A Pilot, Predictive Surveillance Model in Pharmacovigilance Using Machine Learning Approaches
Author:
Publisher
Springer Science and Business Media LLC
Link
https://link.springer.com/content/pdf/10.1007/s12325-024-02870-5.pdf
Reference19 articles.
1. World Health Organization. What is pharmacovigilance? https://www.who.int/teams/regulation-prequalification/regulation-and-safety/pharmacovigilance. Accessed 8 Mar 2024.
2. European Medicines Agency. Signal management. https://www.ema.europa.eu/en/human-regulatory/post-authorisation/pharmacovigilance/signal-management. Accessed 8 Mar 2024.
3. European Medicines Agency and Heads of Medicines Agencies. EMA/827661/2011 Rev1*. Guideline on good pharmacovigilance practices (GVP) Module IX—Signal management (Rev 1). 2017.
4. Gosselt HR, Bazelmans EA, Lieber T, van Hunsel FPAM, Härmark L. Development of a multivariate prediction model to identify individual case safety reports which require clinical review. Pharmacoepidemiol Drug Saf. 2022;31(12):1300–7. https://doi.org/10.1002/pds.5553.
5. Bae JH, Baek YH, Lee JE, Song I, Lee JH, Shin JY. Machine Learning for Detection of Safety Signals From Spontaneous Reporting System Data: Example of Nivolumab and Docetaxel. Frontiers in Pharmacology. 2021;11(602365). doi:https://doi.org/10.3389/fphar.2020.602365.
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