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2011 White Paper on Recent Issues in Bioanalysis & Regulatory Findings from Audits and Inspections

Garofolo, Fabio and Rocci Jr., Mario and Dumont, Isabelle and Martinez, Suzanne and Lowes, Steve and Woolf, Eric and van Amsterdam, Peter and Bansal, Surendra and Gomes Barra, Airadna and Bauer, Ronald and Booth, Brian and Carrasco-Triguero, Montserrat and DeSilva, Binodh and Dunn, John and Gallicano, Keith and Gouty, Dominique and Ho, Stacy and Hucker, Richard and Jemal, Mohammed and Katori, Noriko and Le Blaye, Olivier and Lee, Jean and Li, Wenkui and Michael, Steve and Nehls, Corey and Nicholson, Robert and Ormsby, Eric and Tang, Daniel and Viswanathan, C and Wiener, Russel and Young, Graeme (2011) 2011 White Paper on Recent Issues in Bioanalysis & Regulatory Findings from Audits and Inspections. Bioanalysis, 3 (18). pp. 2081-2096. ISSN 1757-6180

Abstract

The 5th Workshop on Recent Issues in Bioanalysis was organized by the Calibration and Validation Group (CVG) as a two-day full immersion workshop for contract research organizations, pharmaceutical companies and regulatory agencies to discuss, review, share perspectives, provide potential solutions and agree upon consistent approaches on recent issues in the bioanalysis of both small and large molecules. The foundation of the workshop was based on high quality, better compliance and scientific excellence. As in the previous editions of this significant event, recommendations were suggested and a consensus was achieved among panelists and attendees on topics of interest in the bioanalytical field. This workshop led to the creation of the present 2011 White Paper in Bioanalysis, which aims to provide an authoritative guide that addresses major recent bioanalytical issues and ‘hot’ topics and how to solve them.

Item Type: Article
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Date Deposited: 13 Oct 2015 13:15
Last Modified: 13 Oct 2015 13:15
URI: https://oak.novartis.com/id/eprint/5219

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