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Chinese Journal of Clinical Pharmacology and Therapeutics ›› 2013, Vol. 18 ›› Issue (6): 654-660.

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Phase Ⅰ clinical trial design and the problems need to focus

QIAN Wei, XIAO Da-wei   

  1. Department of Phase Ⅰ Clinical Trials, Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical College, Nanjing 210008, Jiangsu, China
  • Received:2012-08-03 Revised:2012-12-03 Published:2013-06-19

Abstract: Phase I clinical trials, especially the first in human trials (FIH) of drugs are with greatly challenging. There are many great progresses in design technology abroad. The starting dose, placebo-controlled, increasing doses, the trail termination criteria and risk assessment involved in the Phase I clinical trial were reviewed in this article.

Key words: PhaseⅠclinical trials, First in human, Protocol design, Assessment of risk

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