Special Report

Comprehensive graphical presentation of data from incurred sample reanalysis

*Author for correspondence:

Pharmaceutical Research Institute, Pharmacology Department, 8 Rydygiera Street, 01–793 Warsaw, Poland

Faculty of Mathematics & Information Science, Warsaw University of Technology, 75 Koszykowa Street, 00–662 Warsaw, Poland

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Michał Kaza

Pharmaceutical Research Institute, Pharmacology Department, 8 Rydygiera Street, 01–793 Warsaw, Poland

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Published Online:19 Jun 2017https://doi.org/10.4155/bio-2017-0038

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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.

Keywords:

Papers of special note have been highlighted as: • of interest; •• of considerable interest

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Vol. 9, No. 12

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Published online 19 June 2017

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Acknowledgements

This paper is to commemorate 65th anniversary of the Pharmaceutical Research Institute in Warsaw, Poland. The authors gratefully acknowledge contributions of the study directors (K Buś-Kwaśnik, M Filist, E Gilant and M Kaza from the Pharmacology Department of Pharmaceutical Research Institute) and their research teams to generate regulatory compliant datasets. Thanks are also due to A Kutner, K Buś-Kwaśnik and M Filist from the Pharmacology Department for the critical reviewing of the manuscript. The authors are thankful to L Tajber and K McComiskey from the Trinity College, Dublin, Ireland, for critical reading of the manuscript and to student trainee D Matyskiel for technical assistance.

Financial & competing interests disclosure

Financial support of the European Union (European Regional Development Fund) is gratefully acknowledged: the datasets D and E were obtained within the projects conducted under the Polish Innovative Economy Operational Programme 2007–2013 (POIG.01.03.01-14-032/12-01 – consortium with Vipharm SA, Poland and POIG.01.03.01-14-001/12 consortium with Pol-Nil SA, Poland, respectively). Financial support of the National Centre for Research and Development of the Republic of Poland is gratefully acknowledged: the dataset G was obtained within the project No. K1/IN1/14/159003/NCBR/12 (consortium with LEK-AM Pharmaceutical Company Ltd., Poland); the datasets F and J were obtained within the project PBS1/B7/7/2012 (consortium with Biopharm Ltd., Poland). The other datasets were obtained within the projects sponsored by Farmak JSC, Kiev, Ukraine; 4 Medicine Rek sp. k., Warsaw, Poland; Valeant Sp. z o.o. sp.j., Rzeszów, Poland. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.

No writing assistance was utilized in the production of this manuscript.

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