Výsledky vyhledávání - "Carla J. Jonker"

Akademický článek

Contribution of patient registries to regulatory decision making on rare diseases medicinal products in Europe

Autor: Carla J. Jonker, Elisabeth Bakker, Xavier Kurz, Kelly Plueschke

Publikováno v: Frontiers in Pharmacology, Vol 13 (2022)

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, study design and little knowledge o

Externí odkaz: https://doaj.org/article/c8802a5bb27f4f60947bf5660b93552c

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Contribution of Real-World Evidence in European Medicines Agency's Regulatory Decision Making

Autor: Elisabeth Bakker, Kelly Plueschke, Carla J. Jonker, Xavier Kurz, Viktoriia Starokozhko, Peter G. M. Mol

Publikováno v: Clinical Pharmacology & Therapeutics, 113(1), 135-151. Nature Publishing Group

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 cycle

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::9d12ce57148839066800fb07819fe443
https://doi.org/10.1002/cpt.2766

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Capturing Data in Rare Disease Registries to Support Regulatory Decision Making: A Survey Study Among Industry and Other Stakeholders

Autor: Patricia McGettigan, Sieta T. de Vries, Carla J. Jonker, Peter G. M. Mol, Arno W. Hoes, H. Marijke van den Berg

Publikováno v: Drug Safety. ADIS INT LTD
Drug Safety

Introduction In rare diseases, registry-based studies can be used to provide natural history data pre-approval and complement drug efficacy and/or safety knowledge post-approval. Objective The objective of this study was to investigate the opinion of

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::0c41e2e660712cce8e385c2113960c4f
https://doi.org/10.1007/s40264-021-01081-z

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Inhibitor development in previously untreated patients with severe haemophilia: A comparison of included patients and outcomes between a clinical study and a registry‐based study

Autor: H. Marijke van den Berg, Peter G. M. Mol, Arno W. Hoes, Carla J. Jonker, Katrien Oude Rengerink

Publikováno v: Haemophilia
Haemophilia, 26(5), 809-816. Wiley

Aim The aim of this study was to investigate whether a disease registry could serve as a suitable alternative to clinical studies to investigate safety of orphan drugs in children. Methods We used individual patient data from previously untreated pat

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::79e64a1ea19bfbc09b81e736685858fc
https://doi.org/10.1111/hae.14100

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Drug Registries and Approval of Drugs

Autor: Marcel S.G. Kwa, Peter G. M. Mol, Arno W. Hoes, Carla J. Jonker, H. Marijke van den Berg

Publikováno v: Clinical Therapeutics, 40(5), 768-773. Elsevier
Clinical Therapeutics, 40(5), 768. Excerpta Medica

Purpose As part of the approval process, regulatory authorities often require postauthorization studies that involve patient registries; it is unknown, however, whether such registry studies are adequately completed. We investigated whether registry

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::13cd909aa67b55052250635c9415f949
https://doi.org/10.1016/j.clinthera.2018.04.005

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Registries supporting new drug applications

Autor: Peter G. M. Mol, Arno W. Hoes, Marcel S.G. Kwa, Carla J. Jonker, H. Marijke van den Berg

Publikováno v: Pharmacoepidemiology and Drug Safety
Pharmacoepidemiology and Drug Safety, 26(12), 1451. John Wiley and Sons Ltd
Pharmcoepidemiology and Drug Safety, 26(12), 1451-1457. Wiley

Purpose: Knowledge of the benefits and risks of new drugs is incomplete at the time of marketing approval. Registries offer the possibility for additional, post-approval, data collection. For all new drugs, which were approved in the European Union b

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::5091c5ef203ab1b98a76944056807318
http://europepmc.org/articles/PMC5725674

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Additional Efficacy of Milligram-Equivalent Doses of Atorvastatin over Simvastatin

Autor: Mieke D. Trip, Carla J. Jonker, Charles Janus, John J.P. Kastelein, A. C. Bredero, P. J. Lansberg, Dick C. Basart, Marjel van Dam, Martin H. Prins, Hans A. Werner, Rolf Zwertbroek, Han A. M. Spierenburg

Publikováno v: Clinical Drug Investigation. 19:327-334

Objectives: This single-blind, multicentre study in a large cohort of hypercholesterolaemic patients with or without coronary heart disease (CHD) was designed to evaluate the additional low density lipoprotein cholesterol (LDL-C)— lowering effect o

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_________::a880b3b39160a431bf59930f8a012b48
https://doi.org/10.2165/00044011-200019050-00002

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