Description
Book SynopsisThis guide offers an overview of the most common types of trial undertaken in early clinical development. The coverage discusses the different methodologies and the impact of new technologies, both clinical and statistical, on clinical development.
Trade Review"An Introduction to Statistics in Early Phase Trials" is an admirably concise and practical guide to the pertinent context, principles and formulae for statisticians inexpert in the application of their discipline to Phase I and II clinical research". (Journal of Clinical Research Best Practices, 1 March 2011)
“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)
Table of ContentsChapter 1 Early phase trials 1
Chapter 2 Introduction to pharmacokinetics 13
Chapter 3 Sample size calculations for clinical trials 37
Chapter 4 Crossover trial basics 55
Chapter 5 Multi-period crossover trials 71
Chapter 6 First time into man 87
Chapter 7 Bayesian and frequentist methods 113
Chapter 8 First-time-into-new-population studies 125
Chapter 9 Bioequivalence studies 139
Chapter 10 Other Phase I trials 169
Chapter 11 Phase II trials: general issues 187
Chapter 12 Dose–response studies 197
Chapter 13 Phase II trials with toxic therapies 211
Chapter 14 Interpreting and applying early phase trial results 223
Chapter 15 Go/No-Go criteria 231
Appendix 245
References 251
Index 257
