Copenhagen Centre for Regulatory Science

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  1. 2019
  2. 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

  3. 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

  4. 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

  5. Published

    Impact of European Benefit-Risk reassessment procedures on drug prescribing practices in Denmark

    De Bruin, M. L. (., Hallgreen, Christine Erikstrup & Andersen, Morten, Aug 2019.

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

  6. 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

  7. 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

  8. 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

  9. Published

    Global, Regional, and National Cancer Incidence, Mortality, Years of Life Lost, Years Lived With Disability, and Disability-Adjusted Life-Years for 29 Cancer Groups, 1990 to 2017: A Systematic Analysis for the Global Burden of Disease Study

    Collaboration, G. B. O. D. C. & Ofori-Asenso, R., 27 Sep 2019, In: JAMA Oncology. 12, p. 1749-1768

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

  10. Published

    MEDICINES AUTHORITY REGULATOR AND INDUSTRY PERCEPTIONS OF BIOSIMILAR INTERCHANGEABILITY

    Druedahl, Louise C., De Bruin, M. L., Hoogland, H., Minssen, Timo, van de Weert, Marco, Kälvemark Sporrong, Sofia & Almarsdóttir, Anna Birna, Dec 2019, p. E45-E46.

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

  11. Published

    POST-MARKETING RISK COMMUNICATION: HOW DO DANISH GPS READ LETTERS FROM REGULATORS AND INDUSTRY ABOUT EMERGENT RISKS?

    Møllebæk, Mathias, Kaae, Susanne & Villadsen, L. S., Dec 2019, p. E46-E46.

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

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