Fit‐for‐Purpose Method Validation and Assays for Biomarker Characterization to Support Drug Development

The use of novel biomarkers has become a prominent component of decision-making processes in drug development. They are used in the in vitro and preclinical models and early clinical phase for quick-hit and early-attrition decisions. This article focuses on quantitative method validation and assay for biomarker characterization to support drug development using the fit-for-purpose approach. Keywords: biomarkers; in vitro models; fit-for-purpose approach; protein expression