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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...
| Autores principales: | , , , |
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| Formato: | Online Artículo Texto |
| Lenguaje: | English |
| Publicado: |
BioMed Central
2015
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| Materias: | |
| Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4625856/ https://www.ncbi.nlm.nih.gov/pubmed/26511061 http://dx.doi.org/10.1186/s13023-015-0349-z |