LEADER 03073nam 2200613 450 001 9910818219503321 005 20230807212122.0 010 $a1-118-47097-4 010 $a1-118-47099-0 010 $a1-118-47096-6 035 $a(CKB)3710000000252413 035 $a(EBL)1824197 035 $a(SSID)ssj0001348618 035 $a(PQKBManifestationID)11788662 035 $a(PQKBTitleCode)TC0001348618 035 $a(PQKBWorkID)11371813 035 $a(PQKB)11244241 035 $a(MiAaPQ)EBC1824197 035 $a(DLC) 2014021547 035 $a(Au-PeEL)EBL1824197 035 $a(CaPaEBR)ebr10960597 035 $a(CaONFJC)MIL654224 035 $a(OCoLC)906188339 035 $a(EXLCZ)993710000000252413 100 $a20141106h20152015 uy 0 101 0 $aeng 135 $aur|n|---||||| 181 $ctxt 182 $cc 183 $acr 200 10$aStatistical thinking for non-statisticians in drug regulation /$fRichard Kay 205 $aSecond edition. 210 1$aChichester, England :$cWiley Blackwell,$d2015. 210 4$dİ2015 215 $a1 online resource (370 p.) 300 $aDescription based upon print version of record. 311 $a1-322-22944-9 311 $a1-118-47094-X 320 $aIncludes bibliographical references and index. 327 $aBasic ideas in clinical trial design -- Sampling and inferential statistics -- Confidence intervals and p-values -- Tests for simple treatment comparisons -- Adjusting the analysis -- Regression and analysis of covariance -- Intention-to-treat and analysis sets -- Power and sample size -- Statistical significance and clinical importance -- Multiple testing -- Non-parametric and related methods -- Equivalence and non-inferiority -- The analysis of survival data -- Interim analysis and data monitoring committees -- Bayesian statistics -- Adaptive designs -- Observational studies -- Meta-analysis -- Methods for the safety analysis and safety monitoring -- Diagnosis -- The role of statistics and statisticians. 330 $a Statistical Thinking for Non-Statisticians in Drug Regulation, Second Edition, is a need-to-know guide to understanding statistical methodology, statistical data and results within drug development and clinical trials.It provides non-statisticians working in the pharmaceutical and medical device industries with an accessible introduction to the knowledge they need when working with statistical information and communicating with statisticians. It covers the statistical aspects of design, conduct, analysis and presentation of data from clinical trials in drug regulation and improves the ability 606 $aDrugs$xTesting 606 $aDrugs$xDesign 615 0$aDrugs$xTesting. 615 0$aDrugs$xDesign. 676 $a615.5/80724 700 $aKay$b R$g(Richard),$f1949-$0845734 801 0$bMiAaPQ 801 1$bMiAaPQ 801 2$bMiAaPQ 906 $aBOOK 912 $a9910818219503321 996 $aStatistical thinking for non-statisticians in drug regulation$91888026 997 $aUNINA