Biomarker qualification pilot process at the US Food and Drug Administration
Journal Title: The AAPS Journal - Year 2007, Vol 9, Issue 1
Abstract
New biomarkers of safety and efficacy are becoming powerful tools in drug development. Their application can be accelerated if a consensus can be reached about their qualification for regulatory applications. This consensus requires a review structure within the US Food and Drug Administration (FDA) that can evaluate qualification data for these biomarkers and determine whether these biomarkers can be qualified. A pilot process and corresponding Biomarker Qualification Review Team have been developed to test how the FDA can work on biomarker qualification.
Authors and Affiliations
Federico Goodsaid, Felix Frueh
Keywords
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- EP ID EP681578
- DOI 10.1208/aapsj0901010
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