An Introduction to Statistics in Early Phase

* An overview of the most common types of trial undertaken in early clinical development * A simple and concise overview of the different methodologies and the impact of new technologies, clinical and statistical, on clinical development * Describes how information at the end of early phase development can be brought together to facilitate and enhance decisions pertinent to a clinical development programme * The first text that gives an overview of the issues and topics associated with early phase clinical development

Steven A. Julious, Medical Statistics Group, School of Health and Related Research, University of Sheffield, UK

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

Early phase trials	p. 1
Introduction to pharmacokinetics	p. 13
Sample size calculations for cinical trials	p. 37
Crossover trial basics	p. 55
Multi-period crossover trials	p. 71
First time into man	p. 87
Bayesian and frequentist methods	p. 113
First-time-into-new-population studies	p. 125
Bioequivalence studies	p. 139
Other Phase I trials	p. 169
Phase II trials: general issues	p. 187
Dose-response studies	p. 197
Phase II tirals with toxic therapies	p. 211
Interpreting and applying early phase trial results	p. 223
Go/No-Go criteria	p. 231
Appendix	p. 245
Reference	p. 251
Index	p. 257
Table of Contents provided by Ingram. All Rights Reserved.

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An Introduction to Statistics in Early Phase Trials

Summary

Author Biography

Table of Contents

Supplemental Materials