Strategic paths for biomarker qualification.
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.
Goodsaid
Federico M
FM
Genomics Group, Office of Clinical Pharmacology, Office of Translational Science, Center for Drug Evaluation and Research, FDA, MD 20903-0002, United States. Federico.Goodsaid@fda.hhs.gov
Frueh
Felix W
FW
Mattes
William
W
D000818:Animals; D015415:Biomarkers / Q000032:analysis*; D006801:Humans; D012015:Reference Standards
D015415:Biomarkers