Post-Authorization Safety Studies of Medicinal Products: The PASS Book

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.

Discusses all types of observational studies in post-marketing drug safety assessment, from spontaneous reporting systems, to pragmatic trials, with examples from real-world settingsPresents various types of post-authorization safety studiesOffers solutions to the common challenges in the design and conduct of these studiesHighlights active surveillance programs, including common data models for rapid signal detection of drug safety issues

1. Introduction 2. Risk Management Process 3. Data Sources for PASS 4. Study Designs for PASS 5. Analytical Approaches for PASS 6. Benefit-Risk Evaluation 7. Other PASS 8. EU PAS Register