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What evidence do we need for biomarker qualification?
Chris Leptak1, Joseph P Menetski2, John A Wagner3
1Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD 20993, USA.
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.
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