A BRIEF REVIEW ON SAFETY SIGNAL MANAGEMENT PROCESS
- Global Vigilance Department, Fresenius kabi Oncology Ltd, Gurgaon-122001, Haryana, India.
- Departement of Pharmacovigilance, Fresenius Kabi, Oberursel, Germany.
- Abstract
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- Corresponding Author
The field of pharmacovigilance (or drug safety surveillance) has evolved significantly over the last few years. Important utility of pharmacovigilance is detection and dissemination of signal. It has power to prevent the epidemics of serious adverse drug reaction before damage to community. The historical medical calamities (e.g. thalidomide tragedy) could have been prevented if process like signal detection and pharmacovigilance would have been practiced since that time. Post-marketing detection and surveillance of potential safety hazards are crucial tasks in pharmacovigilance. To disclose such safety risks, a wide set of techniques has been developed for spontaneous reporting data and, more recently, for longitudinal data. This paper gives a broad overview of the signal detection process and introduces some types of data sources mostly used.
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[Pooja Joshi, Rajul Rastogi and Hans J. Gamperl. (2017); A BRIEF REVIEW ON SAFETY SIGNAL MANAGEMENT PROCESS Int. J. of Adv. Res. 5 (Jan). 2487-2492] (ISSN 2320-5407). www.journalijar.com
Global Vigilance Department, Fresenius kabi Oncology Ltd, Gurgaon-122001, Haryana, India
