Comprehensive graphical presentation of data from incurred sample reanalysis

Author:

Rudzki Piotr J1,Biecek Przemysław2,Kaza Michał1

Affiliation:

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.

Publisher

Future Science Ltd

Subject

Medical Laboratory Technology,Clinical Biochemistry,General Pharmacology, Toxicology and Pharmaceutics,General Medicine,Analytical Chemistry

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