Quantitative evaluation of safety in drug development
Subtitle: design, analysis and reporting
By: edited by Qi Jiang, Amgen Inc, Thousand Oaks, California, USA, H. Amy Xia, Amgen Inc, Thousand Oaks, California, USA
Series: Chapman & Hall/CRC biostatistics series; Chapman & Hall/CRC biostatistics series (Unnumbered)
Publisher: CRC Press, Taylor & Francis Group
Published: 2015
Place of publication: Boca Raton
Language: eng
Number of pages: 349
ISBN-13: 9781466555457
Copyright date: 2015
Subjects: Drug Evaluation; Bayes Theorem; Biostatistics; Methods; Drug Discovery; Pharmacovigilance
Notes: Includes bibliographical references and index.
Table of contents: title: Incorporating quantitative safety evaluation into risk management / Jüergen Küebler; title: Bayesian metaexperimental design for evaluating cardiovascular risk / Joseph G. Ibrahim, Ming-Hui Chen, H. Amy Xia, Thomas Liu and Violeta Hennessey; title: Non-inferiority study design and analysis for safety endpoints / /Steven Snapinn and Qi Jiang; title: Program safety analysis plan : an implementation guide / Brenda Crowe, H. Amy Xia, Mary Nilsson, Seta Shahin, Wei Wang, and Qi Jiang; title: Why a DMC safety report differs from a safety section written at the end of the trial / Mark Schactman and Janet Wittes; title: Safety surveillance and signal detection process / Atsuko Shibata and José M. Vega; title: Bayesian adaptive trials for drug safety / Jason T. Connor; title: Observational safety study design, analysis, and reporting / Hong Qiu, Jesse A. Berlin, and Paul E. Stang; title: Emerging role of observational health-care data in pharmacovigilance / Patrick Ryan, David Madigan, and Martijn Schuemie; title: Roadmap for causal inference in safety analysis / Jordan C. Brooks, Alan S. Go, Daniel E. Singer, and Mark J. van der Laan; title: Safety graphics / Susan P. Duke, Qi Jiang, Liping Huang, Mary Banach, and Max Cherny; title: Bayesian network meta-analysis for safety evaluation / Bradley P. Carlin and Hwanhee Hong; title: Regulatory issues in meta-analysis of safety data / Aloka G. Chakravarty and Mark Levenson; title: Bayesian applications for drug safety evaluation / H. Amy Xia and Karen L. Price; title: Benefit-risk assessment approaches / Chunlei Ke, Qi Jiang, and Steven Snapinn; title: Detecting safety signals in subgroups / Christy Chuang-Stein, Yoichi Ii, Norisuke Kawai, Osamu Komiyama and Kazuhiko Kuribayashi; title: Overview of safety evaluation and quantitative approaches from preclinical and early phases of drug development / John Sullivan and Hisham Hamadeh.