Drug-induced liver injury (DILI) is a leading cause of acute liver failure and transplantation. DILI can be the result of impaired hepatobiliary transporters, with altered bile formation, flow, and subsequent cholestasis.
Summary from the HESI workshop on embryo‐fetal development testing, considers how we might design developmental toxicity testing if we started over with 21st century knowledge and techniques. The paper considers what might make current protocols more predictive for human risk.
The strengths and limitations of three nonclinical repolarization assays used to define the risk of clinical drug-induced delayed ventricular repolarization (a surrogate marker of the rare but potentially lethal arrhythmia Torsades de Pointes) were compared during a retrospective analysis of an anonymized database of 150 drugs submitted to the U.S. Food and Drug Administration (FDA) and characterized by a HESI Consortium.