Quantitative Evaluation of Safety in Drug Development

Study Design Incorporating Quantitative Safety Evaluation into Risk Management Jurgen Kubler Bayesian Meta-Experimental 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 Safety Monitoring 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 Jose M. Vega Evaluation/Analysis 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 Risk-Benefit 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 during Preclinical and Early Phases of Drug Development John Sullivan and Hisham Hamadeh Index