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@article{190387,
        author = {Dr Ankita Jain and Samiya Pawne},
        title = {Advancing Drug Safety and Efficacy: The Synergistic Role of Pharmacokinetics, Pharmacovigilance, and Real-World Data},
        journal = {International Journal of Innovative Research in Technology},
        year = {2026},
        volume = {12},
        number = {8},
        pages = {3391-3400},
        issn = {2349-6002},
        url = {https://ijirt.org/article?manuscript=190387},
        abstract = {Ensuring the safety and efficacy of pharmaceuticals is a fundamental principle of contemporary healthcare. This review examines the interrelated roles of pharmacokinetics (PK), pharmacovigilance (PV), and real-world data (RWD) in enhancing therapeutic outcomes. Pharmacokinetics provides critical insights into the processes of drug absorption, distribution, metabolism, and excretion (ADME), which directly influence dosage regimens and facilitate predictions of individual patient responses. Pharmacovigilance is essential for preserving the safety and efficacy of pharmaceutical products throughout their entire life cycle. As the complexity of drug development increases and the global healthcare market expands rapidly, there is a heightened necessity for robust pharmacovigilance systems. Historically, these systems have focused primarily on post-marketing surveillance, but they have now evolved to encompass proactive risk management and the early detection of adverse events. Concurrently, the emergence of real-world data derived from electronic health records (EHRs), insurance claims, and patient registries offers a significant enhancement to controlled clinical trials. This integration enables a more comprehensive evaluation of drug performance across diverse populations. This article discusses the fundamental principles of pharmacovigilance and pharmacokinetics as well as the various factors that influence them. By analyzing the synergies among these domains, this review underscores how their integration can enhance drug development processes, inform regulatory decision-making, and advance personalized medicine strategies. A coordinated approach that effectively leverages pharmacokinetics, pharmacovigilance, and real-world data is imperative for fostering a safer and more effective therapeutic landscape.},
        keywords = {Pharmacokinetics; Pharmacovigilance; Real-World Data; Drug Safety; Drug Efficacy; Personalized Medicine; Regulatory Science; Adverse Drug Reactions, List of abbreviations, PK- Pharmacokinetics, PV- Pharmacovigilance, RWD- Real World Data, ADME- Absorption, Distribution, Metabolism, and Excretion, EHRs- Electronic Health Records, ADRs- Adverse Drug Reactions, WHO- World Health Organization, US FDA- United States Food and Drug Administration, EMA- European Medicines Agency, CDSCO- Central Drugs Standard Control Organization, RWE- Real World Evidence, AI- Artificial Intelligence, FAERS- FDA Adverse Event Reporting System, EU- European Union, RCTs- Randomized Controlled Trials, DDI- Drug-drug interaction, PROs- Patient Reported Outcomes},
        month = {January},
        }