The AAPS Journal

, Volume 9, Issue 1, pp E105–E108

Biomarker qualification pilot process at the US Food and Drug Administration

Authors

    • Genomics Group, Office of Clinical Pharmacology, Office of Translational Science, Center for Drug Evaluation and ResearchUS Food and Drug Administration
  • Felix Frueh
    • Genomics Group, Office of Clinical Pharmacology, Office of Translational Science, Center for Drug Evaluation and ResearchUS Food and Drug Administration
Article

DOI: 10.1208/aapsj0901010

Cite this article as:
Goodsaid, F. & Frueh, F. AAPS J (2007) 9: E105. doi:10.1208/aapsj0901010

Abstract

New biomarkers of safety and efficacy are becoming powerful tools in drug development. Their application can be accelerated if a consensus can be reached about their qualification for regulatory applications. This consensus requires a review structure within the US Food and Drug Administration (FDA) that can evaluate qualification data for these biomarkers and determine whether these biomarkers can be qualified. A pilot process and corresponding Biomarker Qualification Review Team have been developed to test how the FDA can work on biomarker qualification.

Keywords

BiomarkervalidationFDA

Copyright information

© American Association of Pharmaceutical Scientists 2007