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- Wiley
More About This Title An Introduction to Statistics in Early PhaseTrials
- English
English
- Conveys key ideas in a concise manner understandable by non-statisticians
- Explains how to optimise designs in a constrained or fixed resource setting
- Discusses decision making criteria at the end of Phase II trials
- Highlights practical day-to-day issues and reporting of early phase trials
An Introduction to Statistics in Early Phase Trials is an essential guide for all researchers working in early phase clinical trial development, from clinical pharmacologists and pharmacokineticists through to clinical investigators and medical statisticians. It is also a valuable reference for teachers and students of pharmaceutical medicine learning about the design and analysis of clinical trials.
- English
English
Say-Beng Tan, Singapore Clinical Research Institute and Duke-NUS Graduate Medical School, Singapore
David Machin, Children's Cancer and Leukaemia Group (CCLG), University of Leicester, UK
- English
English
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
References
Index
- English
English
“An Introduction to Statistics in Early Phase Trials provides concise descriptions of many early phase trial designs, along with the statistical equations necessary to gather and analyze the data” (Annals of Pharmacotherapy, 2010)
"I enjoyed reading the work of Dr. Julious, Tan, and Machin,found it quite useful, and recommend it to others teaching about, working with, or considering work in the learning phase of drug development." (Journal of Biopharmaceutical Statistics, 2011)