【摘要】 由于内在和外在等多因素综合作用影响,药物在不同地区上市的说明书存在着差异,这些差异主要表现在药物使用剂量的差异上。本文从吸收、分布、代谢和清除的角度对种族因素对药物代谢的影响进行了分析;对人用药品注册技术要求国际协调会(ICH)、美国食品药品监督管理局(FDA)、日本医药品医疗器械综合机构(PMDA)、中国食品药品监督管理局(CFDA)相关临床试验指导原则进行了总结;并且对2011~2015年间在中国、美国、欧盟、日本四地区上市的药物进行了比较,筛选出了存在剂量差异的药物,讨论了可能产生差异的原因。这种分析总结在国内尚属首次,为中国药物上市的发展提供了一定的基础研究数据。更多还原

【Abstract】 Because of the combination of internal and external factors,there are differences in the labels of drugs listed in different regions which were shown in dosage. This paper analyzes the effects of racial factors on drug metabolism from the perspectives of absorption,distribution,metabolism and elimination,and summarizes the principles involved such as International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use( ICH),Food and Drug Administration( FDA),Pharmaceuticals and Medical Devices Agency( PMDA) and China Food and Drug Administration( CFDA). This paper also compares the drugs listed in China,the United States,the European Union and Japan in 2011-2015,screens the drugs with different doses,and discusses the possible reasons that caused these differences.This review and analysis is the first in China and provides a basic research data for the development of Chinese pharmaceutical listing.更多还原