Pharmacovigilance in Post Marketing Studies Ensuring Long Term Safety Monitoring
Journal: International Journal of Trend in Scientific Research and Development (Vol.8, No. 4)Publication Date: 2024-08-20
Authors : Ziyauddin Sayyed Rachel Wilson J G Naveen Goud Chidireddy Devi Divya;
Page : 995-1001
Keywords : Pharmacovigilance; Post-Marketing Surveillance; Adverse Drug Reactions; Long-Term Safety Monitoring; Electronic Health Records; Active Surveillance; Data Integration; Artificial Intelligence; Big Data Analytics; Drug Safety;
Abstract
Pharmacovigilance in post marketing studies is critical for ensuring the long term safety and efficacy of pharmaceutical products after they have been released to the market. While clinical trials provide initial insights into a drugs safety and effectiveness, post marketing surveillance plays a crucial role in identifying adverse drug reactions ADRs and long term effects that may not become apparent until a drug is used by a broader, more diverse patient population. This abstract explores the importance of pharmacovigilance in post marketing studies, emphasizing the methodologies used to monitor drug safety, including spontaneous reporting systems, electronic health records, and active surveillance programs. It also addresses the challenges faced in this field, such as underreporting of ADRs, data integration issues, and the need for robust regulatory frameworks to manage and respond to safety signals. The role of modern technologies, including artificial intelligence and big data analytics, in enhancing pharmacovigilance efforts is also discussed. By ensuring rigorous and continuous safety monitoring, pharmacovigilance helps to mitigate risks, improve patient outcomes, and contribute to the overall efficacy of public health interventions. The ongoing evolution of pharmacovigilance practices is essential for adapting to new safety challenges and maintaining high standards of drug safety throughout the lifecycle of medicinal products. Ziyauddin Sayyed | Rachel Wilson J | G Naveen Goud | Chidireddy Devi Divya "Pharmacovigilance in Post-Marketing Studies: Ensuring Long-Term Safety Monitoring" Published in International Journal of Trend in Scientific Research and Development (ijtsrd), ISSN: 2456-6470, Volume-8 | Issue-4 , August 2024, URL: https://www.ijtsrd.com/papers/ijtsrd67271.pdf Paper Url: https://www.ijtsrd.com/pharmacy/other/67271/pharmacovigilance-in-postmarketing-studies-ensuring-longterm-safety-monitoring/ziyauddin-sayyed
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