經(jīng)過驗證遵從良好實驗室規(guī)范（GLP）并適合目的的全切片圖像（WSI）系統(tǒng)，不僅可用于GLP條件下非臨床毒理學研究的數(shù)字組織病理學評價和同行評議，而且可提高全球化數(shù)字組織病理學評價和同行評議的靈活性，并可提供數(shù)字化圖像數(shù)據(jù)用于今后人工智能和機器學習圖像分析。簡要介紹了美國食品和藥品監(jiān)督管理局和經(jīng)濟合作與發(fā)展組織關于在GLP條件下非臨床毒理學研究中使用WSI或數(shù)字組織病理學的指導原則，硬件和軟件的驗證，合同研究組織驗證WSI數(shù)據(jù)的采集和傳輸，委托方驗證WSI數(shù)據(jù)的下載和查看，以及使用經(jīng)過驗證的WSI系統(tǒng)對大鼠吸入毒理學試驗所開展的數(shù)字組織病理學評價和同行評議，以期為中國藥物非臨床毒理學研究使用WSI進行組織病理學評價和同行評議提供一定參考，加快與國際先進國家接軌的進程。

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.

江蘇省新藥一站式高效非臨床評價公共服務平臺建設項目（BM2021002）