- 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. 581-591Research output: Contribution to journal › Journal article › Research › peer-review
- 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
- 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
- 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
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
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. 1656-1657Research output: Contribution to journal › Conference abstract in journal › Research › peer-review
- 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, , 2021, In: Frontiers in Pharmacology. 12, 14 p., 682890.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
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
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. 1-17Research output: Contribution to journal › Journal article › Research › peer-review
- 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
- 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
- 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. 133-138Research output: Contribution to journal › Journal article › Research › peer-review
- 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. 625-632Research output: Contribution to journal › Journal article › Research › peer-review
- 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
- 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
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
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
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
- 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
- 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
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. 2254-2258Research output: Contribution to journal › Journal article › Research › peer-review
- 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
- 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
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. 988-1000Research output: Contribution to journal › Journal article › Research › peer-review
- 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. 328-336Research 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
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
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
- 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
- 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
- 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
- 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. 17-29Research output: Contribution to journal › Journal article › 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
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
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
- In preparation
Early access approaches to the regulation of medicines
Møllebæk, Mathias, 2024, (In preparation) Handbook of Global Pharmaceutical and Society Studies. Edward Elgar PublishingResearch output: Chapter in Book/Report/Conference proceeding › Encyclopedia chapter › 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
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
- 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. 500-507Research output: Contribution to journal › Journal article › Research › peer-review
- 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. 1587-1598Research output: Contribution to journal › Review › 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
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
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
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
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
- 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
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
- 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
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
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
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
Health and Human Rights: Ethical Issues of Outsourcing Clinical Trials
Møllebæk, Mathias, 8 Dec 2018Research output: Other contribution › Net publication - Internet publication › Research
- Published
How and Why to Involve Patients in Drug Development: Perspectives from the Pharmaceutical Industry, Regulatory Authorities and Patient Organizations
Hansen, M. B., Nørgaard, Lotte Stig & Hallgreen, Christine Erikstrup, 2020, In: Therapeutic Innovation & Regulatory Science. 54, p. 577-585 9 p.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
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
Hydroxysine initiation following drug safety advisories on cardiac arrhythmias in the UK and Canada: A longitudinal cohort study
Morrow, R., Mintzes, B., Souverein, P., Hallgreen, Christine Erikstrup, Ahmed, B., Roughead, E., De Bruin, M. L., Kristiansen, S., Lexchin, J., Kemp-Casey, A., Sketris, I., Mangin, D., Pearson, S., Puil, L., Lopert, R., Bero, L., Gnjidic, D., Sarpatwari, A. & Dormuth, C., 2022, In: Pharmacoepidemiology and Drug Safety. 31, S2, p. 76-76 1 p.Research output: Contribution to journal › Conference abstract in journal › Research › peer-review
- Published
Hydroxyzine Initiation Following Drug Safety Advisories on Cardiac Arrhythmias in the UK and Canada: A Longitudinal Cohort Study
Morrow, R. L., Mintzes, B., Souverein, P. C., Hallgreen, Christine Erikstrup, Ahmed, B., Roughead, E. E., De Bruin, M. L., Kristiansen, S. B., Lexchin, J., Kemp-Casey, A., Sketris, I., Mangin, D., Pearson, S. A., Puil, L., Lopert, R., Bero, L., Gnjidic, D., Sarpatwari, A. & Dormuth, C. R., 2022, In: Drug Safety. 45, p. 623–638Research output: Contribution to journal › Journal article › 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
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
Impact of a Treatment Guide on Intravenous Fluids in Minimising the Risk of Hospital-Acquired Hyponatraemia in Denmark
Sindahl, Per, Overgaard-Steensen, C., Wallach-Kildemoes, H., De Bruin, M. L., Kemp, K. & Gardarsdottir, H., 2023, In: Journal of Clinical Medicine. 12, 15, 14 p., 5105.Research output: Contribution to journal › Journal article › Research › peer-review
- Published
Impact of implementing a guide on intravenous fluids to minimize the risk of hospital-acquired hyponatremia in Denmark
Sindahl, Per, Overgaard-Steensen, C., Wallach-Kildemoes, H., De Bruin, M. L., Kemp, K. & Gardarsdottir, H., 2022, In: Pharmacoepidemiology and Drug Safety. 31, S2, p. 184-185Research output: Contribution to journal › Conference abstract in journal › Research › peer-review
- Published
Impact of regulatory interventions to restrict the combined use of renin-angiotensin system-acting agents: A Danish nationwide drug utilisation study
Sindahl, Per, Ofori-Asenso, R., Hallgreen, Christine Erikstrup, Kemp, K., Gardarsdottir, H. & Bruin, M. L. D., 2022, In: British Journal of Clinical Pharmacology. 88, 3, p. 1379-1384Research output: Contribution to journal › Journal article › Research › peer-review
- 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
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
- Submitted
Implementation of electronic distribution of Direct Healthcare Professional Communications (DHPCs) by the Danish Medicines Agency: A survey study of physicians’ experiences and preferences
Sindahl, P., Møllebæk, Mathias, Gardarsdottir, H., De Bruin, M. L. (., Hallgreen, Christine Erikstrup & Clemmensen, M. H., 2023, (Submitted) In: Therapeutic Advances in Drug Safety.Research output: Contribution to journal › Journal article › Research › peer-review
- Published
Improving Interactions Between Health Technology Assessment Bodies and Regulatory Agencies: A Systematic Review and Cross-Sectional Survey on Processes, Progress, Outcomes, and Challenges
Ofori-Asenso, R., Hallgreen, Christine Erikstrup & De Bruin, M. L., 2020, In: Frontiers in Medicine. 7, 17 p., 582634.Research output: Contribution to journal › Review › 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
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
Influence of drug safety advisories on drug utilisation: an international interrupted time series and meta-analysis
Morrow, R. L., Mintzes, B., Souverein, P. C., De Bruin, M. L., Roughead, E. E., Lexchin, J., Kemp-Casey, A., Puil, L., Sketris, I., Mangin, D., Hallgreen, Christine Erikstrup, Pearson, S., Lopert, R., Bero, L., Ofori-Asenso, R., Gnjidic, D., Sarpatwari, A., Perry, L. T. & Dormuth, C. R., 2022, In: BMJ quality & safety. 31, 3, p. 179–190Research output: Contribution to journal › Journal article › Research › peer-review
- Published
Influence of drug safety advisories on drug utilization: An international interrupted time series and meta-analysis study
Morrow, R. L., Mintzes, B., Souverein, P. C., De Bruin, M. L., Roughead, E. E., Lexchin, J., Kemp-Casey, A., Puil, L., Sketris, I., Mangin, D., Hallgreen, Christine Erikstrup, Pearson, S., Lopert, R., Bero, L., Ofori-Asenso, R., Gnjidic, D., Sarpatwari, A. & Dormuth, C. R., Aug 2021, In: Pharmacoepidemiology and Drug Safety. 30, S1, p. 33-34Research output: Contribution to journal › Conference abstract in journal › Research
- Accepted/In press
Information Sources for Drug Safety and Communicating Risks in Clinical Practice
Tong, V., Møllebæk, Mathias & Aslani, P., 2024, (Accepted/In press) Principles and Practice of Pharmacovigilance and Drug Safety. Jose, J., Cox, A. R. & Paudyal, V. (eds.). SpringerResearch output: Chapter in Book/Report/Conference proceeding › Book chapter › Research › peer-review
- 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
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
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
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
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
Machine learning-driven development of a disease risk score for COVID-19 hospitalization and mortality: a Swedish and Norwegian register-based study
Shakibfar, Saeed, Zhao, J., Li, H., Nordeng, H., Lupattelli, A., Pavlovic, M., Sandve, G. K., Nyberg, F., Wettermark, B., Hajiebrahimi, M., Andersen, Morten & Sessa, Maurizio, 2023, In: Frontiers in Public Health. 11, 16 p., :1258840.Research output: Contribution to journal › Journal article › Research › peer-review
- Published
Major bleeding in users of direct oral anticoagulants in atrial fibrillation: A pooled analysis of results from multiple population-based cohort studies
van den Ham, H. A., Souverein, P. C., Klungel, O. H., Platt, R. W., Ernst, P., Dell'Aniello, S., Schmiedl, S., Grave, B., Rottenkolber, M., Huerta, C., Martin Merino, E., Leon-Munoz, L. M., Montero, D., Andersen, Morten, Aakjær, Mia, De Bruin, M. L. & Gardarsdottir, H., 2021, In: Pharmacoepidemiology and Drug Safety. 30, 10, p. 1339-1352Research 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
Marketing authorization pathways and clinical evidence supporting approval of orphan medicinal products in EU between January 2015 and October 2021
Hallgreen, Christine Erikstrup, Møllebæk, Mathias & Corap, E., 2022, In: Pharmacoepidemiology and Drug Safety. 31, S2, p. 266-267Research output: Contribution to journal › Conference abstract in journal › Research › peer-review
- Published
Maternal and neonatal outcomes associated with COVID-19 infection: A systematic review
Smith, V., Seo, D., Warty, R., Payne, O., Salih, M., Chin, K. L., Ofori-Asenso, R., Krishnan, S., da Silva Costa, F., Vollenhoven, B. & Wallace, E., 2020, In: PLoS ONE. 15, 6, 13 p., 0234187.Research output: Contribution to journal › Review › 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
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
Medication Adherence Measurement Methods in Registration Trials Supporting the Approval of New Medicines: A Cross-Sectional Analysis of Centralized Procedures in the European Union 2010–2020
Mantila, K. M., Pasmooij, A. M. G., Hallgreen, Christine Erikstrup, Mol, P. G. M. & van Boven, J. F. M., 2022, In: Clinical Pharmacology and Therapeutics. 112, 5, p. 1051-1060Research output: Contribution to journal › Journal article › Research › peer-review
- Published
Medication adherence in registration trials supporting the approval of new medicines in the European Union
Mantila, K. M., Mol, P. G. M., Pasmooij, M., Hallgreen, Christine Erikstrup & van Boven, J. F. M., 2022, In: International Journal of Clinical Pharmacy. 44, 1, p. 279-280Research output: Contribution to journal › Conference abstract in journal › 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
- 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
Methodological and disciplinary competence and insecurity in qualitative research
Kälvemark Sporrong, Sofia, Kaae, Susanne, Nørgaard, Lotte Stig, Møllebæk, Mathias, Cantarero Arevalo, Lourdes, Druedahl, Louise C., Waaseth, M., Ljungberg Persson, C., Bekker, C. L. & Lindell, Johanna Falby, 2022, Contemporary research methods in pharmacy and health services. Desselle, S. P., Garcia-Cárdenas, V., Anderson, C., Aslani, P., Chen, A. M. H. & Chen, T. F. (eds.). 1 ed. Academic Press, p. 567-574Research output: Chapter in Book/Report/Conference proceeding › Book chapter › Research › peer-review
- Published
Mod en hverdagsetik for lægemiddelbrug: Towards an everyday ethics for medicines use: About people, medicines and multiplicity
Lau, Sofie Rosenlund & Møllebæk, Mathias, 2022, In: Tidsskrift for Forskning i Sygdom og Samfund. 19, 37, p. 19-41 22 p.Research output: Contribution to journal › Journal article › Research › peer-review
- Published
New Information on Old Medicinal Products: A Cross-Sectional Analysis of Guidance for Paediatric Use for Substances on the European Priority List of Off-Patent Medicinal Products
Mogensen, A. K. B., Christiansen, Helle, De Bruin, M. L. & Hallgreen, Christine Erikstrup, 2022, In: Pediatric Drugs. 24, p. 679–687Research output: Contribution to journal › Journal article › Research › peer-review
- Published
Novel Treatment Strategies for Secondary Prevention of Cardiovascular Disease: A Systematic Review of Cost-Effectiveness
Marquina, C., Zomer, E., Vargas-Torres, S., Zoungas, S., Ofori-Asenso, R., Liew, D. & Ademi, Z., 2020, In: PharmacoEconomics. 19 p.Research output: Contribution to journal › Review › Research › peer-review
- Published
POST-MARKETING RISK COMMUNICATION: HOW DO DANISH GPS READ LETTERS FROM REGULATORS AND INDUSTRY ABOUT EMERGENT RISKS?
Møllebæk, Mathias, Kaae, Susanne & Villadsen, L. S., Dec 2019, p. E46-E46.Research output: Contribution to conference › Conference abstract for conference › Research › peer-review
- Published
Paper Tigers in the Clinic? Rhetorical Argument Fields in Health Policy Implementation
Møllebæk, Mathias, 2023, Rhetorical Argumentation: The Copenhagen School: Windsor Studies in Argumentation. Kock, C. & Lantz, M. (eds.). Windsor, ON, Vol. 13. p. 408-433Research output: Chapter in Book/Report/Conference proceeding › Book chapter › Research › peer-review
- Published
Perspectives on how to build bridges between regulation, health technology assessment and clinical guideline development: a qualitative focus group study with European experts
Hogervorst, M. A., Møllebæk, Mathias, Vreman, R. A., Lu, T. A., Wang, J., De Bruin, M. L., Leufkens, H. G. M., Mantel-Teeuwisse, A. & Goettsch, W., 2023, In: BMJ Open. 13, 8, 11 p., e072309.Research output: Contribution to journal › Journal article › Research › peer-review
- Published
Pharmaceuticalization
Møllebæk, Mathias, 2021, Palgrave Encyclopedia of Health Humanities. Crawford, P. & Kadetz, P. (eds.). Springer, 5 p.Research output: Chapter in Book/Report/Conference proceeding › Encyclopedia chapter › Research › peer-review
- Published
Pharmacogenetic-Pharmacokinetic Interactions in Drug Marketing Authorization Applications via the European Medicines Agency between 2014 and 2017
Maliepaard, M., Toiviainen, T., De Bruin, M. L. & Meulendijks, D., 2020, In: Clinical Pharmacology and Therapeutics. 108, 2, p. 338-349Research output: Contribution to journal › Journal article › Research › peer-review
- Published
Poor adherence and persistence to sodium glucose co-transporter 2 inhibitors in real world settings: evidence from a systematic review and meta-analysis
Ofori-Asenso, R., Sahle, B. W., Chin, K. L., Mazidi, M., Ademi, Z., De Bruin, M. L. & Liew, D., 2021, In: Diabetes/Metabolism Research and Reviews. 37, 1, 11 p., e3350.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
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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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