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Chinese Journal of Clinical Pharmacology and Therapeutics ›› 2007, Vol. 12 ›› Issue (3): 346-348.

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Main points of design about phase I tolerant clinical trials of injectable preparation

HAN Rong, XUE Jie, QI Jian-guo   

  1. Affiliated Hospital of Traditional Chinese Medicine, Xinjiang Medical University, Urumqi 830000, Xinjiang, China
  • Received:2007-02-13 Revised:2007-03-18 Online:2007-03-26 Published:2020-11-06

Abstract: In order to consummate the various specification in phase I tolerant clinical trials, through using medicine dosage, increasing the dosage plan, the treatment course, choosing the fluid, giving the medicine method, stochastically entering the group, the physics and chemistry result judgment, human body responding aspect and so on, we summarize and propose the standard sequence of operation.It proves effective to improve the quality from the clinical trials.

Key words: phase I, tolerant trials, clinical trials

CLC Number: