Statistical issues in drug development
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| Main Author: | |
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| Corporate Author: | |
| Format: | Electronic eBook |
| Language: | English |
| Published: |
Chichester, England ; Hoboken, NJ :
John Wiley & Sons,
c2007.
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| Edition: | 2nd ed. |
| Series: | Statistics in practice.
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| Subjects: | |
| Online Access: | An electronic book accessible through the World Wide Web; click to view |
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Table of Contents:
- A brief and superficial history of statistics for drug developers
- Design and interpretation of clinical trials as seen by a statistician
- Probability, Bayes, P-values, tests of hypotheses, and confidence intervals
- The work of the pharmaceutical statistician
- Allocating treatments to patients in clinical trials
- Baselines and covariate information
- The measurement of treatment effects
- Demographic subgroups : representation and analysis
- Multiplicity
- Intention to treat, missing data and related matters
- One-sided and two-sided tests and other issues to do with significance and P-values
- Determining the sample size
- Multicentre trials
- Active control equivalence studies
- Meta-analysis
- Cross-over trials
- n-of-1 trials
- Sequential trials
- Dose-finding
- Concerning pharmacokinetics and pharmacodynamics
- Bioequivalence studies
- Safety data, harms, drug monitoring, and pharmaco-epidemiology
- Pharmaco-economics and portfolio management
- Concerning pharmacogenetics, pharmacogenomics, and related matters.