临床前药物安全评价毒性病理学靶器官毒性的检查和评价要结合大体病理学、组织病理学及临床病理学检查结果进行全面考虑、逐步分析，并使用国际统一推荐的诊断术语及诊断标准，避免主观、不确切的诊断。简要介绍了临床前药物安全评价毒性病理学靶器官毒性检查的基本原则，大体病理学检查，组织病理学检查，毒性病理学诊断方法、程序及注意事项，诊断术语及诊断标准的国际统一，临床病理学参数分析，解剖病理学与临床病理学数据结合一致性分析等内容，以期为我国临床前药物安全评价毒性病理学靶器官毒性检查及评价提供一定参考。

Examination and assessment of target organ toxicity in toxicologic pathology of preclinical safety evaluation of drugs should combine the results of the gross pathology, histopathology and clinical pathology examination data in a well-considered, stepwise approach. In addition, the nomenclature and diagnostic criteria recommended by INHAND should be used to avoid subjective and inappropriate diagnosis. In this paper, we briefly introduced the basic principles for the examination of organ toxicity in toxicology studies, gross pathology, histopathology, diagnostic approach, procedures, and considerations, international harmonization of diagnostic term and criteria, clinical pathology parameters analysis, results of a well-concerted combination of anatomical and clinical pathology data so as to provide some reference for the examination and assessment of target organ toxicity in toxicologic pathology in the field of preclinical safety evaluation of drugs in China.

“十二五”国家科技重大专项课题（2015ZX09501004-002，2015ZX09501007-004）