氨己烯酸的研发与注册的简介

被引：4

作者：

陈霞 ^{[1
,2
,3
]}

机构：

[1] 首都医科大学附属北京天坛医院Ⅰ期临床研究室

[2] 首都医科大学附属北京天坛医院国家神经系统疾病临床医学研究中心

[3] 首都医科大学人脑保护高精尖创新中心

来源：

中国临床药理学杂志 | 2020年 / 36卷 / 20期

关键词：

氨己烯酸; 临床研发; 药物不良反应;

D O I：

10.13699/j.cnki.1001-6821.2020.20.046

中图分类号：

R971 [神经系统药物];

学科分类号：

100115 [医学神经生物学];

摘要：

本文以氨己烯酸的研发和注册过程为案例,描述了此化合物从药物设计、临床药理学研究、治疗性确证和发现安全性问题的整个过程。重点讲述针对氨己烯酸引起的视野缩窄药物不良反应所做的全面研究,以及在此基础上针对两个不同适应证所作的获益风险评估。

引用

页码：3359 / 3361+3386 +3386

页数：4

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