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" Quantitative evaluation of safety in drug development : "
edited by Qi Jiang, Amgen Inc, Thousand Oaks, California, USA, H. Amy Xia, Amgen Inc, Thousand Oaks, California, USA.
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BL
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| Record Number
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565365
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| Doc. No
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b394584
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| Title & Author
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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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| Series Statement
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Chapman & Hall/CRC biostatistics series
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| Page. NO
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xv, 349 pages :: illustrations (some color) ;; 24 cm.
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| ISBN
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9781466555457 (hardcover : alk. paper)
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: 1466555459 (hardcover : alk. paper)
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| Bibliographies/Indexes
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Includes bibliographical references and index.
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| Contents
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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.
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| Subject
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Drug Evaluation.
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Bayes Theorem.
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Biostatistics-- methods.
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Drug Discovery.
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Pharmacovigilance.
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| Dewey Classification
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615.1072/7
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| LC Classification
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RS57.Q365 2015
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| NLM classification
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QV 771
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| Added Entry
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Jiang, Qi, (Biostatistician)
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Xia, H. Amy
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