Extended 3D and 4D cumulative plots for evaluation of unmatched incurred sample reanalysis

Aim: Incurred sample reanalysis (ISR) helps ensure the reliability of pharmacokinetic studies. An appropriate graph may facilitate the evaluation of an unmatched reanalyses or a failed ISR test. Methods: We evaluated different ways of visualizing multidimensional ISR data using an extended cumulative ISR plot. Results: 3D and 4D cumulative ISR plots enable comprehensive data analysis using a single plot. We propose to use color for percentage difference classes in bar and XY-scatter plots. For the latter the shape of symbols may represent analyte concentration class, study phase, analyst or subject. Conclusion: The extended 3D and 4D cumulative ISR plots facilitate...