title: Qualification of cardiac troponins for nonclinical use: a regulatory perspective.
abstract: The US Food and Drug Administration (FDA) Biomarker Qualification Review Team presents its perspective on the recent qualification of cardiac troponins for use in nonclinical safety assessment studies. The goal of this manuscript is to provide greater transparency into the qualification process and factors that were considered in reaching a regulatory decision. This manuscript includes an overview of the data that were submitted and a discussion of the strengths and shortcomings of these data supporting the qualification decision. The cardiac troponin submission is the first literature-based biomarker application to be reviewed by the FDA and insights gained from this experience may aid future submissions and help streamline the characterization and qualification of future biomarkers.
authors.affiliation: Division of Cardiovascular and Renal Products, Center for Drug Evaluation and Research, Office of New Drugs, US Food and Drug Administration, United States. Electronic address: Elizabeth.hausner@fda.hhs.gov.
authors.forename: E A
authors.initials: EA
authors.lastname: Hausner
authors.forename: K A
authors.initials: KA
authors.lastname: Hicks
authors.forename: J K
authors.initials: JK
authors.lastname: Leighton
authors.forename: A
authors.initials: A
authors.lastname: Szarfman
authors.forename: A M
authors.initials: AM
authors.lastname: Thompson
authors.forename: P
authors.initials: P
authors.lastname: Harlow
mesh_terms: D000818:Animals; D015415:Biomarkers / Q000032:analysis; D017277:Drug Approval; D006801:Humans; D009206:Myocardium / Q000737:chemistry*; D014336:Troponin / Q000032:analysis*; D014481:United States; D014486:United States Food and Drug Administration
chemical_list: D015415:Biomarkers; D014336:Troponin
keywords: Analytical; BQRT; Biomarker Qualification Review Team; Biomarkers; CDER; CLSI; Cardiac troponins; Center for Drug Evaluation and Research; Clinical and Laboratory Standards Institute; DDT; Drug Development Tool; Drug Development Tools; ELISA; FDA; Food and Drug Administration; H&E; HESI; Health and Environmental Sciences Institute; Histopathology; ILSI; IND; International Life Sciences Institute; Investigational New Drug; LOD; LOI; NDA; NOAEL; New Drug Application; Qualification; Safety assessment; enzyme-linked immunosorbent assay; hematoxylin and eosin; letter of intent; limit of detection; no observed adverse effect level