Main 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.

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