Literature DB >> 20811041

Translational medicine and the value of biomarker qualification.

Federico M Goodsaid1, Donna L Mendrick.   

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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Year:  2010        PMID： 20811041     DOI： 10.1126/scitranslmed.3001040

Source DB:  PubMed          Journal:  Sci Transl Med        ISSN： 1946-6234            Impact factor:   17.956


  19 in total

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