title: 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.
authors: Medicines & Healthcare Products Regulatory Agency, 151 Buckingham Palace Road, London, SW1W 9SZ, UK.
authors: Anna P
authors: AP
authors: Valeri
authors: Michelle
authors: M
authors: Beharry
authors: David R
authors: DR
authors: Jones
mesh_terms: D000818:Animals; D015415:Biomarkers / Q000032:analysis*; D004341:Drug Evaluation / Q000331:legislation & jurisprudence*; D006077:Government Agencies; D006801:Humans; D006113:United Kingdom; D054928:Validation Studies as Topic
chemical_list: D015415:Biomarkers