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2 results on '"Miro Parezanović"'

1. A comprehensive quality control system suitable for academic research: application in a pediatric study

Author

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, and Eva Wissmann

Subjects
Male, Quality Control, medicine.medical_specialty, Bioanalysis, Adolescent, Computer science, media_common.quotation_subject, Clinical Biochemistry, Sample (statistics), 030226 pharmacology & pharmacy, 01 natural sciences, Pediatrics, Analytical Chemistry, 03 medical and health sciences, 0302 clinical medicine, External quality assessment, medicine, Quality monitoring, Humans, Medical physics, Quality (business), General Pharmacology, Toxicology and Pharmaceutics, Child, Reliability (statistics), media_common, business.industry, 010401 analytical chemistry, General Medicine, 0104 chemical sciences, Medical Laboratory Technology, Quality control system, Research Design, Child, Preschool, Female, Renal disorders Radboud Institute for Health Sciences [Radboudumc 11], business, Quality assurance
Abstract

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.

Published
2020

2. A quality control system for ligand-binding assay of plasma renin activity: Proof-of-concept within a pharmacodynamic study

Author

Fabian Konstantin Suessenbach, Nina Makowski, Martin Feickert, Tanja Gangnus, Jutta Tins, Bjoern Bengt Burckhardt, Stephanie Läer, Jörg Breitkreutz, Ingrid Klingmann, Florian Lagler, Jan de Hoon, Michiel Dalinghaus, Milica Bajcetic, Saskia de Wildt, Anne Keatley Clarke, Johannes Breur, Christoph Male, Laslo Ablonczy, Thomas Mir, Vladislav Vukomanovic, Milan Dukic, Ida Jovanovic, Bjoern B. Burckhardt, Willi Cawello, Karl Kleine, Angelika Moder, Emina Obarcanin, Peter Wagner, Jennifer Walsh, Anne van Hecken, Lucie Spatenkova, Mohsin Ali, Bojana Božić, Maja Bijelić Ilja Burdman, Agnes Ciplea, Muhammad Faisal, Samieh Farahani, Milica Lazic, Fabian Suessenbach, 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, Anke Bartels, 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, and Eva Wissmann

Subjects
Male, Quality Control, medicine.medical_specialty, Adolescent, media_common.quotation_subject, Clinical Biochemistry, Pharmaceutical Science, Angiotensin-Converting Enzyme Inhibitors, Enzyme-Linked Immunosorbent Assay, 01 natural sciences, Plasma renin activity, Proof of Concept Study, Analytical Chemistry, Food and drug administration, Renin-Angiotensin System, Enalapril, Drug Discovery, Renin, medicine, Humans, Medical physics, Quality (business), Child, Spectroscopy, media_common, Heart Failure, 010405 organic chemistry, Chemistry, Ligand binding assay, 010401 analytical chemistry, Infant, Reproducibility of Results, Prognosis, 0104 chemical sciences, Pharmacodynamic Study, Quality control system, Proof of concept, Child, Preschool, Female, Drug Monitoring, Renal disorders Radboud Institute for Health Sciences [Radboudumc 11]
Abstract

Contains fulltext : 220641.pdf (Publisher’s version ) (Closed access) While the role of plasma renin activity (PRA) in heart failure has been widely studied in adults, comprehensive data on pediatric heart failure remain lacking. This drawback is increasingly being addressed by academic research. Nevertheless, such pediatric investigations are commonly conducted only once due to ethical constraints. Therefore, the quality of bioanalytical data must be ensured to acquire meaningful insights into maturing humoral parameters. However, appropriate post-validation assessment of bioanalytical runs is currently underrepresented by regulatory guidance. Thus, for applications in an academic environment, an easy-to-handle six-step bioanalytical quality control system was designed based on regulatory guidelines (e.g. U.S. Food and Drug Administration) combined with international recommendations (e.g. Clinical and Laboratory Standards Institute) and current scientific discussion. Its applicability to an enzyme-linked immunosorbent assay for determination of PRA was investigated within three pediatric trials of the EU-funded "Labeling of Enalapril in Neonates up to Adolescents" project. This quality control system identified 15 % bioanalytical runs as non-compliant to the predefined specifications and ensured the reliable quantification of 940 pharmacodynamic samples. The inter-run assessment of quality controls was able to demonstrate the comparability of the study results. Furthermore, 86 % of incurred sample reanalysis pairs complied with regulatory requirements (>67 %), thus underlining the long-term reproducibility of the utilized ligand-binding assay. Successful participation in interlaboratory testing confirmed the accuracy of the applied method throughout the entire study period. Further investigations showed no notable differences between the five applied lots of the PRA assay. The applicability of this quality control system was proven in an academic environment and ensured reliable results for PRA over the entire 24-month study period.

Published
2020

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