Translational Medicine and the Value of Biomarker Qualification

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Science Translational Medicine  01 Sep 2010:
Vol. 2, Issue 47, pp. 47ps44
DOI: 10.1126/scitranslmed.3001040

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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.


  • Citation: F. M. Goodsaid, D. L. Mendrick, Translational medicine and the value of biomarker qualification. Sci. Transl. Med. 2, 47ps44 (2010).

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