Copenhagen Centre for Regulatory Science

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  1. 2019
  2. Published

    Incidence of direct Oral anticoagulation use for non Valvular atrial fibrillation and characteristics of users in six European countries (2008-2015): A cross-National Drug Utilization Study

    Ibanez, L., Sabate, M., Vidal, X., Ballarin, E., Rottenkolber, M., Schmiedl, S., Heeke, A., Huerta, C., Martin Merino, E., Montero, D., Leon-Munoz, L. M., Gasse, C., Moore, N., Droz, C., Lassalle, R., Aakjaer, M., Andersen, M., De Bruin, M. L., Groenwold, R., Van den Ham, R. & 3 others, Souverein, P., Klungel, O. & Gardarsdottir, H., Aug 2019, p. 397-397.

    Research output: Contribution to conference › Conference abstract for conference › Research › peer-review

  3. Published

    Risk of major bleeding associated with the use of direct oral anticoagulants compared to vitamin K antagonists in patients with atrial fibrillation: A European multi-country population-based cohort study

    Souverein, P. C., Van den Ham, H. A., Huerta, C., Martin Merino, E., Montero, D., Leon-Munoz, L. M., Schmiedl, S., Rottenkolber, M., Andersen, Morten, Aakjær, Mia, De Bruin, M. L., Klungel, O. H. & Gardarsdottir, H., Aug 2019, p. 553-553.

    Research output: Contribution to conference › Conference abstract for conference › Research › peer-review

  4. Published

    Risk of major bleeding associated with the use of individual direct oral anticoagulants compared to vitamin K antagonists in patients with non-valvular atrial fibrillation: a meta-analysis of results from multiple population-based cohort studies using a common protocol in Europe and Canada

    van den Ham, H., Souverein, P., Klungel, O., Platt, R., Ernst, P., Dell'Aniello, S., Schmiedl, S., Grave, B., Rottenkolber, M., Huerta, C., Martin Merino, E., Leon-Munoz, L., Montero, D., Andersen, Morten, Aakjær, Mia, De Bruin, M. & Gardarsdottir, H., Aug 2019, p. 410-411.

    Research output: Contribution to conference › Conference abstract for conference › Research › peer-review

  5. Published

    The effectiveness of direct to healthcare professional communication – A systematic review of communication factor studies

    Møllebæk, Mathias, Kaae, Susanne, De Bruin, M. L., Callréus, T., Jossan, S. & Hallgreen, Christine Erikstrup, May 2019, In: Research in Social and Administrative Pharmacy. 15, 5, p. 475-482

    Research output: Contribution to journal › Review › Research › peer-review

  6. Published

    The EU regulatory landscape of non-biological complex drugs (NBCDs) follow-on products: Observations and recommendations

    Klein, K., Stolk, P., De Bruin, M. L., Leufkens, H. G. M., Crommelin, D. J. A. & De Vlieger, J. S. B., 3 Apr 2019, In: European Journal of Pharmaceutical Sciences. 133, p. 228-235 8 p.

    Research output: Contribution to journal › Journal article › Research › peer-review

  7. Published

    Genetic susceptibility to radiation-induced breast cancer after Hodgkin lymphoma

    Opstal-van Winden, A. W. J., de Haan, H. G., Hauptmann, M., Schmidt, M. K., Broeks, A., Russell, N. S., Janus, C. P. M., Krol, A. D. G., van der Baan, F. H., De Bruin, M. L., van Eggermond, A. M., Dennis, J., Anton-Culver, H., Haiman, C. A., Sawyer, E. J., Cox, A., Devilee, P., Hooning, M. J., Peto, J., Couch, F. J. & 10 others, Pharoah, P., Orr, N., Easton, D. F., Aleman, B. M. P., Strong, L. C., Bhatia, S., Cooke, R., Robison, L. L., Swerdlow, A. J. & van Leeuwen, F. E., 7 Mar 2019, In: Blood. 133, 10, p. 1130-1139 10 p.

    Research output: Contribution to journal › Journal article › Research › peer-review

  8. Published

    Postauthorization Changes to Specific Obligations of Conditionally Authorized Medicines in the European Union: A Retrospective Cohort Study

    Bloem, L. T., Mantel-Teeuwisse, A. K., Leufkens, H. G. M., De Bruin, M. L., Klungel, O. H. & Hoekman, J., Feb 2019, In: Clinical Pharmacology and Therapeutics. 105, 2, p. 426-435 10 p.

    Research output: Contribution to journal › Journal article › Research › peer-review

  9. Published

    Adjusting for unmeasured confounding using validation data: simplified two-stage calibration for survival and dichotomous outcomes

    Hjellvik, V., De Bruin, M. L., Samuelsen, S. O., Karlstad, Ø., Andersen, Morten, Haukka, J., Vestergaard, P., de Vries, F. & Furu, K., 2019, In: Statistics in Medicine. 38, 15, p. 2719-2734

    Research output: Contribution to journal › Journal article › Research › peer-review

  10. Published

    Body of evidence and approaches applied in the clinical development programme of fixed-dose combinations in the European Union from 2010 to 2016

    Nøhr-Nielsen, A., De Bruin, M. L., Thomsen, M., Pipper, C. B., Lange, Theis, Bjerrum, Ole Jannik & Lund, Trine Meldgaard, 2019, In: British Journal of Clinical Pharmacology. 85, 8, p. 1829-1840 12 p.

    Research output: Contribution to journal › Journal article › Research › peer-review

  11. Published

    Comparisons of direct and indirect utilities in adult epilepsy populations: A systematic review

    Foster, E., Chen, Z., Ofori-Asenso, R., Norman, R., Carney, P., O'Brien, T. J., Kwan, P., Liew, D. & Ademi, Z., 2019, In: Epilepsia. 60, 12, p. 2466-2476 11 p.

    Research output: Contribution to journal › Review › Research › peer-review

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