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Characteristics of safety information obtained from postmarketing observational studies for re-examination in Japan

BACKGROUND: In Japan, postmarketing surveillance (PMS) studies are required for newly approved drug products to further collect safety information in clinical settings. “PMS study” is a general term encompassing both postmarketing observational (PMO) studies and postmarketing intervention studies fo...

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Detalles Bibliográficos
Autores principales:	Watanabe, Tatsuya, Narukawa, Mamoru
Formato:	Online Artículo Texto
Lenguaje:	English
Publicado:	Springer International Publishing 2016
Materias:	Research
Acceso en línea:	https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4923017/ https://www.ncbi.nlm.nih.gov/pubmed/27386350 http://dx.doi.org/10.1186/s40064-016-2365-4

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