Drug safety assessment in clinical trials /
| Other Authors: | |
|---|---|
| Format: | Book |
| Language: | English |
| Published: |
New York :
Dekker,
[1993]
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| Series: | Statistics, textbooks and monographs ;
v. 138. |
| Subjects: |
Table of Contents:
- Preclinical drug safety evaluation / James T. Mayne
- Adverse drug events in clinical trials / Deborah S. Kirby
- Laboratory testing in clinical trials / Deborah S. Kirby
- Drug Research in the elderly / Piet M. Hooymans and Robert Janknegt
- Drug assessment in critical illness / M.I. Bowden and J.F. Bion
- Laboratory data in multicenter trials: monitoring, adjustment, and summarization / Lawrence K. Oliver and Christy Chuang-Stein
- Genie score: a multivariate assessment of laboratory abnormalities / Gene Sogliero-Gilbert, Lonni Zubkoff-Schulz and Naitee Ting
- Laboratory parameters and drug safety / Norman E. Pitts
- Unified approach to the analysis of safety data in clinical trials / Christy Chuang-Stein and Noel R. Mohberg
- Use of hazard functions in safety analysis / David S. Salsburg
- Meta-analysis of drug safety data / Gary G. Koch ... [et al.]
- Design and analysis considerations for safety data, particularly adverse events / Karl E. Peace
- Clinical trial adverse drug experience reporting requirements in the major countries: one manufacturer's approach / Max W. Talbott and Ellen D. Kelso.
- (cont.) Safety surveillance / Norman E. Pitts
- Postmarketing surveillance: applications and limitations with special reference to the fluoroquinolones / Robert Janknegt and Yechiel A. Hekskter.