Copenhagen Centre for Regulatory Science

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  1. Published

    "Biosimilar, so it looks alike, but what does it mean?" A qualitative study of Danish patients' perceptions of biosimilars

    Varma, M., Almarsdóttir, Anna Birna & Druedahl, Louise C., 2022, In: Basic & Clinical Pharmacology & Toxicology. 130, 5, p. 581-591

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

  2. Published

    A closer look at the World Health Organization's prescribing indicators: J Pharmacol Pharmacother

    Ofori-Asenso, R., 2016, In: Journal of Pharmacology and Pharmacotherapeutics. 7, p. 51-54 4 p.

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

  3. Published

    A cross-sectional survey of knowledge pertaining to IV fluid therapy and hyponatraemia among nurses working at emergency departments in Denmark

    Sindahl, P., Overgaard-Steensen, C., Wallach-Kildemoes, H., De Bruin, M. L., Kjær, M. B. N., Kemp, K. & Gardarsdottir, H., 2021, In: International Emergency Nursing. 57, 101010.

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

  4. 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

  5. Published

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

    Coppens, D. G. M., de Wilde, S., Guchelaar, H. J., De Bruin, M. L., Leufkens, H. G. M., Meij, P. & Hoekman, J., 2018, In: Cytotherapy. 20, 6, p. 769-778 10 p.

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

  6. Published

    A qualitative study of biosimilar manufacturer and regulator perceptions on intellectual property and abbreviated approval pathways

    Druedahl, Louise C., Almarsdóttir, Anna Birna, Kälvemark Sporrong, Sofia, De Bruin, M. L., Hoogland, H., Minssen, Timo, van de Weert, Marco, Kesselheim, A. S. & Sarpatwari, A., 2020, In: Nature Biotechnology. 38, 11, p. 1253-1256 4 p.

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

  7. Published

    ADVERSE CHILDHOOD EXPERIENCES SHOULD BE PRIORITY IN GLOBAL RESPONSE TO COVID-19

    Sahle, B. W., Ofori-Asenso, R. & Renzaho, A. M. N., 2020, In: Journal of Paediatrics and Child Health. 56, 10, p. 1656-1657

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

  8. Published

    Adherence to Direct Oral Anticoagulants in Patients With Non-Valvular Atrial Fibrillation: A Cross-National Comparison in Six European Countries (2008–2015)

    Sabaté, M., Vidal, X., Ballarin, E., Rottenkolber, M., Schmiedl, S., Grave, B., Huerta, C., Martin-Merino, E., Montero, D., Leon-Muñoz, L. M., Gasse, C., Moore, N., Droz, C., Lassalle, R., Aakjær, M., Andersen, M., De Bruin, M. L., Souverein, P., Klungel, O. H., Gardarsdottir, H. & 1 others, Ibáñez, L., 2021, In: Frontiers in Pharmacology. 12, 14 p., 682890.

    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

    Angiotensin converting enzyme genotypes and mortality from COVID-19: An ecological study

    Aung, A. K., Aitken, T., Teh, B. M., Yu, C., Ofori-Asenso, R., Chin, K. L. & Liew, D., 2020, In: Journal of Infection. 81, 6, p. 961-965 5 p.

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

  11. Published

    Are Drug Safety Advisories Compatible with Physicians’ Information Behavior? Semi-Structured Interviews with General Practitioners about Direct to Healthcare Professional Communication

    Møllebæk, Mathias & Kaae, Susanne, 2022, In: European Journal of Health Communication. 3, 3, p. 1-17

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

  12. Published

    Are Further Interventions Needed to Prevent and Manage Hospital-Acquired Hyponatraemia? A Nationwide Cross-Sectional Survey of IV Fluid Prescribing Practices

    Sindahl, P., Overgaard-Steensen, C., Wallach-Kildemoes, H., De Bruin, M. L., Leufkens, H. G. M., Kemp, K. & Gardarsdottir, H., 2020, In: Journal of Clinical Medicine. 9, 9, 16 p., 2790.

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

  13. 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

  14. Published

    Association Between Nutrient Patterns and Hypertension Among Adults in the United States: A Population-Based Survey

    Mazidi, M., Ofori-Asenso, R., George, E. S. & Vatanparast, H., 2020, In: High Blood Pressure and Cardiovascular Prevention. 27, 2, p. 133-138

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

  15. Published

    Association of Spicy Chilli Food Consumption With Cardiovascular and All-Cause Mortality: A Meta-Analysis of Prospective Cohort Studies

    Ofori-Asenso, R., Mohsenpour, M. A., Nouri, M., Faghih, S., Liew, D. & Mazidi, M., 2021, In: Angiology. 72, 7, p. 625-632

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

  16. Published

    Association of Statin Use With Disability-Free Survival and Cardiovascular Disease Among Healthy Older Adults

    Zhou, Z., Ofori-Asenso, R., Curtis, A. J., Breslin, M., Wolfe, R., McNeil, J. J., Murray, A. M., Ernst, M. E., Reid, C. M., Lockery, J. E., Woods, R. L., Tonkin, A. M. & Nelson, M. R., 2020, In: Journal of the American College of Cardiology. 76, 1, p. 17-27 11 p.

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

  17. Published

    Bar iatr ic surgery reduces branched-chain amino acids? levels: a systematic review and meta-analysis

    Barati-Boldaji, R., Esmaeilinezhad, Z., Babajafari, S., Kazemi, A., Clark, C. C. T., Mazidi, M., Ofori-Asenso, R., Haghighat, N., Shafiee, M. & Mazloomi, S. M., 2021, In: Nutrition Research. 87, p. 80-90

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

  18. 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

  19. Published

    Breast Cancer Risk After Radiation Therapy for Hodgkin Lymphoma: Influence of Gonadal Hormone Exposure

    Krul, I. M., Opstal-van Winden, A. W. J., Aleman, B. M. P., Janus, C. P. M., van Eggermond, A. M., De Bruin, M. L., Hauptmann, M., Krol, A. D. G., Schaapveld, M., Broeks, A., Kooijman, K. R., Fase, S., Lybeert, M. L., Zijlstra, J. M., van der Maazen, R. W. M., Kesminiene, A., Diallo, I., de Vathaire, F., Russell, N. S. & van Leeuwen, F. E., 2017, In: International Journal of Radiation Oncology Biology Physics. 99, 4, p. 843-853 11 p.

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

  20. Published

    Can we go for less? Assessing perceptions of EU requirements for comparability clinical trials for biosimilars

    Druedahl, Louise C., 2020.

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

  21. Published

    Cancer is associated with severe disease in COVID-19 patients: a systematic review and meta-analysis

    Ofori-Asenso, R., Ogundipe, O., Agyeman, A. A., Chin, K. L., Mazidi, M., Ademi, Z., De Bruin, M. L. & Liew, D., 2020, In: ecancermedicalscience. 14, 10 p., 1047.

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

  22. Published

    Cancer risk among insulin users: comparing analogues with human insulin in the CARING five-country cohort study

    But, A., De Bruin, M. L., Bazelier, M. T., Hjellvik, V., Andersen, Morten, Auvinen, A., Starup-Linde, J., Schmidt, M. K., Furu, K., de Vries, F., Karlstad, Ø., Ekström, N. & Haukka, J., Sep 2017, In: Diabetologia. 60, 9, p. 1691-1703

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

  23. Published

    Challenges in qualitative social pharmacy research: Reflections based on a conference workshop

    Kälvemark Sporrong, Sofia, Kaae, Susanne, Nørgaard, Lotte Stig, Møllebæk, Mathias, Waaseth, M., Cantarero Arevalo, Lourdes, Persson, C. L., Bekker, C. L., Lindell, Johanna Falby & Druedahl, Louise C., 2022, In: Research in Social and Administrative Pharmacy. 18, 1, p. 2254-2258

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

  24. Submitted

    Challenges in the implementation of EU risk minimization measures for medicinal products in clinical practice guidelines: mixed methods multi-case study

    Møllebæk, Mathias, Gardarsdottir, H., Bikou, A., Kodrič, A., Silva , A. M., Andersen, A., Kontogiorgis, C., Poplavska, E., Ahmadizar, F., Dermiki-Gkana, F., Rutkovska, I., Ribeiro-Vaz , I., Kos, M., Sousa Ferreira, P. B., Grupstra , R., Alves, T. L. & Almarsdóttir, Anna Birna, 4 Feb 2024, (Submitted) In: Drug Safety.

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

  25. In preparation

    Clinical evidence and use of extrapolation in European biosimilar marketing authorizations

    Druedahl, Louise C., Vive Nielsen, C. & Hallgreen, Christine Erikstrup, 2023, (In preparation) In: BioDrugs.

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

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