Medical Product Safety Evaluation by Chen, Jie; Heyse, Joseph; Lai, Tze Leung;

Short description:

Medical Product Safety Evaluation: Biological Models and Statistical Methods presents cutting-edge biological models and statistical methods that are tailored to specific objectives and data types for safety analysis and benefit-risk assessment. Issues and challenges in the design and analysis of safety studies are covered.

Long description:

Medical Product Safety Evaluation: Biological Models and Statistical Methods presents cutting-edge biological models and statistical methods that are tailored to specific objectives and data types for safety analysis and benefit-risk assessment. Some frequently encountered issues and challenges in the design and analysis of safety studies are discussed with illustrative applications and examples.

Medical Product Safety Evaluation: Biological Models and Statistical Methods presents cutting-edge biological models and statistical methods that are tailored to specific objectives and data types for safety analysis and benefit-risk assessment. Some frequently encountered issues and challenges in the design and analysis of safety studies are discussed with illustrative applications and examples.

The book is designed not only for biopharmaceutical professionals, such as statisticians, safety specialists, pharmacovigilance experts, and pharmacoepidemiologists, who can use the book as self-learning materials or in short courses or training programs, but also for graduate students in statistics and biomedical data science for a one-semester course. Each chapter provides supplements and problems as more readings and exercises.

"This book provides comprehensive coverage of the statistical methods for evaluating medical product safety in different stages of development life-cycle: from pre-clinical to clinical, and to post marketing studies. As the evaluation of safety of medical products including drugs, vaccines, devices are becoming increasingly important, more and more novel and complex statistical methods have recently been proposed and used. This book gives a very detailed account of the framework for safety evaluation as well as in-depth descriptions of many advanced statistical methods. As far as I am aware, it is the only book that covers such a broad arrays of topics in safety evaluation. Therefore, this book should be appealing to a very large audience, including graduate students and professional statisticians in industry, government, and academia. I think it can be used as a textbook (as many parts of the materials have been used for short courses or part of graduate degree course) or a reference book for practicing statisticians... Overall, I found the book to be a very important contribution to the scientific community."
~Ivan Chan, AbbVie

Table of Contents:

Introduction. Safety Databases. Safety Analysis Strategy. Summarizing Safety Data. Preclinical Safety. QT Interval Correction and Prolongation. Safety Boundaries. Sequential Sampling and Hypothesis Testing. Reporting Disproportionality. Bayes and Empirical Bayes Methods. Survival Methods. Safety Meta-Analysis. Methods for Observational Studies. Design of Safety Studies. Confounding and bias. Issues and Challenges in Safety Evaluation