Copenhagen Centre for Regulatory Science

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  1. 2022
  2. Published

    Impact of implementing a guide on intravenous fluids to minimize the risk of hospital-acquired hyponatremia in Denmark

    Sindahl, Per, Overgaard-Steensen, C., Wallach-Kildemoes, H., De Bruin, M. L., Kemp, K. & Gardarsdottir, H., 2022, In: Pharmacoepidemiology and Drug Safety. 31, S2, p. 184-185

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

  3. Published

    Impact of regulatory interventions to restrict the combined use of renin-angiotensin system-acting agents: A Danish nationwide drug utilisation study

    Sindahl, Per, Ofori-Asenso, R., Hallgreen, Christine Erikstrup, Kemp, K., Gardarsdottir, H. & Bruin, M. L. D., 2022, In: British Journal of Clinical Pharmacology. 88, 3, p. 1379-1384

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

  4. Published

    Influence of drug safety advisories on drug utilisation: an international interrupted time series and meta-analysis

    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., Perry, L. T. & Dormuth, C. R., 2022, In: BMJ quality & safety. 31, 3, p. 179–190

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

  5. Published

    Interchangeability of biosimilars: A study of expert views and visions regarding the science and substitution

    Druedahl, Louise C., Kälvemark Sporrong, Sofia, Minssen, Timo, Hoogland, H., De Bruin, M. L. (., van de Weert, Marco & Almarsdóttir, Anna Birna, 2022, In: PLOS One. 17, 1, p. 1-13 13 p.

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

  6. 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

  7. Published

    Mandatory requirements for pediatric drug development in the EU and the US for novel drugs: A comparative study

    Christiansen, Helle, De Bruin, M. L. & Hallgreen, Christine Erikstrup, 2022, In: Frontiers in Medicine. 9, 11 p., 1009432.

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

  8. Published

    Marketing authorization pathways and clinical evidence supporting approval of orphan medicinal products in EU between January 2015 and October 2021

    Hallgreen, Christine Erikstrup, Møllebæk, Mathias & Corap, E., 2022, In: Pharmacoepidemiology and Drug Safety. 31, S2, p. 266-267

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

  9. Published

    Medication Adherence Measurement Methods in Registration Trials Supporting the Approval of New Medicines: A Cross-Sectional Analysis of Centralized Procedures in the European Union 2010–2020

    Mantila, K. M., Pasmooij, A. M. G., Hallgreen, Christine Erikstrup, Mol, P. G. M. & van Boven, J. F. M., 2022, In: Clinical Pharmacology and Therapeutics. 112, 5, p. 1051-1060

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

  10. Published

    Medication adherence in registration trials supporting the approval of new medicines in the European Union

    Mantila, K. M., Mol, P. G. M., Pasmooij, M., Hallgreen, Christine Erikstrup & van Boven, J. F. M., 2022, In: International Journal of Clinical Pharmacy. 44, 1, p. 279-280

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

  11. Published

    Methodological and disciplinary competence and insecurity in qualitative research

    Kälvemark Sporrong, Sofia, Kaae, Susanne, Nørgaard, Lotte Stig, Møllebæk, Mathias, Cantarero Arevalo, Lourdes, Druedahl, Louise C., Waaseth, M., Ljungberg Persson, C., Bekker, C. L. & Lindell, Johanna Falby, 2022, Contemporary research methods in pharmacy and health services. Desselle, S. P., Garcia-Cárdenas, V., Anderson, C., Aslani, P., Chen, A. M. H. & Chen, T. F. (eds.). 1 ed. Academic Press, p. 567-574

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

  12. Published

    Mod en hverdagsetik for lægemiddelbrug: Towards an everyday ethics for medicines use: About people, medicines and multiplicity

    Lau, Sofie Rosenlund & Møllebæk, Mathias, 2022, In: Tidsskrift for Forskning i Sygdom og Samfund. 19, 37, p. 19-41 22 p.

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

  13. Published

    New Information on Old Medicinal Products: A Cross-Sectional Analysis of Guidance for Paediatric Use for Substances on the European Priority List of Off-Patent Medicinal Products

    Mogensen, A. K. B., Christiansen, Helle, De Bruin, M. L. & Hallgreen, Christine Erikstrup, 2022, In: Pediatric Drugs. 24, p. 679–687

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

  14. 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

  15. 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

  16. Published

    Status of Planned and Ongoing Paediatric Trials Investigating COVID-19 Vaccines: A Cross-Sectional Study of Paediatric Clinical Trials Planned in Agreed PIPs and/or Registered in Clinical Trial Databases

    Christiansen, H., Thirstrup, Steffen & Hallgreen, Christine Erikstrup, 2022, In: Therapeutic Innovation & Regulatory Science. 56, p. 474–482

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

  17. 2021
  18. 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 journal › Conference abstract in journal › Research

  19. 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

  20. 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

  21. 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

  22. 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

  23. Published

    Comparing risk of major bleeding between users of different oral anticoagulants in patients with nonvalvular atrial fibrillation

    Souverein, P. C., van den Ham, H. A., Huerta, C., Merino, E. M., Montero, D., Leon-Munoz, L. M., Schmiedl, S., Heeke, A., Rottenkolber, M., Andersen, Morten, Aakjær, Mia, De Bruin, M. L., Klungel, O. H. & Gardarsdottir, H., 2021, In: British Journal of Clinical Pharmacology. 87, 3, p. 988-1000

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

  24. 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 journal › Journal article › Research › peer-review

  25. Published

    Effective implementation approaches for healthy ageing interventions for older people: A rapid review

    Owusu-Addo, E., Ofori-Asenso, R., Batchelor, F., Mahtani, K. & Brijnath, B., 2021, In: Archives of Gerontology and Geriatrics. 92, 9 p., 104263.

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

  26. 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 journal › Journal article › Research › peer-review

  27. Published

    Major bleeding in users of direct oral anticoagulants in atrial fibrillation: A pooled analysis of results from multiple population-based cohort studies

    van den Ham, H. A., Souverein, P. C., Klungel, O. H., Platt, R. W., Ernst, P., Dell'Aniello, S., Schmiedl, S., Grave, B., Rottenkolber, M., Huerta, C., Martin Merino, E., Leon-Munoz, L. M., Montero, D., Andersen, Morten, Aakjær, Mia, De Bruin, M. L. & Gardarsdottir, H., 2021, In: Pharmacoepidemiology and Drug Safety. 30, 10, p. 1339-1352

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

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