Human liver organoids are functional 3-dimensional in vitro models of the liver that can serve as a novel platform to address diverse research questions related to drug-induced liver injury. Organoid models provide a more physiologic in vitro system to study hepatotoxicity compared to 2-dimensional, traditional tissue culture. In addition, personalized approaches using patient organoids are powerful tools that hold the promise for improving patient outcomes. In this session, attendees learn about the unique aspects of these valuable research tools that can offer a personalized approach in medicine by recreating patient-specific organ models, and the role of organoids in drug development and testing toxicity from a regulatory perspective.