LEADER 03244nam 2200649Ia 450 001 9910816269003321 005 20200520144314.0 010 $a1-282-48277-7 010 $a9786612482779 010 $a0-470-68616-2 010 $a0-470-31917-8 035 $a(CKB)2550000000006555 035 $a(EBL)480423 035 $a(OCoLC)593295610 035 $a(SSID)ssj0000339296 035 $a(PQKBManifestationID)11274386 035 $a(PQKBTitleCode)TC0000339296 035 $a(PQKBWorkID)10324240 035 $a(PQKB)10422692 035 $a(MiAaPQ)EBC480423 035 $a(Au-PeEL)EBL480423 035 $a(CaPaEBR)ebr10361214 035 $a(CaONFJC)MIL248277 035 $a(PPN)22125644X 035 $a(EXLCZ)992550000000006555 100 $a20090814d2010 uy 0 101 0 $aeng 135 $aur|n|---||||| 181 $ctxt 182 $cc 183 $acr 200 13$aAn introduction to statistics in early phase trials /$fSteven Julious, Say-Beng Tan, David Machin 205 $a1st ed. 210 $aChichester, West Sussex ;$aHoboken, NJ $cJohn Wiley$d2010 215 $a1 online resource (271 p.) 300 $aDescription based upon print version of record. 311 $a0-470-05985-0 320 $aIncludes bibliographical references and index. 327 $aAn 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 therapies 327 $aChapter 14 Interpreting and applying early phase trial resultsChapter 15 Go/No-Go criteria; Appendix; References; Index 330 $aAll 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 t 606 $aDrugs$xTesting$xStatistical methods 606 $aClinical trials$xStatistical methods 615 0$aDrugs$xTesting$xStatistical methods. 615 0$aClinical trials$xStatistical methods. 676 $a610.15195 676 $a615/.19012 700 $aJulious$b Steven A$01677321 701 $aMachin$b David$f1939-$0520765 701 $aTan$b Say Beng$01677322 801 0$bMiAaPQ 801 1$bMiAaPQ 801 2$bMiAaPQ 906 $aBOOK 912 $a9910816269003321 996 $aAn introduction to statistics in early phase trials$94044115 997 $aUNINA