中国临床药理学杂志Issue(3)：286-288,3.DOI:10.13699/j.cnki.1001-6821.2016.03.029
抗高血压复方药物合理研发及评价的考虑
Considerations of development and evaluations for antihypertensive fixed -dose single-pill combinations
徐伟仙 1王涛 2王水强 2康彩练 2华尉利 2赵红艳 3谢松梅2
作者信息
- 1. 北京大学 第三医院 心血管内科，北京100191
- 2. 国家食品药品监督管理总局 药品审评中心，北京 100038
- 3. 山东大学 附属济南市中心医院 保健科心血管病房，济南 250013
- 折叠
摘要
Abstract
Combination therapy is an important principle of antihyperten-sive therapy for the patients whose blood pressure is not well controlled by single antihypertensive therapy.Fixed -dose single -pill combinations can improve the compliance of patients with respect to the free combina-tion of antihypertensive drugs in some cases , but it is not convenient to adjust the categories and doses of the drugs in the clinical practice.Therefore , the key points of the developing rationality , technical consi-derations of clinical development and evaluations and the monitoring of regulatory authorities will be discussed in this paper in order to provide reference for the developing antihypertensive drugs in rational and scien-tific ways.关键词
抗高血压药物/固定剂量复方Key words
antihypertensive drug/fixed-dose single-pill combinations分类
医药卫生引用本文复制引用
徐伟仙,王涛,王水强,康彩练,华尉利,赵红艳,谢松梅..抗高血压复方药物合理研发及评价的考虑[J].中国临床药理学杂志,2016,(3):286-288,3.
