PCOL390

040240

A biomarker is a defined characteristic that is measured as an indicator of normal biological processes, pathogenic processes, or responses to an exposure or intervention, including therapeutic interventions. These indicators may be molecular, histologic, radiographic, or physiologic characteristics. Biomarkers can be used in a variety of settings including basic, translational, and clinical research and in clinical practice settings. This course will provide an introduction to the exploration, validation, and application of biomarkers during the drug development process and in predicting and monitoring drug efficacy and safety during patient care. Key concepts in bioanalytical technologies used in biomarker measurements will also be introduced. The pathways for regulatory biomarker interpretation and acceptance will also be discussed.

GRD - Regular Grades A, B, C, D, E

Undergraduate

018093