Towards consensus practices to qualify safety biomarkers for use in early drug development

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 regu...

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Published inNature biotechnology Vol. 28; no. 5; pp. 446 - 454
Main Authors Sistare, Frank D, Dieterle, Frank, Troth, Sean, Holder, Daniel J, Gerhold, David, Andrews-Cleavenger, Dina, Baer, William, Betton, Graham, Bounous, Denise, Carl, Kevin, Collins, Nathaniel, Goering, Peter, Goodsaid, Federico, Gu, Yi-Zhong, Guilpin, Valerie, Harpur, Ernie, Hassan, Alita, Jacobson-Kram, David, Kasper, Peter, Laurie, David, Lima, Beatriz Silva, Maciulaitis, Romaldas, Mattes, William, Maurer, Gérard, Obert, Leslie Ann, Ozer, Josef, Papaluca-Amati, Marisa, Phillips, Jonathan A, Pinches, Mark, Schipper, Matthew J, Thompson, Karol L, Vamvakas, Spiros, Vidal, Jean-Marc, Vonderscher, Jacky, Walker, Elizabeth, Webb, Craig, Yu, Yan
Format Journal Article
LanguageEnglish
Published United States Nature Publishing Group 01.05.2010
Subjects
Animals
Biological markers
Biomarkers
Biotechnology industry
Drug Discovery - legislation & jurisprudence
Drug Discovery - methods
Drug-Related Side Effects and Adverse Reactions
Drugs
Humans
Pharmaceutical industry
Pharmaceutical Preparations - standards
Product development
Product/Service Evaluations
Stakeholders
Standardization
Switzerland
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Summary: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.
ISSN:1087-0156
1546-1696
DOI:10.1038/nbt.1634