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Chinese Journal of Clinical Pharmacology and Therapeutics ›› 2006, Vol. 11 ›› Issue (8): 952-954.

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General consideration of clinical investigation for registration of fixed dose combination anti-hypertension drugs

KANG Cai-lian, GAO Chen-yan   

  1. Center for Drug Evaluation of State Food and Drug Administration , Beijing 100038 , China
  • Received:2006-08-03 Revised:2006-08-14 Online:2006-08-26 Published:2020-11-05

Abstract: Fixed dose combination anti-hypertension drugs have the benefits such as free combination of the efficacy or/and safety of various kinds of anti-hypertension drugs , increasing patient's compliance , reducing the cost of treatment.The goal and the content of clinical investigation for registration are different for drugs which have different marketed groundwork.This article will illuminate the general consideration of clinical trials for different kinds marketed groundwork of fixed dose combination anti-hypertension drugs , including marketed drugs in China, none-marketed in China but marketed in foreign countries, none-marked in any countries.

Key words: drug registration, clinical investiga, fixed dose combination of anti-hypertension drugs

CLC Number: