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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...
Autores principales: | , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
BioMed Central
2013
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3852769/ https://www.ncbi.nlm.nih.gov/pubmed/24131572 http://dx.doi.org/10.1186/1750-1172-8-164 |