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Review
. 2010 Jan;2(1):53-68.
doi: 10.4155/bio.09.134.

2009 White Paper on recent issues in regulated bioanalysis from the 3rd Calibration and Validation Group Workshop

Natasha Savoie  1 , Fabio Garofolo, Peter van Amsterdam, Brian P Booth, Douglas M Fast, Michael Lindsay, Steve Lowes, Robert Masse, Louise Mawer, Eric Ormsby, Rupinder Phull, Mario L Rocci Jr, Patrick T Vallano, Xia Yin
Affiliations
Review

2009 White Paper on recent issues in regulated bioanalysis from the 3rd Calibration and Validation Group Workshop

Natasha Savoie et al. Bioanalysis. 2010 Jan.

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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