Copenhagen Centre for Regulatory Science

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  1. 2021
  2. Published

    Pharmaceuticalization

    Møllebæk, Mathias, 2021, Palgrave Encyclopedia of Health Humanities. Crawford, P. & Kadetz, P. (eds.). Springer, 5 p.

    Research output: Chapter in Book/Report/Conference proceeding › Encyclopedia chapter › Research › peer-review

  3. Published

    Poor adherence and persistence to sodium glucose co-transporter 2 inhibitors in real world settings: evidence from a systematic review and meta-analysis

    Ofori-Asenso, R., Sahle, B. W., Chin, K. L., Mazidi, M., Ademi, Z., De Bruin, M. L. & Liew, D., 2021, In: Diabetes/Metabolism Research and Reviews. 37, 1, 11 p., e3350.

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

  4. Published

    Postmarket Safety Communication for Protection of Public Health: A Comparison of Regulatory Policy in Australia, Canada, the European Union, and the United States

    Bhasale, A. L., Sarpatwari, A., De Bruin, M. L., Lexchin, J., Lopert, R., Bahri, P. & Mintzes, B. J., 2021, In: Clinical Pharmacology and Therapeutics. 109, 6, p. 1424-1442

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

  5. Published

    Prescribers' compliance with summary of product characteristics of dabigatran, rivaroxaban and apixaban—A European comparative drug utilization study

    Rottenkolber, M., Schmiedl, S., Ibáñez, L., Sabate, M., Ballarin, E., Vidal, X., Leon-Munoz, L. M., Huerta, C., Merino, E. M., Montero, D., Gasse, C., Andersen, Morten, Aakjær, Mia, De Bruin, M. L. (., Gerlach, R. G., Tauscher, M., Souverein, P. C., Van den Ham, R., Klungel, O. H. & Gardarsdottir, H., 2021, In: Basic & Clinical Pharmacology & Toxicology. 128, 3, p. 440-454

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

  6. Published

    Prevalence and correlates of falls in a middle-aged population with osteoarthritis: Data from the Osteoarthritis Initiative

    Ofori-Asenso, R., Ackerman, I. N. & Soh, S., 2021, In: Health and Social Care in the Community (Print Edition). 29, 2, p. 436-444 9 p.

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

  7. Published

    Rationing health and social goods during pandemics: Guidance for Ghanaian decision makers

    Laar, A., DeBruin, D., Ofori-Asenso, R., Laar, M. E., Redman, B. & Caplan, A., 2021, In: Clinical Ethics. 16, 3, p. 165-170

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

  8. Published

    Real-world adherence, persistence, and in-class switching during use of dipeptidyl peptidase-4 inhibitors: a systematic review and meta-analysis involving 594,138 patients with type 2 diabetes

    Ogundipe, O., Mazidi, M., Chin, K. L., Gor, D., McGovern, A., Sahle, B. W., Jermendy, G., Korhonen, M. J., Appiah, B., Ademi, Z., De Bruin, M. L., Liew, D. & Ofori-Asenso, R., 2021, In: Acta Diabetologica. 58, 1, p. 39-46

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

  9. Published

    Regulating Patient Access to Therapeutics in Denmark: a Rhetorical Analysis of Welfare Imaginaries in Public Controversy

    Møllebæk, Mathias, 2021, In: Journal of Law and the Biosciences . 8, 2, 19 p., Isaa047.

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

  10. Published

    Regulatory density as a means to refine current regulatory approaches for increasingly complex medicines

    Klein, K., Stolk, P., De Bruin, M. L. & Leufkens, H., 2021, In: Drug Discovery Today. 26, 10, p. 2221-2225

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

  11. Published

    Surveillance of Antidepressant Safety (SADS): Active Signal Detection of Serious Medical Events Following SSRI and SNRI Initiation Using Big Healthcare Data

    Aakjær, Mia, De Bruin, M. L., Kulahci, M. & Andersen, Morten, 2021, In: Drug Safety. 44, p. 1215–1230

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

  12. Published

    Why do general practitioners disregard direct to healthcare professional communication? A user-oriented evaluation to improve drug safety communication

    Møllebæk, Mathias & Kaae, Susanne, 2021, In: Basic & Clinical Pharmacology & Toxicology. 128, 3, p. 463-471 9 p.

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

  13. 2020
  14. Published

    ELSI Implications of Prioritizing Biological Therapies in the Times of COVID-19

    Druedahl, Louise C., Lebret, Audrey & Minssen, Timo, Oct 2020, In: Journal of Law, Medicine & Ethics. 48, 3, p. 579-582

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

  15. Published

    Measures of geographic accessibility to health care in the Ashanti Region of Ghana

    Ashiagbor, G., Ofori-Asenso, R., Forkuo, E. K. & Agyei-Frimpong, S., Sep 2020, In: Scientific African. 9, 12 p., e00453.

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

  16. Published

    Regulating advanced therapy medicinal products through the Hospital Exemption: an analysis of regulatory approaches in nine EU countries

    Coppens, D. G. M., Gardarsdottir, H., De Bruin, M. L., Meij, P., Leufkens, H. G. M. & Hoekman, J., Aug 2020, In: Regenerative Medicine. 15, 8, p. 2015-2028 14 p.

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

  17. Published

    Preparation of Direct Healthcare Professional Communication: An Exploratory Study on the Experiences and Perceptions of European Pharmaceutical Companies and the EMA

    Fanø, A. B., Møllebæk, Mathias & Kaae, Susanne, May 2020, In: Therapeutic Innovation & Regulatory Science. 54, 3, p. 631-639

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

  18. 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

  19. 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

  20. 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

  21. 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

  22. 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

  23. 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

  24. 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

  25. 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

  26. 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

  27. Published

    Comparison of electronic self-reported prescription medication use during pregnancy with the national prescription register in Denmark

    Laursen, M., Hallgreen, Christine Erikstrup, Dreyer, N., Bourke, A., Mt-Isa, S. & Blackburn, S., 2020, In: Pharmacoepidemiology and Drug Safety. 29, 3, p. 328-336

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

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