儿科用药非临床安全性评价要则及中药评价的特殊性

摘要

In current research and development of new drugs,the demand for toxicological study using neonatal and juvenile animals is becoming increasingly urgent. In this paper,we discussed the characteristics,importance and necessity of nonclinical safety evaluation for pediatric drugs,considerations for research design,selection of animal species and age,route and duration of drug administration and evaluation indexes. In addition,the characteristics of nonclinical safety evaluation of new traditional Chinese materia medica used for children were analyzed. It is hoped that these studies will not only provide support and reference for nonclinical safety evaluation of pediatric drugs but help accumulate material in formulating relevant guidelines.%目前新药研发过程中，对新生和幼龄动物非临床发育毒性研究的需求变得越来越迫切。本文对儿科用药非临床安全性技术评价的本质、重要性和必要性、研究设计考虑、种属选择、年龄匹配、给药途径、给药持续时间和观察指标等方面进行了讨论，并针对中药新药儿科用药的安全性评价特点进行了分析，以期为我国儿童用药非临床安全性研究提供支持和参考，为制定我国相关指导原则积累素材。