: 2; Issue: 1 Linguagem: Inglês
10.4155/bio.09.134
ISSN1757-6199
AutoresNatasha Savoie, Fabio Garofolo, Peter van Amsterdam, Brian Booth, Douglas M. Fast, Michael Lindsay, Steve Lowes, Robert Massé, Louise Mawer, Eric Ormsby, Rupinder Phull, Mario L. Rocci, Patrick T. Vallano, Xia Yin,
Tópico(s)Clinical Laboratory Practices and Quality Control
ResumoThe 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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