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Chapter 8 AI-based pharmacovigilance and drug safety

  • Rishabha Malviya , Shristy Verma , Sonali Sundram und Harshil Shah
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Abstract

Pharmacovigilance (PV), a scientific and applied field, aims to identify, evaluate, understand, and minimize adverse drug-related effects. The chapter provides information about artificial intelligence-based tools for pharmacovigilance, drug safety, and its regulatory aspects. It encompasses the scientific and applied endeavors made to identify, assess, comprehend, and mitigate the adverse consequences of drugs or possible drug-related issues. ADR detection and reporting, technological AE coding, safety individual reporting, severity assessment, and connection to suspected drugs are among the most significant duties in the PV sector. To gather data regarding adverse drug reactions (ADRs) along with adverse drug events (ADEs), process reports according to international clinical standards, obtain drug-drug interactions, estimate drug side effects, indicate clinical trials, and incorporate estimation unpredictability toward diagnostic classification algorithms, artificial intelligence (AI) is being utilized for pharmacovigilance and patient safety. The lack of cross-specialty opportunities for training, privacy issues, data models for health care organizations, and insufficient education and training in nations with middle and low incomes are some of the challenges that have been addressed in the context of pharmacology as well as drug safety.

Abstract

Pharmacovigilance (PV), a scientific and applied field, aims to identify, evaluate, understand, and minimize adverse drug-related effects. The chapter provides information about artificial intelligence-based tools for pharmacovigilance, drug safety, and its regulatory aspects. It encompasses the scientific and applied endeavors made to identify, assess, comprehend, and mitigate the adverse consequences of drugs or possible drug-related issues. ADR detection and reporting, technological AE coding, safety individual reporting, severity assessment, and connection to suspected drugs are among the most significant duties in the PV sector. To gather data regarding adverse drug reactions (ADRs) along with adverse drug events (ADEs), process reports according to international clinical standards, obtain drug-drug interactions, estimate drug side effects, indicate clinical trials, and incorporate estimation unpredictability toward diagnostic classification algorithms, artificial intelligence (AI) is being utilized for pharmacovigilance and patient safety. The lack of cross-specialty opportunities for training, privacy issues, data models for health care organizations, and insufficient education and training in nations with middle and low incomes are some of the challenges that have been addressed in the context of pharmacology as well as drug safety.

Heruntergeladen am 23.12.2025 von https://www.degruyterbrill.com/document/doi/10.1515/9783111574288-008/html
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