摘要
研究围绕儿童用口服溶液剂的特点,对相关行业指南及指导原则进行梳理分析,阐述研发及审评中的药学关注问题,以提高儿童用口服溶液剂的质量。
Based on the characteristics of oral solution for pediatric use,this paper summarizes and analyzes the relevant industry guidelines and guiding principles.In order to improve the quality of oral solution for pediatric use,the pharmaceutical concerns in research,development and evaluation are expounded.
作者
吴一凡
刘福利
王亚敏
WU Yifan;LIU Fuli;WANG Yamin(Center for Drug Evaluation,National Medical Products Administration,Beijing 100022)
出处
《中国医药工业杂志》
CAS
CSCD
北大核心
2022年第11期1579-1582,共4页
Chinese Journal of Pharmaceuticals
关键词
儿童用药
口服溶液剂
辅料
微生物控制
给药装置
pediatric medicine
oral solution
excipient
microbiological control
dosage delivery device
