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010 a| 2021038017;

020 a| 9781138594067q| (hardback);

020 a| 9781032191119q| (paperback);

020 z| 9780429488801q| (ebook);

035 a| (WaSeSS)ssj0002537917;

042 a| pcc;

049 a| EREEa| NEHH;

050 00 a| RM302.5b| .Q36 2022;

082 00 a| 615.7/042| 23/eng/20211027;

245 00 a| Quantitative drug safety and benefit-risk evaluationh| [electronic resource] :b| practical and cross-disciplinary approaches /c| edited by Willaim Wang, Melvin Munsaka, James Buchanan and Judy X. Li.;

250 a| First edition.;

260 a| Boca Raton :b| CRC Press/Taylor & Francis Group,c| 2022.;

300 a| xx, 381 pages :b| illustrations ;c| 24 cm;

490 0 a| Statistics;

504 a| Includes bibliographical references and index.;

505 0 a| 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.;

506 a| Available only to authorized users.;

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"--c| Provided by publisher.;

538 a| Mode of access: World Wide Web;

650 0 a| Pharmacovigilancex| Statistical methods.=| ^A1361985;

650 0 a| Drugsx| Testingx| Statistical methods.=| ^A4660;

650 0 a| Health risk assessmentx| Statistical methods.=| ^A166224;

655 0 a| Electronic books.=| ^A491897;

700 1 a| Wang, Williamc| (Biometrician)?| UNAUTHORIZED;

856 40 z| Full text available from Taylor & Francis eBooksu| https://go.openathens.net/redirector/ecu.edu?url=https%3A%2F%2Fwww.taylorfrancis.com%2Fbooks%2F9780429488801;

949 a| CLICK ON WEB ADDRESSw| ASISh| JOYNER188;

949 a| CLICK ON WEB ADDRESSw| ASISh| HSL77;

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596 a| 1 3 4;

998 a| 6682567;

999 a| CLICK ON WEB ADDRESSw| ASISc| 1i| 6682567-1001l| JNETm| JOYNERr| Ys| Yt| JNESSBKu| 12/19/2025x| EBOOKz| JERESOURCE;

999 a| CLICK ON WEB ADDRESSw| ASISc| 1i| 6682567-2001l| HSLELECm| HSLr| Ys| Yt| HEBKu| 12/19/2025x| EBOOKz| HERESOURCE;

999 a| CLICK ON WEB ADDRESSw| ASISc| 1i| 6682567-3001l| MNETm| JMUSICr| Ys| Yt| MNESSBKu| 12/19/2025x| EBOOKz| JERESOURCE;

Quantitative drug safety and benefit-risk evaluation practical and cross-disciplinary approaches / edited by Willaim Wang, Melvin Munsaka, James Buchanan and Judy X. Li.

Other author	Wang, William (Biometrician)
Format	Electronic
Edition	First edition.
Publication Info	Boca Raton : CRC Press/Taylor & Francis Group, 2022.
Description	xx, 381 pages : illustrations ; 24 cm
Supplemental Content	Full text available from Taylor & Francis eBooks
Subjects	Pharmacovigilance--Statistical methods. Drugs--Testing. --Statistical methods. Health risk assessment--Statistical methods.

Series	Statistics
Contents	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.
Abstract	"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"-- Provided by publisher.
Bibliography note	Includes bibliographical references and index.
Access restriction	Available only to authorized users.
Technical details	Mode of access: World Wide Web
Genre/form	Electronic books.
LCCN	2021038017
ISBN	9781138594067 (hardback)
ISBN	9781032191119 (paperback)
ISBN	(ebook)

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Quantitative drug safety and benefit-risk evaluation practical and cross-disciplinary approaches / edited by Willaim Wang, Melvin Munsaka, James Buchanan and Judy X. Li.

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