A longitudinal assessment of miR-122 and GLDH as biomarkers of drug-induced liver injury in the rat.

Context: There is an ongoing search for specific and translational biomarkers of drug-induced liver injury (DILI). MicroRNA-122 (miR-122) has previously shown potential as a sensitive, specific, and translational biomarker of DILI in both rodent, and human studies.

Objective: To build on previous work within the field, we examined biomarker kinetics in a rat model of acetaminophen (APAP)-induced liver injury to confirm the sensitivity, and specificity of miR-122 and glutamate dehydrogenase (GLDH).

MicroRNAs as potential circulating biomarkers of drug-induced liver injury: key current and future issues for translation to humans.

Drug-induced liver injury (DILI) is a common form of adverse drug reaction seen within the clinic. Sensitive, specific and non-invasive biomarkers of liver toxicity are required to help diagnose hepatotoxicity and also to identify safety liabilities during drug development. Limitations exist in the current gold standard DILI biomarkers: alanine aminotransferase is not liver-specific and therefore gives rise to false-positive signals.