POST-AUTHORIZATION SAFETY STUDIES OF MEDICINAL PRODUCTS. THE PASS BOOK

1. History and Regulatory Aspects of PASS
Introduction
1.1: Development of Post-Authorization Safety Requirements
1.2: Role of PASS in Establishing Early Drug Safety Profiles
2. Risk Management Process
Introduction
2.1: Risk Assessment
2.2: Risk Minimization
3. Pharmacovigilance
Introduction
3.1: Signal Detection
3.2: Signal Clarification
3.3: Signal Evaluation
3.4: Disproportionality Analysis Methods
4. Signal Management
Introduction
4.1: Interventional PASS
4.2: Non-Interventional PASS
5. Data Sources for PASS
Introduction
5.1: Spontaneous Reporting Systems
5.2: Health Insurance Administrative Claims
5.3: Electronic Medical Records
5.4: Registries
5.5: Big Data
5.6: Social Media and Mobile Medical Applications
5.7: Publicly Available Cross-Sectional Data
6. Study Designs for PASS
Introduction
6.1: Disproportionality Analysis and Proactive Safety Surveillance
6.2: Drug Utilization and Cohort Event Monitoring Studies
6.3: Cohort Event Monitoring Studies
6.4: Retrospectice Study Designs
6.4.1: Self-controlled Designs
6.4.2: Cohort Designs
6.5: Prospective Study Designs
6.6: Enriched Study Designs
7. Analytical Approaches for Bias Control in PASS
Introduction
7.1: Exposure Propensity Scores
7.2: Disease Risk Scores
7.3: Instrumental Variables
7.4: Causal Inference
7.5: Data Analytic Platforms
7.6: Multi-Category Exposure Comparisons
8. Proactive Safety Surveillance
Introduction
8.1: Proactive Safety Surveillance Programs
8.2: Proactive Safety Surveillance Methods
9. Benefit-Risk Evaluation
Introduction
9.1: Benefit-Risk Evaluation Frameworks
9.2: Post-Authorization Effectiveness Studies
10. PASS for Biologics and Devices
Introduction
10.1: PASS for Biosimilars and Interchangeable Biologic Products
10.2: PASS for Medical Devices and Combination Products
10.3: PASS for Vaccines
11. Transparency
Introduction
11.1: EU PAS Register
11.2: ClinicalTrials.gov
11.3: CPRD Protocol Summaries
11.4: Pharmaceutical and Biopharmaceutical Companies
12. Resources
13. Abbreviations and Notations
14. Glossary

• 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

Authors
• Ayad K. Ali, BPharmSc, MSPharm, PhD, RPh, MACE, Senior Pharmacoepidemiologist, Global Patient Safety, Eli Lilly and Company, IN, USA.
• Abraham G. Hartzema, PharmD, MSPH, PhD, FISPE, Professor and Eminent Scholar, Department of Pharmaceutical Outcomes and Policy, College of Pharmacy, University of Florida, Gainesville, FL, USA