Comprehensive graphical presentation of data from incurred sample reanalysis

Abstract Aim: Incurred sample reanalysis (ISR) contributes to the reliability of pharmacokinetic studies. Despite regulatory guidelines having adopted ISR methodology, graphical presentation of data has been overlooked. Materials & methods: Different graphs were tested for datasets including limited, standard and large numbers of ISR pairs. The datasets covered both passed and failed cases. Results: We have developed a combination of complementary plots enabling the visual inspection of ISR data quality: %difference versus mean concentration and cumulative ISR plot. The former shows individual ISR datapoints and concentration-dependent trends, while the latter presents the contribution of individual pairs to the overall result...