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Postmarketing Research

  • Stephen P. Glasser
  • Elizabeth Delzell
  • Maribel Salas

Abstract

In the past, postmarketing research, postmarketing surveillance and pharmacovigilance were synonymous with phase IV studies because the main activities of the regulatory agency (e.g. FDA) were focused on the monitoring of adverse drug events and inspections of drug manufacturing facilities and products. (1) However, the fact that not all FDA mandated (classical phase IV trials) research consists of randomized controlled trials (RCTs), and not all postmarketing activities are limited to safety issues (pharmacovigilance), these terms require clarification. This chapter attempts to clarify the confusing terminology; and, to discuss many of the postmarketing research designs-both their place in clinical research as well as their limitations.

Keywords

Cardiac Rehabilitation Adverse Drug Event Health Outcome Research Conditional Approval Neonatal Abstinence Syndrome 
These keywords were added by machine and not by the authors. This process is experimental and the keywords may be updated as the learning algorithm improves.

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Copyright information

© Springer Science + Business Media B.V 2008

Authors and Affiliations

  • Stephen P. Glasser
    • 1
  • Elizabeth Delzell
    • 2
  • Maribel Salas
    • 3
  1. 1.Univesity of Alabama at Birmingham, Birmingham, AlabamaBirmingham
  2. 2.Department of Epidemiology School of Public HealthUniversity of Alabama at BirminghamBirmingham
  3. 3.Department of Medicine and School of Public HealthUniversity of Alabama at BirminghamBirmingham

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