The passage of the FDA Modernization Act 2.0 in 2022 has provided additional impetus to develop new approach methods for predicting the effects of drug candidates in humans from models such as microphysiological systems based on human-derived induced pluripotent stem cells. Here, we highlight progress in the field and strategies to address various challenges, including the application of artificial intelligence tools.

中文翻译：

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应对从模型系统预测药物效应的新方法的挑战

2022 年 FDA 现代化法案 2.0 的通过为开发新方法提供了额外的动力，这些新方法可通过基于人源诱导多能干细胞的微生理系统等模型来预测候选药物对人体的影响。在这里，我们重点介绍该领域的进展以及应对各种挑战的策略，包括人工智能工具的应用。