LEADER 02460oam 22005652 450 001 9910861081003321 005 20240513010317.0 010 $a1-000-71081-5 010 $a1-000-71003-3 010 $a0-429-27506-4 035 $a(CKB)4100000009930727 035 $a(MiAaPQ)EBC5981919 035 $a(OCoLC)1130379655 035 $a(OCoLC-P)1130379655 035 $a(FlBoTFG)9780429275067 035 $a(MiAaPQ)EBC31202573 035 $a(Au-PeEL)EBL31202573 035 $a(EXLCZ)994100000009930727 100 $a20191123d2018 uy 0 101 0 $aeng 135 $aur||||||||||| 181 $ctxt$2rdacontent 182 $cc$2rdamedia 183 $acr$2rdacarrier 200 10$aStatistics in regulatory science /$fby Shein-Chung Chow 205 $a1st ed. 210 1$aBoca Raton :$cCRC Press,$d[2018] 215 $a1 online resource (553 pages) 225 1 $aChapman and Hall/CRC Biostatistics Series 311 $a0-367-22476-3 320 $aIncludes bibliographical references and index. 327 $aTotality-of-the-evidence -- Hypotheses testing versus confidence interval -- Endpoint selection -- Non-inferiority margin -- Missing data -- Multiplicity -- Sample size -- Reproducible research -- Extrapolation -- Consistency evaluation -- Drug products with multiple components -- Adaptive trial design -- Selection criteria in adaptive dose finding -- Generic drugs and biosimilars -- Precision and personalized medicine -- Big data analytics -- Rare disease drug development. 330 $a"The proposed book will focus on practical issues in pharmaceutical/clinical research and development from both regulatory and scientific perspectives. The book will outline and clarify those issues that have been commonly misused in the subject area of regulatory science"--$cProvided by publisher. 410 0$aChapman & Hall/CRC biostatistics series. 606 $aDrugs$xTesting 606 $aClinical trials$xStatistical methods 606 $aPharmacy$xResearch 606 $aResearch$xStatistical methods 615 0$aDrugs$xTesting. 615 0$aClinical trials$xStatistical methods. 615 0$aPharmacy$xResearch. 615 0$aResearch$xStatistical methods. 676 $a615.19 700 $aChow$b Shein-Chung$f1955-$0254512 801 0$bOCoLC-P 801 1$bOCoLC-P 906 $aBOOK 912 $a9910861081003321 996 $aStatistics in regulatory science$94167033 997 $aUNINA