keywords: Biomarkers, surrogate, pharmacodynamics, drug-development, metabolism, pharmacologic
Biomarkers are characteristics that are objectively measured and evaluated as an indicator of normal biologic processes or a pharmacologic response to a therapeutic intervention. Biomarkers fast track the development and discovery of new drugs and make the process most cost effective. There uses have been on the increase in guiding decisions in every phase of drug development. Safety and efficacy biomarkers are the two types of biomarkers. Safety biomarkers are used to ascertain the safety of a particular therapeutic intervention while efficacy biomarkers are used to demonstrate the effectiveness of a particular therapeutic intervention example include surrogate biomarkers, predictive biomarkers, diagnostic biomarkers, pharmacodynamic biomarkers, prognostic biomarkers. The development of a new drug involves discovery and development in the preclinical research and four phases in the clinical trials. Application of biomarkers in drugs development include the evaluation of dose-response and optimal regimen for desired pharmacologic effect, safety markers to determine dose-response for toxicity, and determination of the role of differences in metabolism. Biomarker cut across various aspects of life sciences but this review will focus on application of biomarkers in drugs development.