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2010 white paper on recent issues in regulated bioanalysis & global harmonization of bioanalytical guidance |
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| Authors: | Savoie Natasha Garofolo Fabio van Amsterdam Peter Bansal Surendra Beaver Chris Bedford Patrick Booth Brian P Evans Christopher Jemal Mohammed Lefebvre Marc Lopes de Silva Arthur Leonardo Lowes Steve Marini Joseph C Massé Robert Mawer Louise Ormsby Eric Rocci Mario L Viswanathan Ct Wakelin-Smith Jason Welink Jan White Joleen T Woolf Eric |
| Affiliation: | Algorithme Pharma Inc., 575 Armand-Frappier Blvd, Laval (Montreal), Quebec, Canada. |
| 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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