New drug development : design, methodology, and analysis /
Main Author: | |
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Format: | Book |
Language: | English |
Published: |
Hoboken, N.J. :
Wiley-Interscience,
[2007]
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Series: | Statistics in practice.
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Subjects: |
Table of Contents:
- New drug development
- The regulatory environment for new drug development
- Drug discovery
- Nonclinical research
- Design and methodology in clinical trials
- Statistical analysis
- Statistical significance : employment of hypothesis testing
- Clinical significance : employment of confidence intervals
- Sample-size estimation
- Safety assessment in clinical trials
- Efficacy assessment in clinical trials
- Pharmaceutical and biopharmaceutical drug manufacturing
- Postmarketing surveillance and evidence-based medicine
- Unifying themes and concluding comments.