LEADER 03245nam 2200637Ia 450 001 9910139509803321 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$b[electronic resource] /$fSteven Julious, Say-Beng Tan, David Machin 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$0886695 701 $aMachin$b David$f1939-$0520765 701 $aTan$b Say Beng$0886696 801 0$bMiAaPQ 801 1$bMiAaPQ 801 2$bMiAaPQ 906 $aBOOK 912 $a9910139509803321 996 $aAn introduction to statistics in early phase trials$91980094 997 $aUNINA LEADER 02392oam 2200553Ia 450 001 9910699132903321 005 20230902161552.0 035 $a(CKB)5470000002400569 035 $a(OCoLC)557529683 035 $a(EXLCZ)995470000002400569 100 $a20100317d2009 ua 0 101 0 $aeng 135 $aurcn||||||||| 181 $ctxt$2rdacontent 182 $cc$2rdamedia 183 $acr$2rdacarrier 200 10$aLinkages between TAA, one-stop career center partners, and economic development agencies$b[electronic resource] $ean occasional paper prepared as part of the evaluation of the Trade Adjustment Assistance program /$fKate Dunham 210 1$a[Washington, D.C.] :$c[U.S. Department of Labor, Employment and Training Administration] ;$a[Oakland, CA]:$c[Social Policy Research Associates],$d[2009] 215 $a1 online resource (27 pages) 225 1 $aETA occasional paper ;$v2009-16 300 $a"Final report." 300 $a"July 2009." 300 $aETA series statement supplied from external sources. 300 $aTitle and description from title screen (viewed February 25, 2010). 300 $a"In conjunction with reserach team members from : Social Policy Research Associates and Mathematica Policy Research, Inc." 300 $a"DOL contract no. AK-13690000430." 300 $a"SPR pproject no. 1147." 410 0$aETA occasional paper ;$v2009-16. 517 $aLinkages between TAA, one-stop career center partners, and economic development agencies 606 $aTrade adjustment assistance$zUnited States 606 $aDisplaced workers$xServices for$zUnited States 606 $aForeign trade and employment$zUnited States 606 $aOccupational training$zUnited States 606 $aEconomic development 615 0$aTrade adjustment assistance 615 0$aDisplaced workers$xServices for 615 0$aForeign trade and employment 615 0$aOccupational training 615 0$aEconomic development. 700 $aDunham$b Kate$01405058 712 02$aSocial Policy Research Associates. 712 02$aUnited States.$bEmployment and Training Administration. 801 0$bEU0 801 1$bEU0 801 2$bGPO 906 $aBOOK 912 $a9910699132903321 996 $aLinkages between TAA, one-stop career center partners, and economic development agencies$93493060 997 $aUNINA