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Mohammad Wasiullah,

Piyush Yadav,

Satish Kumar Yadav,

Rishabh Chauhan,
- Principal, Department of Pharmacy, Prasad Institute Technology, Jaunpur, Uttar Pradesh, India
- Academic Head, Department of Pharmacy, Prasad Institute of Technology,Jaunpur, Uttar Pradesh, India
- Associate Professor, Department of Pharmacy, Prasad Institute of Technology, Jaunpur, Uttar Pradesh, India
- Scholar, Department of Pharmacy, Prasad Institute of Technology, Jaunpur, Uttar Pradesh, India
Abstract
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Artificial intelligence (AI) is revolutionizing pharmacovigilance (PV) by enhancing the detection, assessment, and prevention of adverse drug reactions (ADRs). This review
examines how AI technologies—such as machine learning (ML), natural language processing(NLP), and big data analytics—tackle existing challenges in pharmacovigilance (PV), including issues like underreporting, large data volumes, and inefficiencies in data processing. AI improves drug safety by automating data collection, enabling real-time adverse event detection, and predicting potential risks, allowing for proactive risk management. Despite challenges in data quality, model interpretability, and regulatory compliance, AI’s role in PV is advancing rapidly, promising more efficient and accurate drug safety monitoring. A concise summary of the article, touching on how artificial intelligence (AI) is transforming pharmacovigilance (PV) by enhancing the detection, analysis, and prediction of drug-related adverse events. This review highlights the advancements AI brings to drug safety, such as enhancing efficiency, minimizing human error, and enabling real-time analysis of massive datasets from diverse sources.
Keywords: Artificial Intelligence (AI), Pharmacovigilance (PV), Signal Detection, Predictive Analytics, Natural Language Processing (NLP)
[This article belongs to Research & Reviews : Journal of Computational Biology (rrjocb)]
Mohammad Wasiullah, Piyush Yadav, Satish Kumar Yadav, Rishabh Chauhan. Artificial Intelligence in Pharmacovigilance: Improving Drug Safety. Research & Reviews : Journal of Computational Biology. 2025; 14(01):-.
Mohammad Wasiullah, Piyush Yadav, Satish Kumar Yadav, Rishabh Chauhan. Artificial Intelligence in Pharmacovigilance: Improving Drug Safety. Research & Reviews : Journal of Computational Biology. 2025; 14(01):-. Available from: https://journals.stmjournals.com/rrjocb/article=2025/view=0
References
1. Salas M, Petracek J, Yalamanchili P, Aimer O, Kasthuril D, Dhingra S, Junaid T, Bostic T. The Use of Artificial Intelligence in Pharmacovigilance: A Systematic Review of the Literature. Pharmaceut Med. 2022 Oct;36(5):295-306. doi: 10.1007/s40290-022-00441-z
2. Pilipiec P, Liwicki M, Bota A. Using Machine Learning for Pharmacovigilance: A Systematic Review. Pharmaceutics. 2022 Jan 23;14(2):266. doi: 10.3390/pharmaceutics14020266.
3. Basile AO, Yahi A, Tatonetti NP. Artificial Intelligence for Drug Toxicity and Safety. Trends Pharmacol Sci. 2019 Sep;40(9):624-635. doi: 10.1016/j.tips.2019.07.005
4. Wang X, Hripcsak G, Markatou M, Friedman C. Active computerized pharmacovigilance using natural language processing, statistics, and electronic health records: a feasibility study. J Am Med Inform Assoc. 2009 May-Jun;16(3):328-37. doi: 10.1197/jamia.M3028.
5. Tartarone A, Gallucci G, Lazzari C, Lerose R, Lombardi L, Aieta M. Crizotinib-induced cardiotoxicity: the importance of a proactive monitoring and management. Future Oncology. 2015 Jul 31;11(14):2043-8.
6. Omar NE, Soliman AF, Eshra M, Saeed T, Hamad A, Abou-Ali A. Postmarketing safety of anaplastic lymphoma kinase (ALK) inhibitors: an analysis of the FDA Adverse Event Reporting System (FAERS). ESMO open. 2021 Dec 1;6(6):100315.
7. Chuang CH, Chen HL, Chang HM, Tsai YC, Wu KL, Chen IH, Chen KC, Lee JY, Chang YC, Chen CL, Tu YK. Systematic review and network meta-analysis of anaplastic lymphoma kinase (ALK) inhibitors for treatment-naïve ALK-positive lung cancer. Cancers. 2021 Apr 19;13(8):1966.
8. Rothenstein JM, Letarte N. Managing treatment–related adverse events associated with Alk inhibitors. Current Oncology. 2014 Feb;21(1):19-26.
9. Marques L, Costa B, Pereira M, Silva A, Santos J, Saldanha L, Silva I, Magalhães P, Schmidt S, Vale N. Advancing precision medicine: A review of innovative In Silico approaches for drug development, clinical pharmacology and personalized healthcare. Pharmaceutics. 2024 Feb 27;16(3):332.
10. Zhao Y, Yu Y, Wang H, Li Y, Deng Y, Jiang G, Luo Y. Machine learning in causal inference: Application in pharmacovigilance. Drug Safety. 2022 May;45(5):459-76.Ghosh, A., & Kumar, S. (2022). Artificial Intelligence for Early Detection of Adverse Drug Reactions. Journal of Clinical Pharmacology, 62(1), 103-111.
11. Siddiqui MF, Alam A, Kalmatov R, Mouna A, Villela R, Mitalipova A, Mrad YN, Rahat SA, Magarde BK, Muhammad W, Sherbaevna SR. Leveraging healthcare system with nature-inspired computing techniques: an overview and future perspective. Nature-Inspired Intelligent Computing Techniques in Bioinformatics. 2022 Nov 1:19-42.
12. Bas TG, Duarte V. Biosimilars in the Era of Artificial Intelligence—International Regulations and the Use in Oncological Treatments. Pharmaceuticals. 2024 Jul 10;17(7):925.
13. Houssein EH, Mohamed RE, Ali AA. Machine learning techniques for biomedical natural language processing: a comprehensive review. IEEE Access. 2021 Oct 13;9:140628-53.
14. Shah AA, Gupta A. Nanocarriers: Potential Vehicles for Managed Delivery of Bioactive Compounds in Therapeutics. InMicrobial Bioactive Compounds: Industrial and Agricultural Applications 2023 Dec 30 (pp. 135-160).
15. Méneret A, Garcin B, Frismand S, Lannuzel A, Mariani LL, Roze E. Treatable hyperkinetic movement disorders not to be missed. Frontiers in neurology. 2021 Dec 1;12:659805.
16. Cossu G, Colosimo C. Hyperkinetic movement disorder emergencies. Current neurology and neuroscience reports. 2017 Jan;17(1):6.
17. Edwards MJ, Schrag A. Hyperkinetic psychogenic movement disorders. Handbook of Clinical Neurology. 2011 Jan 1;100:719-29.
18. Berardelli I, Pasquini M, Conte A, Bologna M, Berardelli A, Fabbrini G. Treatment of psychiatric disturbances in common hyperkinetic movement disorders. Expert Review of Neurotherapeutics. 2019 Jan 2;19(1):55-65.
19. Pietracupa S, Bruno E, Cavanna AE, Falla M, Zappia M, Colosimo C. Scales for hyperkinetic disorders: a systematic review. Journal of the Neurological Sciences. 2015 Nov 15;358(1-2):9-21.
20. Kumar M, Nguyen TPN, Kaur J, Singh TG, Soni D, Singh R, Kumar P. Opportunities and challenges in application of artificial intelligence in pharmacology. Pharmacol Rep. 2023 Feb;75(1):3-18. doi: 10.1007/s43440-022-00445-1.
21. Liang L, Hu J, Sun G, Hong N, Wu G, He Y, Li Y, Hao T, Liu L, Gong M. Artificial Intelligence-Based Pharmacovigilance in the Setting of Limited Resources. Drug Saf. 2022 May;45(5):511-519. doi: 10.1007/s40264-022-01170-7.
22. Gholap AD, Uddin MJ, Faiyazuddin M, Omri A, Gowri S, Khalid M. Advances in Artificial Intelligence in Drug Delivery and Development: A Comprehensive Review. Computers in Biology and Medicine. 2024 Jun 7:108702.

Research & Reviews : Journal of Computational Biology
| Volume | 14 |
| Issue | 01 |
| Received | 14/12/2024 |
| Accepted | 07/01/2025 |
| Published | 20/01/2025 |