中国临床药理学杂志2018，Vol.34Issue(19)：2366-2371,2375,7.DOI:10.13699/j.cnki.1001-6821.2018.19.035
研发儿科人群用药策略的借鉴和审评思考
Investigation strategy and evaluation consideration of medicinal products in the pediatric population
陈颖 1鲁爽1
作者信息
- 1. 国家食品药品监督管理总局 药品审评中心,北京 100022
- 折叠
摘要
Abstract
Objective Medicinal products in the pediatric population have always been taken seriously by Chinese and even worldwide regula-tory authorities.This article mainly introduces the relevant policies for the marketing approval of pediatrics in major countries or regions , such as Europe, the United States and Japan , as well as the practice of drug evaluation in China , and compares the current relevant regulatory strate-gies in China so as to provide reference for scientific development of drugs, and to provide more drug options for pediatric population .关键词
儿科用药研发/临床试验/监管策略/审评实践Key words
investigation of medicinal products in the pediatric popula-tion/clinical trial/regulatory policy/practice of drug evaluation分类
医药卫生引用本文复制引用
陈颖,鲁爽..研发儿科人群用药策略的借鉴和审评思考[J].中国临床药理学杂志,2018,34(19):2366-2371,2375,7.
