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

doi:10.4155/bio.09.134

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 Savoie¹, 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

PMID: 21083120
DOI: 10.4155/bio.09.134

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.

. 2010 Jan;2(1):53-68.

doi: 10.4155/bio.09.134.

Authors

Affiliation

¹ Algorithme Pharma Inc., Laval (Montreal) QC, Canada.

PMID: 21083120
DOI: 10.4155/bio.09.134

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

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

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