News & Events
News & Events
July 21, 2020
C-Path’s PSTC, D-RSC Receive Positive FDA Response to Plan for Liver Safety Biomarker
Biomarker aims to provide an additional tool for detecting the onset of hepatic injury in clinical trials involving patients with inherited muscle disorders.
TUCSON, Ariz., July 21, 2020 — Critical Path Institute (C-Path) announced today that the Biomarker Qualification Program (BQP) at the Center for Drug Evaluation and Research (CDER) from the U.S. Food and Drug Administration (FDA) issued a positive response to the Qualification Plan (QP) for glutamate dehydrogenase (GLDH) as a safety biomarker for drug-induced liver injury (DILI), developed by C-Path’s Predictive Safety Testing Consortium (PSTC) and Duchenne Regulatory Science Consortium (D-RSC).
January 22, 2018
Critical Path Institute Receives Regulatory Support for Liver Injury BiomarkerTucson, AZ — January 22, 2018 — Critical Path Institute (C-Path) announced today that the European Medicines Agency (EMA) has issued a Letter of Support for measurement of glutamate dehydrogenase (GLDH) as a biomarker of hepatocellular liver injury. The letter was awarded to C-Path’s Predictive Safety Testing Consortium (PSTC) and Duchenne Regulatory Science Consortium (D-RSC)...
October 18, 2017
C-Path and CDISC Announce Therapeutic Area User Guide for Duchenne Muscular DystrophyOctober 18, 2017 TUCSON, Ariz., and AUSTIN, Texas – October 18, 2017 –Critical Path Institute (C-Path) and The Clinical Data Interchange Standards Consortium (CDISC) announce the open availability of a Duchenne Muscular Dystrophy Therapeutic Area User Guide (TAUG-DMD v1.0), which describes the most common clinical concepts relevant to Duchenne studies using the CDISC standard format. This format...
August 3, 2015
Critical Path Institute Launches New Consortium Dedicated To Duchenne Muscular DystrophyAugust 3, 2015 Critical Path Institute Launches New Consortium Dedicated To Duchenne Muscular Dystrophy Tucson, Arizona – August 3, 2015: Critical Path Institute (C-Path), a pioneering non-profit organization dedicated to accelerating the pace and reducing the costs of medical product development, announced the formation of its tenth consortium: The Duchenne Regulatory Sciences Consortium (D-RSC). In...