Medical Product Safety Evaluation: Biological Models and Statistical Methods

1st Edition

Jie Chen, Joseph Heyse, Tze Leung Lai

Chapman and Hall/CRC
Published September 10, 2018
Reference - 354 Pages - 50 B/W Illustrations
ISBN 9781466508088 - CAT# K14688
Series: Chapman & Hall/CRC Biostatistics Series

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Features

Shows how application of statistical methods will ensure early detection of true safety signals, reducing the rate of false signals and false non-signals, and hence protecting the interest of consumers

Discusses the statistical methods that can best be employed within this framework to accurately, robustly, and flexibly detect safety signals

Summary

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.

 

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