啮齿动物致癌性试验原发性肿瘤合并统计分析指南是在美国食品药品监督管理局（FDA）的要求下，由国际上多个毒性病理学会、美国食品药品监督管理局（FDA）、国际通用毒性病理术语及诊断标准（INHAND）和临床前数据交换标准（SEND）专家组建的工作组共同制定，主要目的是帮助药理学或毒理学审评人员和生物统计学家对药物临床前啮齿动物致癌性试验肿瘤数据进行统计分析，对专题病理学家和同行评议病理学家解释肿瘤数据也有帮助。简要介绍肿瘤合并进行统计分析的理论依据，更高层次肿瘤分类以支持肿瘤合并统计分析，以及肿瘤合并分析方法和典型案例，以期为我国药物临床前安全性评价机构进行啮齿动物致癌性试验原发性肿瘤合并统计分析提供参考。

Guide for combining primary tumors for statistical analysis in rodent carcinogenicity studies was in accordance with the requirements of the U.S. Food and Drug Administration（FDA）. It was jointly developed by a working group composed of experts from several international societies of toxicologic pathology, the FDA, the International Harmonization of Nomenclature and Diagnostic Criteria（INHAND）, and Standard for Exchange of Nonclinical Data（SEND）, with a primary goal of assisting pharmacology/toxicology reviewers and biostatisticians in statistical analysis of tumor data of preclinical rodent carcinogenicity study. The guide will also be useful to study pathologists and peer-review pathologists in interpreting the tumor data. This paper briefly introduced theoretical basis for combining tumors for statistical analysis, a higher-level hierarchy of tumor types to support combinations for statistical analysis, as well as methods for tumor combination for analysis and typical examples, so as to provide some references for combining primary tumors for statistical analysis in rodent carcinogenicity studies in facilities for preclinical safety evaluation of drugs in China.

R965.3

基于AI的创新药物研发服务平台项目