Role of Pharmacovigilance in Drug Discovery and Post Marketing Surveillance

Pharmacovigilance is a cornerstone of both the pharmaceutical industry and the healthcare system. It is aimed to ensure guaranteed patient safety and is considered an arm of patient care. Pharmacovigilance is essential at many stages of the drug discovery and development process. Drug safety assures that a patients safety and well being are protected throughout the whole drug development lifecycle, including when the drug is easily available on the market. Pharmacovigilance comprises pre and post marketing surveillance. Pre clinical screening, which collects information on ADRs from phases I to III of clinical trials, and post marketing surveillance, which gathers data from the post approval stage and during the course of a drugs shelf life. During clinical trials pharmacovigilance mandates the timely submission of reports on adverse events during clinical trials to regulatory authorities, notification of such events to all investigators and ethics committees, and a safety review by independent Drug Safety Monitoring Boards DSMB . Predicting or evaluating potential ADRs at this early stage of the drug development pipeline is the focus of PV. Finding previously unrecognized adverse effects as well as good effects is the major goal of PMS research by utilizing various pharmacovigilance methodologies. K. Sravanathi Bai | V. Venu "Role of Pharmacovigilance in Drug Discovery & Post-Marketing Surveillance" Published in International Journal of Trend in Scientific Research and Development (ijtsrd), ISSN: 2456-6470, Volume-7 | Issue-3 , June 2023, URL: https://www.ijtsrd.com.com/papers/ijtsrd57400.pdf Paper URL: https://www.ijtsrd.com.com/pharmacy/other/57400/role-of-pharmacovigilance-in-drug-discovery-and-postmarketing-surveillance/k-sravanathi-bai