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Clinical evidence for orphan medicinal products-a cause for concern?

BACKGROUND: The difficulties associated with organising clinical studies for orphan medicinal products (OMPs) are plentiful. Recent debate on the long-term effectiveness of some OMPs, led us to question whether the initial standards for clinical evidence for OMPs, set by the European Medicines Agenc...

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Autores principales: Picavet, Eline, Cassiman, David, Hollak, Carla E, Maertens, Johan A, Simoens, Steven
Formato: Artigo
Lenguaje:Inglês
Publicado: BioMed Central 2013
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Acceso en línea:https://ncbi.nlm.nih.gov/pmc/articles/PMC3852769/
https://ncbi.nlm.nih.gov/pubmed/24131572
https://ncbi.nlm.nih.govhttp://dx.doi.org/10.1186/1750-1172-8-164
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