Determination of parameters of developmental toxicity study on pediatric drugs and focus of attention for safety evaluation of traditional Chinese medicine
10.3867/j.issn.1000-3002.2016.01.004
- VernacularTitle:儿科用药发育毒性研究指标设定及中药安全性评价的特别关注点
- Author:
Li ZHOU
;
Zuyue SUN
- Publication Type:Journal Article
- Keywords:
pediatric drugs;
juvenile animal;
non-clinical safety evaluation;
developmental toxicity;
traditional Chinese materia medica
- From:
Chinese Journal of Pharmacology and Toxicology
2016;(1):21-28
- CountryChina
- Language:Chinese
-
Abstract:
There is an increasing demand for neonatal and juvenile animal toxicity studies during the research and development of new drugs. In this paper,we discussed general evaluation parameters of pediatric non-clinical safety with pediatric drugs,such as growth and development and food intake,and paramenters of other organs and systems, such as the central nervous system,reproductive system, behavior evaluation in combination with our own experience. In addition,the characteristics of non-clin?ical safety evaluation of new traditional Chinese medicine materia medica used for juvenile animals were analyzed. This paper is intended reference for non-clinical safety evaluation of pediatric drugs and to gain some experience related to formulation of new guidelines.
