A comprehensive quality control system suitable for academic research -application in a pediatric study

Bioanalysis
Nina MakowskiBjoern B Burckhardt

Abstract

Aim: Clinical research in pediatrics is progressively initiated by academia. As the reliability of pharmacodynamic measures is closely linked to the quality of bioanalytical data, bioanalytical quality assurance is crucial. However, clear guidance on comprehensive bioanalytical quality monitoring in the academic environment is lacking. Methods & results: By applying regulatory guidelines, international recommendations and scientific discussions, a five-step quality control system for monitoring the bioanalysis of aldosterone by immunoassay was developed. It comprised performance qualification, calibration curve evaluation, analysis of the intra- and inter-run performance via quality control samples, incurred sample reanalysis and external quality assessment by interlaboratory testing. A total of 55 out of 70 runs were qualified for the quantification of aldosterone in the study sample enabling the evaluation of 954 pediatric samples and demonstrating reliability over the 29-month bioanalysis period. Conclusion: The bioanalytical quality control system successfully monitored the aldosterone assay performance and proved its applicability in the academic environment.

References

Mar 27, 2010·European Journal of Clinical Pharmacology·Roosmarijn F W De CockCatherijne A J Knibbe
Jan 18, 2011·Journal of Pharmaceutical and Biomedical Analysis·E RozetPh Hubert
Jul 27, 2014·Archives of Disease in Childhood·Samira Samiee-ZafarghandyJohannes N van den Anker
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Jun 20, 2017·Bioanalysis·Piotr J RudzkiMichał Kaza
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Oct 12, 2018·Bioanalysis·Eric N Fluhler
Nov 10, 2018·Bioanalysis·Faye Vazvaei
Dec 28, 2018·Journal of Pharmaceutical and Biomedical Analysis·Michał KazaPiotr J Rudzki
Feb 13, 2019·The AAPS Journal·Piotr J RudzkiMichał Kaza

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Citations

Apr 29, 2020·Bioanalysis·Michał Kaza, Piotr J Rudzki

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Methods Mentioned

BETA
Pharmacotherapy
ELISA

Clinical Trials Mentioned

NCT02652728
NCT02652741
NCT02654678

Software Mentioned

Tracker
OriginPro
Excel

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