Copenhagen Centre for Regulatory Science

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  1. 2018
  2. 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

  3. 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

  4. 2019
  5. 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

  6. 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

  7. 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

  8. 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

  9. 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

  10. 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

  11. 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

  12. 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

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