毒性病理学是药物临床前安全性评价的重要环节，由于计算机技术和医疗技术的飞速发展，毒性病理学正在从模拟方法向数字方法过渡。人工智能（AI）作为一种新型的技术，已经广泛应用于药物研发的各个阶段，包括临床前安全性评价阶段的毒性病理学检查。但是，AI作为一种新兴的技术，在毒性病理学中的应用也面临巨大的挑战。目前，美国食品药品监督管理局（FDA）已经批准了多种基于AI或机器学习（ML）的医疗器械用于临床辅助诊断。为了加强这类设备的审查和监管，国内外发布了一系列法规和指导原则。总结AI和数字病理学的发展、AI在毒性病理学中的应用、FDA批准的基于AI和ML的医疗器械，以及国内外相关的指导原则和法规，以期为AI在毒性病理学中的应用和监管提供新的思考。

Toxicologic pathology plays a crucial role in the preclinical safety evaluation of drugs. With the rapid advances in computer and medical technologies, toxicologic pathology is transiting from traditional simulation methods to digital approaches. Artificial intelligence (AI), as an emerging technology, has been widely applied across various stages of drug development, including toxicologic pathology assessments during the preclinical safety evaluation phase. However, the application of AI in toxicologic pathology faces significant challenges due to its novelty. Currently, U.S. FDA has approved several AI or machine learning (ML)-based medical devices for clinical diagnostic assistance. To strengthen the review and regulation of these medical devices, a series of regulations guidelines have been issued both domestically and internationally. This article provides an overview of the development of AI and digital pathology, application progress of AI in toxicologic pathology, AI and ML-based medical devices approved by U. S. FDA, and the relevant regulatory guidelines and regulations from both domestic and international perspectives, aiming to offer new insights into the application and regulation of AI in toxicologic pathology.

R965

药品监管科学全国重点实验室课题（2023SKLDRS0127）