| Literature DB >> 20458314 |
Frank D Sistare1, Frank Dieterle, Sean Troth, Daniel J Holder, David Gerhold, Dina Andrews-Cleavenger, William Baer, Graham Betton, Denise Bounous, Kevin Carl, Nathaniel Collins, Peter Goering, Federico Goodsaid, Yi-Zhong Gu, Valerie Guilpin, Ernie Harpur, Alita Hassan, David Jacobson-Kram, Peter Kasper, David Laurie, Beatriz Silva Lima, Romaldas Maciulaitis, William Mattes, Gérard Maurer, Leslie Ann Obert, Josef Ozer, Marisa Papaluca-Amati, Jonathan A Phillips, Mark Pinches, Matthew J Schipper, Karol L Thompson, Spiros Vamvakas, Jean-Marc Vidal, Jacky Vonderscher, Elizabeth Walker, Craig Webb, Yan Yu.
Abstract
Application of any new biomarker to support safety-related decisions during regulated phases of drug development requires provision of a substantial data set that critically assesses analytical and biological performance of that biomarker. Such an approach enables stakeholders from industry and regulatory bodies to objectively evaluate whether superior standards of performance have been met and whether specific claims of fit-for-purpose use are supported. It is therefore important during the biomarker evaluation process that stakeholders seek agreement on which critical experiments are needed to test that a biomarker meets specific performance claims, how new biomarker and traditional comparators will be measured and how the resulting data will be merged, analyzed and interpreted.Mesh：
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Year: 2010 PMID： 20458314 DOI： 10.1038/nbt.1634
Source DB: PubMed Journal: Nat Biotechnol ISSN： 1087-0156 Impact factor: 54.908