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 presents a systematic and unified approach for modern nonparametric treatment of missing and modified data via examples of density and hazard rate estimation, nonparametric regression, filtering signals, and time series analysis. All basic types of missing at random and not at random, biasing, truncation, censoring, and measurement errors are discussed, and their treatment is explained. Ten chapters of the book cover basic cases of direct data, biased data, nondestructive and destructive missing, survival data modified by truncation and censoring, missing survival data, stationary and nonstationary time series and processes, and ill-posed modifications. The coverage is suitable for self-study or a one-semester course for graduate students with a prerequisite of a standard course in introductory probability. Exercises of various levels of difficulty will be helpful for the instructor and self-study. The book is primarily about practically important small samples. It explains when consistent estimation is possible, and why in some cases missing data should be ignored and why others must be considered. If missing or data modification makes consistent estimation impossible, then the author explains what type of action is needed to restore the lost information. The book contains more than a hundred figures with simulated data that explain virtually every setting, claim, and development. The companion R software package allows the reader to verify, reproduce and modify every simulation and used estimators. This makes the material fully transparent and allows one to study it interactively. Sam Efromovich is the Endowed Professor of Mathematical Sciences and the Head of the Actuarial Program at the University of Texas at Dallas. He is well known for his work on the theory and application of nonparametric curve estimation and is the author of Nonparametric Curve Estimation: Methods, Theory, and Applications. Professor Sam Efromovich is a Fellow of the Institute of Mathematical Statistics and the American Statistical Association.

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.