关于化学药品改良型新药临床药理研究的考虑  

Considerations regarding the clinical pharmacology research of chemical modified drugs

作　　者：刘美霞 贺锐锐 王骏 LIU Mei-xia;HE Rui-rui;WANG Jun(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：《中国临床药理学杂志》2023年第7期1060-1064,共5页The Chinese Journal of Clinical Pharmacology

摘　　要：化学药品改良型新药已成为当前新药研发的热点方向之一。临床药理研究对改良型新药的开发至关重要,但目前国内尚未发布针对改良型新药临床药理研究的指导原则。本文主要结合美国食品药品监督管理局已上市化学药品改良型新药研究实例,对化学药品改良型新药的临床药理研究提出几点思考,以期为国内化学药品改良型新药的研发提供一些参考。Chemical modified drugs have become one of the hot directions of new drug research and development.Clinical pharmacology research is critical to the development of chemical modified drugs.At present,no guidelines have been issued in China for clinical pharmacology research of chemical modified drugs.This paper mainly combines the research examples of chemical modified drugs already listed by the US Food and Drug Administration,and puts forward some thoughts on the clinical pharmacology research,in order to provide reference for the research and development of chemical modified drugs in China.

关 键 词：改良型新药 临床药理研究 改剂型药物 相对生物利用度 药代动力学 

分 类 号：R97[医药卫生—药品]