The Use of Pharmacoepidemiology to Study Beneficial Drug Effects

Brian L. Strom, Kenneth L. Melmon

Research output: Chapter in Book/Report/Conference proceedingChapter

6 Scopus citations

Abstract

In order to be approved for marketing in the United States, drugs must be proven to be safe and effective using "adequate and well-controlled investigations." This chapter clarifies the different definitions of various types of beneficial drug effects and discusses the need for postmarketing studies of drug effectiveness. Unique methodologic problems raised by studies of beneficial drug effects, and potential solutions to these problems, are also discussed. Finally, specific examples of approaches to the study of efficacy are presented.

Original languageEnglish (US)
Title of host publicationPharmacoepidemiology, Fifth Edition
PublisherWiley-Blackwell
Pages655-677
Number of pages23
ISBN (Print)0470654759, 9780470654750
DOIs
StatePublished - Jan 3 2012
Externally publishedYes

All Science Journal Classification (ASJC) codes

  • General Medicine
  • Pharmacology, Toxicology and Pharmaceutics(all)

Keywords

  • Beneficial drug effect
  • Confounding by indication
  • Drug effect
  • Effectiveness
  • Efficacy
  • Non-experimental study
  • Observational study
  • Postmarketing study
  • Premarketing study

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