眼底疾病治疗药物非临床研究策略  

Non-clinical research strategy for the treatment of fundus diseases

作　　者：王若男 钱仪敏 宋硕 李华 马璟 WANG Ruo-nan;QIAN Yi-min;SONG Shuo;LI Hua;MA Jing(China State Institute of Pharmaceutical Industry National Shanghai Center for New Drug Safety Evaluation&Research,Shanghai InnoStar Biotech Co.,Ltd.,Shanghai 201203,China)

机构地区：[1]中国医药工业研究总院国家上海新药安全评价研究中心,上海益诺思生物技术股份有限公司,上海201203

出　　处：《中国新药杂志》2020年第15期1723-1728,共6页Chinese Journal of New Drugs

基　　金：国家“重大新药创制”科技重大专项资助项目(2018ZX 09201017-008)。

摘　　要：随着人类生活方式的改变,老龄化进程的加快,干眼症、青光眼、黄斑变性、糖尿病视网膜病变等眼部疾病的发病率不断升高。药物的研发离不开非临床研究的支撑,因此创新型眼科药物迅猛发展的同时,其非临床研究策略也需要不断地完善发展,以加快眼科药物的研发速率,为临床研究提供保障。本文结合文献及实际案例,对眼底疾病治疗药物的非临床研究策略进行归纳,希望能够对眼底疾病治疗药物的开发提供参考依据。As human lifestyle changes and population ageing,the incidence of eye diseases such as dry eye,glaucoma,macular degeneration,diabetic retinopathy is increasing.The development of drugs is inseparable from the support of non-clinical research.Therefore,in the meantime that the innovative ophthalmic drugs are developing rapidly,their non-clinical research strategies need to be continuously improved to accelerate the development rate of ophthalmic drugs,providing guarantee for clinical research.This article combines literatures and actual cases to summarize the non-clinical research strategies of drugs for the treatment of fundus disease,hoping to provide references for the development of these drugs.

关 键 词：眼底疾病 眼科药物 非临床研究 安全性 

分 类 号：R99[医药卫生—毒理学]