عنوان

Quantitative evaluation of safety in drug development :

(Number (ISBN

1466555459 (hardcover : alk. paper)

(Number (ISBN

9781466555457 (hardcover : alk. paper)

Number

b394584

Title Proper

Quantitative evaluation of safety in drug development :

General Material Designation

[Book]

Other Title Information

design, analysis and reporting /

First Statement of Responsibility

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

Specific Material Designation and Extent of Item

xv, 349 pages :

Other Physical Details

illustrations (some color) ;

Dimensions

24 cm.

Series Title

Chapman & Hall/CRC biostatistics series

Text of Note

Includes bibliographical references and index.

Text of Note

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.

Number

Edition

Class number

Book number

Class number

Jiang, Qi, (Biostatistician)

Xia, H. Amy

Date of Transaction

20160325064739.0

Cataloguing Rules (Descriptive Conventions))

rda

Electronic name

[Book]

Y