Copenhagen Centre for Regulatory Science

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  1. 2019
  2. 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

  3. Published

    Risk of major bleeding associated with the use of direct oral anticoagulants compared to vitamin K antagonists in patients with atrial fibrillation: A European multi-country population-based cohort study

    Souverein, P. C., Van den Ham, H. A., Huerta, C., Martin Merino, E., Montero, D., Leon-Munoz, L. M., Schmiedl, S., Rottenkolber, M., Andersen, Morten, Aakjær, Mia, De Bruin, M. L., Klungel, O. H. & Gardarsdottir, H., Aug 2019, p. 553-553.

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

  4. Published

    Risk of major bleeding associated with the use of individual direct oral anticoagulants compared to vitamin K antagonists in patients with non-valvular atrial fibrillation: a meta-analysis of results from multiple population-based cohort studies using a common protocol in Europe and Canada

    van den Ham, H., Souverein, P., Klungel, O., Platt, R., Ernst, P., Dell'Aniello, S., Schmiedl, S., Grave, B., Rottenkolber, M., Huerta, C., Martin Merino, E., Leon-Munoz, L., Montero, D., Andersen, Morten, Aakjær, Mia, De Bruin, M. & Gardarsdottir, H., Aug 2019, p. 410-411.

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

  5. 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

  6. 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

  7. 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

  8. 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

  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

    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

  11. 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

  12. 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

  13. 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

  14. 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

  15. 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

  16. 2018
  17. 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

  18. Published

    Impact of the 2012 pharmacovigilance legislation on the harmonisation of DHPCS in the EU

    Olafsdottir, G., Bukhave, S. M., Kalligeros, G., Hallgreen, Christine Erikstrup & De Bruin, M. L., Aug 2018, p. 515-516.

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

  19. 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

  20. 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

  21. 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

  22. 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

  23. 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

  24. 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

  25. 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

  26. 2017
  27. 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

  28. 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

  29. 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

  30. Published

    Practical Points to Address Uncertainties in Risk Management Planning

    Shakir, S., Bloem, L., De Bruin, M. L., Hoekman, J., Leufkens, H. & Ryan, P., Aug 2017, p. 458-459.

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

  31. 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

  32. Published

    Infradiaphragmatic irradiation and high procarbazine doses increase colorectal cancer risk in Hodgkin lymphoma survivors

    van Eggermond, A. M., Schaapveld, M., Janus, C. P., de Boer, J. P., Krol, A. D., Zijlstra, J. M., van der Maazen, R. W., Kremer, L. C., van Leerdam, M. E., Louwman, M. W., Visser, O., De Bruin, M. L., Aleman, B. M. & van Leeuwen, F. E., 25 Jul 2017, In: B J C. 117, 3, p. 306-314 9 p.

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

  33. 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

  34. 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

  35. 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

  36. 2016
  37. 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

  38. 2015
  39. 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

  40. 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

  41. 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

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