首页|眼科药械组合产品国内外现状及质量评价

眼科药械组合产品国内外现状及质量评价

扫码查看
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。
Current status and quality evaluation of domestic and foreign ophthalmic drug and device combination products
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.

OphthalmologyDrug-device combination productsCorneal contact lensesPunctual plugsIntraocular lensQuality evaluation

魏智涵、黄元礼、赵丹妹、杜晓丹、柯林楠、许芸

展开 >

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

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

2024

中国药师
国家药品监督管理局高级研修学院,武汉医药(集团)股份有限公司

中国药师

CSTPCD
影响因子:0.944
ISSN:1008-049X
年,卷(期):2024.28(10)