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IMI SAFE-T and C-Path PSTc obtain regulatory support for new liver safety biomarkers

20:00 EDT 18 Oct 2016 | AAAS

(The Critical Path Institute (C-Path)) IMI's SAFE-T (Safer and Faster Evidence Based Translation) Consortium and C-Path's Predictive Safety Testing Consortium (PSTC) announced today that FDA and EMA issued Letters of Support for new liver safety biomarkers: cytokeratin 18 (CK-18), high mobility group protein B1 (HMGB1), osteopontin, and macrophage colony-stimulating factor 1 receptor (MCSFR1, or CSF1R). Higher levels of these biomarkers in patients diagnosed with Drug-Induced Liver Injury (DILI) could indicate a risk for progression toward liver failure.

Original Article: IMI SAFE-T and C-Path PSTc obtain regulatory support for new liver safety biomarkers

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