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Adjusting for both sequential testing and systematic error in safety surveillance using observational data: Empirical calibration and MaxSPRT
Post‐approval safety surveillance of medical products using observational healthcare data can help identify safety issues beyond those found in pre‐approval trials. When testing sequentially as data accrue, maximum sequential probability ratio testing (MaxSPRT) is a common approach to maintaining no...
Autores principales: | Schuemie, Martijn J., Bu, Fan, Nishimura, Akihiko, Suchard, Marc A. |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
John Wiley & Sons, Inc.
2023
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10107810/ https://www.ncbi.nlm.nih.gov/pubmed/36642826 http://dx.doi.org/10.1002/sim.9631 |
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