Home Biomarker FNIH & C-Path Achieve First Ever Qualification of Clinical Safety Biomarker by...

FNIH & C-Path Achieve First Ever Qualification of Clinical Safety Biomarker by FDA

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As reported in EurekAlert!, the Foundation for the National Institutes of Health (FNIH) Biomarkers Consortium (BC) and the Critical Path Institute (C-Path) Predictive Safety Testing Consortium (PSTC) have received the first ever qualification of a clinical safety biomarker awarded by the U.S. Food and Drug Administration (FDA)— a major milestone that will improve the detection of drug-induced kidney injury in early phase drug development.

The newly qualified biomarker can now be used in Phase I clinical trials to aid in the detection of acute kidney tubular injury in healthy volunteers. This will help improve the development of safe and effective medicines where concern has been raised that an investigational drug may cause kidney injury. Read the press release for more information. Funding for this effort was made possible by Amgen, Inc., AstraZeneca, C-Path, Johnson & Johnson, Eli Lilly and Company, Merck (known as MSD outside the United States and Canada) and Pfizer.

 

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