Bookedited by Ayad K. Ali, Abraham G. Hartzema.
Summary: Post-Authorization Safety Studies of Medicinal Products: The PASS Book bridges the gap in the literature by providing a complete look at post-authorization safety studies and important pharmacoepidemiology and pharmacovigilance aspects. It covers various types and limitations of active surveillance programs, including the use of large databases and disparate data sources for rapid signal detection, as well as novel and advanced design and analysis approaches for causal interference from observational data. This book serves as an important reference for pharmacovigilance scientists and pharmacoepidemiologists who are searching for the appropriate study design to answer safety research questions. Readers will be able to effectively and efficiently design and interpret findings from post-authorization safety studies with the goal of improving the benefit-risk balance of a drug in order to optimize patient safety.
Contents:
Intro
Title page
Table of Contents
Copyright
List of Contributors
Foreword
Chapter 1. Introduction
Risk Management and Benefit-Risk Evaluation
Transparency
About This Book
Chapter 2. Risk Management Process
Chapter 2.1. Risk Assessment
Chapter 2.2. Risk Minimization
Chapter 3. Data Sources for Post-Authorization Safety Studies
Chapter 3.1. Health Insurance Administrative Claims
Chapter 3.2. Electronic Medical Records
Chapter 3.3. Registries
Chapter 3.4. Big Data
Chapter 3.5. Social Media
Chapter 4. Study Designs for Post-Authorization Safety Studies
Chapter 4.1. Drug Utilization and Prescription-Event Monitoring StudiesChapter 4.2. Self-Controlled Studies
Chapter 4.3. Cohort and Nested Case-Control Studies
Chapter 4.4. Enriched Studies
Chapter 4.5. Prospective Studies
Chapter 5. Analytical Approaches for Post-Authorization Safety Studies
Chapter 5.1. Exposure Propensity Scores
Chapter 5.2. Disease Risk Scores
Chapter 5.3. Instrumental Variables
Chapter 5.4. Data Analytic Platforms
Chapter 5.5. Proactive Safety Surveillance
Chapter 6. Benefit-Risk Evaluation
Chapter 6.1. Benefit-Risk Evaluation Frameworks
Chapter 6.2. Post-Authorization Effectiveness StudiesChapter 7. Post-Authorization Safety Studies for Specialty Products
Chapter 7.1. Post-Authorization Safety Studies for Biosimilars and Interchangeable Biologic Products
Chapter 7.2. Post-Authorization Safety Studies for Medical Devices and Combination Products
Chapter 7.3. Post-Authorization Safety Studies for Vaccines
Chapter 8. The European Union Post-Authorization Study Register
Disclaimer/Acknowledgments
Introduction
Index