عنوان

Quantitative evaluation of safety in drug development :

1466555459 (hardcover : alk. paper)

9781466555457 (hardcover : alk. paper)

b394584

Quantitative evaluation of safety in drug development :

[Book]

design, analysis and reporting /

edited by Qi Jiang, Amgen Inc, Thousand Oaks, California, USA, H. Amy Xia, Amgen Inc, Thousand Oaks, California, USA.

xv, 349 pages :

illustrations (some color) ;

24 cm.

Chapman & Hall/CRC biostatistics series

Includes bibliographical references and index.

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.

0

Bayes Theorem.

Biostatistics-- methods.

Drug Discovery.

Drug Evaluation.

Pharmacovigilance.

Jiang, Qi, (Biostatistician)

Xia, H. Amy

20160325064739.0

rda

[Book]

Y