眼科药械组合产品国内外现状及质量评价
Current status and quality evaluation of domestic and foreign ophthalmic drug and device combination products
魏智涵 1黄元礼 2赵丹妹 2杜晓丹 2柯林楠 2许芸3
作者信息
- 1. 中国食品药品检定研究院,北京 102629;中国药科大学工学院,南京 210009
- 2. 中国食品药品检定研究院,北京 102629
- 3. 中国药科大学工学院,南京 210009
- 折叠
摘要
眼科药械组合产品是当下眼部疾病治疗的一种新型手段,有着生物利用度高、靶向性强、依从性好的特点.然而,人眼生理结构的复杂性、药与器械的相互作用等因素给相关产品的研发和监管带来诸多困难.本文从眼科药械组合产品的相关法规、产品研究现状、质量评价等方面进行分析讨论,为保证产品研发与管理过程中的安全性和有效性提供参考依据.
Abstract
Ophthalmic drug-device combination products are a new method of ophthalmic disease treatment,which is characterized by high bioavailability,strong targeting and good compliance.However,it is difficult for products to be developed and regulated due to the complexity of the human eye structure,drug-device interactions,and other factors.To provide a basis for guaranteeing the safety and efficacy of products development and management,the related regulations,current research,and evaluation of the quality of products are summarized in this paper.
关键词
眼科/药械组合产品/角膜接触镜/泪点塞/人工晶状体/质量评价Key words
Ophthalmology/Drug-device combination products/Corneal contact lenses/Punctual plugs/Intraocular lens/Quality evaluation引用本文复制引用
出版年
2024
NETL
NSTL
万方数据