- 2019
- 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, , Aug 2019, p. 397-397.Research output: Contribution to conference › Conference abstract for conference › Research › peer-review
- 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
- 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
- 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. 475-482Research output: Contribution to journal › Review › Research › peer-review
- 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
- 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, , 7 Mar 2019, In: Blood. 133, 10, p. 1130-1139 10 p.Research output: Contribution to journal › Journal article › Research › peer-review
- 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
- 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. 2719-2734Research output: Contribution to journal › Journal article › Research › peer-review
- 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
- 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
- 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
- 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
- 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, , 2019, In: British Journal of Clinical Pharmacology. Supplement. 85, p. 2524-2539Research output: Contribution to journal › Journal article › Research › peer-review
- 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
- 2018
- Published
Health and Human Rights: Ethical Issues of Outsourcing Clinical Trials
Møllebæk, Mathias, 8 Dec 2018Research output: Other contribution › Net publication - Internet publication › Research
- 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
- 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. 1328-1333Research output: Contribution to journal › Review › Research › peer-review
- 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. 296-303Research output: Contribution to journal › Journal article › Research › peer-review
- 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. 120-127Research output: Contribution to journal › Review › Research › peer-review
- 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. 517-517Research output: Contribution to journal › Conference abstract in journal › Research › peer-review
- 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
- 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
- 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
- 2017
- 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. 1442-1450Research output: Contribution to journal › Journal article › Research › peer-review
- 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. 1691-1703Research output: Contribution to journal › Journal article › Research › peer-review
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 2016
- 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
- 2015
- 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
- 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
- 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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247
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Novel Treatment Strategies for Secondary Prevention of Cardiovascular Disease: A Systematic Review of Cost-Effectiveness
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237
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MEDICINES AUTHORITY REGULATOR AND INDUSTRY PERCEPTIONS OF BIOSIMILAR INTERCHANGEABILITY
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Cancer risk among insulin users: comparing analogues with human insulin in the CARING five-country cohort study
Research output: Contribution to journal › Journal article › Research › peer-review
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Medicines safety information from regulators in clinical practice guidelines: a mixed-method case study
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Challenges in the implementation of EU risk minimization measures for medicinal products in clinical practice guidelines: mixed methods multi-case study
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The Work 'Digital' Does in Pharmaceutical Markets
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