FDA供企业用药物升压效应评估指导原则的介绍  

Introductions for assessment of pressor effects of drugs guidance for industry by FDA

作　　者：孙昱 萧惠来 SUN Yu;XIAO Huilai(Center for Drug Evaluation,National Medical Products Administration,Beijing 100022,China)

机构地区：[1]国家药品监督管理局药品审评中心,北京100022

出　　处：《药物评价研究》2018年第10期1749-1752,共4页Drug Evaluation Research

摘　　要：药品如果产生长期的升压作用,可使使用者的心血管风险增加。在开发过程中系统地描述药物对血压的影响,逐渐引起监管部门的重视。美国食品药品管理局(FDA)于2018年5月发布了"供企业用药物升压效应评估指导原则",旨在解决药品开发期间评估效应时血压测量的准确性。详细介绍该指导原则主要内容,期望对我国的新药研发和药品监管有所帮助。If the drug produces a long-term boost, it increases the cardiovascular risk of the user. In the process of development, the effects of drugs on blood pressure were systematically described, which gradually attracted the attention of regulators. In May 2018,FDA announced Assessment of Pressor Effects of Drugs Guidance for Industry, aiming to address the accuracy of blood pressure measurement when evaluating the effect during drug development. The main content of this guideline is introduced in detail, which is expected to be helpful for the development of new drugs and drug regulation in China.

关 键 词：美国食品药品管理局 药物升压效应 血压监测 新药研发 药品监管 

分 类 号：R954[医药卫生—药学]