Transl Clin Pharmacol.  2015 Jun;23(1):31-34. 10.12793/tcp.2015.23.1.31.

Assessment of statistical power for covariate effects in data from phase I clinical trials

• Kim Y
• Son H
• Son M
• Lee D
• Heo YA
• Park K

• KMID: 2148857
• DOI: http://doi.org/10.12793/tcp.2015.23.1.31

Abstract

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

Keyword

Simulation; Covariate effect; Phase I clinical trial; NONMEM

MeSH Terms

Absorption
Clinical Trials, Phase I as Topic*
Creatinine
Dataset
Healthy Volunteers
Hope
Creatinine

Figure

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  Figure 1. Observed concentration vs time for drug X. Dots and error bars represent mean and standard deviation at each time point.

Reference

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