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. 2010 Sep 1;2(47):47ps44.
doi: 10.1126/scitranslmed.3001040.

Translational medicine and the value of biomarker qualification

Federico M Goodsaid  1 , Donna L Mendrick
Affiliations

Translational medicine and the value of biomarker qualification

Federico M Goodsaid et al. Sci Transl Med. .

Abstract

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.

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