MARC Record from marc_columbia

LEADER: 04687cam a2200733 i 4500
001 15818022
005 20220421220730.0
006 m o d
007 cr |||||||||||
008 211009s2022 flu ob 001 0 eng
010 $a 2021038018
035 $a(OCoLC)1310753566
035 $a(OCoLC)on1310753566
035 $a(NNC)15818022
040 $aDLC$beng$erda$cDLC$dTYFRS$dOCLCF$dDLC$dOCLCO
019 $a1273731408$a1280699299
020 $a9780429488801$q(ebook)
020 $a0429488807
020 $z9781138594067$q(hardback)
020 $z9781032191119$q(paperback)
020 $a9780429949999$q(electronic bk. : EPUB)
020 $a0429949995$q(electronic bk. : EPUB)
020 $a9780429950001$q(electronic bk. : PDF)
020 $a0429950004$q(electronic bk. : PDF)
020 $a9780429949982$q(electronic bk. : Mobipocket)
020 $a0429949987$q(electronic bk. : Mobipocket)
037 $a9780429488801$bTaylor & Francis
042 $apcc
050 00 $aRM302.5
072 7 $aMAT$x029000$2bisacsh
072 7 $aMED$x071000$2bisacsh
072 7 $aMED$x090000$2bisacsh
072 7 $aPBT$2bicssc
082 00 $a615.7/04$223/eng/20211027
049 $aZCUA
245 00 $aQuantitative methodologies and process for safety monitoring and ongoing benefit risk evaluation /$cedited by Willaim Wang.
250 $aFirst edition.
264 1 $aBoca Raton :$bCRC Press,$c2022.
300 $a1 online resource.
336 $atext$btxt$2rdacontent
337 $acomputer$bc$2rdamedia
338 $aonline resource$bcr$2rdacarrier
490 1 $aStatistics
504 $aIncludes bibliographical references and index.
505 0 $aThe emergence of aggregate safety assessment across the regulatory landscape -- Aggregate safety assessment planning in clinical development -- Safety signalling and causal evaluation -- Safety monitoring through external committees -- An overview on statistical methodologies for safety monitoring and benefit-risk assessment -- Quantitative methods for blinded safety monitoring -- Bayesian safety methodology -- Likelihood-based methods for safety monitoring -- Meta-analysis for drug safety assessment -- Design consideration for pragmatic trials with insight from cardiovascular outcome trials -- Post-market safety assessment using observational studies and the FDA Sentinel system -- Analysis considerations for real-world evidence and clinical trials related to safety -- Trends and recent progress in benefit-risk assessment planning for medical products and devices -- Estimands in safety and benefit risk evaluation -- Visual analytics for safety and benefit risk evaluation.
520 $a"Quantitative Methodologies and Process for Safety Monitoring and Ongoing Benefit Risk Evaluation provides a comprehensive coverage on safety monitoring methodologies, covering both global trends and regional initiatives. Pharmacovigilance has traditionally focused on the handling of individual adverse event reports however recently there had been a shift towards aggregate analysis to better understand the scope of product risks. Written to be accessible not only to statisticians but also to safety scientists with a quantitative interest, this book aims to bridge the gap in knowledge between medical and statistical fields creating a truly multi-disciplinary approach that is very much needed for 21st century safety evaluation"--$cProvided by publisher.
588 $aDescription based on print version record.
650 0 $aPharmacovigilance$xStatistical methods.
650 0 $aDrugs$xTesting$xStatistical methods.
650 0 $aHealth risk assessment$xStatistical methods.
650 6 $aPharmacovigilance$xMéthodes statistiques.
650 6 $aMédicaments$xEssais cliniques$xMéthodes statistiques.
650 6 $aRisques pour la santé$xÉvaluation$xMéthodes statistiques.
650 7 $aMATHEMATICS / Probability & Statistics / General$2bisacsh
650 7 $aMEDICAL / Pharmacology$2bisacsh
650 7 $aMEDICAL / Biostatistics$2bisacsh
650 7 $aDrugs$xTesting$xStatistical methods.$2fast$0(OCoLC)fst00898954
650 7 $aHealth risk assessment$xStatistical methods.$2fast$0(OCoLC)fst00953266
655 4 $aElectronic books.
700 1 $aWang, William$c(Biometrician),$eeditor.
776 08 $iPrint version:$tQuantitative methodologies and process for safety monitoring and ongoing benefit risk evaluation$bFirst edition.$dBoca Raton : CRC Press, 2022$z9781138594067$w(DLC) 2021038017
830 0 $aStatistics (CRC Press).
856 40 $uhttp://www.columbia.edu/cgi-bin/cul/resolve?clio15818022$zTaylor & Francis eBooks
852 8 $blweb$hEBOOKS