人体耐受性试验中体重因素对人体等效剂量转换计算的影响

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

临床健康人体耐受性试验最大推荐起始剂量(maximumrecommended starting dose,MRSD)一般是将相关动物研究得到的无明显不良反应的最高剂量(no observed adverse effect level,NOAEL)用标准系数换算成人体等效剂量(human equivalent dose,HED),根据科学判断,从最合适动物得到的HED除以安全系数(safetyfactor,SF)得到MRSD。本文论述了体重因素对HED转换计算的影响。

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.