TY - BOOK AU - Julious,Steven A. AU - Machin,David AU - Tan,Say Beng TI - An introduction to statistics in early phase trials SN - 9780470059852 (hbk.) U1 - 615.1901 PY - 2010/// CY - The Atrium, Southern Gate, Chichester, West Sussex, UK, Hoboken, NJ PB - Wiley-Blackwell KW - Drugs KW - Testing KW - Statistical methods KW - Clinical trials N1 - 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 ER -