- 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. 1656–1665Research output: Contribution to journal › Journal article › Research › peer-review
- 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. 1215–1230Research output: Contribution to journal › Journal article › Research › peer-review
- 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. 2105-2115Research output: Contribution to journal › Journal article › Research › peer-review
- 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
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. 1312-1313Research output: Contribution to journal › Conference abstract in journal › Research › peer-review
- 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, , 2023, In: Drug Safety. 46, 7, p. 689-702Research output: Contribution to journal › Journal article › Research › peer-review
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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. 80-90Research output: Contribution to journal › Review › 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
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. 1424-1442Research output: Contribution to journal › Journal article › Research › peer-review
- 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. 713-722Research 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
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
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
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
- 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
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
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
- 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
- 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
- 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
- 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
- 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. 474–482Research output: Contribution to journal › Journal article › Research › peer-review
- 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. 1749-1768Research output: Contribution to journal › Journal article › 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
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
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
- 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
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
- 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
- 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
- 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. 351-361Research output: Contribution to journal › Journal article › Research › peer-review
- 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
- 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
- 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
- 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
- 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
- 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. 579-582Research output: Contribution to journal › Journal article › Research › peer-review
- 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, , 2023, In: Frontiers in Pharmacology. 14, 12 p., 1207976.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
- 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. 1416-1429Research output: Contribution to journal › Journal article › Research › peer-review
- 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. 631-639Research 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
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
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Novel Treatment Strategies for Secondary Prevention of Cardiovascular Disease: A Systematic Review of Cost-Effectiveness
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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
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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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