Copenhagen Centre for Regulatory Science

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  1. Published

    Investigation of the potential association between the use of fluoxetine and occurrence of acute pancreatitis: a Danish register-based cohort study

    Aakjær, Mia, Kristiansen, S. B., Pape, K., Sessa, Maurizio, Dalhoff, Kim, De Bruin, M. L. & Andersen, Morten, 2022, In: International Journal of Epidemiology. 51, 5, p. 1656–1665

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

  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 journal › Journal article › Research › peer-review

  3. Published

    Serious arrhythmia in initiators of citalopram, escitalopram, and other selective serotonin reuptake inhibitors: A population-based cohort study in older adults

    Aakjær, Mia, Werther, S. K., De Bruin, M. L. & Andersen, Morten, 2022, In: Clinical and Translational Science. 15, 9, p. 2105-2115

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

  4. Published

    Concomitant medication use and its implications on the hazard pattern in pharmacoepidemiological studies: Example of antidepressants, benzodiazepines and fracture risk

    Abbing-Karahagopian, V., Souverein, P. C., Korevaar, J. C., Leufkens, H. G. M., Egberts, T. C. G., Gardarsdottir, H. & De Bruin, M. L., 22 Sep 2015, In: Epidemiology Biostatistics and Public Health. 12, 3, e11273.

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

  5. Published

    Flash presentation: Impact of 2018 EU Risk Minimisation Measures and Revised Pregnancy Prevention Programme on Utilisation and Prescribing Trends of Valproates

    Abtahi, S., Pajouheshnia, R., Duran-Salinas, C., Riera-Arnau, J., Gamba, M., Alsina, E., Hallgreen, Christine Erikstrup, Limoncella, G., Bartolini, C., Holthuis, E., Martin-Perez, M., Brown, J., Sturkenboom, M., Klungel, O. & Lot, O., 2022, In: Drug Safety. 45, 10, p. 1312-1313

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

  6. Published

    Impact of 2018 EU Risk Minimisation Measures and Revised Pregnancy Prevention Programme on Utilisation and Prescribing Trends of Medicinal Products Containing Valproate: An Interrupted Time Series Study

    Abtahi, S., Pajouheshnia, R., Durán, C. E., Riera-Arnau, J., Gamba, M., Alsina, E., Hoxhaj, V., Andersen, M., Bartolini, C., Kristiansen, S. B., Brown, J., Hallgreen, C. E., Garcia-Poza, P., Gardarsdottir, H., Gini, R., Girardi, A., Holthuis, E., Huerta, C., Ibánez, L., Limoncella, G. & 8 others, Martín-Pérez, M., Paoletti, O., Roberto, G., Souverein, P., Swart, K. M. A., Wing, K., Sturkenboom, M. & Klungel, O., 2023, In: Drug Safety. 46, 7, p. 689-702

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

  7. Published

    Will COVID-19 be a litmus test for post-Ebola sub-Saharan Africa?

    Agyeman, A. A., Laar, A. & Ofori-Asenso, R., 2020, In: Journal of Medical Virology. 92, 9, p. 1373-1375 3 p.

    Research output: Contribution to journal › Comment/debate › Research › peer-review

  8. Published

    Smell and Taste Dysfunction in Patients With COVID-19: A Systematic Review and Meta-analysis

    Agyeman, A. A., Chin, K. L., Landersdorfer, C. B., Liew, D. & Ofori-Asenso, R., 2020, In: Mayo Clinic Proceedings. 95, 8, p. 1621-1631 11 p.

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

  9. Published

    Rethinking pandemic preparation: Global Health Security Index (GHSI) is predictive of COVID-19 burden, but in the opposite direction

    Aitken, T., Chin, K. L., Liew, D. & Ofori-Asenso, R., 2020, In: Journal of Infection. 81, 2, p. 353-355 3 p.

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

  10. Submitted

    Medicines safety information from regulators in clinical practice guidelines: a mixed-method case study

    Andersen, A., Møllebæk, Mathias & Almarsdóttir, Anna Birna, 27 Feb 2024, (Submitted) In: Journal of Pharmaceutical Health Services Research.

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

  11. Published

    Water scarcity and COVID-19 in sub-Saharan Africa

    Anim, D. O. & Ofori-Asenso, R., 2020, In: Journal of Infection. 81, 2, p. E108-E109 2 p.

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

  12. 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

  13. 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

  14. 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

  15. Published

    Data management and data analysis techniques in pharmacoepidemiological studies using a pre-planned multi-database approach: a systematic literature review

    Bazelier, M. T., Eriksson, I., de Vries, F., Schmidt, M. K., Raitanen, J., Haukka, J., Starup-Linde, J., De Bruin, M. L. & Andersen, Morten Sten, Sep 2015, In: Pharmacoepidemiology and Drug Safety. 24, 9, p. 897-905 9 p.

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

  16. 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

  17. Published

    Regulatory authority and clinical acceptability: Physicians' responses to regulatory drug safety warnings

    Bhasale, A. L., Sarpatwari, A., Lipworth, W., Møllebæk, Mathias, McEwin, E. J., Gautam, N., Santiago Ortiz, A. & Mintzes, B. J., 2022, In: British Journal of Clinical Pharmacology. 88, 2, p. 713-722

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

  18. 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

  19. Published

    Risk Factors Associated with Post-Marketing Changes in Specific Obligations of Conditionally Authorised Products in the EU

    Bloem, L. T., Mantel-Teeuwisse, A. K., Leufkens, H. G. M., De Bruin, M. L., Klungel, O. H. & Hoekman, J., Aug 2017, p. 605-605.

    Research output: Contribution to conference › Conference abstract for conference › Research

  20. Published

    Registries in European post-marketing surveillance: a retrospective analysis of centrally approved products, 2005-2013

    Bouvy, J. C., Blake, K., Slattery, J., De Bruin, M. L., Arlett, P. & Kurz, X., Dec 2017, In: Pharmacoepidemiology and Drug Safety. 26, 12, p. 1442-1450

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

  21. Published

    Epidemiology of adverse drug reactions in Europe: a review of recent observational studies

    Bouvy, J. C., De Bruin, M. L. & Koopmanschap, M. A., May 2015, In: Drug Safety. 38, 5, p. 437-53 17 p.

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

  22. Published

    The association of diabetes mellitus and insulin treatment with expression of insulin-related proteins in breast tumors

    Bronsveld, H. K., De Bruin, M. L., Wesseling, J., Sanders, J., Hofland, I., Jensen, V., Bazelier, M. T., ter Braak, B., de Boer, A., Vestergaard, P. & Schmidt, M. K., 2018, In: BMC Cancer. 18, 11 p., 224.

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

  23. 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

  24. 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 journal › Comment/debate › Research › peer-review

  25. Published

    Early signs that COVID-19 is being contained in Australia

    Chin, K. L., Ofori-Asenso, R., Jordan, K. A., Jones, D. & Liew, D., 2020, In: Journal of Infection. 81, 2, p. 351-353 3 p.

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

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