Wiley-VCH - Julious, Steven / Tan, Say-Beng / Machin, David - An Introduction to Statistics in Early Phase Trials

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Ernst & Sohn

Julious, Steven / Tan, Say-Beng / Machin, David An Introduction to Statistics in Early Phase Trials 1. Edition March 2010 93.90 Euro 2010. 264 Pages, Hardcover ISBN 978-0-470-05985-2 - John Wiley & Sons	Sample Chapter
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Short description This 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. It also describes how information at the end of early phase development can be brought together to facilitate and enhance decisions pertinent to a clinical development program. This is an essential resource for both researchers working in early phase trials and students of pharmaceutical medicine. From the 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 References Index

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