试论药物非临床生殖毒性试验中的真实性、规范性、科学性和创新性  

Authenticity,normativity,scientificity and innovativeness of study on drug non-clinical reproductive toxicity

作　　者：孙祖越[1] 周莉[1] 吴建辉[1] 

机构地区：[1]上海市计划生育科学研究所 中国生育调节药物毒理检测中心,上海200032

出　　处：《中国药理学通报》2014年第5期597-604,共8页Chinese Pharmacological Bulletin

基　　金：国家科技部“重大新药创制”科技重大专项(No 2011ZX09301-005);上海市“科技创新行动计划”实验动物研究项目(No 11140901300,11140901303);上海市科委研发公共服务平台项目(No 13DZ2291300)

摘　　要：实验人员、设施、设备、仪器、技术和技巧等要素,是开展药物非临床生殖毒性研究的必要条件,其间的真实性、规范性、科学性和创新性,才是成功开展研究的重要保证。这4个概念彼此独立,交相映衬,互为支撑。真实性是药物非临床生殖毒性研究的根本,科学性是灵魂,规范性是实现真实性和科学性的保障,创新性需要立足于真实性,通过规范性和科学性两方面的验证,才能可靠且具有活力,这也许是创新性的成功之路。Elements, including experimental personnel, facilities, equipment, apparatus, technology and skills, are essential to carrying out pre-clinical reproductive toxicity research. As to a study, authenticity, normativity, scientificity and innovativeness guarantee the success. These four elements are independent of each other, but mutually supported. Authenticity and scientificity are the footstone and soul, respectively, for drug non-clinical reproductive toxicity research. Normativity guarantees authenticity and scientificity, and innovativeness relies on authenticity. Normativity and scientificity ensure the reliability and dynamics of experimental results which perhaps is an effective way accessing innovation.

关 键 词：药物 非临床试验 生殖毒性 真实性 规范性 科学 性 创新性 

分 类 号：R114[医药卫生—卫生毒理学] R321[医药卫生—公共卫生与预防医学]