Drug-induced liver injury (DILI) is a patient-specific, temporal, multifactorial pathophysiological process that cannot yet be recapitulated in a single in vitro model. Current preclinical testing regimes for the detection of human DILI thus remain inadequate. A systematic and concerted research effort is required to address the deficiencies in current models and to present a defined approach towards the development of new or adapted model systems for DILI prediction. This Perspective defines the current status of available models and the mechanistic understanding of DILI, and proposes our vision of a roadmap for the development of predictive preclinical models of human DILI.

中文翻译：

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应对药物性肝损伤的挑战：临床前预测模型开发和部署的路线图。

药物性肝损伤（DILI）是一种患者特异性、暂时性、多因素的病理生理过程，尚无法在单一体外模型中重现。因此，目前用于检测人类 DILI 的临床前测试制度仍然不足。需要系统性和协调一致的研究工作来解决当前模型的缺陷，并提出一种明确的方法来开发用于 DILI 预测的新的或改编的模型系统。本视角定义了现有模型的现状和对 DILI 机制的理解，并提出了我们对人类 DILI 预测临床前模型开发路线图的愿景。