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An introduction to statistics in early phase trials / Steven A. Julious, Say Beng Tan, David Machin.

By: Contributor(s): Publication details: The Atrium, Southern Gate, Chichester, West Sussex, UK ; Hoboken, NJ : Wiley-Blackwell, 2010.Description: 263 p. : ill. ; 26 cmISBN:
  • 9780470059852 (hbk.)
  • 0470059850 (hbk.)
Subject(s): DDC classification:
  • 615.1901 JUL 2010
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.
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Includes bibliographical references and index.

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.