title: Implementing fit-for-purpose biomarker assay approaches: a bioanalytical perspective.
authors.affiliation: Genentech, Inc., BioAnalytical Sciences, 1 DNA Way, South San Francisco, CA 94080, USA.
authors.forename: Kyra J
authors.initials: KJ
authors.lastname: Cowan
mesh_terms: D015415:Biomarkers / Q000032:analysis*; D002623:Chemistry Techniques, Analytical; D055808:Drug Discovery; D006801:Humans; D054928:Validation Studies as Topic
chemical_list: D015415:Biomarkers
keywords: assay; biomarkers; calibrator; fit-for-purpose; parallelism; validation