Critical Path Institute receives regulatory support for liver injury biomarker

(Critical Path Institute (C-Path)) The European Medicines Agency (EMA) issued a Letter of Support to C-Path's Predictive Safety Testing Consortium and Duchenne Regulatory Science Consortium for measurement of glutamate dehydrogenase (GLDH) as a biomarker of hepatocellular liver injury. The biomarker has strong potential for use in humans and warrants additional exploration and gathering of data. EMA encourages the biomarker's use in both nonclinical and exploratory clinical studies.
Source: EurekAlert! - Biology - Category: Biology Source Type: news