What evidence do we need for biomarker qualification?
review · Level V
Where this comes from
- Record sourced from PubMed, PMID 29167393.
- Also identified by DOI 10.1126/scitranslmed.aal4599.
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Abstract
Biomarkers can facilitate all aspects of the drug development process. However, biomarker qualification-the use of a biomarker that is accepted by the U.S. Food and Drug Administration-needs a clear, predictable process. We describe a multistakeholder effort including government, industry, and academia that proposes a framework for defining the amount of evidence needed for biomarker qualification. This framework is intended for broad applications across multiple biomarker categories and uses.
Medical subject headings
- Biomarkers