title: Strategic paths for biomarker qualification.
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.
authors.affiliation: 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
authors.forename: Federico M
authors.initials: FM
authors.lastname: Goodsaid
authors.forename: Felix W
authors.initials: FW
authors.lastname: Frueh
authors.forename: William
authors.initials: W
authors.lastname: Mattes
mesh_terms: D000818:Animals; D015415:Biomarkers / Q000032:analysis*; D006801:Humans; D012015:Reference Standards
chemical_list: D015415:Biomarkers