Piotr J Rudzki1, Przemysław Biecek2, Michał Kaza1. 1. Pharmaceutical Research Institute, Pharmacology Department, 8 Rydygiera Street, 01-793 Warsaw, Poland. 2. Faculty of Mathematics & Information Science, Warsaw University of Technology, 75 Koszykowa Street, 00-662 Warsaw, Poland.
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 as well as time-dependent trends. CONCLUSION: The proposed visualization of ISR data shows at a glance whether acceptance criteria for each sample and whole experiment are met or not. Standardized graphical presentation of ISR outcomes may increase quality of bioanalytical data.
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 as well as time-dependent trends. CONCLUSION: The proposed visualization of ISR data shows at a glance whether acceptance criteria for each sample and whole experiment are met or not. Standardized graphical presentation of ISR outcomes may increase quality of bioanalytical data.