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Book Cover
Author Julious, Steven A.

Title An introduction to statistics in early phase trials / Steven A. Julious, Say Beng Tan, David Machin
Published Chichester, UK ; Hoboken, NJ : Wiley-Blackwell, 2010
Online access available from:
ProQuest Ebook Central Subscription    View Resource Record  


Description 1 online resource (263 pages) : illustrations
Contents Early phase trials -- Introduction to pharmacokinetics -- Sample size calculations for clinical trials -- Crossover trial basics -- Multi-period crossover trials -- First time into man -- Bayesian and frequentist methods -- First-time-into-new-population studies -- Bioequivalence studies -- Other phase I trials -- Phase II trials : general issues -- Dose-response studies -- Phase II trials with toxic therapies -- Interpreting and applying early phase trial results -- Go/no-go criteria
Summary * 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
Bibliography Includes bibliographical references and index
Notes Print version record
Subject Clinical trials -- Statistical methods.
Drugs -- Testing -- Statistical methods.
Clinical Trials, Phase I as Topic -- methods.
Biometry -- methods.
Clinical Trials, Phase II as Topic -- methods.
Models, Statistical.
Statistics as Topic -- methods.
Form Electronic book
Author Machin, David, 1939-
Tan, Say Beng.
ISBN 0470319178 (electronic bk.)
9780470319178 (electronic bk.)