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.
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)
出处
《中国新药杂志》
CAS
CSCD
北大核心
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)。
关键词
眼底疾病
眼科药物
非临床研究
安全性
fundus disease
ophthalmic drugs
non-clinical research
safety
