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Pragmatic clinical trials in the context of regulation of medicines

The pragmatic clinical trial addresses scientific questions in a setting close to routine clinical practice and sometimes using routinely collected data. From a regulatory perspective, when evaluating a new medicine before approving marketing authorization, there will never be enough patients studie...

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Detalles Bibliográficos
Autores principales: Gedeborg, Rolf, Cline, Charles, Zethelius, Björn, Salmonson, Tomas
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Taylor & Francis 2019
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6450602/
https://www.ncbi.nlm.nih.gov/pubmed/30251577
http://dx.doi.org/10.1080/03009734.2018.1515280