长期毒性和致癌试验病理学检查内容推荐目录--美国毒性病理学会(STP)的建议  

RECOMMENDED TISSUE LIST FOR HISTOPATHOLOGIC EXAMINATION IN REPEAT-DOSE TOXICITY AND CARCINOGENICITY STUDIES:INTRODUCTION OF THE PROPOSAL OF THE SOCIETY OF TOXICOLOGICAL PATHOLOGY(STP)

作　　者：陈珂[1,2] 杜艳春[1,2] 邱爽[1,2] 华晓萍[1,2] 张银柱[3] 李宏霞[1,2,3] 岑小波[1,2,3] 王莉[1,2] 胡春燕 

机构地区：[1]四川大学华西医院·国家成都中药安个性评价中心,成都610041 [2]成都华西海圻医药科技有限公司 [3]四川大学公共卫生学院

出　　处：《现代预防医学》2009年第6期1136-1137,共2页Modern Preventive Medicine

基　　金：国家科技重大专项“规范化药物安全评价技术平台的建设”(2008ZX09035);国家科技支撑计划“药物安全关键技术研究”(2006BAI14B06)资助

摘　　要：本文介绍了美国毒性病理学会(STP)制定并推荐的组织病理学检查内容的标准目录,该目录不受给药途径、实验动物的种系、试验周期、受试药物的种类限制,适用于美国新药注册时的长期毒性试验和致癌试验。并与我国现行的《化学药物长期毒性试验技术指导原则》和《中药、天然药物长期毒性试验技术指导原则》中的相关规定进行比较。This study introduced the standard list of tissues which was devised and recommended by the Society of Toxicologic Pathology （STP） and was used for evaluating histopathology in repeat-dose toxicity and carcinogenicity studies, and that is used to support the registration of new pharmaceutical products. The reconunendcd tissue list is intended to be used for all types of repeat-dose toxicity and carcinogenieity studies, regardless of the mute of administration, species or strain of mammalian laboratory＂ animal, duration, or class of drug to be tested. The study compared the standard list with the relative regulation or active guidelines in ‘long - terra toxicity test of chemicals technique guideline＇ and‘long - term toxicity test of Chinese traditional medicine and natural drugs technique guideline＇.

关 键 词：长期毒性试验 致癌试验 病理学检查内容 推荐目录 美国毒性病理学会(STP) 

分 类 号：R114[医药卫生—卫生毒理学]