切換：
- 簡略
- 詳細(MARC)
- ISBD
-
Quantitative drug safety and benefit-risk evaluation :practical and cross-disciplinary approaches /
紀錄類型 ： 書目-語言資料,印刷品: 單行本
其他作者 ： Wang, William
出版項 ： Boca Raton, FL :CRC Press,2022.
面頁冊數 ： 1 online resource :illustrations.
內容註 ： The 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.
標題 ： Drugs - Testing - Statistical methods. -
標題 ： Health risk assessment - Statistical methods. -
標題 ： Pharmacovigilance -
標題 ： Risk Assessment - statistics & numerical data -
版本 ： First edition.
ISBN ： 9780429488801
ISBN ： 0429488807
ISBN ： 9780429949999
ISBN ： 0429949995
ISBN ： 9780429950001
ISBN ： 0429950004
ISBN ： 9780429949982
ISBN ： 0429949987
LEADER 03405nam 2200541 i 4500
001 54271
003 DLC
005 20240309140824.1
006 m o d
007 cr |||||||||||
008 211009t20222022flua ob 001 0 eng
010 $a 2021038018
020 $a9780429488801$qelectronic book
020 $a0429488807$qelectronic book
020 $a9780429949999$qelectronic book
020 $a0429949995$qelectronic book
020 $a9780429950001$qelectronic book
020 $a0429950004$qelectronic book
020 $a9780429949982$qelectronic book
020 $a0429949987$qelectronic book
020 $z9781138594067$qhardcover
020 $z9781032191119$qpaperback
035 $aebs2992556
037 $a9780429488801$bTaylor & Francis
040 $aNhCcYBP$cNhCcYBP
041 $aeng
042 $apcc
050 4$aRM302.5$b.Q36 2022
072 7$aMAT$x029000$2bisacsh
072 7$aMED$x071000$2bisacsh
072 7$aMED$x090000$2bisacsh
072 7$aPBT$2bicssc
082 00$a615.7/04$223/eng/20211027
245 00$aQuantitative drug safety and benefit-risk evaluation :$bpractical and cross-disciplinary approaches /$cedited by William Wang, Melvin Munsaka, James Buchanan and Judy X. Li.
250 $aFirst edition.
264 1$aBoca Raton, FL :$bCRC Press,$c2022.
264 4$c�2022
300 $a1 online resource :$billustrations.
336 $atext$btxt$2rdacontent
337 $acomputer$bc$2rdamedia
338 $aonline resource$bcr$2rdacarrier
490 1 $aChapman & Hall/CRC Biostatistics Series
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.
533 $aElectronic reproduction.$bIpswich, MA$nAvailable via World Wide Web.
588 $aDescription based on online resource; title from digital title page (viewed on April 11, 2022).
650 0$aDrugs$xTesting$xStatistical methods.$350230
650 0$aHealth risk assessment$xStatistical methods.$3106750
650 2$aPharmacovigilance$3106751
650 2$aRisk Assessment$xstatistics & numerical data$3106752
700 1 $aWang, William$c(Biometrician),$eeditor.$3106753
710 2 $aEBSCOhost$387894
758 $ihas work:$aQuantitative methodologies and process for safety monitoring and ongoing benefit risk evaluation (Text)$1https://id.oclc.org/worldcat/entity/E39PCFPYRjw4WRxDJY4h67fCkP$4https://id.oclc.org/worldcat/ontology/hasWork
776 08$iPrint version:$tQuantitative methodologies and process for safety monitoring and ongoing benefit risk evaluation$bFirst edition.$dBoca Raton : CRC Press, 2022$z9781138594067$w(DLC) 2021038017
830 0$aChapman & Hall/CRC biostatistics series.$389702
856 40$uhttps://search.ebscohost.com/login.aspx?direct=true&scope=site&db=nlebk&db=nlabk&AN=2992556$zClick to View (限總院院內)
Quantitative drug safety and benefit-risk evaluation :practical and cross-disciplinary approaches /edited by William Wang, Melvin Munsaka, James Buchanan and Judy X. Li. - First edition. - 1 online resource :illustrations. - Chapman & Hall/CRC Biostatistics Series. - Chapman & Hall/CRC biostatistics series..
Includes bibliographical references and index.
The 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.
Electronic reproduction.
Ipswich, MA
Available via World Wide Web.
ISBN: 9780429488801
Source: 9780429488801Taylor & Francis
LCCN: 2021038018Subjects--Topical Terms:
50230
Drugs
--Testing
LC Class. No.: RM302.5 / .Q36 2022
Dewey Class. No.: 615.7/04
Includes bibliographical references and index.
The 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.
Electronic reproduction.
Ipswich, MA
Available via World Wide Web.
ISBN: 9780429488801
Source: 9780429488801Taylor & Francis
LCCN: 2021038018Subjects--Topical Terms:
50230
Drugs
--Testing
LC Class. No.: RM302.5 / .Q36 2022
Dewey Class. No.: 615.7/04
- 館藏(0)
- 心得(0)
- 標籤
- 相同喜好的讀者(0)
- 相關資料(0)
發表心得