|
|||||
|
|
2009 White Paper on recent issues in regulated bioanalysis from the 3rd Calibration and Validation Group Workshop |
|
| Authors: | Savoie Natasha Garofolo Fabio van Amsterdam Peter Booth Brian P Fast Douglas M Lindsay Michael Lowes Steve Masse Robert Mawer Louise Ormsby Eric Phull Rupinder Rocci Mario L Vallano Patrick T Yin Xia |
| Affiliation: | Algorithme Pharma Inc., Laval (Montreal) QC, Canada. |
| 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. |
| Keywords: | |
| 本文献已被 PubMed 等数据库收录！ | |