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Authoring a periodic adverse drug experience report…here's what you need to know!
Aggregate reporting involves preparation and submission of safety reports for a given medicinal product to worldwide regulatory agencies and constitutes an essential part of safety monitoring of a medicinal product. There are specific aggregate safety reports required for a molecule in development c...
Autores principales: | Kulkarni, Tejashree N., Kulkarni, Niranjan G. |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Wolters Kluwer - Medknow
2019
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6463498/ https://www.ncbi.nlm.nih.gov/pubmed/31008077 http://dx.doi.org/10.4103/picr.PICR_126_18 |
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