Biomarkers

Biomarkers are defined as characteristics that are objectively measured and evaluated as indicators of normal biological processes, pathogenic processes, or pharmacologic responses to a therapeutic intervention (NIH, 2001; FDA-NIH Biomarker Working Group, 2016). They serve as essential tools in clinical research and practice, categorized into types such as diagnostic, prognostic, predictive, and pharmacodynamic markers to guide medical decision-making. While specific molecules like HER2 or C-reactive protein function as biomarkers, the term itself refers to the broad conceptual framework of measurable indicators rather than a single therapeutic target. In drug development, biomarkers are used to identify appropriate patient populations and monitor the safety and efficacy of experimental therapies (National Center for Biotechnology Information, 2016). Because "Biomarkers" is a general classification, it does not have a specific molecular structure or a direct mechanism of action for drug interaction.

Other names

Biological markersMolecular markersClinical markersSurrogate endpoints

Not applicable. Biomarkers are indicators of biological or pathological states and do not possess a mechanism of action as they are not therapeutic targets themselves.