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What is the definition for a Known biomarker? What do you understand by drug biomarker? How do I need to interpret the and/or in the Health call?


Please use the definitions as shown here (and please see also the corresponding literature)

A biomarker is a characteristic that is objectively measured and evaluated as an indicator of normal biologic processes, pathogenic processes, or pharmacologic responses to a therapeutic intervention (NHI Biomarkers Definitions Working Group; 2001)

A valid biomarker is defined as “a biomarker that is measured in an analytical test system with well-established performance characteristics and for which there is an established scientific framework or body of evidence that elucidates the physiologic, toxicological, pharmacologic, or clinical significance of the test results

(FDA. Guidance for industry - pharmacogenomic data submissions. 2005)

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