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Patterns of use and impact of standardised MedDRA query analyses on the safety evaluation and review of new drug and biologics license applications
PURPOSE: Standardised MedDRA Queries (SMQs) have been developed since the early 2000’s and used by academia, industry, public health, and government sectors for detecting safety signals in adverse event safety databases. The purpose of the present study is to characterize how SMQs are used and the i...
| Autores principales: | , , , |
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| Formato: | Online Artículo Texto |
| Lenguaje: | English |
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Public Library of Science
2017
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| Materias: | |
| Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5453490/ https://www.ncbi.nlm.nih.gov/pubmed/28570569 http://dx.doi.org/10.1371/journal.pone.0178104 |