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Statistical Evaluation of Drug Safety Data
- Source :
- Therapeutic Innovation and Regulatory Science; January 2014, Vol. 48 Issue: 1 p109-120, 12p
- Publication Year :
- 2014
-
Abstract
- There has been growing awareness of the importance of the statistical evaluation of drug safety data both in the premarketing and postmarketing settings. Careful and comprehensive approaches are warranted in safety evaluation. This paper offers a high-level review of some key issues and emerging statistical methodological developments. Specifically, the following topics are discussed: prospective program-level safety planning, evaluation, and reporting; the impact of adverse event grouping on statistical analysis; the applications of Bayesian methods in safety signal detection; meta-analysis for analyzing safety data; and safety graphics. Aspects related to benefit-risk assessments are also covered.
Details
- Language :
- English
- ISSN :
- 21684790 and 21684804
- Volume :
- 48
- Issue :
- 1
- Database :
- Supplemental Index
- Journal :
- Therapeutic Innovation and Regulatory Science
- Publication Type :
- Periodical
- Accession number :
- ejs52304633
- Full Text :
- https://doi.org/10.1177/2168479013510917