中药儿科用药非临床安全性评价的一般考虑  

General consideration of non-clinical safety evaluation of traditional Chinese medicine for pediatric use

作　　者：黄芳华[1] 朱飞鹏[1] 笪红远[1] 韩玲[1] 

机构地区：[1]国家食品药品监督管理总局药品审评中心,北京100038

出　　处：《中国新药杂志》2015年第24期2779-2781,共3页Chinese Journal of New Drugs

摘　　要：中药儿科用药是新药开发的一个热点,由于儿科人群的特殊性,对其安全性评价应特别关注。本文针对申报的中药儿科用药的非临床安全性评价存在的问题进行了探讨,阐述了中药儿科用药进行幼年动物毒理学研究的必要性和意义,明确了何种情况下需要进行幼年动物毒理试验以及幼年动物毒理学试验设计应考虑的问题等。Traditional Chinese medicine（ TCM） for pediatric use is a hotspot of new drug development in recent years. Because of specificity of pediatric population,special attention should be paid to the safety evaluation for these TCMs. Here we summaried problems existed in non-clinical safety evaluation of traditional Chinese medicine for pediatric use,and presented the need and the significance of studies in juvenile animals in the non-clinical safety evaluation of TCM for pediatric use. Also,we outlined the situations needed to be carry out in juvenile animal toxicology studies. Finally,we gave some suggests on design of juvenile animal toxicology studies.

关 键 词：中药儿科用药 非临床安全性评价 幼年动物 试验设计 

分 类 号：R288[医药卫生—中药学]