計量生物学
Online ISSN : 2185-6494
Print ISSN : 0918-4430
ISSN-L : 0918-4430
第I相試験の薬物動態解析における統計的側面—薬物動態データの分布と要約統計量—
橋本 敏夫山田 雅之笠井 英史
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2015 年 36 巻 Special_Issue 号 p. S19-S31

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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.

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© 2015 日本計量生物学会
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