Copenhagen Centre for Regulatory Science

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  1. 2019
  2. Published

    Dynamics of switching, adherence, and persistence of dipeptidyl peptidase-4 inhibitors use: A nationwide cohort study

    Ofori-Asenso, R., Ilomaki, J., Chin, K. L., Mazidi, M., Zomer, E., Bell, J. S., Magliano, D. J. & Liew, D., 2019, In: Diabetes Research and Clinical Practice. 158, 10 p., 107909.

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

  3. Published

    How do we know it's good? A workshop on quality criteria in qualitative social and clinical pharmacy research

    Kälvemark Sporrong, Sofia, Kaae, Susanne, Nørgaard, Lotte Stig, Druedahl, Louise C. & Amin, M., 2019, In: Research in Social and Administrative Pharmacy. 15, p. e54 1 p.

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

  4. 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

  5. Published

    Medicines authority regulators and industry perspectives on the European regulation of biosimilars

    Druedahl, Louise C., De Bruin, M. L. (., van de Weert, Marco, Minssen, Timo, Hoogland, H. & Almarsdóttir, Anna Birna, 2019.

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

  6. 2018
  7. Published

    Health and Human Rights: Ethical Issues of Outsourcing Clinical Trials

    Møllebæk, Mathias, 8 Dec 2018

    Research output: Other contribution › Net publication - Internet publication › Research

  8. Published

    Impact of the 2012 pharmacovigilance legislation on the harmonisation of DHPCS in the EU

    Olafsdottir, G., Bukhave, S. M., Kalligeros, G., Hallgreen, Christine Erikstrup & De Bruin, M. L., Aug 2018, p. 515-516.

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

  9. Published

    EU decision-making for marketing authorization of advanced therapy medicinal products: a case study

    de Wilde, S., Coppens, D. G. M., Hoekman, J., de Bruin, M. L., Leufkens, H. G. M., Guchelaar, H. & Meij, P., Jul 2018, In: Drug Discovery Today. 23, 7, p. 1328-1333

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

  10. Published

    When More Is Less: An Exploratory Study of the Precautionary Reporting Bias and Its Impact on Safety Signal Detection

    Klein, K., Scholl, J. H. G., De Bruin, M. L., van Puijenbroek, E. P., Leufkens, H. G. M. & Stolk, P., Feb 2018, In: Clinical Pharmacology and Therapeutics. 103, p. 296-303

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

  11. Published

    Global Regulatory Differences for Gene- and Cell-Based Therapies: Consequences and Implications for Patient Access and Therapeutic Innovation

    Coppens, D. G. M., De Bruin, M. L., Leufkens, H. G. M. & Hoekman, J., Jan 2018, In: Clinical Pharmacology and Therapeutics. 103, p. 120-127

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

  12. Published

    A decade of marketing approval of gene and cell based therapies in the United States, European Union, and Japan: A regulatory decision-making evaluation

    Coppens, D. G. M., de Wilde, S., Guchelaar, H. J., De Bruin, M. L., Leufkens, H. G. M., Meij, P. & Hoekman, J., 2018, In: Pharmacoepidemiology and Drug Safety. 27, S2, p. 517-517

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

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