A European Bioanalysis Forum recommendation for requiring a context-of-use statement for successful development and validation of biomarker assays.

Autor: Cowan KJ; Merck KGaA, Research & Development, Drug Metabolism & Pharmacokinetics New Biological Entities, 64293Darmstadt, Germany., Kunz U; Boehringer Ingelheim Pharma GmbH & Co. KG, Translational Medicine & Clinical Pharmacology, 88400Biberach an der Riss, Germany., Blattmann P; Idorsia Pharmaceuticals Ltd, Translational Sciences, 4123Allschwil, Switzerland., Gulati P; F. Hoffmann La Roche Ltd Bioanalysis & Biomarkers Chapter, Pharmaceutical Sciences, 4070Basel, Switzerland., Hughes R; Resolian Bioanalytics, Newmarket Road, Fordham, CB7 5WW, United Kingdom., Andersen L; Novo Nordisk A/S, Clinical LCMS Bioanalysis, DK-2760, Maaløv, Denmark., Goodman J; Bioanalytical Services, Celerion, Lincoln, NE 68502, USA., Lambert F; Charles River Laboratories, Immunology, Bioanalysis & Biomarkers, EH33 2NE, Edinburgh, United Kingdom., Lawrence J; Invox Pharma, Translational Sciences, CB21 6AD, Cambridge, United Kingdom., Thwaites D; LabCorp Drug Development, LabCorp Drug Development, Immunology & Immunotoxicology, HG3 1PY, Harrogate, United Kingdom., Golob M; Nuvisan GmbH, Bioanalysis, 89231, Neu-Ulm, Germany., Nelson R; BioAgilytix Laboratories, 22339Hamburg, Germany., Timmerman P; European Bioanalysis Forum vzw (EBF), Havenlaan 86c b204, 1000Brussels, Belgium.
Jazyk: angličtina
Zdroj: Bioanalysis [Bioanalysis] 2024; Vol. 16 (16), pp. 835-842. Date of Electronic Publication: 2024 Aug 05.
DOI: 10.1080/17576180.2024.2376436
Abstrakt: The European Bioanalysis Forum, alongside key industry stakeholders, has been driving the discussions around the implementation of context-of use for biomarker assays to ensure that these assays are validated appropriately depending on their purpose. Insights into understanding why the implementation of context-of-use in assay strategies has also shown that the key stakeholder, or requester for the biomarker data, is responsible for providing the context-of-use statement for all biomarker assay requests. Experts from across the industry haves repeatedly sought a cross-industry recommended format in which the context-of-use statement could be provided. In this manuscript, the European Bioanalysis Forum suggests a format for this.
Databáze: MEDLINE
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