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Factors Affecting the Timing of Signal Detection of Adverse Drug Reactions

We investigated factors affecting the timing of signal detection by comparing variations in reporting time of known and unknown ADRs after initial drug release in the USA. Data on adverse event reactions (AERs) submitted to U.S. FDA was used. Six ADRs associated with 6 drugs (rosuvastatin, aripipraz...

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Detalles Bibliográficos
Autores principales: Hashiguchi, Masayuki, Imai, Shungo, Uehara, Keiko, Maruyama, Junya, Shimizu, Mikiko, Mochizuki, Mayumi
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Public Library of Science 2015
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4671724/
https://www.ncbi.nlm.nih.gov/pubmed/26641634
http://dx.doi.org/10.1371/journal.pone.0144263