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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Autors principals: 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
Format: Artigo
Idioma:Inglês
Publicat: BioMed Central 2014
Matèries:
Research
Accés en línia:https://ncbi.nlm.nih.gov/pmc/articles/PMC3907589/
https://ncbi.nlm.nih.gov/pubmed/24461084
https://ncbi.nlm.nih.govhttp://dx.doi.org/10.1186/1750-1172-9-13
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