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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...
Autores principales: | Große-Michaelis, Ilona, Proestel, Scott, Rao, Radhika M., Dillman, Brian S., Bader-Weder, Silvia, Macdonald, Lynn, Gregory, William |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Springer International Publishing
2022
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Materias: | |
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 |
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