嚙齒動(dòng)物致癌性試驗(yàn)原發(fā)性腫瘤合并統(tǒng)計(jì)分析指南是在美國(guó)食品藥品監(jiān)督管理局（FDA）的要求下，由國(guó)際上多個(gè)毒性病理學(xué)會(huì)、美國(guó)食品藥品監(jiān)督管理局（FDA）、國(guó)際通用毒性病理術(shù)語(yǔ)及診斷標(biāo)準(zhǔn)（INHAND）和臨床前數(shù)據(jù)交換標(biāo)準(zhǔn)（SEND）專家組建的工作組共同制定，主要目的是幫助藥理學(xué)或毒理學(xué)審評(píng)人員和生物統(tǒng)計(jì)學(xué)家對(duì)藥物臨床前嚙齒動(dòng)物致癌性試驗(yàn)?zāi)[瘤數(shù)據(jù)進(jìn)行統(tǒng)計(jì)分析，對(duì)專題病理學(xué)家和同行評(píng)議病理學(xué)家解釋腫瘤數(shù)據(jù)也有幫助。簡(jiǎn)要介紹腫瘤合并進(jìn)行統(tǒng)計(jì)分析的理論依據(jù)，更高層次腫瘤分類以支持腫瘤合并統(tǒng)計(jì)分析，以及腫瘤合并分析方法和典型案例，以期為我國(guó)藥物臨床前安全性評(píng)價(jià)機(jī)構(gòu)進(jìn)行嚙齒動(dòng)物致癌性試驗(yàn)原發(fā)性腫瘤合并統(tǒng)計(jì)分析提供參考。

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的創(chuàng)新藥物研發(fā)服務(wù)平臺(tái)項(xiàng)目