中国临床药理学杂志2017，Vol.33Issue(24)：2649-2652,4.DOI:10.13699/j.cnki.1001-6821.2017.24.025
药物在中美欧日四地区上市剂量差异研究
Study on listing dose differences of drugs in China, America, European Union and Japan
摘要
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),Pharnaceuticals 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.关键词
剂量差异/中国/美国/欧盟/日本Key words
dose differences/China/America/European Union/Japan分类
医药卫生引用本文复制引用
王维聪,郑昕,江骥,胡蓓..药物在中美欧日四地区上市剂量差异研究[J].中国临床药理学杂志,2017,33(24):2649-2652,4.基金项目
国家自然科学基金青年基金资助项目(81503164) （81503164）
国家“十三五”重大新药创制专项“创新药物早期临床药理学评价技术平台建设”(2017ZX09304031-001)基金资助项目 （2017ZX09304031-001）
