Abstract
This chapter examines how vaccines go through the clinical trials process on their way to gaining approval for use in humans. The regulatory agencies that play a role in overseeing the conduct of clinical trials of vaccines vary in different regions of the world, but the overall goal-to provide evidence that a new vaccine is safe and effective-is the same in every country. This chapter also focuses on good clinical practice (GCP) guidelines that standardize the way in which clinical trials are performed in Australia, Europe, Japan, and the United States.
Original language | English (US) |
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Title of host publication | Vaccinology |
Subtitle of host publication | An Essential Guide |
Publisher | Wiley-Blackwell |
Pages | 260-272 |
Number of pages | 13 |
ISBN (Electronic) | 9781118638033 |
ISBN (Print) | 9780470656167 |
DOIs | |
State | Published - Dec 9 2014 |
Keywords
- Clinical trials
- Good clinical practice
- Human vaccines
- Vaccine safety and efficacy
ASJC Scopus subject areas
- General Medicine