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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Detalhes bibliográficos
Main Authors: 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: Artigo
Idioma:Inglês
Publicado em: BioMed Central 2014
Assuntos:
Research
Acesso em linha: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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