Translational Medicine and the Value of Biomarker Qualification
SCIENCE TRANSLATIONAL MEDICINE(2010)
摘要
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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