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The influence of the European paediatric regulation on marketing authorisation of orphan drugs for children
BACKGROUND: Drug development for rare diseases is challenging, especially when these orphan drugs (OD) are intended for children. In 2007 the EU Paediatric Drug Regulation was enacted to improve the development of high quality and ethically researched medicines for children through the establishment...
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| Veröffentlicht in: | Orphanet J Rare Dis |
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| Hauptverfasser: | , , , |
| Format: | Artigo |
| Sprache: | Inglês |
| Veröffentlicht: |
BioMed Central
2014
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| Schlagworte: | |
| Online Zugang: | https://ncbi.nlm.nih.gov/pmc/articles/PMC4237943/ https://ncbi.nlm.nih.gov/pubmed/25091201 https://ncbi.nlm.nih.govhttp://dx.doi.org/10.1186/s13023-014-0120-x |
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