Copenhagen Centre for Regulatory Science

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  1. Published

    "Biosimilar, so it looks alike, but what does it mean?" A qualitative study of Danish patients' perceptions of biosimilars

    Varma, M., Almarsdóttir, Anna Birna & Druedahl, Louise C., 2022, In: Basic & Clinical Pharmacology & Toxicology. 130, 5, p. 581-591

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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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

  10. 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

  11. 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

  12. 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

  13. 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

  14. 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

  15. 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

  16. 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

  17. 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

  18. 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

  19. 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

  20. 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

  21. 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

  22. 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

  23. 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

  24. 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

  25. 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

  26. 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

  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

  28. 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

  29. 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

  30. 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

  31. 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

  32. 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

  33. 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

  34. Published

    Drug Repurposing in Crohn's Disease Using Danish Real-World Data

    Shakibfar, Saeed, Allin, K. H., Jess, T., Barbieri, M. A., Battini, V., Simoncic, E., Kirchgesner, J., Ulven, Trond & Sessa, Maurizio, 2024, In: Pragmatic and observational research. 15, p. 17-29

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

  35. Published

    Dynamics of switching, adherence, and persistence of dipeptidyl peptidase-4 inhibitors use: A nationwide cohort study

    Ofori-Asenso, R., Ilomaki, J., Chin, K. L., Mazidi, M., Zomer, E., Bell, J. S., Magliano, D. J. & Liew, D., 2019, In: Diabetes Research and Clinical Practice. 158, 10 p., 107909.

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

  36. 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

  37. Published

    EU decision-making for marketing authorization of advanced therapy medicinal products: a case study

    de Wilde, S., Coppens, D. G. M., Hoekman, J., de Bruin, M. L., Leufkens, H. G. M., Guchelaar, H. & Meij, P., Jul 2018, In: Drug Discovery Today. 23, 7, p. 1328-1333

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

  38. 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

  39. 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

  40. 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

  41. Published

    Effects of Statins for Secondary Prevention on Functioning and Other Outcomes Among Nursing Home Residents

    Zullo, A. R., Ofori-Asenso, R., Wood, M., Zuern, A., Lee, Y., Wu, W., Rudolph, J. L., Liew, D. & Steinman, M. A., 2020, In: Journal of the American Medical Directors Association. 21, 4, p. 500-507

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

  42. 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

  43. 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

  44. Published

    Evidence Synthesis in Harm Assessment of Medicines Using the Example of Rosiglitazone and Myocardial Infarction

    Rietbergen, C., Stefansdottir, G., Leufkens, H. G., Knol, M. J., De Bruin, M. L. & Klugkist, I., 2018, In: Frontiers in Medicine. 4, 12 p., 228.

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

  45. Published

    Evidence synthesis in harm assessment of medicines using the example of rosiglitazone and myocardial infarction

    Rietbergen, C., Stefansdottir, G., Leufkens, H. G., Knol, M. J., De Bruin, M. L. & Klugkist, I., 1 Jan 2017, In: Frontiers in Medicine. 4, FEB, 228.

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

  46. 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

  47. 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

  48. 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

  49. Published

    Frailty Confers High Mortality Risk across Different Populations: Evidence from an Overview of Systematic Reviews and Meta-Analyses

    Ofori-Asenso, R., Chin, K. L., Sahle, B. W., Mazidi, M., Zullo, A. R. & Liew, D., 2020, In: Geriatrics (Switzerland). 5, 1, 14 p., 17.

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

  50. Published

    Genetic susceptibility to radiation-induced breast cancer after Hodgkin lymphoma

    Opstal-van Winden, A. W. J., de Haan, H. G., Hauptmann, M., Schmidt, M. K., Broeks, A., Russell, N. S., Janus, C. P. M., Krol, A. D. G., van der Baan, F. H., De Bruin, M. L., van Eggermond, A. M., Dennis, J., Anton-Culver, H., Haiman, C. A., Sawyer, E. J., Cox, A., Devilee, P., Hooning, M. J., Peto, J., Couch, F. J. & 10 others, Pharoah, P., Orr, N., Easton, D. F., Aleman, B. M. P., Strong, L. C., Bhatia, S., Cooke, R., Robison, L. L., Swerdlow, A. J. & van Leeuwen, F. E., 7 Mar 2019, In: Blood. 133, 10, p. 1130-1139 10 p.

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

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