药学研究2024,Vol.43Issue(9):876-879,4.DOI:10.13506/j.cnki.jpr.2024.09.008
混悬型滴眼剂仿制药药学研究的相关考虑
Consideration of pharmaceutical study for the generic drugs of ophthalmic suspension
王家强 1魏婷婷 1杨文智1
作者信息
- 1. 国家药品监督管理局药品审评中心,北京 100076
- 折叠
摘要
Abstract
Ophthalmic suspension is a sterile liquid preparation formed by dispersing insoluble solid drugs in a disper-sion medium.This paper preliminarily discusses the formulation,manufacturing process,quality study,container and stability study of ophthalmic suspension,and summarizes the key study parameters of ophthalmic suspension development process from the domestic and foreign references,in order to help the industry to develop ophthalmic suspension generic drugs.关键词
混悬型滴眼剂/仿制药/药学研究Key words
Ophthalmic suspension/Generic drugs/Pharmaceutical study分类
药学引用本文复制引用
王家强,魏婷婷,杨文智..混悬型滴眼剂仿制药药学研究的相关考虑[J].药学研究,2024,43(9):876-879,4.