著者

橋本 敏夫 山田 雅之 笠井 英史

出版者

日本計量生物学会

雑誌

計量生物学 (ISSN:09184430)

巻号頁・発行日

vol.36, no.Special_Issue, pp.S19-S31, 2015-06-30 (Released:2015-09-08)

参考文献数

14

被引用文献数

3

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This paper reviews the statistical aspects in pharmacokinetic analysis of clinical Phase 1 trials. Based on the understanding that most pharmacokinetic parameters follow a lognormal distribution, it is considered to be appropriate to summarize them by the geometric mean, geometric CV or geometric SD. Then we conducted simulation studies of a pharmacokinetic model to investigate whether pharmacokinetic parameters follow a lognormal distribution. Using numerical examples obtained by the simulation, we described in detail how to display the summary statistics of pharmacokinetic parameters. We also indicated that geometric mean is also useful to summarize the plasma concentration, and that the concetration below the lower limit of quantification shoud be carefully handled.