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Monitoring the manufacturing and quality of medicines: a fundamental task of pharmacovigilance
The collection and assessment of individual case safety reports (ICSRs) is important to detect unknown adverse drug reactions particularly in the first decade after approval of new chemical entities. However, regulations require that these activities are routinely undertaken for all medicinal produc...
Autores principales: | Sardella, Marco, Belcher, Glyn, Lungu, Calin, Ignoni, Terenzio, Camisa, Manuela, Stenver, Doris Irene, Porcelli, Paolo, D’Antuono, Margherita, Castiglione, Nicola Gian, Adams, Anna, Furlan, Giovanni, Grisoni, Ilaria, Hall, Sarah, Boga, Laura, Mancini, Valentina, Ciuca, Mircea, Chonzi, David, Edwards, Brian, Mangoni, Arduino A, Tuccori, Marco, Prokofyeva, Elena, De Gregorio, Fabio, Bertazzoli Grabinski Broglio, Mario, van Leeuwen, Bert, Kruger, Paola, Rausch, Christian, Le Louet, Hervé |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
SAGE Publications
2021
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8361554/ https://www.ncbi.nlm.nih.gov/pubmed/34394910 http://dx.doi.org/10.1177/20420986211038436 |
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