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Contribution of industry funded post-marketing studies to drug safety: survey of notifications submitted to regulatory agencies

Objectives To investigate the practice of post-marketing studies in Germany during a three year period and to evaluate whether these trials meet the aims specified in the German Medicinal Products Act. Design Survey of notifications submitted to German regulatory agencies before post-marketing studi...

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Detalles Bibliográficos
Autores principales: Spelsberg, Angela, Prugger, Christof, Doshi, Peter, Ostrowski, Kerstin, Witte, Thomas, Hüsgen, Dieter, Keil, Ulrich
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BMJ Publishing Group Ltd. 2017
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5477378/
https://www.ncbi.nlm.nih.gov/pubmed/28174182
http://dx.doi.org/10.1136/bmj.j337