眼用制剂变更研究的常见问题分析  

Analysis for common problems of ophthalmic preparations in change research

作　　者：张豹子 田洁[2] 宁黎丽[2] 

机构地区：[1]上海市食品药品监督管理局认证审评中心,上海200020 [2]国家食品药品监督管理总局药品审评中心,北京100038

出　　处：《中国新药杂志》2013年第21期2479-2481,2502,共4页Chinese Journal of New Drugs

摘　　要：眼用制剂是一种直接作用于眼部的特殊剂型。国内外都对眼用制剂的研究开发提出了很高的质量要求。眼用制剂的变更研究也有着一定的技术要求和特点,一直是申请人关注的热点。为了更好地规范研发工作,节约审评资源,本文整理了关于眼用制剂变更研究中常见的问题,并给出合理化的建议,以供研究人员和申请人参考。Ophthalmic preparations are a special formulation directly acting on eye. For research and development of ophthalmic preparations, high quality requirements have been put forward. Also, change research of ophthalmic preparations has certain technical requirements and characteristics. Applicants should play attention for the requirements. In order to better regulate the research and development work and to save review resources, in this paper, we summarized common problems of ophthalmic preparations in change research, and gave rationalization recommendations for providing references for researchers and applicants.

关 键 词：眼用制剂 变更研究 申报 常见问题分析 

分 类 号：R95[医药卫生—药学]