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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 in-study monitoring and post-study inspection of data. It helps find the root cause of unmatched ISR, thus increasing reliability of bioanalytical data.