ABSTRACT

State-of-the-Art Methods for Drug Safety AssessmentResponding to the increased scrutiny of drug safety in recent years, Quantitative Evaluation of Safety in Drug Development: Design, Analysis and Reporting explains design, monitoring, analysis, and reporting issues for both clinical trials and observational studies in biopharmaceutical product deve

chapter 1|10 pages

Incorporating Quantitative Safety Evaluation into Risk Management

ByJürgen Kübler

chapter 2|26 pages

Bayesian Meta-Experimental Design for Evaluating Cardiovascular Risk

ByJoseph G. Ibrahim, Ming-Hui Chen, H. Amy Xia, Thomas Liu, Violeta Hennessey

chapter 3|16 pages

Non-Inferiority Study Design and Analysis for Safety Endpoints

BySteven Snapinn, Qi Jiang

chapter 4|14 pages

Program Safety Analysis Plan: An Implementation Guide

ByBrenda Crowe, H. Amy Xia, Mary Nilsson, Seta Shahin, Wei Wang, Qi Jiang

chapter 5|24 pages

Why a DMC Safety Report Differs from a Safety Section Written at the End of the Trial

ByMark Schactman, Janet Wittes

chapter 6|16 pages

Safety Surveillance and Signal Detection Process

ByAtsuko Shibata, José M. Vega

chapter 7|16 pages

Bayesian Adaptive Trials for Drug Safety

ByJason T. Connor

chapter 8|16 pages

Observational Safety Study Design, Analysis, and Reporting

ByHong Qiu, Jesse A. Berlin, Paul E. Stang

chapter 9|32 pages

Emerging Role of Observational Health-Care Data in Pharmacovigilance

ByPatrick Ryan, David Madigan, Martijn Schuemie

chapter 10|22 pages

Roadmap for Causal Inference in Safety Analysis

ByJordan C. Brooks, Alan S. Go, Daniel E. Singer, Mark J. van der Laan

chapter 11|28 pages

Safety Graphics

BySusan P. Duke, Qi Jiang, Liping Huang, Mary Banach, Max Cherny

chapter 12|14 pages

Bayesian Network Meta-Analysis for Safety Evaluation

ByBradley P. Carlin, Hwanhee Hong

chapter 13|14 pages

Regulatory Issues in Meta-Analysis of Safety Data

ByAloka G. Chakravarty, Mark Levenson

chapter 14|16 pages

Bayesian Applications for Drug Safety Evaluation

ByH. Amy Xia, Karen L. Price

chapter 15|22 pages

Risk-Benefit Assessment Approaches

ByChunlei Ke, Qi Jiang, Steven Snapinn

chapter 16|32 pages

Detecting Safety Signals in Subgroups

ByChristy Chuang-Stein, Yoichi Ii, Norisuke Kawai, Osamu Komiyama, Kazuhiko Kuribayashi