Statistical thinking for non-statisticians in drug regulation /
Statistical Thinking for Non-Statisticians in Drug Regulation, Second Edition, is a need-to-know guide to understanding statistical methodology, statistical data and results within drug development and clinical trials.It provides non-statisticians working in the pharmaceutical and medical device ind...
Κύριος συγγραφέας: | |
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Μορφή: | Ηλ. βιβλίο |
Γλώσσα: | English |
Έκδοση: |
Chichester, West Sussex, UK ; Hoboken, New Jersey :
Wiley Blackwell,
2015.
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Έκδοση: | Second edition. |
Θέματα: | |
Διαθέσιμο Online: | Full Text via HEAL-Link |
Πίνακας περιεχομένων:
- Basic ideas in clinical trial design
- Sampling and inferential statistics
- Confidence intervals and p-values
- Tests for simple treatment comparisons
- Adjusting the analysis
- Regression and analysis of covariance
- Intention-to-treat and analysis sets
- Power and sample size
- Statistical significance and clinical importance
- Multiple testing
- Non-parametric and related methods
- Equivalence and non-inferiority
- The analysis of survival data
- Interim analysis and data monitoring committees
- Bayesian statistics
- Adaptive designs
- Observational studies
- Meta-analysis
- Methods for the safety analysis and safety monitoring
- Diagnosis
- The role of statistics and statisticians.