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AAPS J. 2007 March; 9(1): E105–E108.
Published online 2007 March 23. doi:  10.1208/aapsj0901010
PMCID: PMC2751298

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.

Keywords: Biomarker, validation, FDA

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Selected References

These references are in PubMed. This may not be the complete list of references from this article.
1. US Food and Drug Administration.Guidance for industry— pharmacogenomic data submissions. Available at: Accessed October 25, 2006.
2. US Food and Drug Administration.Table of valid genomic biomarkers in the context of approved drug labels. Available at: Accessed October 25, 2006.
3. Goodsaid F, Frueh F. Process map proposal for the validation of genomic biomarkers. Pharmacogenomics. 2006;7:773–773. doi: 10.2217/14622416.7.5.773. [PubMed] [Cross Ref]
4. Clinton P, Wechsler J. What Ever Happened to Critical Path.Pharmaceutical Executive. 2006; Available at: http://www.pharmexec. com/pharmexec/article/article Detail.jsp?id=282481&pageID=6. Accessed November 12, 2006.
5. US Food and Drug Administration.Predictive Safety Testing Consortium. Available at: Accessed October 25, 2006.

Articles from The AAPS Journal are provided here courtesy of American Association of Pharmaceutical Scientists