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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書誌詳細
主要な著者: 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
フォーマット: Artigo
言語:Inglês
出版事項: BioMed Central 2014
主題:
Research
オンライン･アクセス: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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