儿科人群药物临床试验技术指导原则(征求意见稿)解读(一)  

Interpretation of guidance for clinical investigation of medicinal products in the pediatric population

作　　者：张弨[1] 王晓玲[2] 母双[3] 翟所迪[1] 李在玲[4] 单爱莲[5] 

机构地区：[1]北京大学第三医院药剂科,北京100191 [2]北京儿童医院临床药理机构,北京100231 [3]北京大学人民医院医学伦理委员会,北京100044 [4]北京大学第三医院儿科,北京100191 [5]北京大学第一医院临床药理研究所,北京100191

出　　处：《中国临床药理学杂志》2015年第24期2496-2498,共3页The Chinese Journal of Clinical Pharmacology

摘　　要：儿科人群的生理功能和脏器结构与成年人不同,因此儿童不能简单地看做成年人的缩小。儿童治疗药物的研发有助于提高我国儿童的健康水平,且儿童药物的临床试验不能完全参照成年人来进行,但我国一直以来没有统一的规范来指导儿童药物的临床试验。为此,2015年国家食品药品监督管理总局出台了《儿科人群药物临床试验技术指导原则(征求意见稿)》这使得我国儿科人群药物临床试验更加规范更加科学和伦理。本文对该指导原则进行解读,以期有助于儿科人群药物临床试验的规范开展。The pediatric population is different from adults in their physiological function and tissues structure,and therefore they should not be assumed simply as the small adults.The drug development for pediatric population is helpful to improve the health of children in the whole country.However,the clinical investigation of medicinal products for adults can not apply for children and there has not available guidance for children for a while.Accordingly,Chinese Food and Drug Administration（CFDA） issues the guidance for clinical investigation of medicinal products in the pediatric population,which ensure the clinical trials are more scientific and ethic.This paper means to interpret the guidance and therefore to help the development of clinical trials in pediatric population.

关 键 词：儿科人群 儿童 药物临床试验 解读 

分 类 号：R985[医药卫生—药品] R246.4[医药卫生—药学]