Lacey L F, Keene O N, Pritchard J F, Bye A
Department of Clinical Pharmacology, Glaxo Wellcome Research and Development Limited, Middlesex, United Kingdom.
J Biopharm Stat. 1997 Mar;7(1):171-8. doi: 10.1080/10543409708835177.
We investigated the hypothesis that distributions of continuous pharmacokinetic variables are positively skewed in nature and that logarithmic transformation of these variables restores normality. The distributions of common continuous noncompartmental pharmacokinetic variables were investigated for four different Glaxo Wellcome compounds, administered by three different routes of administration: ranitidine (po), sumatriptan (sc), ondansetron (iv), and bismuth, from ranitidine bismuth citrate (po). The distributions of all the investigated noncompartmental pharmacokinetic variables were adequately described by a log-normal distribution, whereas statistically significant departures from normality occurred in the majority of cases. Thus, unless there is strong and consistent evidence for a departure from log-normality, the parametric statistical analysis of common noncompartmental pharmacokinetic variables should be carried out after a priori log transformation.
连续药代动力学变量的分布本质上呈正偏态,并且这些变量的对数转换可恢复正态性。对葛兰素威康公司的四种不同化合物,通过三种不同给药途径进行给药,研究了常见连续非房室药代动力学变量的分布:雷尼替丁(口服)、舒马曲坦(皮下注射)、昂丹司琼(静脉注射)以及来自枸橼酸铋雷尼替丁的铋(口服)。所有研究的非房室药代动力学变量的分布均可用对数正态分布充分描述,然而在大多数情况下,与正态性存在统计学上的显著偏差。因此,除非有强有力且一致的证据表明偏离对数正态性,否则常见非房室药代动力学变量的参数统计分析应在先验对数转换后进行。