Signal Analysis in Pharmacovigilance: Principles and Processes

This book provides detailed concepts and information on principles and processes of signal analysis in pharmacovigilance along with case studies. It covers the fundamental concepts and principles of pharmacovigilance, emphasizing the need for robust signal detection and analysis methods. The book reviews the diverse array of databases and tools employed for signal detection, including electronic health records (EHRs), social media mining, claims data, and distributed data networks. In turn, the book discusses the application of molecular dynamics, molecular docking, and the use of the FDA Adverse Event Reporting System (FAERS) database in signal analysis.

Toward the end, the book explores the identification, validation, and assessment of signals associated with vaccines. This book is useful for graduate, post-graduate students of pharmaceutical sciences, and scientists in pharmacology research and drug development.