Copenhagen Centre for Regulatory Science

  1. 2021
  2. 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 journalJournal articleResearchpeer-review

  3. 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 journalReviewResearchpeer-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 journalJournal articleResearchpeer-review

  5. Published

    Evolving biosimilar clinical requirements: A qualitative interview study with industry experts and European national medicines agency regulators

    Druedahl, Louise C., Kälvemark Sporrong, Sofia, van de Weert, Marco, De Bruin, M. L. (., Hoogland, H., Minssen, Timo & Almarsdóttir, Anna Birna, 2021, In: BioDrugs. 35, p. 351-361

    Research output: Contribution to journalJournal articleResearchpeer-review

  6. 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 journalJournal articleResearchpeer-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 journalJournal articleResearchpeer-review

  8. Published

    Cost Burden and Cost-Effective Analysis of the Nationwide Implementation of the Quality in Acute Stroke Care Protocol in Australia

    Marquina, C., Ademi, Z., Zomer, E., Ofori-Asenso, R., Tate, R. & Liew, D. L., 2021, In: Journal of Stroke & Cerebrovascular Diseases. 30, 8, 9 p., 105931.

    Research output: Contribution to journalJournal articleResearchpeer-review

  9. 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 journalJournal articleResearchpeer-review

  10. Published

    Influence of drug safety advisories on drug utilization: An international interrupted time series and meta-analysis study

    Morrow, R. L., Mintzes, B., Souverein, P. C., De Bruin, M. L., Roughead, E. E., Lexchin, J., Kemp-Casey, A., Puil, L., Sketris, I., Mangin, D., Hallgreen, Christine Erikstrup, Pearson, S., Lopert, R., Bero, L., Ofori-Asenso, R., Gnjidic, D., Sarpatwari, A. & Dormuth, C. R., Aug 2021, In: Pharmacoepidemiology and Drug Safety. 30, S1, p. 33-34

    Research output: Contribution to journalConference abstract in journalResearch

  11. 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 proceedingEncyclopedia chapterResearchpeer-review

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