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Predictors of orphan drug approval in the European Union

OBJECTIVE: To encourage the development of drugs for rare diseases, orphan drug legislation has been introduced in the USA (1983) and in the EU (2000). Recent literature discusses factors that may influence the development of new orphan medicinal products in the EU. This study aims to identify predi...

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Detalles Bibliográficos
Autores principales: Heemstra, Harald E., de Vrueh, Remco L., van Weely, Sonja, Büller, Hans A., Leufkens, Hubert G. M.
Formato: Texto
Lenguaje:English
Publicado: Springer-Verlag 2008
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2668549/
https://www.ncbi.nlm.nih.gov/pubmed/18210097
http://dx.doi.org/10.1007/s00228-007-0454-6