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How Often Do Safety Signals Occur by Chance in First‐in‐Human Trials?
Clinicians working on first‐in‐human clinical studies need to be able to judge whether safety signals observed on an investigational drug were more likely to have occurred by chance or to have been caused by the drug. We retrospectively reviewed 84 Novartis studies including 1,234 healthy volunteers...
| Autores principales: | , , , , |
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| Formato: | Online Artículo Texto |
| Lenguaje: | English |
| Publicado: |
John Wiley and Sons Inc.
2018
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| Materias: | |
| Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6132364/ https://www.ncbi.nlm.nih.gov/pubmed/29702733 http://dx.doi.org/10.1111/cts.12558 |