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Lessons Learned on Observed-to-Expected Analysis Using Spontaneous Reports During Mass Vaccination

2024 . Gordillo-Marañón, Maria | Candore, Gianmario | Hedenmalm, Karin | Browne, Kate | Flynn, Robert | Piccolo, Loris | Santoro, Aniello | Zaccaria, Cosimo | Kurz, Xavier

The REporting of A Disproportionality Analysis for DrUg Safety Signal Detection Using Individual Case Safety Reports in PharmacoVigilance (READUS-PV): Explanation and Elaboration

Enhanced Safety Surveillance of GSK’s Inactivated Quadrivalent Seasonal Influenza Vaccine in Belgium, Germany, and Spain During the 2022/2023 Influenza Season

2024 . de la Cueva, Ignacio Salamanca | Gerber, Jennifer E. | Hastie, Andrew | Brotons, Carlos | Panzer, Falko | Pirçon, Jean-Yves | Talsma, Paul | Eckermann, Tamara | Nikic, Vanja | Gomez, Xavier Martinez | Alsdurf, Hannah

Examining the Effect of Missing Data and Unmeasured Confounding on External Comparator Studies: Case Studies and Simulations

2024 . Rippin, Gerd | Sanz, Héctor | Hoogendoorn, Wilhelmina E. | Ballarini, Nicolás M. | Largent, Joan A. | Demas, Eleni | Postmus, Douwe | Framke, Theodor | Dávila, Lukas M. Aguirre | Quinten, Chantal | Pignatti, Francesco

Optimal Significance Levels and Sample Sizes for Signal Detection Methods Based on Non-constant Hazards

2024 . Sauzet, Odile | Dyck, Julia | Cornelius, Victoria

Validation of a Novel Method to Assess the Clinical Quality of Information in Pregnancy-Related Pharmacovigilance Case Reports: A ConcePTION Project

2024 . Weetink, Yrea | Egberts, Toine | van Hunsel, Florence | Lewis, David | Yates, Laura Michelle | Winterfeld, Ursula | van Puijenbroek, Eugene

Consensus Guidelines: Best Practices for the Prevention, Detection and Management of Hepatitis B Virus Reactivation in Clinical Trials with Immunosuppressive/Immunomodulatory Therapy

2024 . Cohen, Eric B. | Regev, Arie | Garg, Anju | Di Bisceglie, Adrian M. | Lewis, James H. | Vierling, John M. | Hey-Hadavi, Judith | Steplewski, Klaudia | Fettiplace, Anna | Chen, Chunlin L. | Pehlivanov, Nonko | Kendrick, Stuart | I. Avigan, Mark

Safety and Effectiveness of COVID-19 Vaccines During Pregnancy: A Living Systematic Review and Meta-analysis

Comparative Analysis of Information Provided in German Adverse Drug Reaction Reports Sent by Physicians, Pharmacists and Consumers

2023 . Christ, Patrick | Dubrall, Diana | Schmid, Matthias | Sachs, Bernhardt

Comment on 'Drug–Drug Interaction of the Sodium Glucose Co-Transporter 2 Inhibitors with Statins and Myopathy: A Disproportionality Analysis Using Adverse Events Reporting Data'

2023 . Kuss, Oliver | Rathmann, Wolfgang

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