A comprehensive quality control system suitable for academic research: application in a pediatric study
-
Published:2020-03
Issue:5
Volume:12
Page:319-333
-
ISSN:1757-6180
-
Container-title:Bioanalysis
-
language:en
-
Short-container-title:Bioanalysis
Author:
Makowski Nina1, Ciplea Agnes M1, Ali Mohsin1, Burdman Ilja1, Bartel Anke1, Burckhardt Bjoern B1ORCID, Läer Stephanie, Breitkreutz Jörg, Klingmann Ingrid, Lagler Florian, de Hoon Jan, Dalinghaus Michel, Bajcetic Milica, de Wildt Saskia, Keatley Clarke Anne, Breur Johannes, Male Christoph, Ablonczy Laslo, Mir Thomas, Vukomanovic Vladislav, Dukic Milan, Jovanovic Ida, Burckhardt Bjoern, Cawello Willi, Kleine Karl, Moder Angelika, Obarcanin Emina, Wagner Peter, Walsh Jennifer, van Hecken Anne, Spatenkova Lucie, Mohsin Ali, Božić Bojana, Bijelić Maja, Burdman Ilja, Ciplea Agnes, Faisal Muhammed, Farahani Samieh, Feickert Martin, Gangnus Tanja, Lazic Milica, Makowski Nina, Süssenbach Fabian, van der Meulen Marijke, Popović Saša, Parezanović Miro, Smeets Nori, Swoboda Vanessa, Bojanin Dragana, Đorđević Stefan, Dragić Jasminka, Holle Ann-Kathrin, Jovičić Bosiljka, Košutić Jovan, Kozomara Gordana, Majid Haidara, Mitrović Jadranka, Ninić Sanja, Parezanovic Miro, Parezanovic Vojislav, Pavlović Andrija, Prijić Sergej, Rebić Branislava, Stefanović Igor, Tordas Daniel, Vulićević Irena, Bartel Anke, čeko Andjelka, Herborts Marissa, Hennink Annelies, Kosanović Bosiljka, Kostic Sanja, Isailović Ljiljana, Maksimovic Jasmina, Manai Badies, Martinović Nada, Máté Gyöngyi, Perišić Miloš, Reljić Jelena, Pirker Regina, Salamomovic Marta, Schlesner Claudia, Tins Jutta, Wissmann Eva
Affiliation:
1. Institute of Clinical Pharmacy & Pharmacotherapy, Heinrich Heine University, Universitaetsstrasse 1, 40225 Duesseldorf, Germany
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.
Publisher
Future Science Ltd
Subject
Medical Laboratory Technology,Clinical Biochemistry,General Pharmacology, Toxicology and Pharmaceutics,General Medicine,Analytical Chemistry
Reference23 articles.
1. European Medicines Agency. Guideline on bioanalytical method validation: EMEA/CHMP/EWP/192217/2009 Rev. 1 Corr. 2** (2011). https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-bioanalytical-method-validation_en.pdf 2. US FDA. Guidance for industry: bioanalytical method validation (2018). https://www.fda.gov/files/drugs/published/Bioanalytical-Method-Validation-Guidance-for-Industry.pdf 3. European Medicines Agency. ICH harmonised guideline: bioanalytical method validation M10 (draft version). https://www.ema.europa.eu/en/documents/scientific-guideline/draft-ich-guideline-m10-bioanalytical-method-validation-step-2b_en.pdf 4. Discontinuation and Nonpublication of Randomized Clinical Trials Conducted in Children 5. Incurred sample reanalysis: ‘too much of a good thing?’
Cited by
2 articles.
订阅此论文施引文献
订阅此论文施引文献，注册后可以免费订阅5篇论文的施引文献，订阅后可以查看论文全部施引文献
|
|