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A Structured Methodology to Assess Safety Signal Strength and Inform Causality Assessment

Causality assessment of safety signals observed with medicinal products is a foundational element of pharmacovigilance and regulatory practice, typically performed by a global introspection process. We have developed a novel, structured methodological framework to support the global introspection pr...

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Detalles Bibliográficos
Autores principales:	Sullivan, Tim, Nord, Magnus, Domalik, Doug, Ysander, Magnus, Hermann, Richard P.
Formato:	Online Artículo Texto
Lenguaje:	English
Publicado:	Springer International Publishing 2022
Materias:	Current Opinion
Acceso en línea:	https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9334375/ https://www.ncbi.nlm.nih.gov/pubmed/35781676 http://dx.doi.org/10.1007/s40290-022-00436-w

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