摘要
儿童用药安全是颇受关注的社会问题和公共卫生问题,本身又涉及新药研发,临床评价研究,药品上市后再评价与药物警戒各个环节。本文针对儿童用药的特点及不合理用药的现状,影响儿童用药安全性的主要因素,对从非临床到临床乃至药物上市后再评价全链条安全性评价研究的模式探索的必要性进行初步分析,并列举了国内的部分成果,希望能为儿童用药安全评价研究提供一定的参考。
The safety of pediatric drug is an important social and public health problem, which involves all the aspects such as drug development, clinical evaluation, post-marketing reevaluation and pharmacovigilance. This review analyzes the mode exploration of pediatric drug safety evaluation from non clinical to clinical then to post-marketing reevaluation,which focus on the characteristics of pediatric drug and major influence factor of pediatric drug safety. And also this review has listed some internal achievements, hoping to provide some reference to pediatric drug safety evaluation.
出处
《中国药物警戒》
2017年第11期657-661,共5页
Chinese Journal of Pharmacovigilance
基金
协和青年科研基金(3332015135)
北京市科协2015年度金桥工程种子资金:北京市儿童合理用药宣传调研及我国儿童药物研发的专利分析
关键词
儿童用药安全
评价研究
体系
pediatric drug safety
evaluation study
system
