随着数字组织图像分析和全切片图像（WSI）在毒性病理学诊断和同行评议的应用日益广泛，传统病理学逐渐向数字病理学过渡。近10年来，人工智能（AI）及机器学习（ML）的快速发展促进了组织病理学诊断模式的转变，数字组织图像分析和AI已成为新药研发、药物非临床安全性评价中毒性病理学诊断和病理学同行评议中不可或缺的工具和技术手段。概述数字组织图像分析在毒性病理学中应用和挑战、AI的发展进程及在毒性病理学中应用和挑战，以期为我国药物非临床安全性评价毒理学试验组织图像分析和AI在毒性病理学中的应用提供一定参考。

With the increasing application of digital tissue image analysis and whole slide image (WSI) in the diagnosis and peer review of toxicologic pathology, traditional pathology gradually transits to digital pathology. In recent ten years, the rapid development of artificial intelligence (AI) and machine learning (ML) has promoted the transformation of histopathological diagnosis mode. Digital tissue image analysis and AI have become indispensable tools and technical means for the research and development of new drugs, the toxicologic pathology diagnosis during non-clinical safety evaluation of drugs and the pathology peer review. This paper summarizes the application and challenge of digital tissue image analysis in toxicologic pathology, the development process of AI and its application and challenge in toxicologic pathology, in order to provide some reference for the application of tissue image analysis and AI in toxicology experiments of non-clinical safety evaluation of drugs in China.

R965.3