Copenhagen Centre for Regulatory Science

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  1. Published

    Marketing authorization pathways and clinical evidence supporting approval of orphan medicinal products in EU between January 2015 and October 2021

    Hallgreen, Christine Erikstrup, Møllebæk, Mathias & Corap, E., 2022, In: Pharmacoepidemiology and Drug Safety. 31, S2, p. 266-267

    Research output: Contribution to journal › Conference abstract in journal › Research › peer-review

  2. Published

    How and Why to Involve Patients in Drug Development: Perspectives from the Pharmaceutical Industry, Regulatory Authorities and Patient Organizations

    Hansen, M. B., Nørgaard, Lotte Stig & Hallgreen, Christine Erikstrup, 2020, In: Therapeutic Innovation & Regulatory Science. 54, p. 577-585 9 p.

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

  3. Published

    Regional Disparity in First-in-Class Anticancer Drug Development in the US, EU, and Japan

    Hino, Y., Okada, M., Hallgreen, Christine Erikstrup, De Bruin, M. L., Doty, R. E., Matsumaru, N. & Tsukamoto, K., 2023, In: Biological and Pharmaceutical Bulletin. 46, 5, p. 700-706

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

  4. 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

  5. Published

    Perspectives on how to build bridges between regulation, health technology assessment and clinical guideline development: a qualitative focus group study with European experts

    Hogervorst, M. A., Møllebæk, Mathias, Vreman, R. A., Lu, T. A., Wang, J., De Bruin, M. L., Leufkens, H. G. M., Mantel-Teeuwisse, A. & Goettsch, W., 2023, In: BMJ Open. 13, 8, 11 p., e072309.

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

  6. Published

    Are monitoring instructions provided in direct healthcare professional communications (DHPCs) of sufficient quality? A retrospective analysis of DHPCs sent out between 2007 and 2018

    Højer, M. G., De Bruin, M. L., Boskovic, A. & Hallgreen, Christine Erikstrup, 2020, In: BMJ Open. 10, 5, 9 p., e036498.

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

  7. 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

  8. Published

    Incidence of Direct Oral Anticoagulant use in patients with non-valvular atrial fibrillation and characteristics of users in six European countries (2008-2015): A cross-national drug utilization study

    Ibáñez, L., Sabaté, M., Vidal, X., Ballarin, E., Rottenkolber, M., Schmiedl, S., Heeke, A., Huerta, C., Martin Merino, E., Montero, D., Leon-Muñoz, 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., 2019, In: British Journal of Clinical Pharmacology. Supplement. 85, p. 2524-2539

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

  9. Published

    Fixed-dose combination of empagliflozin and linagliptin for the treatment of patients with type 2 diabetes mellitus: A systematic review and meta-analysis

    Katsiki, N., Ofori-Asenso, R., Ferrannini, E. & Mazidi, M., 2020, In: Diabetes, Obesity and Metabolism. 22, 6, p. 1001-1005 5 p.

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

  10. 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

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