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Biomarker qualification

Executive Summary

Verbal feedback from FDA on a package of nephrotoxicity biomarkers submitted by a consortium of drug companies "has been quite positive, so we expect a good read," Critical Path Institute CEO Raymond Woosley tells "The Pink Sheet." The agency is reviewing data on seven biomarkers as part of a pilot program to determine how to qualify biomarkers for specific uses. Data indicate they are "far more sensitive and can pick up injury much earlier and with much greater specificity" than existing indicators of kidney disease, he says. The same firms are planning a clinical trial "to get these not just used in drug development, but used in medicine," Woosley says. The consortium operates under the auspices of C-Path (1"The Pink Sheet" July 9, 2007, p. 3)...

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