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

Published on Nov. 08, 2024Total Views: 374 times Total Downloads: 33 times Download Mobile

Author: WEI Zhihan 1, 2 HUANG Yuanli 1 ZHAO Danmei 1 DU Xiaodan 1 KE Linnan 1 XU Yun 2

Affiliation: 1. National Institutes for Food and Drug Control , Beijing 102629, China 2. College of Engineering, China Pharmaceutical University , Nanjing 210009, China

Keywords: Ophthalmology Drug-device combination products Corneal contact lenses Punctual plugs Intraocular lens Quality evaluation

DOI: 10.12173/j.issn.2097-4922.202407043

Reference: WEI Zhihan, HUANG Yuanli, ZHAO Danmei, DU Xiaodan, KE Linnan, XU Yun.Current status and quality evaluation of domestic and foreign ophthalmic drug and device combination products[J].Yaoxue QianYan Zazhi,2024, 28(2):350-356.DOI: 10.12173/j.issn.2097-4922.202407043.[Article in Chinese]

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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.

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References

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