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Important Considerations for Signal Detection and Evaluation

Safety clinicians have a wealth of resources describing how to perform signal detection. Nevertheless, there are some nuances concerning approaches taken by regulatory authorities and statistical considerations that should be appreciated. New approaches, such as the FDA Medical Queries, illustrate t...

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Detalles Bibliográficos
Autores principales: Buchanan, James, Li, Mengchun
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Springer International Publishing 2023
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10276783/
https://www.ncbi.nlm.nih.gov/pubmed/37067682
http://dx.doi.org/10.1007/s43441-023-00518-0