LEADER 03547nam 2200685 450 001 9910807253803321 005 20200520144314.0 010 $a1-118-76310-6 010 $a1-118-76307-6 010 $a1-118-76309-2 035 $a(CKB)3710000000342202 035 $a(EBL)1926645 035 $a(OCoLC)882620442 035 $a(SSID)ssj0001400923 035 $a(PQKBManifestationID)11800788 035 $a(PQKBTitleCode)TC0001400923 035 $a(PQKBWorkID)11344957 035 $a(PQKB)11119127 035 $a(PQKBManifestationID)16037974 035 $a(PQKB)21316184 035 $a(MiAaPQ)EBC1926645 035 $a(DLC) 2014026252 035 $a(Au-PeEL)EBL1926645 035 $a(CaPaEBR)ebr11012473 035 $a(CaONFJC)MIL708911 035 $a(PPN)192131540 035 $a(EXLCZ)993710000000342202 100 $a20150206h20152015 uy 0 101 0 $aeng 135 $aurcnu|||||||| 181 $ctxt 182 $cc 183 $acr 200 00$aStatistical methods for evaluating safety in medical product development /$feditor, A. Lawrence Gould 210 1$aChichester, England :$cWiley,$d2015. 210 4$dİ2015 215 $a1 online resource (391 p.) 225 1 $aStatistics in Practice 300 $aDescription based upon print version of record. 311 $a1-322-77629-6 311 $a1-119-97966-8 320 $aIncludes bibliographical references and index. 327 $aSafety graphics / A. Lawrence Gould -- QSAR modeling : prediction of biological activity from chemical structure / Andy Liaw and Vladimir Svetnik -- Ethical and practical issues in phase I trials in healthy volunteers / Stephen Senn -- Phase I trials / A. Lawrence Gould -- Summarizing adverse event risk / A. Lawrence Gould -- Statistical analysis of recurrent adverse events / Liqun Diao, Richard J. Cook, and Ker-Ai Lee -- Cardiovascular toxicity, especially QT/QTc prolongation / Arne Ring and Robert Schall -- Hepatic toxicity / Donald C. Trost -- Neurotoxicity / A. Lawrence Gould -- Safety monitoring / Jay Herson -- Sequential testing for safety evaluation / Jie Chen -- Evaluation of post-marketing safety using spontaneous reporting databases / Ismail Ahmed, Bernard Begaud, and Pascale Tubert-Bitter / Pharmacovigilance using observational/longitudinal databases and web-based information / A. Lawrence Gould. 330 $aThis book gives professionals in clinical research valuable information on the challenging issues of the design, execution, and management of clinical trials, and how to resolve these issues effectively. It also provides understanding and practical guidance on the application of contemporary statistical methods to contemporary issues in safety evaluation during medical product development. Each chapter provides sufficient detail to the reader to undertake the design and analysis of experiments at various stages of product development, including comprehensive references to the relevant literature 410 0$aStatistics in practice. 606 $aClinical trials 606 $aClinical trials$vStatistical methods 606 $aDrugs$xTesting 615 0$aClinical trials. 615 0$aClinical trials 615 0$aDrugs$xTesting. 676 $a615.5072/4 702 $aGould$b Lawrence$g(A. Lawrence), 801 0$bMiAaPQ 801 1$bMiAaPQ 801 2$bMiAaPQ 906 $aBOOK 912 $a9910807253803321 996 $aStatistical methods for evaluating safety in medical product development$93983155 997 $aUNINA