LEADER 03692oam 2200601I 450 001 9910829143003321 005 20240402030312.0 010 $a0-429-08795-0 010 $a1-4665-5547-5 024 7 $a10.1201/b17846 035 $a(CKB)2670000000560356 035 $a(EBL)1591629 035 $a(SSID)ssj0001368647 035 $a(PQKBManifestationID)11748229 035 $a(PQKBTitleCode)TC0001368647 035 $a(PQKBWorkID)11463541 035 $a(PQKB)11790974 035 $a(MiAaPQ)EBC1591629 035 $a(OCoLC)899003680 035 $a(EXLCZ)992670000000560356 100 $a20180331h20152015 uy 0 101 0 $aeng 135 $aur|n|---||||| 181 $ctxt 182 $cc 183 $acr 200 00$aQuantitative evaluation of safety in drug development $edesign, analysis and reporting /$fedited by Qi Jiang, Amgen Inc, Thousand Oaks, California, USA; H. Amy Xia, Amgen Inc, Thousand Oaks, California, USA 205 $a1st ed. 210 1$aBoca Raton :$cCRC Press,$d[2015] 210 4$dİ2015 215 $a1 online resource (374 p.) 225 1 $aChapman and Hall/CRC Biostatistics Series 300 $aDescription based upon print version of record. 311 $a1-322-63791-1 311 $a1-4665-5545-9 320 $aIncludes bibliographical references at the end of each chapters. 327 $aFront Cover; Contents; Preface; Editors; Contributors; Chapter 1: Incorporating Quantitative Safety Evaluation into Risk Management; Chapter 2: Bayesian Meta-Experimental Design for Evaluating Cardiovascular Risk; Chapter 3: Non-Inferiority Study Design and Analysis for Safety Endpoints; Chapter 4: Program Safety Analysis Plan: An Implementation Guide; Chapter 5: Why a DMC Safety Report Differs from a Safety Section Written at the End of the Trial; Chapter 6: Safety Surveillance and Signal Detection Process; Chapter 7: Bayesian Adaptive Trials for Drug Safety 327 $aChapter 8: Observational Safety Study Design, Analysis, and ReportingChapter 9: Emerging Role of Observational Health-Care Data in Pharmacovigilance; Chapter 10: Roadmap for Causal Inference in Safety Analysis; Chapter 11: Safety Graphics; Chapter 12: Bayesian Network Meta-Analysis for Safety Evaluation; Chapter 13: Regulatory Issues in Meta-Analysis of Safety Data; Chapter 14: Bayesian Applications for Drug Safety Evaluation; Chapter 15: Risk-Benefit Assessment Approaches; Chapter 16: Detecting Safety Signals in Subgroups 327 $aChapter 17: Overview of Safety Evaluation and Quantitative Approaches during Preclinical and Early Phases of Drug DevelopmentBack Cover 330 $aState-of-the-Art Methods for Drug Safety AssessmentResponding to the increased scrutiny of drug safety in recent years, Quantitative Evaluation of Safety in Drug Development: Design, Analysis and Reporting explains design, monitoring, analysis, and reporting issues for both clinical trials and observational studies in biopharmaceutical product development. It presents the latest statistical methods for drug safety assessment. The book's three sections focus on study design, safety monitoring, and data evaluation/analysis. The book addresses key challenges across regulatory agencies, industry, 410 0$aChapman & Hall/CRC biostatistics series (Unnumbered) 606 $aDrug development 615 0$aDrug development. 676 $a615.1072/7 676 $a615.10727 702 $aJiang$b Qi$c(Biostatistician), 702 $aXi$b H. Amy 801 0$bFlBoTFG 801 1$bFlBoTFG 906 $aBOOK 912 $a9910829143003321 996 $aQuantitative evaluation of safety in drug development$94041334 997 $aUNINA