| Autor: |
Nina Makowski, Agnes M Ciplea, Mohsin Ali, Ilja Burdman, Anke Bartel, Bjoern B Burckhardt, Stephanie Läer, Jörg Breitkreutz, Ingrid Klingmann, Florian Lagler, Jan de Hoon, Michel Dalinghaus, Milica Bajcetic, Saskia de Wildt, Anne Keatley Clarke, Johannes Breur, Christoph Male, Laslo Ablonczy, Thomas Mir, Vladislav Vukomanovic, Milan Dukic, Ida Jovanovic, Bjoern Burckhardt, Willi Cawello, Karl Kleine, Angelika Moder, Emina Obarcanin, Peter Wagner, Jennifer Walsh, Anne van Hecken, Lucie Spatenkova, Ali Mohsin, Bojana Božić, Maja Bijelić, Agnes Ciplea, Muhammed Faisal, Samieh Farahani, Martin Feickert, Tanja Gangnus, Milica Lazic, Fabian Süssenbach, Marijke van der Meulen, Saša Popović, Miro Parezanović, Nori Smeets, Vanessa Swoboda, Dragana Bojanin, Stefan Đorđević, Jasminka Dragić, Ann-Kathrin Holle, Bosiljka Jovičić, Jovan Košutić, Gordana Kozomara, Haidara Majid, Jadranka Mitrović, Sanja Ninić, Miro Parezanovic, Vojislav Parezanovic, Andrija Pavlović, Sergej Prijić, Branislava Rebić, Igor Stefanović, Daniel Tordas, Irena Vulićević, Andjelka čeko, Marissa Herborts, Annelies Hennink, Bosiljka Kosanović, Sanja Kostic, Ljiljana Isailović, Jasmina Maksimovic, Badies Manai, Nada Martinović, Gyöngyi Máté, Miloš Perišić, Jelena Reljić, Regina Pirker, Marta Salamomovic, Claudia Schlesner, Jutta Tins, Eva Wissmann |
| Rok vydání: |
2020 |
| Předmět: |
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| Zdroj: |
Bioanalysis, 12, 5, pp. 319-333
Bioanalysis, 12, 319-333 |
| ISSN: |
1757-6180 |
| Popis: |
Item does not contain fulltext 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. |
| Databáze: |
OpenAIRE |
| Externí odkaz: |
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