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The effect of exposure misclassification in spontaneous ADR reports on the time to detection of product‐specific risks for biologicals: a simulation study |
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| Authors: | Niels S. Vermeer Hans C. Ebbers Sabine M. J. M. Straus Hubert G. M. Leufkens Toine C. G. Egberts Marie L. De Bruin |
| Affiliation: | 1. Utrecht Institute for Pharmaceutical Sciences (UIPS), Division of Pharmacoepidemiology and Clinical Pharmacology, Utrecht University, Utrecht, The Netherlands;2. Medicines Evaluation Board, Utrecht, The Netherlands;3. Medical Informatics, Erasmus Medical Center, Rotterdam, The Netherlands;4. Department of Clinical Pharmacy, University Medical Center Utrecht, Utrecht, The Netherlands |
| Abstract: | |
| Keywords: | spontaneous reports exposure misclassification signal detection disproportionality biological biosimilars pharmacoepidemiology |