期刊
CLINICAL PHARMACOLOGY & THERAPEUTICS
卷 83, 期 2, 页码 368-371出版社
NATURE PUBLISHING GROUP
DOI: 10.1038/sj.clpt.6100451
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A framework for developing evidentiary standards for qualification of biomarkers is a key need identified in the Food and Drug Administration's Critical Path Initiative. 1 This article describes a systematic framework that was developed by Pharmaceutical Research and Manufacturers of America (PhRMA) committees and tested at a workshop in collaboration with the Food and Drug Administration and academia. With some necessary refinements, this could be applied to create an appropriately individualized evidentiary standard for any biomarker purpose.
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