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Chinese Journal of Clinical Pharmacology and Therapeutics ›› 2005, Vol. 10 ›› Issue (12): 1408-1411.

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Analysis of body weight effects on human equivalent dose calculations in clinical trials for therapeutics in adult healthy volunteers

ZHANG Xiao-hui, LI Juan1, ZHENG Qing-shan1   

  1. National Base of Drug Clinical Trial,Affiliated Hospital of Changchun Traditional Chinese Medical College,Changchun 130021,Jilin,China;
    1Anhui Provincial Center for Drug Clinical Evaluation,YijishanHospital of Wannan Medical College,Wuhu 241001,Anhui,China
  • Received:2005-11-24 Revised:2005-11-30 Online:2005-12-26 Published:2020-11-11

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Abstract: The maximum recommended starting dose(MRSD) for “first in human” clinical trials of new molecular entities in adult healthy volunteers derived from that no observed adverse effect level was converted to human equivalent dose using standard conversion factor determined in the tested species,judging reasonably, then was divided by the safety factor from the fittest animal.This article analysis of body weight effects on HED calculations.

Key words: body weight, dose lonvestion, human equiralent dose, clinical trial

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