Use of biomarkers in the context of orphan medicines designation in the European Union

The use of biomarkers within the procedures of the Committee of Orphan Medicinal Products (COMP) of the European Medicines Agency (EMA) is discussed herein. The applications for Orphan Medicinal Product designation in the EU are evaluated at two stages. At the time of orphan designation application,...

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Detalles Bibliográficos
Autores principales: Tsigkos, Stelios, Llinares, Jordi, Mariz, Segundo, Aarum, Stiina, Fregonese, Laura, Dembowska-Baginska, Bozenna, Elbers, Rembert, Evers, Pauline, Foltanova, Tatiana, Lhoir, Andre, Corrêa-Nunes, Ana, O’Connor, Daniel, Voordouw, Albertha, Westermark, Kerstin, Sepodes, Bruno
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BioMed Central 2014
Materias:
Research
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3907589/
https://www.ncbi.nlm.nih.gov/pubmed/24461084
http://dx.doi.org/10.1186/1750-1172-9-13

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