The AAPS Journal

, Volume 9, Issue 1, pp E105–E108 | Cite as

Biomarker qualification pilot process at the US Food and Drug Administration



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.


Biomarker validation FDA 


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Copyright information

© American Association of Pharmaceutical Scientists 2007

Authors and Affiliations

  1. 1.Genomics Group, Office of Clinical Pharmacology, Office of Translational Science, Center for Drug Evaluation and ResearchUS Food and Drug AdministrationSilver Spring

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