A measured characteristic of either normal biological processes, pathogenic processes, or responses to an exposure or intervention, including therapeutic interventions. Molecular, histologic, radiographic, or physiologic characteristics are types of biomarkers. A biomarker is not an assessment of how an individual feels, functions, or survives.

Source: FDA-NIH Biomarker Working Group. BEST (Biomarkers, EndpointS, and other Tools) Resource (Internet). Silver Spring (MD): U.S. Food and Drug Administration; 2016-20 Co-published by U.S. National Institutes of Health, Bethesda (MD). Published on January 28, 2016, last update: 2 May 2018.


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