03245nam 2200637Ia 450 991013950980332120200520144314.01-282-48277-797866124827790-470-68616-20-470-31917-8(CKB)2550000000006555(EBL)480423(OCoLC)593295610(SSID)ssj0000339296(PQKBManifestationID)11274386(PQKBTitleCode)TC0000339296(PQKBWorkID)10324240(PQKB)10422692(MiAaPQ)EBC480423(Au-PeEL)EBL480423(CaPaEBR)ebr10361214(CaONFJC)MIL248277(PPN)22125644X(EXLCZ)99255000000000655520090814d2010 uy 0engur|n|---|||||txtccrAn introduction to statistics in early phase trials[electronic resource] /Steven Julious, Say-Beng Tan, David MachinChichester, West Sussex ;Hoboken, NJ John Wiley20101 online resource (271 p.)Description based upon print version of record.0-470-05985-0 Includes bibliographical references and index.An Introduction to Statistics in Early Phase Trials; 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 therapiesChapter 14 Interpreting and applying early phase trial resultsChapter 15 Go/No-Go criteria; Appendix; References; IndexAll new medicines and devices undergo early phase trials to assess, interpret and better understand their efficacy, tolerability and safety. An Introduction to Statistics in Early Phase Trials describes the practical design and analysis of these important early phase clinical trials and provides the crucial statistical basis for their interpretation. It clearly and concisely provides an overview of the most common types of trials undertaken in early phase clinical research and explains the different methodologies used. The impact of statistical technologies on clinical development and tDrugsTestingStatistical methodsClinical trialsStatistical methodsDrugsTestingStatistical methods.Clinical trialsStatistical methods.610.15195615/.19012Julious Steven A886695Machin David1939-520765Tan Say Beng886696MiAaPQMiAaPQMiAaPQBOOK9910139509803321An introduction to statistics in early phase trials1980094UNINA