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. 2008 Feb;83(2):368-71.
doi: 10.1038/sj.clpt.6100451. Epub 2007 Dec 19.

A prototypical process for creating evidentiary standards for biomarkers and diagnostics

C A Altar  1 , D Amakye, D Bounos, J Bloom, G Clack, R Dean, V Devanarayan, D Fu, S Furlong, L Hinman, C Girman, C Lathia, L Lesko, S Madani, J Mayne, J Meyer, D Raunig, P Sager, S A Williams, P Wong, K Zerba
Affiliations

A prototypical process for creating evidentiary standards for biomarkers and diagnostics

C A Altar et al. Clin Pharmacol Ther. 2008 Feb.

Abstract

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. 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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