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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...

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Detalles Bibliográficos
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
Formato: Online Artículo Texto
Lenguaje:English
Publicado: SAGE Publications 2021
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