title: Translational medicine and the value of biomarker qualification.
abstract: The gap between development of exploratory biomarkers and their acceptance in drug development and regulatory review is a hurdle in the development of better therapies. The U.S. Food and Drug Administration has developed a regulatory process for biomarker qualification to accelerate the process by which new biomarkers are integrated in the development of therapies.
authors.affiliation: Genomics Group, Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, U.S. Food and Drug Administration (FDA), Silver Spring, MD 20903, USA. federico.goodsaid@fda.hhs.gov
authors.forename: Federico M
authors.initials: FM
authors.lastname: Goodsaid
authors.forename: Donna L
authors.initials: DL
authors.lastname: Mendrick
mesh_terms: D000818:Animals; D015415:Biomarkers / Q000378:metabolism*; D017277:Drug Approval; D006801:Humans; D057170:Translational Research, Biomedical; D014481:United States; D014486:United States Food and Drug Administration
chemical_list: D015415:Biomarkers