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

Determination of parameters of developmental toxicity study on pediatric drugs and focus of attention for safety evaluation of traditional Chinese medicine

目前新药开发过程中,对新生和幼龄动物非临床发育毒性研究的需求越来越迫切。本文结合作者实验室的经验,对儿科用药非临床安全性评价生长发育、摄食量等一般评价指标,以及中枢神经系统、生殖系统、行为学评估等特殊靶器官或系统评价指标的设定等进行讨论,并针对中药安评的特别关注点进行分析,以期为我国儿童用药非临床安全性研究提供支持和参考,为制定我国相关的指导原则积累素材。

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-clinical 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.