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应用全切片图像进行毒性病理学同行评议的研究进展
引用本文:周围,邱爽,陈珂,岑小波,胡春燕.应用全切片图像进行毒性病理学同行评议的研究进展[J].现代药物与临床,2023,46(10):2284-2288.
作者姓名:周围  邱爽  陈珂  岑小波  胡春燕
作者单位:国家药品监督管理局 药品审评中心, 北京 100022;成都华西海圻医药科技有限公司(国家成都新药安全性评价中心), 四川 成都 610000
摘    要:全切片图像是通过数字切片扫描仪将整个组织切片扫描生成的二维图像,近年来已广泛应用于病理学教学、组织切片讨论、科研等领域。参照美国毒性病理学会(STP)对全切片图像在诊断中的应用建议、经济合作与发展组织(OECD)和美国食品药品管理局(FDA)关于使用全切片图像进行病理学同行评议的指导原则,对药物非临床研究质量管理规范(GLP)条件下应用全切片图像进行毒性病理学同行评议的工作流程、内容和要求进行相关总结。同时结合中国合同研究组织(CRO)采用全切片图像开展毒性病理学评价进行概述,以期提升我国毒性病理学评价和病理学同行评议工作的规范性与专业水平。

关 键 词:毒性病理学评价  全切片图像  同行评议  病理学  药物非临床研究
收稿时间:2023/8/3 0:00:00

Research progress in using whole slide images for peer review of toxicologic pathology
ZHOU Wei,QIU Shuang,CHEN Ke,CEN Xiaobo,HU Chunyan.Research progress in using whole slide images for peer review of toxicologic pathology[J].Drugs & Clinic,2023,46(10):2284-2288.
Authors:ZHOU Wei  QIU Shuang  CHEN Ke  CEN Xiaobo  HU Chunyan
Institution:Center for Drug Evaluation, National Medical Products Administration, Beijing 100022, China;West China-Frontier Pharma Tech Co., Ltd. (National Chengdu Center for Safety Evaluation of Drugs), Chengdu 610000, China
Abstract:Whole slide images (WSI) are a type of two-dimensional image generated by scanning the entire tissue slides with a digital scanner, which have been widely used in various fields in pathology, including teaching, tissue slide discussion and scientific research in recent years. According to the recommendation of the Society of Toxicologic Pathology (STP) on the application of WSI in diagnosis and the guidance of Organization for Economic Co-operation and Development (OECD) and US Food and Drug Administration (FDA) on WSI use for peer review of toxicologic pathology, this article summarized the procedures, contents, and requirements of WSI peer review under Good Laboratory Practice (GLP) conditions. In addition, it provided an overview of toxicologic pathology evaluation using WSI carried out by contract research organizations (CROs) in China, as an attempt to advance the standardization and professionalism of toxicologic pathology evaluation and pathology peer review in China.
Keywords:toxicologic pathology evaluation  whole slide image  peer review  pathology  nonclinical safety evaluation of drugs
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