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" Quantitative evaluation of safety in drug development : "
[edited by] Qi Jiang, H. Amy Xi.
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BL
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| Record Number
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753521
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b573482
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| Main Entry
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[edited by] Qi Jiang, H. Amy Xi.
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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, H. Amy Xi.
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| Publication Statement
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Boca Raton, Florida : Taylor & Francis, 2015
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| Series Statement
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Chapman & Hall/CRC biostatistics series.
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| ISBN
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1466555475
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: 9781466555471
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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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Drugs -- Testing.
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| Subject
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MEDICAL -- Pharmacology.
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| Subject
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Pharmaceutical arithmetic.
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| Added Entry
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H Amy Xia
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Qi Jiang, (Biostatistician)
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