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混悬型滴眼剂仿制药药学研究的相关考虑

王家强 魏婷婷 杨文智

药学研究2024,Vol.43Issue(9):876-879,4.
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.

药学研究

OACSTPCD

2095-5375

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