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Advances in artificial intelligence for drug safety
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Xu CHEN1, 2, Li-xia FU1, 2, Yi-min CUI1, 2, 3
Chinese Journal of Clinical Pharmacology | 2025, 41(24) : 3567 - 3574
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Chinese Journal of Clinical Pharmacology | 2025, 41(24): 3567-3574
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Advances in artificial intelligence for drug safety
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Xu CHEN1, 2, Li-xia FU1, 2, Yi-min CUI1, 2, 3
Affiliations
  • 1.Institute of Clinical Pharmacology, Peking University First Hospital, Beijing 100034, China
  • 2.Beijing Key Laboratory of Clinical Pharmacology and Translation of Innovative Drugs, Beijing 100191, China
  • 3.Department of Pharmacy Administration and Clinical Pharmacy, School of Pharmaceutical Sciences, Peking University, Beijing 100191, China
Published: 2025-12-28 doi: 10.13699/j.cnki.1001-6821.2025.24.019
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Drug safety spans the full lifecycle of drug research and development, manufacture, distribution and usage, serving as both the cornerstone of public health maintenance and a core issue in regulatory science. Traditional drug safety monitoring models face numerous challenges regarding data processing efficiency, agility in risk identification and comprehensiveness. However, the advancement of artificial intelligence (AI) technologies offers unprecedented opportunities for this field. From a full lifecycle perspective, this paper systematically reviews and analyzes the key technologies and application progress of AI in safety assessment across three stages: preclinical research, clinical trials, and post-marketing pharmacovigilance. Currently, AI technologies, represented by machine learning and natural language processing, have demonstrated significant potential in drug toxicity prediction, the automated identification of adverse events, and real-time safety monitoring. Nevertheless, uneven data quality, insufficient model interpretability, and imperfect regulatory compliance remain the primary bottlenecks hindering the widespread application of AI in the field of drug safety. Future development will focus on the fusion of multi-modal data, the enhancement of model interpretability, and the application of federated learning for privacy protection, with the aim of constructing a more precise and reliable intelligent drug safety monitoring system.

drug safety  /  artificial intelligence  /  drug safety evaluation  /  pharmacovigilance  /  full lifecycle
Xu CHEN, Li-xia FU, Yi-min CUI. Advances in artificial intelligence for drug safety[J]. Chinese Journal of Clinical Pharmacology, 2025 , 41 (24) : 3567 -3574 . DOI: 10.13699/j.cnki.1001-6821.2025.24.019
Year 2025 volume 41 Issue 24
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doi: 10.13699/j.cnki.1001-6821.2025.24.019
  • Receive Date:2025-07-30
  • Online Date:2026-08-05
  • Published:2025-12-28
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  • Received:2025-07-30
Affiliations
    1.Institute of Clinical Pharmacology, Peking University First Hospital, Beijing 100034, China
    2.Beijing Key Laboratory of Clinical Pharmacology and Translation of Innovative Drugs, Beijing 100191, China
    3.Department of Pharmacy Administration and Clinical Pharmacy, School of Pharmaceutical Sciences, Peking University, Beijing 100191, China
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鹅膏菌科Amanitaceae 2 11 5.26 鹅膏菌属 Amanita 10 4.78
小菇科 Mycenaceae 2 12 5.74 丝盖伞属 Inocybe 5 2.39
多孔菌科 Polyporaceae 8 14 6.70 蜡蘑属 Laccaria 5 2.39
红菇科 Russulaceae 3 23 11.00 小皮伞属 Marasmius 6 2.87
小菇属 Mycena 11 5.26
光柄菇属 Pluteus 5 2.39
红菇属 Russula 17 8.13
栓菌属 Trametes 5 2.39
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