Gardarsdottir HR - Search Results

1

Favourable long-term outcome after coronary artery bypass grafting in a nationwide cohort.

Johannesdottir H, Arnadottir LO, Adalsteinsson JA, Axelsson TA, Sigurdsson MI, Helgadottir S, Helgason D, Gardarsdottir HR, Marteinsson SA, Geirsson A, Thorgeirsson G, Gudbjartsson T. Johannesdottir H, et al. Among authors: gardarsdottir hr. Scand Cardiovasc J. 2017 Dec;51(6):327-333. doi: 10.1080/14017431.2017.1364418. Epub 2017 Aug 13. Scand Cardiovasc J. 2017. PMID: 28805102 Free article.

2

Duration of Effectiveness Evaluation of Additional Risk Minimisation Measures for Centrally Authorised Medicinal Products in the EU Between 2012 and 2021.

Essink SCM, Zomerdijk IM, Straus SMJM, Gardarsdottir H, De Bruin ML. Essink SCM, et al. Drug Saf. 2023 Oct;46(10):1007-1020. doi: 10.1007/s40264-023-01341-0. Epub 2023 Sep 2. Drug Saf. 2023. PMID: 37658281 Free PMC article.

3

Impact of 2018 EU Risk Minimisation Measures and Revised Pregnancy Prevention Programme on Utilisation and Prescribing Trends of Medicinal Products Containing Valproate: An Interrupted Time Series Study.

Abtahi S, Pajouheshnia R, Durán CE, Riera-Arnau J, Gamba M, Alsina E, Hoxhaj V, Andersen M, Bartolini C, Kristiansen SB, Brown J, Hallgreen CE, Garcia-Poza P, Gardarsdottir H, Gini R, Girardi A, Holthuis E, Huerta C, Ibánez L, Limoncella G, Martín-Pérez M, Paoletti O, Roberto G, Souverein P, Swart KMA, Wing K, Sturkenboom M, Klungel O. Abtahi S, et al. Drug Saf. 2023 Jul;46(7):689-702. doi: 10.1007/s40264-023-01314-3. Epub 2023 Jun 9. Drug Saf. 2023. PMID: 37294532 Free PMC article.

4

The role of Real-World Data and evidence in oncology medicines approved in EU in 2018-2019.

Eskola SM, Leufkens HGM, Bate A, De Bruin ML, Gardarsdottir H. Eskola SM, et al. J Cancer Policy. 2023 Jun;36:100424. doi: 10.1016/j.jcpo.2023.100424. Epub 2023 Apr 26. J Cancer Policy. 2023. PMID: 37116794 Free article.

5

Post-approval quality-related regulatory actions for biopharmaceuticals approved in the European Union and the United States between 1995 and 2019.

Alsamil AM, Gardarsdottir H, Leufkens HG, Egberts TC, Giezen TJ. Alsamil AM, et al. Drug Discov Today. 2023 Oct;28(10):103725. doi: 10.1016/j.drudis.2023.103725. Epub 2023 Jul 23. Drug Discov Today. 2023. PMID: 37487844 Free article.

6

Direct-to-participant investigational medicinal product supply in clinical trials in Europe: Exploring the experiences of sponsors, site staff and couriers.

de Jong AJ, Santa-Ana-Tellez Y, Zuidgeest MGP, Grupstra RJ, Jami F, de Boer A, Gardarsdottir H; Trials@Home Consortium. de Jong AJ, et al. Br J Clin Pharmacol. 2023 Dec;89(12):3512-3522. doi: 10.1111/bcp.15850. Epub 2023 Jul 29. Br J Clin Pharmacol. 2023. PMID: 37438875 Free article.

7

Unintended impact of pharmacovigilance regulatory interventions: A systematic review.

Lasys T, Santa-Ana-Tellez Y, Siiskonen SJ, Groenwold RHH, Gardarsdottir H. Lasys T, et al. Br J Clin Pharmacol. 2023 Dec;89(12):3491-3502. doi: 10.1111/bcp.15874. Epub 2023 Aug 28. Br J Clin Pharmacol. 2023. PMID: 37553757 Free article. Review.

8

Recommendations on TNFα inhibitor biosimilar use in clinical practice: a comparison of European gastroenterology IBD guidance.

Meijboom RW, Barbier L, Druedahl LC, Sarnola K, Tolonen HM, Gardarsdottir H, Egberts TCG, Giezen TJ. Meijboom RW, et al. Expert Opin Biol Ther. 2023 Jul-Dec;23(8):801-817. doi: 10.1080/14712598.2023.2189008. Epub 2023 Mar 23. Expert Opin Biol Ther. 2023. PMID: 36947408 Free article.

9

Decentralised, patient-centric, site-less, virtual, and digital clinical trials? From confusion to consensus.

Santa-Ana-Tellez Y, Lagerwaard B, de Jong AJ, Gardarsdottir H, Grobbee DE, Hawkins K, Heath M, Zuidgeest MGP; Trials@Home Consortium. Santa-Ana-Tellez Y, et al. Drug Discov Today. 2023 Apr;28(4):103520. doi: 10.1016/j.drudis.2023.103520. Epub 2023 Feb 6. Drug Discov Today. 2023. PMID: 36754144 Free article. Review.

10

Review of Studies Evaluating Effectiveness of Risk Minimization Measures Assessed by the European Medicines Agency Between 2016 and 2021.

Grupstra RJ, Goedecke T, Scheffers J, Strassmann V, Gardarsdottir H. Grupstra RJ, et al. Clin Pharmacol Ther. 2023 Dec;114(6):1285-1292. doi: 10.1002/cpt.3034. Epub 2023 Oct 16. Clin Pharmacol Ther. 2023. PMID: 37634124 Review.

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