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Four pancreatic injury safety biomarkers identified and evaluated by PSTC, finds study

Critical Path Institute (C-Path) today announced that the Biomarker Qualification Program (BQP) at the Center for Drug Evaluation and Research (CDER) in the U.S. Food and Drug Administration (FDA) issued a Biomarker Letter of Support (LOS) for four pancreatic injury safety biomarkers identified and evaluated by C-Path's Predictive Safety Testing Consortium's (PSTC) Pancreatic Injury Working Group (PIWG). ....

Warren Glaab , Danielle Ellis , Nicholas King , Michael Ringenberg , Nonclinical Drug Safety At Merck Co Inc , Biomarker Qualification Program , Pancreatic Injury Working Group , Critical Path Institute , Predictive Safety Testing Consortium , Drug Administration , Path Institute , Drug Evaluation , Biomarker Letter , Executive Director , Systems Toxicology , Nonclinical Drug Safety , Chair Warren Glaab , Senior Scientific Director ,