Molecular Biomarkers from a Diagnostic Perspective
Klaus Lindpaintner · Pharmaceutical Sciences Encyclopedia · 2010
Abstract The term molecular biomarker comprises any and all in vitro testing for biologically informative molecules in tissues or body fluids, for purposes of diagnosing disease, preventive health screening applications, and prognostication of the natural history of a disorder. Molecular biomarkers may be useful in a number of applications, including mechanistic studies, early clinical pharmacodynamic assessment, dose‐finding studies, and stratification for efficacy. This article focuses on the diagnostic perspective as relevant to novel biomarker tests that accompany the development of a drug.