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Xavier Kurz

Explore the profile of Xavier Kurz including associated specialties, affiliations and a list of published articles. Areas
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Articles 72
Citations 974
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Recent Articles
1.
Pajouheshnia R, Gini R, Gutierrez L, Swertz M, Hyde E, Sturkenboom M, et al.
Pharmacoepidemiol Drug Saf . 2024 Aug; 33(8):e5871. PMID: 39145406
Purpose: Metadata for data dIscoverability aNd study rEplicability in obseRVAtional studies (MINERVA), a European Medicines Agency-funded project (EUPAS39322), defined a set of metadata to describe real-world data sources (RWDSs) and...
2.
Gini R, Pajouheshnia R, Gutierrez L, Swertz M, Hyde E, Sturkenboom M, et al.
Pharmacoepidemiol Drug Saf . 2024 Aug; 33(8):e5884. PMID: 39145403
No abstract available.
3.
Gordillo-Maranon M, Candore G, Hedenmalm K, Browne K, Flynn R, Piccolo L, et al.
Drug Saf . 2024 Apr; 47(7):607-615. PMID: 38592665
During the COVID-19 vaccination campaign, observed-to-expected analysis was used by the European Medicines Agency to contextualise data from spontaneous reports to generate real-time evidence on emerging safety concerns that may...
4.
Lo Re Iii V, Cocoros N, Hubbard R, Dutcher S, Newcomb C, Connolly J, et al.
Clin Epidemiol . 2024 Feb; 16:71-89. PMID: 38357585
Purpose: Few studies have examined how the absolute risk of thromboembolism with COVID-19 has evolved over time across different countries. Researchers from the European Medicines Agency, Health Canada, and the...
5.
Hedenmalm K, Quinten C, Kurz X, Bradley M, Lee H, Eworuke E
Eur J Clin Pharmacol . 2023 Apr; 79(6):849-858. PMID: 37095262
Purpose: Regulators are increasingly concerned with  the impact of recalls on drug adherence. In 2018, N-nitrosamines impurities were detected in valsartan containing medical products. Concerned products were immediately recalled in...
6.
Russek M, Quinten C, de Jong V, Cohet C, Kurz X
Pharmacoepidemiol Drug Saf . 2023 Apr; 32(9):1032-1048. PMID: 37068170
Purpose: Heterogeneous results from multi-database studies have been observed, for example, in the context of generating background incidence rates (IRs) for adverse events of special interest for SARS-CoV-2 vaccines. In...
7.
Bakker E, Plueschke K, Jonker C, Kurz X, Starokozhko V, Mol P
Clin Pharmacol Ther . 2022 Oct; 113(1):135-151. PMID: 36254408
Real-world data/evidence (RWD/RWE) may provide insightful information on medicines' clinical effects to guide regulatory decisions. While its contribution has been recognized for safety monitoring and disease epidemiology across medicines' life...
8.
Wang S, Pottegard A, Crown W, Arlett P, Ashcroft D, Benchimol E, et al.
Value Health . 2022 Oct; 25(10):1663-1672. PMID: 36241338
Objectives: Ambiguity in communication of key study parameters limits the utility of real-world evidence (RWE) studies in healthcare decision-making. Clear communication about data provenance, design, analysis, and implementation is needed....
9.
Wang S, Pottegard A, Crown W, Arlett P, Ashcroft D, Benchimol E, et al.
Pharmacoepidemiol Drug Saf . 2022 Oct; 32(1):44-55. PMID: 36215113
Problem: Ambiguity in communication of key study parameters limits the utility of real-world evidence (RWE) studies in healthcare decision-making. Clear communication about data provenance, design, analysis, and implementation is needed....
10.
Jonker C, Bakker E, Kurz X, Plueschke K
Front Pharmacol . 2022 Aug; 13:924648. PMID: 35991868
Between 2000 and 2021, the European Medicines Agency (EMA) assigned the orphan designation to over 1,900 medicines. Due to their small target populations, leading to challenges regarding clinical trial recruitment,...