药学研究2025，Vol.44Issue(6)：572-575,588,5.DOI:10.13506/j.cnki.jpr.2025.06.010
《化学药品仿制药口服溶液剂药学研究技术指导原则》解读
Interpretation of"Guideline for Pharmaceutical Research of Chemical Generic Drug Oral Solutions"
王功富 1汤佳 2杨巧2
作者信息
- 1. 国家药品监督管理局药品审评中心,北京 100076
- 2. 国家药品监督管理局药品审评检查大湾区分中心,广东 深圳 518000
- 折叠
摘要
Abstract
Oral solutions have the characteristics of uniform dose distribution,flexible dosage administration,and good patient compliance,and has been paid more attention in the field of domestic drug development in recent years.In order to promote the development of domestic generic drugs and clarify the pharmaceutical technical requirements in the research and development process of chemical generic drug oral solutions,the Center for Drug Evaluation of National Medical Prod-ucts Administration officially issued the"Guideline for Pharmaceutical Research of Chemical Generic Drug Oral Solutions"on July 8,2024.This article provides a detailed interpretation,combined the drafting process of the guideline,in order to fa-cilitate better understanding and application by related researchers.关键词
仿制药/口服溶液剂/指导原则/解读Key words
Generic drug/Oral solutions/Guideline/Interpretation分类
医药卫生引用本文复制引用
王功富,汤佳,杨巧..《化学药品仿制药口服溶液剂药学研究技术指导原则》解读[J].药学研究,2025,44(6):572-575,588,5.
