Biomarker Qualification

Biomarker qualification is a scientific process that assesses and validates the use of specific biological markers—like proteins or genetic indicators—as reliable tools for measuring health or disease response in clinical research. Essentially, it ensures that these markers can accurately and consistently reflect what they claim to show, such as how well a treatment is working. By qualifying biomarkers, researchers can more effectively use them in drug development, helping to make decisions about patient care and advancing medical knowledge. This process ultimately aims to improve the safety and effectiveness of new therapies.