APOPTOSIS & NECROSIS: Biomarkers ccK18 and K18 in hepatotoxicity

Hepatotoxicity and Drug-Induced Liver Injury Detection

Detecting potential hepatotoxicity is crucial during drug development and drug safety testing in order to reduce the risk of drug candidate withdrawal, and pharmaceuticals showing unwanted hepatic side effects in future surveillance studies.

Standard hepatic injury biomarkers such as alanine aminotransferase (ALT) and aspartate aminotransferase (AST), show inadequate sensitivity and specificity with limited predictive value. During pre-clinical drug development, AST/ ALT elevations are observed in the absence of hepatic injury. Conversely, tranferases do not increase even when tissue-injury occurs. Around 40 percent of research subjects with drug-induced liver injury (DILI) are not detected in safety studies, and therefore new biomarkers are very much needed. Read more…