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KMID : 1038020150230010031
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Translational and Clinical Pharmacology
2015 Volume.23 No. 1 p.31 ~ p.34
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Assessment of statistical power for covariate effects in data from phase I clinical trials
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Kim Yu-Kyung
Son Han-Kil
Son Mi-Jeong
Lee Dong-Hwan
Heo Young-A
Park Kyung-Soo
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Abstract
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One of the important purposes in population pharmacokinetic studies is to investigate the relationships between parameters and covariates to describe parameter variability. The purpose of this study is to evaluate the model’s ability to correctly detect the parameter-covariate relationship that can be observed in phase I clinical trials. Data were simulated from a two-compartment model with zero-order absorption and first-order elimination, which was built from valsartan’s concentration data collected from a previously conducted study. With creatinine clearance (CLCR) being used as a covariate to be tested, 3 different significance levels of 0.001
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KEYWORD
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Simulation, Covariate effect, Phase I clinical trial, NONMEM
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