MedDRA Labeling Groupings to Improve Safety Communication in Product Labels

The granularity and structure of the International Council for Harmonisation’s (ICH) Medical Dictionary for Regulatory Activities (MedDRA) are useful for precise coding of adverse events (AEs) for data analysis. In product labeling for healthcare practitioners, however, the granularity of MedDRA Pre...

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Detalles Bibliográficos
Autores principales: Große-Michaelis, Ilona, Proestel, Scott, Rao, Radhika M., Dillman, Brian S., Bader-Weder, Silvia, Macdonald, Lynn, Gregory, William
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Springer International Publishing 2022
Materias:
Commentary
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9810671/
https://www.ncbi.nlm.nih.gov/pubmed/35939205
http://dx.doi.org/10.1007/s43441-022-00393-1

Internet

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9810671/
https://www.ncbi.nlm.nih.gov/pubmed/35939205
http://dx.doi.org/10.1007/s43441-022-00393-1

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