Monitoring product safety in the postmarketing environment.

ABSTRACT: The safety profile of a medicinal product may change in the postmarketing environment. Safety issues not identified in clinical development may be seen and need to be evaluated. Methods of evaluating spontaneous adverse experience reports and identifying new safety risks include a review of individual reports, a review of a frequency distribution of a list of the adverse experiences, the development and analysis of a case series, and various ways of examining the database for signals of disproportionality, which may suggest a possible association. Regulatory agencies monitor product safety through a variety of mechanisms including signal detection of the adverse experience safety reports in databases and by requiring and monitoring risk management plans, periodic safety update reports and

SUBMITTER: Sharrar RG 

PROVIDER: S-EPMC4125313 | biostudies-literature | 2013 Oct

REPOSITORIES: biostudies-literature