组织病理学同行评议的GLP要求及关注点探讨

Discussion on GLP Requirements and Considerations in Peer Review of Histopathology

目的:探讨组织病理学同行评议的GLP要求及关注点。方法:简要介绍药物非临床安全性评价领域组织病理学同行评议的指导原则、目的、GLP要求、GLP符合性要求、种类、地点、病理工作组、同行评议病理学家和专题病理学家的职责、动物数量的选择、建议归档文件、同行评议声明以及使用数字扫描全切片图像进行同行评议等内容。结果:组织病理学同行评议可核实并提高病理诊断和病理解释的准确性、一致性及完整性,提高病理报告的质量;同时,可作为毒性病理学家继续教育的重要组成部分。结论:本文探讨组织病理学同行评议的GLP要求及关注点,以期为我国药物非临床安全性评价领域更好地开展符合GLP的组织病理学同行评议提供一些参考。

Objective： To discuss GLP requirements and considerations in peer review of histopathology. Methods： This paper gave a brief introduction to the good laboratory practice （GLP） requirements and considerations in peer review of histopathology in nonclinical safety evaluation of drugs, including guidelines for peer review, purpose of peer review, GLP requirements of peer review, GLP compliant requirements of peer review, types of peer review, site of peer review, pathology working groups （PWGs）, responsibilities of peer review pathologists and study pathologists, animal numbers to be reviewed, documents suggested to be archived , peer review statement, as well as utilizing whole slide images （WSIs） for peer review. Results： Peer review of histopathology can verify and improve the accuracy, consistency and completeness of pathology diagnoses and interpretation, improve the quality of the pathology report and serve as an important source of continuingeducation of toxicologic pathologists. Conclusion： ~e GLP requirements and considerations for peer review of histopathology were discussed with the aim to provide some references for better complying with GLP peer review of histopathology in nonclinical safety evaluation of ~gs in China,