Kim-KincaidAACC19.pdf

AACC 2019 -- Hepatotoxicity is an ongoing focus for drug development. Drug-induced liver injury (DILI) figures prominently in the termination of candidates for new drug applications to the FDA and other regulatory authorities. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) are accepted as the gold standard for identifying liver injury. However, glutamate dehydrogenase (GLDH) is also being recognized as a valuable biomarker for the detection of DILI. Previous studies have established a strong correlation between GLDH and ALT levels in serum. Moreover, ALT and AST are also found in muscle and other non-hepatic tissues, limiting their utility in detecting DILI in subjects with muscle impairments; thus, GLDH can serve as a useful biomarker that confers greater specificity to the liver. Recently, pharmaceutical companies are requesting GLDH in their clinical trial protocols. In response, Covance has validated the Randox GLDH enzyme activity assay in serum and EDTA plasma.