Fit‐for‐Purpose Method Validation and Assays for Biomarker Characterization to Support Drug Development
2010
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
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