Population Pharmacokinetic Method to Predict Within-Subject Variability Using Single-Period Clinical Data.

ABSTRACT: Sample sizes for single-period clinical trials, including pharmacokinetic studies, are statistically determined by within-subject variability (WSV). However, it is difficult to determine WSV without replicate-designed clinical trial data, and statisticians typically estimate optimal sample sizes using total variability, not WSV. We have developed an efficient population-based method to predict WSV accurately with single-period clinical trial data and demonstrate method performance with eperisone. We simulated 1000 virtual pharmacokinetic clinical trial datasets based on single-period and dense sampling studies, with various study sizes and levels of WSV and interindividual variabilities (IIVs). The estimated residual variability (RV) resulting from population pharmacokinetic methods were c

SUBMITTER: Kang WH 

PROVIDER: S-EPMC7913178 | biostudies-literature | 2021 Feb

REPOSITORIES: biostudies-literature