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

Nat Biotechnol. 2010 May;28(5):446-54. doi: 10.1038/nbt.1634. Epub 2010 May 10.


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 terms

  • Animals
  • Biomarkers*
  • Drug Discovery* / legislation & jurisprudence
  • Drug Discovery* / methods
  • Drug-Related Side Effects and Adverse Reactions
  • Humans
  • Pharmaceutical Preparations* / standards


  • Biomarkers
  • Pharmaceutical Preparations