A European Bioanalysis Forum recommendation for requiring a context-of-use statement for successful development and validation of biomarker assays-Reference-Cited by-同舟云学术

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

Published:2024-08-05 Issue: Volume: Page:1-8
ISSN:1757-6180
Container-title:Bioanalysis
language:en
Short-container-title:Bioanalysis

Author:

Cowan Kyra J¹,Kunz Ulrich²,Blattmann Peter³,Gulati Pratiksha⁴,Hughes Richard⁵,Andersen Lene⁶,Goodman Joanne⁷,Lambert Frazer⁸,Lawrence James⁹,Thwaites Daniel¹⁰,Golob Michaela¹¹,Nelson Robert¹²,Timmerman Philip¹³

Affiliation:

1. Merck KGaA, Research & Development, Drug Metabolism & Pharmacokinetics New Biological Entities, 64293Darmstadt, Germany

2. Boehringer Ingelheim Pharma GmbH & Co. KG, Translational Medicine & Clinical Pharmacology, 88400Biberach an der Riss, Germany

3. Idorsia Pharmaceuticals Ltd, Translational Sciences, 4123Allschwil, Switzerland

4. F. Hoffmann La Roche Ltd Bioanalysis & Biomarkers Chapter, Pharmaceutical Sciences, 4070Basel, Switzerland

5. Resolian Bioanalytics, Newmarket Road, Fordham, CB7 5WW, United Kingdom

6. Novo Nordisk A/S, Clinical LCMS Bioanalysis, DK-2760, Maaløv, Denmark

7. Bioanalytical Services, Celerion, Lincoln, NE 68502, USA

8. Charles River Laboratories, Immunology, Bioanalysis & Biomarkers, EH33 2NE, Edinburgh, United Kingdom

9. Invox Pharma, Translational Sciences, CB21 6AD, Cambridge, United Kingdom

10. LabCorp Drug Development, LabCorp Drug Development, Immunology & Immunotoxicology, HG3 1PY, Harrogate, United Kingdom

11. Nuvisan GmbH, Bioanalysis, 89231, Neu-Ulm, Germany

12. BioAgilytix Laboratories, 22339Hamburg, Germany

13. European Bioanalysis Forum vzw (EBF), Havenlaan 86c b204, 1000Brussels, Belgium

Publisher

Informa UK Limited

Link

https://www.tandfonline.com/doi/pdf/10.1080/17576180.2024.2376436

Reference17 articles.

1. European Bioanalysis Forum recommendation on method establishment and bioanalysis of biomarkers in support of drug development

2. Evolving our thinking on biomarker assay validation: are we ready for the next leap?

3. Update to the European Bioanalysis Forum recommendation on biomarkers assays; bringing context of use into practice

4. Recommendations and discussion points on immunogenicity, biomarkers, automation/technology and protein–MS from the 2021 European Bioanalysis Forum Focus Workshops

5. European Bioanalysis Forum Focus Workshop: Biomarkers/CoU – Sharing Experience through Examples [Internet]. Malaga Spain; 2022. Available from: https://e-b-f.eu/fw202203-slides/

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