Welcome to Chinese Journal of Clinical Pharmacology and Therapeutics,Today is Chinese

Chinese Journal of Clinical Pharmacology and Therapeutics ›› 2007, Vol. 12 ›› Issue (3): 349-351.

Previous Articles     Next Articles

Thinking on ethical principle in bioequivalence studies

QIAN Wei1, YANG Jin2, CHEN Lei2, XIAO Da-wei1   

  1. 1Clinical Pharmacology Base, Nanjing First Hospital, Nanjing 210006, Jiangsu, China;
    2Key Laboratory of Drug Metabolism and Pharmacokinetics, China Pharmaceutical University, Nanjing 210009, Jiangsu, China
  • Received:2006-11-07 Revised:2007-02-25 Online:2007-03-26 Published:2020-11-06

Abstract: The clinical trails should be conducted in accordance with the ethical principles that have their origin in the declaration of Helsinki and that are consistent with GCP.A trial should be initiated and continued only if the anticipated benefits justify the risks.According to the principle, this paper gives some thinking on the ethical principle in bioequivalence study of some special drugs.

Key words: bioequivalence, clinical trials, ethics

CLC Number: