药物生殖发育毒性安全性评价中形态学研究存在的问题及其对策  

Standardized morphology study in evaluation of reproductive and developmental toxicity of drugs

作　　者：郭隽[1] 耿兴超[1] 刘晓萌[1] 王伟凡[1] 杨莹[1] 

机构地区：[1]中国食品药品检定研究院国家药物安全评价监测中心,药物非临床安全评价研究北京市重点实验室,北京100176

出　　处：《中国新药杂志》2015年第11期1204-1206,共3页Chinese Journal of New Drugs

基　　金：中国食品药品检定研究院中青年发展基金(2014C2)

摘　　要：生殖发育毒性研究是药物安全性评价的重要组成部分,形态学观察是生殖发育毒性研究中关键环节,在形态学检查中往往缺少标准化的程序,导致检查结果一致性差,对最终评价结果产生影响。因此形态学观察的标准化是发展和完善生殖发育毒性评价的最佳途径,本文通过综述生殖发育毒性诊断标准、术语、结果和讨论方面存在的问题及标准化的途径,深入探讨如何在生殖发育毒性安全性评价中形成统一的、完全接受和认可的标准化检查和评价程序。Reproductive and developmental toxicity studies are an important part of drug safety evaluation. Morphological studies of reproductive and developmental toxicity are a key aspect in the morphological examination. Therefore, the lack of standardized procedures leads to poor consistency and impact on the final results of the evaluation, Thus standardization of morphology is the best way to develop and improve the evaluation of reproductive and developmental toxicity. Reproductive diagnostic criteria should be standardized by reviewing the presence of the terms, results and discussion questions in developmental toxicity. Employees need long-term accumulation, and fully accepted and recognized standardization inspection and evaluation procedures.

关 键 词：药物安全评价 发育毒性 生殖毒性 GLP 

分 类 号：R99[医药卫生—毒理学]