Key principles of nonclinical safety evaluation for pediatric drugs and characteristics of traditional Chinese materia medica evaluation
10.3867/j.issn.1000-3002.2016.01.003
- VernacularTitle:儿科用药非临床安全性评价要则及中药评价的特殊性
- Author:
Zuyue SUN
;
Li ZHOU
;
Ling HAN
- Publication Type:Journal Article
- Keywords:
pediatric drug;
juvenile animal;
nonclinical safety evaluation;
developmental toxicity;
traditional Chinese materia medica
- From:
Chinese Journal of Pharmacology and Toxicology
2016;(1):13-20
- CountryChina
- Language:Chinese
-
Abstract:
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.
