The Food and Drug Administration (FDA) Modernization Act 2.0 "allows for alternatives to animal testing for purposes of drug and biological product applications." This provides an opportunity to develop and improve alternatives to animal studies to assess drugs in the liver. Two dimensional cultures of liver cells fail to maintain their differentiated state and fail to reproduce liver disease phenotypes. Therefore, several platforms using human liver cells are being developed either to (1) assess hepatotoxicity of drugs or (2) create "diseases in a dish" to assess the effectiveness of drugs in treating liver diseases, primarily focused on treating non-alcoholic steatohepatitis (NASH). The technological approaches include precision cut liver slices, human liver spheroids, human liver organoids, bioprinted human liver tissues, and microphysiological systems. This review evaluates each of these technologies and their role in providing alternatives to testing in animals.

中文翻译：

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评估 NASH 药物和肝毒性的动物试验替代方案。

美国食品和药物管理局 (FDA) 现代化法案 2.0“允许在药物和生物产品应用中采用动物试验的替代方法。” 这为开发和改进动物研究的替代方案以评估肝脏中的药物提供了机会。肝细胞的二维培养物无法维持其分化状态并且无法再现肝病表型。因此，正在开发几种使用人类肝细胞的平台，以（1）评估药物的肝毒性或（2）创建“培养皿中的疾病”来评估药物治疗肝脏疾病的有效性，主要集中于治疗非酒精性脂肪性肝炎（纳什）。技术方法包括精密切割肝脏切片、人类肝脏球体、人类肝脏类器官、生物打印人类肝脏组织和微生理系统。本综述评估了每一项技术及其在提供动物测试替代方案方面的作用。