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 language | English (US) |
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Title of host publication | Pharmacoepidemiology, Fifth Edition |
Publisher | Wiley-Blackwell |
Pages | 655-677 |
Number of pages | 23 |
ISBN (Print) | 0470654759, 9780470654750 |
DOIs | |
State | Published - Jan 3 2012 |
Externally published | Yes |
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