Assessment of statistical power for covariate effects in data from phase I clinical trials.
10.12793/tcp.2015.23.1.31
- Author:
Yukyung KIM
1
;
Hankil SON
;
Mijeong SON
;
Donghwan LEE
;
Young A HEO
;
Kyungsoo PARK
Author Information
1. Department of Pharmacology, Yonsei University College of Medicine, Seoul 120-752, Korea. kspark@yuhs.ac
- Publication Type:Clinical Trial ; Original Article
- Keywords:
Simulation;
Covariate effect;
Phase I clinical trial;
NONMEM
- MeSH:
Absorption;
Clinical Trials, Phase I as Topic*;
Creatinine;
Dataset;
Healthy Volunteers;
Hope
- From:Translational and Clinical Pharmacology
2015;23(1):31-34
- CountryRepublic of Korea
- Language:English
-
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
