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 settings
- Presents various types of post-authorization safety studies
- Offers solutions to the common challenges in the design and conduct of these studies
- Highlights active surveillance programs, including common data models for rapid signal detection of drug safety issues
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1. History and Regulatory Aspects of PASS 2. Risk Management Process 3. Pharmacovigilance 4. Signal Management 5. Data Sources for PASS 6. Study Designs for PASS 7. Analytical Approaches for Bias Control in PASS 8. Proactive Safety Surveillance 9. Benefit-Risk Evaluation 10. PASS for Biologics and Devices 11. Transparency 12. Resources 13. Abbreviations and Notations 14. Glossary
Dr. Ali is a senior pharmacoepidemiologist at Eli Lilly. He is a Fulbright Scholar and has received many awards from professional and educational organizations, including complimentary memberships, travelships, and research and publication grants. He presented many of his research in pharmacovigilance and drug safety in national and international venues, and published in peer-reviewed journals. Additionally, he received memberships by election to the American College of Epidemiology and Sigma Xi the Scientific Research Society. He is a pharmacist by training and combines extensive experience in pharmacy practice in community, industrial, and academic settings, especially in pharmacoepidemiologic research and pharmacovigilance applications.
Hartzema, Abraham G.
Dr. Hartzema is an eminent scholar and professor at College of Pharmacy, University of Florida, he served as the academic advisor to Dr. Ali and has extensive experience in pharmacoepidemiology and drug risk management. He is the editor of several books in the area of pharmacoepidemiology, and published numerous research and expert opinion articles in peer-reviewed journals. He also served as the lead scientist for the active surveillance sentinel initiative by the Food and Drug Administration. He also appears in several editions of Who's Who volumes.