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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...
Autores principales: | Gedeborg, Rolf, Cline, Charles, Zethelius, Björn, Salmonson, Tomas |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Taylor & Francis
2019
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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 |
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