Use of Biomarkers in Drug Development for Regulatory Purposes.

Appropriately validated biomarkers are important tools that can benefit drug development and regulatory assessments. For drug development purposes, biomarker development involves identifying a drug development need and context of use (COU) for the biomarker, analytically validating assays, clinically validating the biomarker for the COU, and determining if the biomarker provides benefits over current methods. This perspective provides information on determining a biomarker's COU, fit-for-purpose validation, and regulatory acceptance of biomarkers for drug development.