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010 a| 2014039471;

020 a| 9781466555457 (hardcover : alk. paper);

020 a| 1466555459 (hardcover : alk. paper);

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245 00 a| Quantitative evaluation of safety in drug developmenth| [electronic resource] :b| design, analysis and reporting /c| edited by Qi Jiang, Amgen Inc, Thousand Oaks, California, USA, H. Amy Xia, Amgen Inc, Thousand Oaks, California, USA.;

260 a| Boca Raton :b| CRC Press, Taylor & Francis Group,c| [2015];

300 a| xv, 349 pages :b| illustrations (some color) ;c| 24 cm.;

490 1 a| Chapman & Hall/CRC biostatistics series;

504 a| Includes bibliographical references and index.;

505 0 a| Incorporating quantitative safety evaluation into risk management / Jüergen Küebler -- Bayesian metaexperimental design for evaluating cardiovascular risk / Joseph G. Ibrahim, Ming-Hui Chen, H. Amy Xia, Thomas Liu and Violeta Hennessey -- Non-inferiority study design and analysis for safety endpoints / /Steven Snapinn and Qi Jiang -- Program safety analysis plan : an implementation guide / Brenda Crowe, H. Amy Xia, Mary Nilsson, Seta Shahin, Wei Wang, and Qi Jiang -- Why a DMC safety report differs from a safety section written at the end of the trial / Mark Schactman and Janet Wittes -- Safety surveillance and signal detection process / Atsuko Shibata and José M. Vega -- Bayesian adaptive trials for drug safety / Jason T. Connor -- Observational safety study design, analysis, and reporting / Hong Qiu, Jesse A. Berlin, and Paul E. Stang -- Emerging role of observational health-care data in pharmacovigilance / Patrick Ryan, David Madigan, and Martijn Schuemie -- Roadmap for causal inference in safety analysis / Jordan C. Brooks, Alan S. Go, Daniel E. Singer, and Mark J. van der Laan -- Safety graphics / Susan P. Duke, Qi Jiang, Liping Huang, Mary Banach, and Max Cherny -- Bayesian network meta-analysis for safety evaluation / Bradley P. Carlin and Hwanhee Hong -- Regulatory issues in meta-analysis of safety data / Aloka G. Chakravarty and Mark Levenson -- Bayesian applications for drug safety evaluation / H. Amy Xia and Karen L. Price -- Benefit-risk assessment approaches / Chunlei Ke, Qi Jiang, and Steven Snapinn -- Detecting safety signals in subgroups / Christy Chuang-Stein, Yoichi Ii, Norisuke Kawai, Osamu Komiyama and Kazuhiko Kuribayashi -- Overview of safety evaluation and quantitative approaches from preclinical and early phases of drug development / John Sullivan and Hisham Hamadeh.;

506 a| Available only to authorized users.;

538 a| Mode of access: World Wide Web;

650 12 a| Drug Evaluation.=| ^A917639;

650 22 a| Bayes Theorem.=| ^A927397;

650 22 a| Biostatisticsx| methods.=| ^A1133962;

650 22 a| Drug Discovery.=| ^A1013013;

650 22 a| Pharmacovigilance.?| UNAUTHORIZED;

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

700 1 a| Jiang, Qic| (Biostatistician)?| UNAUTHORIZED;

700 1 a| Xia, H. Amy.?| UNAUTHORIZED;

830 0 a| Chapman & Hall/CRC biostatistics series.=| ^A707265;

856 40 z| Full text available from Ebook Central - Academic Completeu| https://ebookcentral.proquest.com/lib/eastcarolina/detail.action?docID=1591629;

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999 a| CLICK ON WEB ADDRESSw| ASISc| 1i| 5869656-3001l| MNETm| JMUSICr| Ys| Yt| MNESSBKu| 7/18/2022x| EBOOKz| JERESOURCE;

Quantitative evaluation of safety in drug development design, analysis and reporting / edited by Qi Jiang, Amgen Inc, Thousand Oaks, California, USA, H. Amy Xia, Amgen Inc, Thousand Oaks, California, USA.

Other author	Jiang, Qi (Biostatistician)
Other author	Xia, H. Amy.
Format	Electronic
Publication Info	Boca Raton : CRC Press, Taylor & Francis Group, [2015]
Description	xv, 349 pages : illustrations (some color) ; 24 cm.
Supplemental Content	Full text available from Ebook Central - Academic Complete
Subjects	Drug Evaluation. Bayes Theorem. Biostatistics--methods. Drug Discovery. Pharmacovigilance.

Series	Chapman & Hall/CRC biostatistics series Chapman & Hall/CRC biostatistics series. ^A707265
Contents	Incorporating quantitative safety evaluation into risk management / Jüergen Küebler -- Bayesian metaexperimental design for evaluating cardiovascular risk / Joseph G. Ibrahim, Ming-Hui Chen, H. Amy Xia, Thomas Liu and Violeta Hennessey -- Non-inferiority study design and analysis for safety endpoints / /Steven Snapinn and Qi Jiang -- Program safety analysis plan : an implementation guide / Brenda Crowe, H. Amy Xia, Mary Nilsson, Seta Shahin, Wei Wang, and Qi Jiang -- Why a DMC safety report differs from a safety section written at the end of the trial / Mark Schactman and Janet Wittes -- Safety surveillance and signal detection process / Atsuko Shibata and José M. Vega -- Bayesian adaptive trials for drug safety / Jason T. Connor -- Observational safety study design, analysis, and reporting / Hong Qiu, Jesse A. Berlin, and Paul E. Stang -- Emerging role of observational health-care data in pharmacovigilance / Patrick Ryan, David Madigan, and Martijn Schuemie -- Roadmap for causal inference in safety analysis / Jordan C. Brooks, Alan S. Go, Daniel E. Singer, and Mark J. van der Laan -- Safety graphics / Susan P. Duke, Qi Jiang, Liping Huang, Mary Banach, and Max Cherny -- Bayesian network meta-analysis for safety evaluation / Bradley P. Carlin and Hwanhee Hong -- Regulatory issues in meta-analysis of safety data / Aloka G. Chakravarty and Mark Levenson -- Bayesian applications for drug safety evaluation / H. Amy Xia and Karen L. Price -- Benefit-risk assessment approaches / Chunlei Ke, Qi Jiang, and Steven Snapinn -- Detecting safety signals in subgroups / Christy Chuang-Stein, Yoichi Ii, Norisuke Kawai, Osamu Komiyama and Kazuhiko Kuribayashi -- Overview of safety evaluation and quantitative approaches from preclinical and early phases of drug development / John Sullivan and Hisham Hamadeh.
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	2014039471
ISBN	9781466555457 (hardcover : alk. paper)
ISBN	1466555459 (hardcover : alk. paper)

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Quantitative evaluation of safety in drug development design, analysis and reporting / edited by Qi Jiang, Amgen Inc, Thousand Oaks, California, USA, H. Amy Xia, Amgen Inc, Thousand Oaks, California, USA.

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