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

Publication date: Available online 28 December 2019Source: Journal of Pharmaceutical and Biomedical AnalysisAuthor(s): Fabian Konstantin Suessenbach, Nina Makowski, Martin Feickert, Tanja Gangnus, Jutta Tins, Bjoern Bengt Burckhardt, on behalf of the LENA consortiumAbstractWhile the role of plasma renin activity (PRA) in heart failure have 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 pred...
Source: Journal of Pharmaceutical and Biomedical Analysis - Category: Drugs & Pharmacology Source Type: research

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