Copenhagen Centre for Regulatory Science

  1. 2023
  2. Published

    Impact of a Treatment Guide on Intravenous Fluids in Minimising the Risk of Hospital-Acquired Hyponatraemia in Denmark

    Sindahl, Per, Overgaard-Steensen, C., Wallach-Kildemoes, H., De Bruin, M. L., Kemp, K. & Gardarsdottir, H., 2023, In: Journal of Clinical Medicine. 12, 15, 14 p., 5105.

    Research output: Contribution to journalJournal articleResearchpeer-review

  3. Published

    Impact of the 2018 revised Pregnancy Prevention Programme by the European Medicines Agency on the use of oral retinoids in females of childbearing age in Denmark, Italy, Netherlands, and Spain: an interrupted time series analysis

    Durán, C. E., Riera-Arnau, J., Abtahi, S., Pajouheshnia, R., Hoxhaj, V., Gamba, M., Alsina, E., Martin-Perez, M., Garcia-Poza, P., Llorente-Garcia, A., Gonzalez-Bermejo, D., Ibánez, L., Sabaté, M., Vidal, X., Ballarín, E., Sanfélix-Gimeno, G., Rodríguez-Bernal, C., Peiró, S., García-Sempere, A., Sanchez-Saez, F. & 22 others, Ientile, V., Ingrasciotta, Y., Guarneri, C., Tanaglia, M., Tari, M., Herings, R., Houben, E., Swart-Polinder, K., Holthuis, E., Huerta, C., Gini, R., Roberto, G., Bartolini, C., Paoletti, O., Limoncella, G., Girardi, A., Hyeraci, G., Andersen, Morten, Kristiansen, S. B., Hallgreen, Christine Erikstrup, Klungel, O. & Sturkenboom, M., 2023, In: Frontiers in Pharmacology. 14, 12 p., 1207976.

    Research output: Contribution to journalJournal articleResearchpeer-review

  4. Submitted

    Implementation of electronic distribution of Direct Healthcare Professional Communications (DHPCs) by the Danish Medicines Agency: A survey study of physicians’ experiences and preferences

    Sindahl, P., Møllebæk, Mathias, Gardarsdottir, H., De Bruin, M. L. (., Hallgreen, Christine Erikstrup & Clemmensen, M. H., 2023, (Submitted) In: Therapeutic Advances in Drug Safety.

    Research output: Contribution to journalJournal articleResearchpeer-review

  5. Published

    Machine learning-driven development of a disease risk score for COVID-19 hospitalization and mortality: a Swedish and Norwegian register-based study

    Shakibfar, Saeed, Zhao, J., Li, H., Nordeng, H., Lupattelli, A., Pavlovic, M., Sandve, G. K., Nyberg, F., Wettermark, B., Hajiebrahimi, M., Andersen, Morten & Sessa, Maurizio, 2023, In: Frontiers in Public Health. 11, 16 p., :1258840.

    Research output: Contribution to journalJournal articleResearchpeer-review

  6. Published

    Paper Tigers in the Clinic? Rhetorical Argument Fields in Health Policy Implementation

    Møllebæk, Mathias, 2023, Rhetorical Argumentation: The Copenhagen School: Windsor Studies in Argumentation. Kock, C. & Lantz, M. (eds.). Windsor, ON, Vol. 13. p. 408-433

    Research output: Chapter in Book/Report/Conference proceedingBook chapterResearchpeer-review

  7. 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 journalJournal articleResearchpeer-review

  8. 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 journalJournal articleResearchpeer-review

  9. Published

    The therapeutic potential of psychedelics: the European regulatory perspective

    Butlen-Ducuing, F., McCulloch, D. E. W., Haberkamp, M., Mattila, T., Bałkowiec-Iskra, E., Aislaitner, G., Balabanov, P., Lundberg, J., Stenbæk, Dea Siggaard, Elferink, A., Knudsen, Gitte Moos & Thirstrup, Steffen, 2023, In: The Lancet. 401, 10378, p. 714-716 3 p.

    Research output: Contribution to journalComment/debateResearchpeer-review

  10. 2022
  11. 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 journalJournal articleResearchpeer-review

  12. 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 journalJournal articleResearchpeer-review

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