An overview of the Statistical Methods used in Passive Pharmacovigilance


After pharmaceutical products are released into the market, a number of statistical methods are used to monitor the adverse effects of these drugs. If a large enough number of incidences are reported to regulatory bodies, appropriate measures are taken. This research project is dealing with the statistical methods used to decide on how many reports is required before a possible adverse event is observed. There are a number of these methods currently being used and the end result of this project will be the creation of a comprehensive review of the methods as well as a software package that implements the algorithms. This will prove to be beneficial to Risk Sciences International (RSI) as this software allows the delivery of value-added professional services (formal analysis of drug safety) to government and commercial clients.


Christopher Gravel
Faculty Supervisor: 
Dr. Patrick Farrel