Biomarker Qualification at the European Medicines Agency: A Review of Biomarker Qualification Procedures From 2008 to 2020

Regulatory qualification of biomarkers facilitates their harmonized use across drug developers, enabling more personalized medicine. This study reviews various aspects of the European Medicines Agency’s (EMA’s) biomarker qualification procedure, including frequency and outcome, common challenges, an...

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Detalles Bibliográficos
Autores principales: Bakker, Elisabeth, Hendrikse, Natalie M., Ehmann, Falk, van der Meer, Daniëlla S., Llinares Garcia, Jordi, Vetter, Thorsten, Starokozhko, Viktoriia, Mol, Peter G.M.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: John Wiley and Sons Inc. 2022
Materias:
Research
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9313861/
https://www.ncbi.nlm.nih.gov/pubmed/35137949
http://dx.doi.org/10.1002/cpt.2554

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