by Steven A. Julious
An Introduction to Statistics in Early Phase Trials describes the practical design and analysis of these important early phase clinical trials and provides the crucial statistical basis for their interpretation. Provides an overview of the most common types of trials undertaken in early phase clinical research and explains the different methodologies used. The impact of statistical technologies on clinical development and the statistical and methodological basis for making clinical and investment decisions are also explained.
Contents
Chapter 1: Early phase trials
Chapter 2: Introduction to pharmacokinetics
Chapter 3: Sample size calculations for clinical trials
Chapter 4: Crossover trial basics
Chapter 5: Multi-period crossover trials
Chapter 6: First time into man
Chapter 7: Bayesian and frequentist methods
Chapter 8: First-time-into-new-population studies
Chapter 9: Bioequivalence studies
Chapter 10: Other Phase I trials
Chapter 11: Phase II trials: general issues
Chapter 12: Dose–response studies
Chapter 13: Phase II trials with toxic therapies
Chapter 14: Interpreting and applying early phase trial results
Chapter 15: Go/No-Go criteria
Appendix
Index
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