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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:...
Autores principales: | Putzeist, Michelle, Mantel-Teeuwisse, Aukje K., Gispen-De Wied, Christine C., Hoes, Arno W., Leufkens, Hubert G. |
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Formato: | Texto |
Lenguaje: | English |
Publicado: |
Springer-Verlag
2010
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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 |
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