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Review and comparison of clinical evidence submitted to support European Medicines Agency market authorization of orphan-designated oncological treatments
BACKGROUND: Clinical trials for treatments indicated for orphan diseases may be limited due to the low prevalence of such diseases; this can result in implications for both regulatory and health economic perspectives. This study assessed the pivotal clinical evidence packages submitted to support ap...
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| Publicado no: | Orphanet J Rare Dis |
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| Main Authors: | , , , |
| Formato: | Artigo |
| Idioma: | Inglês |
| Publicado em: |
BioMed Central
2015
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| Assuntos: | |
| Acesso em linha: | https://ncbi.nlm.nih.gov/pmc/articles/PMC4625856/ https://ncbi.nlm.nih.gov/pubmed/26511061 https://ncbi.nlm.nih.govhttp://dx.doi.org/10.1186/s13023-015-0349-z |
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