Translational medicine and the value of biomarker qualification.
Level V
Where this comes from
- Record sourced from PubMed, PMID 20811041.
- Also identified by DOI 10.1126/scitranslmed.3001040.
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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.
Medical subject headings
- Biomarkers
- Translational Research, Biomedical