A Review on Post Approval Drug Safety Surveilliance
Prof. Shital G. Dhanmane
, Ms.Pallavi. D.Hudekar , Ms.Mayuri.V.Chavan , Ms.Madhuri.D. Morey , Ms.NIkita .S. Lavhale
Key Words: Drug Safety, Adverse Drug Reaction, Post-Marketing Surveillance, Spontaneous Reporting.
A Review on Post Approval Drug Safety Surveilliance
Dhanmane S. G*, Hudekar P. D, Chavan M.V, Morey M. D, Lavhale N.S.
shital27489@gmail.com, pallavihudekar97@gmail.com, mayurichavan270@gmail.com
moreymadhuri832@gmail.com, nikitalavhale1785@gmail.com
Abstract
Drug safety surveillance following the drug-approval process, concerns remain regarding the safety of new drugs that are introduced into the marketplace. In the case of rare adverse events, the number of subjects that are treated in randomized controlled trials is invariably inadequate to determine the safety of the new pharmaceutical. Identifying safety signals for new and/or existing drugs is a major priority in the protection of public health. Unfortunately, design, analysis, and available data are often quite limited for detecting in a timely fashion any potentially harmful effects of drugs. In this review, we examine a variety of approaches for determining the possibility of adverse drug reactions. Our review includes spontaneous reports, meta-analysis of randomized controlled clinical trials, ecological studies, and analysis of medical claims data. We consider both experimental design and analytic problems as well as potential solutions. Many of these methodologies are then illustrated. This guide proposes the development of a national post-marketing surveillance program that consists of a series of medicines quality sampling and testing activities each with an objective dictated by a country’s specific needs. Each sampling and testing activity is established with its own yearly plan developed in consultation with relevant stakeholders. Post-marketing surveillance and the associated sampling and testing activities should be coordinated and owned by the NRA and designed to address predefined objectives. The national post-marketing surveillance program should be reviewed, updated, and revised yearly.
"A Review on Post Approval Drug Safety Surveilliance", IJNRD - INTERNATIONAL JOURNAL OF NOVEL RESEARCH AND DEVELOPMENT (www.IJNRD.org), ISSN:2456-4184, Vol.7, Issue 7, page no.582-606, July-2022, Available :https://ijnrd.org/papers/IJNRD2207072.pdf
Volume 7
Issue 7,
July-2022
Pages : 582-606
Paper Reg. ID: IJNRD_181970
Published Paper Id: IJNRD2207072
Downloads: 000118787
Research Area: Pharmacy
Country: Buldana, Maharashtra, India
ISSN: 2456-4184 | IMPACT FACTOR: 8.76 Calculated By Google Scholar | ESTD YEAR: 2016
An International Scholarly Open Access Journal, Peer-Reviewed, Refereed Journal Impact Factor 8.76 Calculate by Google Scholar and Semantic Scholar | AI-Powered Research Tool, Multidisciplinary, Monthly, Multilanguage Journal Indexing in All Major Database & Metadata, Citation Generator
Publisher: IJNRD (IJ Publication) Janvi Wave
