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Title An introduction to statistics in early phase trials / Steven A. Julious, Say Beng Tan, David Machin.
Imprint Chichester, UK ; Hoboken, NJ : Wiley-Blackwell, 2010.


 Internet  Electronic Book    AVAILABLE
Description 1 online resource (263 pages) : illustrations
Bibliog. Includes bibliographical references and index.
Note Available only to authorized UTEP users.
Print version record.
Subject Drugs -- Testing -- Statistical methods.
Clinical trials -- Statistical methods.
Clinical Trials, Phase I as Topic -- methods.
Biometry -- methods.
Clinical Trials, Phase II as Topic -- methods.
Models, Statistical.
Statistics as Topic -- methods.
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.
Other Author Machin, David, 1939-
Tan, Say Beng.
Other Title Print version: Julious, Steven A. Introduction to statistics in early phase trials. Chichester, UK ; Hoboken, NJ : Wiley-Blackwell, 2010 9780470059852