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Postmarketing Research

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Essentials of Clinical Research

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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.

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Authors and Affiliations

  1. Univesity of Alabama at Birmingham, Birmingham, Alabama, 1717 11th Ave. South MT 638, Birmingham, AL

    Stephen P. Glasser (Professor of Medicine and Epidemiology)

  2. Department of Epidemiology School of Public Health, University of Alabama at Birmingham, Birmingham, AL

    Elizabeth Delzell Ph.D., D.Sc. (Professor of Epidemiology)

  3. Department of Medicine and School of Public Health, University of Alabama at Birmingham, Birmingham, AL

    Maribel Salas MD, D.Sc., M.Sc. (Assistant Professor at the Division of Preventive Medicine and Professor of Pharmacoepidemiology)

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  1. Stephen P. Glasser
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  2. Elizabeth Delzell Ph.D., D.Sc.
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  3. Maribel Salas MD, D.Sc., M.Sc.
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Editors and Affiliations

  1. University of Alabama at Birmingham, AL, USA

    Stephen P. Glasser

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Glasser, S.P., Delzell, E., Salas, M. (2008). Postmarketing Research. In: Glasser, S.P. (eds) Essentials of Clinical Research. Springer, Dordrecht. https://doi.org/10.1007/978-1-4020-8486-7_5

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  • DOI: https://doi.org/10.1007/978-1-4020-8486-7_5

  • Publisher Name: Springer, Dordrecht

  • Print ISBN: 978-1-4020-8485-0

  • Online ISBN: 978-1-4020-8486-7

  • eBook Packages: MedicineMedicine (R0)

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