毒性病理學是藥物臨床前安全性評價的重要環(huán)節(jié)，由于計算機技術和醫(yī)療技術的飛速發(fā)展，毒性病理學正在從模擬方法向數字方法過渡。人工智能（AI）作為一種新型的技術，已經廣泛應用于藥物研發(fā)的各個階段，包括臨床前安全性評價階段的毒性病理學檢查。但是，AI作為一種新興的技術，在毒性病理學中的應用也面臨巨大的挑戰(zhàn)。目前，美國食品藥品監(jiān)督管理局（FDA）已經批準了多種基于AI或機器學習（ML）的醫(yī)療器械用于臨床輔助診斷。為了加強這類設備的審查和監(jiān)管，國內外發(fā)布了一系列法規(guī)和指導原則?？偨YAI和數字病理學的發(fā)展、AI在毒性病理學中的應用、FDA批準的基于AI和ML的醫(yī)療器械，以及國內外相關的指導原則和法規(guī)，以期為AI在毒性病理學中的應用和監(jiān)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

藥品監(jiān)管科學全國重點實驗室課題（2023SKLDRS0127）