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.
出处
《中国新药杂志》
CAS
CSCD
北大核心
2015年第24期2779-2781,共3页
Chinese Journal of New Drugs
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
traditional Chinese medicine（TCM） for pediatric use
non-clinical safety evaluation
juvenile animals
study design
