人工智能（AI）的进步正在深刻改变非临床毒性病理学家的工作方式和流程，但AI在药物非临床安全性评价这一高度接受监管领域中的应用仍面临诸多挑战。系统综述AI在非临床毒性病理学中的最新进展，包括AI在非临床毒性病理学中的应用、AI在非临床毒性病理学中的监管现状和相关指南、非临床毒性病理学中AI模型开发的考虑要点以及AI在非临床毒性病理学中应用面临的挑战与将来发展方向，以期AI技术与毒性病理学家专业知识的结合能提升药物非临床安全性评价的质量与效率。

Advancements of artificial intelligence (AI) are profoundly changing the way and workflow of nonclinical toxicologic pathologists, but the application of AI in the highly regulated field of nonclinical safety evaluation of drugs still faces numerous challenges. This paper systematically reviews the latest progress of AI in nonclinical toxicologic pathology, such as application of AI in nonclinical toxicologic pathology, current regulatory status and relevant guidelines for AI in nonclinical toxicologic pathology, key considerations for AI model development in nonclinical toxicologic pathology, as well as challenges and future directions for the use of AI in nonclinical toxicologic pathology, with the aim of enhancing the quality and efficiency of nonclinical drug safety evaluation by integrating AI technology with the scientific expertise of toxicologic pathologists.

R965.2

国家发改委基于AI的创新药物研发服务平台项目