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

Suessenbach, F K; Makowski, Nina; Feickert, Martin; Gangnus, Tanja; Tins, Jutta; Burckhardt, Bjoern B.; Läer, Stephanie; Breitkreutz, Jörg; Klingmann, Ingrid; Lagler, Florian B.; Hoon, Jan de; Dalinghaus, Michiel; Bajcetic, Milica; Wildt, Saskia de; Clarke, Anne; Breur, Johannes M.P.J.; Male, Christoph; Ablonczy, Laslo; Mir, Thomas S.; Vukomanovic, Vladislav; M, Dukić; Jovanovic, Ida; Cawello, Willi; Kleine, K.; Moder, Angelika; Obarčanin, Emina; Wagner, Peter D.; Walsh, Jennifer; Hecken, Anne Van; Spatenkova, Lucie; Ali, Mohsin; Božić, Bojana; Burdman, Maja Bijelić Ilja; Ciplea, Agnes Maria; Faisal, Muhammad; Farahani, Samieh; Lazić, Milica; Meulen, Marijke van der; Popović, Saša; Parezanović, Miro; Smeets, Nori J L; Swoboda, Vanessa; Bojanin, Dragana; S, Dordević; Dragić, Jasminka; Holle, Ann-Kathrin; Jovičić, Bosiljka; Košutić, Jovan; Kozomara, Gordana; Majid, Haidara; Mitrovic, J.; Ninić, Sanja; Parezanović, Vojislav; Pavlovic, A; Prijić, Sergej; Rebić, Branislava; Stefanovic, Igor; Tordas, Daniel; Vuličević, Irena; Bartels, Anke; Čeko, Andjelka; Herborts, Marissa; Hennink, Annelies; B, Kosanovic; Kostic, Sanja; Isailović, Ljiljana; Maksimovic, Jasmina; Manai, Badies; Martinović, Nada; Máté, Gyöngyi; Perišić, Miloš; Reljić, Jelena; Salamomovic, Regina Pirker Marta; Schlesner, Claudia; Wissmann, Eva

doi:10.1016/j.jpba.2019.113090

Cited by 2 publications

(3 citation statements)

References 21 publications

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“…In proving the validity and collection of high‐quality data, a quality control system directed the handling of all measurements. This audited quality control system 28 required processing validation and applicability runs with calibration standards and quality control samples. Before each analysis, a system suitability test ensured accurate and reproducible LC‐MS/MS performance.…”

Section: Methodsmentioning

confidence: 99%

Reliable measurement of plasma kinin peptides: Importance of preanalytical variables

Gangnus

Burckhardt

2022

Research and Practice in Thrombosis and Haemostasis

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Section: Methodsmentioning

confidence: 99%

Reliable measurement of plasma kinin peptides: Importance of preanalytical variables

Gangnus

Burckhardt

2022

Research and Practice in Thrombosis and Haemostasis

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“…More detailed information on this study is given in the Supporting Information. To continuously monitor the reproducibility of the assay during the analysis of study samples, ISR was applied based on previously established in‐house bioanalytical QC systems 31,32 . Following regulatory bioanalytical guidelines, reanalysis of 10% of the first 1,000 study samples with concentrations close to the maximum concentration ( c max ) and during the elimination phase is recommended 26,27 .…”

Section: Methodsmentioning

confidence: 99%

“…As part of in-house established comprehensive QC systems, 31,32 ISR was conducted for paediatric plasma samples to continuously monitor and verify the method performance after validation. Eight ISR pairs were randomly selected out of the total available plasma within a wide range for all analytes.…”

Section: Continued Methods Performance Verificationmentioning

confidence: 99%

Low‐volume LC–MS/MS method for the pharmacokinetic investigation of carvedilol, enalapril and their metabolites in whole blood and plasma: Application to a paediatric clinical trial

Gangnus

Burckhardt

2020

Drug Testing and Analysis

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Evidence‐based pharmacotherapy with carvedilol and enalapril in children suffering from heart failure is insufficient owing to limited pharmacokinetic data. Although a few data sets regarding enalapril, its metabolite enalaprilat and carvedilol in children have been published, pharmacokinetic data on carvedilol metabolites are missing. However, for both drug substances, their active metabolites contribute substantially to drug efficacy. As data can hardly be derived from adults owing to the unknown impacts of enzymatic maturation and ontogeny during childhood, customised assays are important to facilitate paediatric evidence‐based pharmacotherapy. Considering ethical paediatric constraints, a low‐volume liquid chromatography coupled to mass spectrometry (LC–MS/MS) assay was developed using whole blood or plasma for the quantification of enalapril, enalaprilat, carvedilol, O‐desmethyl carvedilol, 4‐ and 5‐hydroxyphenyl carvedilol as well as 3‐ and 8‐hydroxy carvedilol. To facilitate broader applications in adults, the elderly and children, a wide calibration range—between 0.024/0.049 and 50.000 ng/ml—was achieved with good linearity (r ≥ 0.995 for all analytes). In compliance with international bioanalytical guidelines, accuracy, precision, sensitivity and internal standard normalised matrix effects were further successfully validated with the exception of those for 3‐hydroxy carvedilol, which was therefore assessed semi‐quantitatively. Distinct haematocrits did not impact matrix effects or recoveries when analysing whole blood. Blood‐to‐plasma ratios were determined for all analytes to form the basis for pharmacokinetic modelling. Finally, incurred sample reanalysis of paediatric samples confirmed the reproducibility of the developed low‐volume LC–MS/MS method during study sample analysis. The assay facilitates the reliable generation of important data and contributes towards a safe drug therapy in children.

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

Cited by 2 publications

References 21 publications

Reliable measurement of plasma kinin peptides: Importance of preanalytical variables

Reliable measurement of plasma kinin peptides: Importance of preanalytical variables

Low‐volume LC–MS/MS method for the pharmacokinetic investigation of carvedilol, enalapril and their metabolites in whole blood and plasma: Application to a paediatric clinical trial

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