Current status and quality evaluation of domestic and foreign ophthalmic drug and device combination products

VernacularTitle:眼科药械组合产品国内外现状及质量评价
Author: Zhihan WEI ^{1
,

2} ; Yuanli HUANG ; Danmei ZHAO ; Xiaodan DU ; Linnan KE ; Yun XU
Author Information

1. 中国食品药品检定研究院,北京 102629
2. 中国药科大学工学院,南京 210009
Keywords: Ophthalmology; Drug-device combination products; Corneal contact lenses; Punctual plugs; Intraocular lens; Quality evaluation
From: China Pharmacist 2024;28(10):350-356
CountryChina
Language:Chinese
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.