非临床毒理学研究使用全切片图像进行组织病理学评价和同行评议的研究进展  

Research progress in utilizing whole slide images for histopathology assessment and peer review of nonclinical toxicology studies

作　　者：葛建雅 李慧 闫振龙 钱庄 胡文元 钟小群 胡静 陈晓俊 李一昊 彭瑞楠 王娅 缪成贤 邵薇 张亚群 吕建军 GE Jianya;LI Hui;YAN Zhenlong;QIAN Zhuang;HU Wenyuan;ZHONG Xiaoqun;HU Jing;CHEN Xiaojun;LI Yihao;PENG Ruinan;WANG Ya;MIAO Chengxian;SHAO Wei;ZHANG Yaqun;LYU Jianjun(InnoStar Bio-tech Nantong Co.,Ltd.,Nantong 226133,China)

机构地区：[1]益诺思生物技术南通有限公司,江苏南通226133

出　　处：《药物评价研究》2022年第8期1493-1499,共7页Drug Evaluation Research

基　　金：江苏省新药一站式高效非临床评价公共服务平台建设项目(BM2021002)。

摘　　要：经过验证遵从良好实验室规范(GLP)并适合目的的全切片图像(WSI)系统,不仅可用于GLP条件下非临床毒理学研究的数字组织病理学评价和同行评议,而且可提高全球化数字组织病理学评价和同行评议的灵活性,并可提供数字化图像数据用于今后人工智能和机器学习图像分析。简要介绍了美国食品和药品监督管理局和经济合作与发展组织关于在GLP条件下非临床毒理学研究中使用WSI或数字组织病理学的指导原则,硬件和软件的验证,合同研究组织验证WSI数据的采集和传输,委托方验证WSI数据的下载和查看,以及使用经过验证的WSI系统对大鼠吸入毒理学试验所开展的数字组织病理学评价和同行评议,以期为中国药物非临床毒理学研究使用WSI进行组织病理学评价和同行评议提供一定参考,加快与国际先进国家接轨的进程。The validation of a fit-for-purpose good laboratory practice(GLP)-compliant whole slide image(WSI)system not only could be successful deployed for the digital histopathology assessment and peer review of a GLP-compliant toxicology studies,but also enabled flexibility in accelerated global working.Furthermore,the digitized data of the WSI system might be reused for advanced artificial intelligence and machine learning image analysis in the future.The paper gave a brief introduction of guidances of the US Food and Drug Administration(FDA)and the Organization for Economic Co-operation and Development(OECD)on the use of WSI or digital histopathology in GLP-compliant nonclinical toxicology studies,hardware and software validation,contract research organization validation of data acquisition and distribution,sponsor validation of the download and viewing of WSI files,as well as digital histopathology evaluation and peer review of a GLP-compliant rodent inhalation toxicology study using validated WSI system,in order to provide some references for utilizing WSI for histopathology assessment and peer review of nonclinical toxicology studies and accelerating the process of toxicological pathology in line with advanced countries worldwide of China.

关 键 词：非临床 毒理学研究 全切片图像 数字组织病理学 同行评议 

分 类 号：R965.3[医药卫生—药理学]