Beyond the hype and toward application: liver complex in vitro models in preclinical drug safety


Drug induced Liver-Injury (DILI) is a leading cause of drug attrition, and complex in vitro models (CIVMs)—including three dimensional (3D) spheroids, Organ-Chips, 3D bio printed tissues, and flow-based systems—could improve preclinical prediction. Although CIVMs have demonstrated good sensitivity and specificity, in DILI detection their adoption remains limited.

This article describes DILI, the challenges with its prediction and the current strategies, and the models that are being used to study it. It reviews data from industry-FDA collaborations and strategic partnerships and finishes with an outlook of CIVMs in preclinical toxicity testing.