Strategic regulatory approaches for the qualification of a biomarker assay for safety use

Abstract

Biomarkers can be defined as key molecular or cellular events that link a specific biological event to a health outcome. As such, biomarkers play an important role in understanding the relationships between exposure to a xenobiotic, the development of chronic human diseases, and the identification of subgroups that are at increased risk of disease. Much progress has been made in identifying and validating new biomarkers to be used in population-based studies. The increasing availability and use of biomarkers to aid informed decision-making in risk-benefit decisions highlights the need for careful assessment of the validity of such models. In particular, models involving new biomarkers require careful validation and regulatory acceptance.