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Analysis of Global Drug Development Pathways and Postmarketing Safety in Japan: Local Studies May Reduce Drug‐Related Deaths

Recent International Conference on Harmonization (ICH) guidelines provide pharmaceutical companies with regulatory justifications to pursue various global drug‐development pathways, in some of which “local” dose‐ranging and/or pivotal phase III studies are skipped. We examined the association betwee...

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Detalles Bibliográficos
Autores principales:	Okubo, Tomoko Kawamura, Ono, Shunsuke
Formato:	Online Artículo Texto
Lenguaje:	English
Publicado:	John Wiley and Sons Inc. 2019
Materias:	Research
Acceso en línea:	https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6662395/ https://www.ncbi.nlm.nih.gov/pubmed/31016896 http://dx.doi.org/10.1111/cts.12631

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