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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

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

Long-Term Safety of Guselkumab in Patients with Psoriatic Disease: An Integrated Analysis of Eleven Phase II/III Clinical Studies in Psoriasis and Psoriatic Arthritis

2023 . Strober, Bruce | Coates, Laura | Lebwohl, Mark G. | DePrimo, Samuel | Leibowitz, Evan | Rowland, Katelyn | Kollmeier, Alexa | Miller, Megan | Wang, Yanli | Li, Shu | Chakravarty, Soumya | Chan, Daphne | Shawi, May | Yang, Ya-Wen | Tesser, John | Rahman, Proton

Improving Data Collection in Pregnancy Safety Studies: Towards Standardisation of Data Elements in Pregnancy Reports from Public and Private Partners, A Contribution from the ConcePTION Project

Renal Safety of Hydroxyethyl starch 130/0.42 After Cardiac Surgery: A Retrospective Cohort Analysis

2021 . Morath, Benedict | Meid, Andreas D. | Rickmann, Johannes | Soethoff, Jasmin | Verch, Markus | Karck, Matthias | Zaradzki, Marcin