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. 2010 Dec;2(12):1945-60.
doi: 10.4155/bio.10.164.

2010 white paper on recent issues in regulated bioanalysis & global harmonization of bioanalytical guidance

Natasha Savoie  1 , Fabio Garofolo, Peter van Amsterdam, Surendra Bansal, Chris Beaver, Patrick Bedford, Brian P Booth, Christopher Evans, Mohammed Jemal, Marc Lefebvre, Arthur Leonardo Lopes de Silva, Steve Lowes, Joseph C Marini, Robert Massé, Louise Mawer, Eric Ormsby, Mario L Rocci Jr, Ct Viswanathan, Jason Wakelin-Smith, Jan Welink, Joleen T White, Eric Woolf
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2010 white paper on recent issues in regulated bioanalysis & global harmonization of bioanalytical guidance

Natasha Savoie et al. Bioanalysis. 2010 Dec.

Abstract

The 4th Calibration and Validation Group Workshop on Recent Issues in Regulated Bioanalysis, a 2-day full immersion workshop, was organized by the Calibration and Validation Group. Contract research organizations, pharmaceutical companies and regulatory agencies came together to discuss several 'hot' topics concerning bioanalytical issues and regulatory challenges and to reach a consensus among panelists and attendees on many points regarding method validation of small and large molecules.

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