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

Autor: Jean W. Lee, Jin Wang, Yuling Wu
Rok vydání: 2020
Předmět:
Zdroj: Biomarkers in Drug Discovery and Development. :149-176
Popis: 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
Databáze: OpenAIRE