- 2017
- 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
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
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
- 2018
- 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
- 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
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
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
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247
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Novel Treatment Strategies for Secondary Prevention of Cardiovascular Disease: A Systematic Review of Cost-Effectiveness
Research output: Contribution to journal › Review › Research › peer-review
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237
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MEDICINES AUTHORITY REGULATOR AND INDUSTRY PERCEPTIONS OF BIOSIMILAR INTERCHANGEABILITY
Research output: Contribution to conference › Conference abstract for conference › Research › peer-review
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177
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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
Research output: Chapter in Book/Report/Conference proceeding › Book chapter › Research › peer-review