Author(s): Goodsaid FM, Frueh FW, Mattes W
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Abstract Biomarkers may be qualified using different qualification processes. A passive approach for qualification has been to accept the end of discussions in the scientific literature as an indication that a biomarker has been accepted. An active approach to qualification requires development of a comprehensive process by which a consensus may be reached about the qualification of a biomarker. Active strategies for qualification include those associated with context-independent as well as context-dependent qualifications.
This article was published in Toxicology
and referenced in Journal of Molecular Biomarkers & Diagnosis