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Regulatory scientific advice in drug development: does company size make a difference?

PURPOSE: To assess whether the content of Scientific Advice (SA) questions addressed to a national drug regulatory agency is associated with company size. This may help to increase understanding about the knowledge, strategic, and regulatory gaps companies face during drug development. METHODOLOGY:...

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Detalles Bibliográficos
Autores principales: Putzeist, Michelle, Mantel-Teeuwisse, Aukje K., Gispen-De Wied, Christine C., Hoes, Arno W., Leufkens, Hubert G.
Formato: Texto
Lenguaje:English
Publicado: Springer-Verlag 2010
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3021701/
https://www.ncbi.nlm.nih.gov/pubmed/21049297
http://dx.doi.org/10.1007/s00228-010-0919-x