Development and Application of a Data-Driven Signal Detection Method for Surveillance of Adverse Event Variability Across Manufacturing Lots of Biologics
Author:
Funder
U.S. Food and Drug Administration
Publisher
Springer Science and Business Media LLC
Subject
Pharmacology (medical),Pharmacology,Toxicology
Link
https://link.springer.com/content/pdf/10.1007/s40264-023-01349-6.pdf
Reference28 articles.
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3. Kulldorff M, Dashevsky I, Avery TR, Chan AK, Davis RL, Graham D, et al. Drug safety data mining with a tree-based scan statistic. Pharmacoepidemiol Drug Saf. 2013;22:517–23.
4. Sandberg L, Taavola H, Aoki Y, Chandler R, Norén GN. Risk factor considerations in statistical signal detection: using subgroup disproportionality to uncover risk groups for adverse drug reactions in VigiBase. Drug Saf. 2020;43:999–1009. https://doi.org/10.1007/s40264-020-00957-w.
5. Beninger P. Opportunities for collaboration at the interface of pharmacovigilance and manufacturing. Clin Ther. 2017;39:702–12. https://doi.org/10.1016/j.clinthera.2017.03.010.
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