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

  26. Published

    Trends in the Dispensing and Costs of Glucose-Lowering Medications Among Older Australians: Findings from National Claims Data

    Chin, K. L., Hidayat, F. M., Ofori-Asenso, R., Ilomaki, J., Bell, J. S., Zoungas, S. & Liew, D. L., 2020, In: Drugs & Aging. 37, 5, p. 393-398 6 p.

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

  27. Published

    Guidance for pediatric use in prescription information for novel medicinal products in the EU and the US

    Christiansen, H., De Bruin, M. L., Frøkjær, Sven & Hallgreen, Christine Erikstrup, 2022, In: PLoS ONE. 17, 4, 19 p., e0266353.

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

  28. 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

  29. 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

  30. Published

    Global, Regional, and National Cancer Incidence, Mortality, Years of Life Lost, Years Lived With Disability, and Disability-Adjusted Life-Years for 29 Cancer Groups, 1990 to 2017: A Systematic Analysis for the Global Burden of Disease Study

    Collaboration, G. B. O. D. C. & Ofori-Asenso, R., 27 Sep 2019, In: JAMA Oncology. 12, p. 1749-1768

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

  31. Published

    A decade of marketing approval of gene and cell-based therapies in the United States, European Union and Japan: An evaluation of regulatory decision-making

    Coppens, D. G. M., de Wilde, S., Guchelaar, H. J., De Bruin, M. L., Leufkens, H. G. M., Meij, P. & Hoekman, J., 2018, In: Cytotherapy. 20, 6, p. 769-778 10 p.

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

  32. Published

    Global Regulatory Differences for Gene- and Cell-Based Therapies: Consequences and Implications for Patient Access and Therapeutic Innovation

    Coppens, D. G. M., De Bruin, M. L., Leufkens, H. G. M. & Hoekman, J., Jan 2018, In: Clinical Pharmacology and Therapeutics. 103, p. 120-127

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

  33. 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

  34. Published

    A decade of marketing approval of gene and cell based therapies in the United States, European Union, and Japan: A regulatory decision-making evaluation

    Coppens, D. G. M., de Wilde, S., Guchelaar, H. J., De Bruin, M. L., Leufkens, H. G. M., Meij, P. & Hoekman, J., 2018, In: Pharmacoepidemiology and Drug Safety. 27, S2, p. 517-517

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

  35. Published

    Publication rates and reported results in a cohort of gene-and cell-based therapy trials

    Coppens, D. G. M., Gardarsdottir, H., Van Den Bogert, C. A., De Bruin, M. L., Leufkens, H. G. M. & Hoekman, J., 2020, In: Regenerative Medicine. 15, 1, p. 1215-1227 13 p.

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

  36. Published

    Impact of European Benefit-Risk reassessment procedures on drug prescribing practices in Denmark

    De Bruin, M. L. (., Hallgreen, Christine Erikstrup & Andersen, Morten, Aug 2019.

    Research output: Contribution to conference › Conference abstract for conference › Research › peer-review

  37. 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

  38. 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

  39. 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

  40. In preparation

    Clinical evidence and use of extrapolation in European biosimilar marketing authorizations

    Druedahl, Louise C., Vive Nielsen, C. & Hallgreen, Christine Erikstrup, 2023, (In preparation) In: BioDrugs.

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

  41. 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

  42. Published

    Medicines authority regulators and industry perspectives on the European regulation of biosimilars

    Druedahl, Louise C., De Bruin, M. L. (., van de Weert, Marco, Minssen, Timo, Hoogland, H. & Almarsdóttir, Anna Birna, 2019.

    Research output: Contribution to conference › Conference abstract for conference › Research › peer-review

  43. Published

    MEDICINES AUTHORITY REGULATOR AND INDUSTRY PERCEPTIONS OF BIOSIMILAR INTERCHANGEABILITY

    Druedahl, Louise C., De Bruin, M. L., Hoogland, H., Minssen, Timo, van de Weert, Marco, Kälvemark Sporrong, Sofia & Almarsdóttir, Anna Birna, Dec 2019, p. E45-E46.

    Research output: Contribution to conference › Conference abstract for conference › Research › peer-review

  44. 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

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

  46. Published

    Lessons learned on the design and the conduct of Post-Authorization Safety Studies: review of 3 years of PRAC oversight

    Engel, P., Almas, M. F., De Bruin, M. L., Starzyk, K., Blackburn, S. & Dreyer, N. A., 2017, In: British Journal of Clinical Pharmacology. 83, 4, p. 884-893 10 p.

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

  47. Published

    Media coverage of drug regulatory agencies' safety advisories: A case study of citalopram and denosumab

    Fabbri, A., O'Keeffe, M., Moynihan, R., Møllebæk, Mathias, Mohammad, A., Bhasale, A., Puil, L. & Mintzes, B., 2020, In: British Journal of Clinical Pharmacology. 86, 7, p. 1416-1429

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

  48. 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

  49. Published

    Comparisons of direct and indirect utilities in adult epilepsy populations: A systematic review

    Foster, E., Chen, Z., Ofori-Asenso, R., Norman, R., Carney, P., O'Brien, T. J., Kwan, P., Liew, D. & Ademi, Z., 2019, In: Epilepsia. 60, 12, p. 2466-2476 11 p.

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

  50. Published

    How to Measure the Impact of Pharmacovigilance Activities on Public Health?

    Gardarsdottir, H., Kant, A., De Bruin, M. L., Hallgreen, Christine Erikstrup, Dal Pan, G. & Way, D., Aug 2017, p. 31-31.

    Research output: Contribution to conference › Conference abstract for conference › Research › peer-review

  51. 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

  52. Published

    How and Why to Involve Patients in Drug Development: Perspectives from the Pharmaceutical Industry, Regulatory Authorities and Patient Organizations

    Hansen, M. B., Nørgaard, Lotte Stig & Hallgreen, Christine Erikstrup, 2020, In: Therapeutic Innovation & Regulatory Science. 54, p. 577-585 9 p.

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

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

  54. Published

    Adjusting for unmeasured confounding using validation data: simplified two-stage calibration for survival and dichotomous outcomes

    Hjellvik, V., De Bruin, M. L., Samuelsen, S. O., Karlstad, Ø., Andersen, Morten, Haukka, J., Vestergaard, P., de Vries, F. & Furu, K., 2019, In: Statistics in Medicine. 38, 15, p. 2719-2734

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

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

  56. 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

  57. Published

    Incidence of direct Oral anticoagulation use for non Valvular atrial fibrillation and characteristics of users in six European countries (2008-2015): A cross-National Drug Utilization Study

    Ibanez, L., Sabate, M., Vidal, X., Ballarin, E., Rottenkolber, M., Schmiedl, S., Heeke, A., Huerta, C., Martin Merino, E., Montero, D., Leon-Munoz, L. M., Gasse, C., Moore, N., Droz, C., Lassalle, R., Aakjaer, M., Andersen, M., De Bruin, M. L., Groenwold, R., Van den Ham, R. & 3 others, Souverein, P., Klungel, O. & Gardarsdottir, H., Aug 2019, p. 397-397.

    Research output: Contribution to conference › Conference abstract for conference › Research › peer-review

  58. Published

    Incidence of Direct Oral Anticoagulant use in patients with non-valvular atrial fibrillation and characteristics of users in six European countries (2008-2015): A cross-national drug utilization study

    Ibáñez, L., Sabaté, M., Vidal, X., Ballarin, E., Rottenkolber, M., Schmiedl, S., Heeke, A., Huerta, C., Martin Merino, E., Montero, D., Leon-Muñoz, L. M., Gasse, C., Moore, N., Droz, C., Lassalle, R., Aakjaer, M., Andersen, M., De Bruin, M. L., Groenwold, R., van den Ham, R. & 3 others, Souverein, P., Klungel, O. & Gardarsdottir, H., 2019, In: British Journal of Clinical Pharmacology. Supplement. 85, p. 2524-2539

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

  59. Published

    Fixed-dose combination of empagliflozin and linagliptin for the treatment of patients with type 2 diabetes mellitus: A systematic review and meta-analysis

    Katsiki, N., Ofori-Asenso, R., Ferrannini, E. & Mazidi, M., 2020, In: Diabetes, Obesity and Metabolism. 22, 6, p. 1001-1005 5 p.

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

  60. Published

    The EU regulatory landscape of non-biological complex drugs (NBCDs) follow-on products: Observations and recommendations

    Klein, K., Stolk, P., De Bruin, M. L., Leufkens, H. G. M., Crommelin, D. J. A. & De Vlieger, J. S. B., 3 Apr 2019, In: European Journal of Pharmaceutical Sciences. 133, p. 228-235 8 p.

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

  61. 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

  62. Published

    When More Is Less: An Exploratory Study of the Precautionary Reporting Bias and Its Impact on Safety Signal Detection

    Klein, K., Scholl, J. H. G., De Bruin, M. L., van Puijenbroek, E. P., Leufkens, H. G. M. & Stolk, P., Feb 2018, In: Clinical Pharmacology and Therapeutics. 103, p. 296-303

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

  63. Published

    Breast Cancer Risk After Radiation Therapy for Hodgkin Lymphoma: Influence of Gonadal Hormone Exposure

    Krul, I. M., Opstal-van Winden, A. W. J., Aleman, B. M. P., Janus, C. P. M., van Eggermond, A. M., De Bruin, M. L., Hauptmann, M., Krol, A. D. G., Schaapveld, M., Broeks, A., Kooijman, K. R., Fase, S., Lybeert, M. L., Zijlstra, J. M., van der Maazen, R. W. M., Kesminiene, A., Diallo, I., de Vathaire, F., Russell, N. S. & van Leeuwen, F. E., 2017, In: International Journal of Radiation Oncology Biology Physics. 99, 4, p. 843-853 11 p.

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

  64. Published

    How do we know it's good? A workshop on quality criteria in qualitative social and clinical pharmacy research

    Kälvemark Sporrong, Sofia, Kaae, Susanne, Nørgaard, Lotte Stig, Druedahl, Louise C. & Amin, M., 2019, In: Research in Social and Administrative Pharmacy. 15, p. e54 1 p.

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

  65. Published

    Challenges in qualitative social pharmacy research: Reflections based on a conference workshop

    Kälvemark Sporrong, Sofia, Kaae, Susanne, Nørgaard, Lotte Stig, Møllebæk, Mathias, Waaseth, M., Cantarero Arevalo, Lourdes, Persson, C. L., Bekker, C. L., Lindell, Johanna Falby & Druedahl, Louise C., 2022, In: Research in Social and Administrative Pharmacy. 18, 1, p. 2254-2258

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

  66. 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

  67. 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

  68. 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

  69. 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

  70. Published

    Effects of green tea or green tea catechin on liver enzymes in healthy individuals and people with nonalcoholic fatty liver disease: A systematic review and meta-analysis of randomized clinical trials

    Mahmoodi, M., Hosseini, R., Kazemi, A., Ofori-Asenso, R., Mazidi, M. & Mazloomi, S. M., 2020, In: Phytotherapy Research. 34, 7, p. 1587-1598

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

  71. Published

    Pharmacogenetic-Pharmacokinetic Interactions in Drug Marketing Authorization Applications via the European Medicines Agency between 2014 and 2017

    Maliepaard, M., Toiviainen, T., De Bruin, M. L. & Meulendijks, D., 2020, In: Clinical Pharmacology and Therapeutics. 108, 2, p. 338-349

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

  72. 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

  73. 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

  74. Published

    Novel Treatment Strategies for Secondary Prevention of Cardiovascular Disease: A Systematic Review of Cost-Effectiveness

    Marquina, C., Zomer, E., Vargas-Torres, S., Zoungas, S., Ofori-Asenso, R., Liew, D. & Ademi, Z., 2020, In: PharmacoEconomics. 19 p.

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

  75. 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

  76. 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

  77. Published

    Dietary patterns are associated with likelihood of hepatic steatosis among US adults

    Mazidi, M., Ofori-Asenso, R. & Kengne, A. P., 2020, In: Journal of Gastroenterology and Hepatology. 35, 11, p. 1916-1922 7 p.

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

  78. In preparation

    The Work 'Digital' Does in Pharmaceutical Markets

    Milne, G., Traulsen, Janine Marie & Møllebæk, Mathias, 2024, (In preparation) Science and Technology Studies (STS) Handbook of Global Pharmaceutical, Biotherapeutics and Society Studies.. Douglas, C., Geiger, S., Kleinhout-Vliek, T., Martin, P. & Wadmann, S. (eds.). Edward Elgar Publishing

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

  79. 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

  80. 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

  81. Published

    POST-MARKETING RISK COMMUNICATION: HOW DO DANISH GPS READ LETTERS FROM REGULATORS AND INDUSTRY ABOUT EMERGENT RISKS?

    Møllebæk, Mathias, Kaae, Susanne & Villadsen, L. S., Dec 2019, p. E46-E46.

    Research output: Contribution to conference › Conference abstract for conference › Research › peer-review

  82. Published

    Hydroxysine initiation following drug safety advisories on cardiac arrhythmias in the UK and Canada: A longitudinal cohort study

    Morrow, R., Mintzes, B., Souverein, P., Hallgreen, Christine Erikstrup, Ahmed, B., Roughead, E., De Bruin, M. L., Kristiansen, S., Lexchin, J., Kemp-Casey, A., Sketris, I., Mangin, D., Pearson, S., Puil, L., Lopert, R., Bero, L., Gnjidic, D., Sarpatwari, A. & Dormuth, C., 2022, In: Pharmacoepidemiology and Drug Safety. 31, S2, p. 76-76 1 p.

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

  83. Published

    Hydroxyzine Initiation Following Drug Safety Advisories on Cardiac Arrhythmias in the UK and Canada: A Longitudinal Cohort Study

    Morrow, R. L., Mintzes, B., Souverein, P. C., Hallgreen, Christine Erikstrup, Ahmed, B., Roughead, E. E., De Bruin, M. L., Kristiansen, S. B., Lexchin, J., Kemp-Casey, A., Sketris, I., Mangin, D., Pearson, S. A., Puil, L., Lopert, R., Bero, L., Gnjidic, D., Sarpatwari, A. & Dormuth, C. R., 2022, In: Drug Safety. 45, p. 623–638

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

  84. 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

  85. 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

  86. 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 proceeding › Book chapter › Research › peer-review

  87. Published

    Rhetoric and STS

    Møllebæk, Mathias, 2020, Communicating about Risks and Safe Use of Medicines: Real Life and Applied Research. Bahri, P. (ed.). Springer, p. 267-284

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

  88. 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

  89. 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

  90. Published

    Targeting with digital biomarkers and digital therapeutics: Epistemic and regulatory shifts

    Møllebæk, Mathias, 2024.

    Research output: Contribution to conference › Conference abstract for conference › Research › peer-review

  91. In preparation

    Developing and updating clinical practice guidelines in the European Union: Exploring governance and work processes in six member states

    Møllebæk, Mathias, Almarsdóttir, Anna Birna, Bikou, A., Kodrič, A., Andersen, A., Kontogiorgis, C., Poplavska, E., Ahmadizar, F., Dermiki-Gkana, F., Rutkovska, I., Ribeiro-Vaz , I., Kos, M., Sousa Ferreira, P. B., Grupstra , R., Alves, T. L. & Almarsdóttir, Anna Birna, 2024, (In preparation) In: Health Policy.

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

  92. In preparation

    Early access approaches to the regulation of medicines

    Møllebæk, Mathias, 2024, (In preparation) Handbook of Global Pharmaceutical and Society Studies. Edward Elgar Publishing

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

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

  94. Submitted

    Challenges in the implementation of EU risk minimization measures for medicinal products in clinical practice guidelines: mixed methods multi-case study

    Møllebæk, Mathias, Gardarsdottir, H., Bikou, A., Kodrič, A., Silva , A. M., Andersen, A., Kontogiorgis, C., Poplavska, E., Ahmadizar, F., Dermiki-Gkana, F., Rutkovska, I., Ribeiro-Vaz , I., Kos, M., Sousa Ferreira, P. B., Grupstra , R., Alves, T. L. & Almarsdóttir, Anna Birna, 4 Feb 2024, (Submitted) In: Drug Safety.

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

  95. Published

    The effectiveness of direct to healthcare professional communication – A systematic review of communication factor studies

    Møllebæk, Mathias, Kaae, Susanne, De Bruin, M. L., Callréus, T., Jossan, S. & Hallgreen, Christine Erikstrup, May 2019, In: Research in Social and Administrative Pharmacy. 15, 5, p. 475-482

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

  96. Published

    Health and Human Rights: Ethical Issues of Outsourcing Clinical Trials

    Møllebæk, Mathias, 8 Dec 2018

    Research output: Other contribution › Net publication - Internet publication › Research

  97. Published

    Body of evidence and approaches applied in the clinical development programme of fixed-dose combinations in the European Union from 2010 to 2016

    Nøhr-Nielsen, A., De Bruin, M. L., Thomsen, M., Pipper, C. B., Lange, Theis, Bjerrum, Ole Jannik & Lund, Trine Meldgaard, 2019, In: British Journal of Clinical Pharmacology. 85, 8, p. 1829-1840 12 p.

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

  98. Published

    A closer look at the World Health Organization's prescribing indicators: J Pharmacol Pharmacother

    Ofori-Asenso, R., 2016, In: Journal of Pharmacology and Pharmacotherapeutics. 7, p. 51-54 4 p.

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

  99. 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

  100. Published

    Improving Interactions Between Health Technology Assessment Bodies and Regulatory Agencies: A Systematic Review and Cross-Sectional Survey on Processes, Progress, Outcomes, and Challenges

    Ofori-Asenso, R., Hallgreen, Christine Erikstrup & De Bruin, M. L., 2020, In: Frontiers in Medicine. 7, 17 p., 582634.

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

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