- 2024
- 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
- 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
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
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
- 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
- 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
Targeting with digital biomarkers and digital therapeutics: Epistemic and regulatory shifts
Møllebæk, Mathias, 2024.Research output: Contribution to conference › Conference abstract for conference › Research › peer-review
- In preparation
The Work 'Digital' Does in Pharmaceutical Markets
Milne, G., Traulsen, Janine Marie & Møllebæk, Mathias, 2024, (In preparation) Science and Technology Studies (STS) Handbook of Global Pharmaceutical, Biotherapeutics and Society Studies.. Douglas, C., Geiger, S., Kleinhout-Vliek, T., Martin, P. & Wadmann, S. (eds.). Edward Elgar PublishingResearch output: Chapter in Book/Report/Conference proceeding › Book chapter › Research › peer-review
- 2023
- 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
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 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 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
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
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
Regional Disparity in First-in-Class Anticancer Drug Development in the US, EU, and Japan
Hino, Y., Okada, M., Hallgreen, Christine Erikstrup, De Bruin, M. L., Doty, R. E., Matsumaru, N. & Tsukamoto, K., 2023, In: Biological and Pharmaceutical Bulletin. 46, 5, p. 700-706Research 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
- 2022
- 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
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
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
- 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
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
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 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
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
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
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
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
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
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
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
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
- 2021
- 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
- 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
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
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
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
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
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
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
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
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
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
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
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
Prescribers' compliance with summary of product characteristics of dabigatran, rivaroxaban and apixaban—A European comparative drug utilization study
Rottenkolber, M., Schmiedl, S., Ibáñez, L., Sabate, M., Ballarin, E., Vidal, X., Leon-Munoz, L. M., Huerta, C., Merino, E. M., Montero, D., Gasse, C., Andersen, Morten, Aakjær, Mia, De Bruin, M. L. (., Gerlach, R. G., Tauscher, M., Souverein, P. C., Van den Ham, R., Klungel, O. H. & Gardarsdottir, H., 2021, In: Basic & Clinical Pharmacology & Toxicology. 128, 3, p. 440-454Research output: Contribution to journal › Journal article › Research › peer-review
- Published
Prevalence and correlates of falls in a middle-aged population with osteoarthritis: Data from the Osteoarthritis Initiative
Ofori-Asenso, R., Ackerman, I. N. & Soh, S., 2021, In: Health and Social Care in the Community (Print Edition). 29, 2, p. 436-444 9 p.Research output: Contribution to journal › Journal article › Research › peer-review
- Published
Rationing health and social goods during pandemics: Guidance for Ghanaian decision makers
Laar, A., DeBruin, D., Ofori-Asenso, R., Laar, M. E., Redman, B. & Caplan, A., 2021, In: Clinical Ethics. 16, 3, p. 165-170Research output: Contribution to journal › Journal article › Research › peer-review
- Published
Real-world adherence, persistence, and in-class switching during use of dipeptidyl peptidase-4 inhibitors: a systematic review and meta-analysis involving 594,138 patients with type 2 diabetes
Ogundipe, O., Mazidi, M., Chin, K. L., Gor, D., McGovern, A., Sahle, B. W., Jermendy, G., Korhonen, M. J., Appiah, B., Ademi, Z., De Bruin, M. L., Liew, D. & Ofori-Asenso, R., 2021, In: Acta Diabetologica. 58, 1, p. 39-46Research output: Contribution to journal › Journal article › Research › peer-review
- Published
Regulating Patient Access to Therapeutics in Denmark: a Rhetorical Analysis of Welfare Imaginaries in Public Controversy
Møllebæk, Mathias, 2021, In: Journal of Law and the Biosciences . 8, 2, 19 p., Isaa047.Research output: Contribution to journal › Journal article › Research › peer-review
- Published
Regulatory density as a means to refine current regulatory approaches for increasingly complex medicines
Klein, K., Stolk, P., De Bruin, M. L. & Leufkens, H., 2021, In: Drug Discovery Today. 26, 10, p. 2221-2225Research 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
Why do general practitioners disregard direct to healthcare professional communication? A user-oriented evaluation to improve drug safety communication
Møllebæk, Mathias & Kaae, Susanne, 2021, In: Basic & Clinical Pharmacology & Toxicology. 128, 3, p. 463-471 9 p.Research output: Contribution to journal › Journal article › Research › peer-review
- 2020
- 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
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
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
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
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
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 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 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
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
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
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
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
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
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
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
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
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
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
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
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
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
Prevalence and attributable health burden of chronic respiratory diseases, 1990–2017: a systematic analysis for the Global Burden of Disease Study 2017
Soriano, J. B., Kendrick, P. J., Paulson, K. R., Gupta, V., Abrams, E. M., Adedoyin, R. A., Adhikari, T. B., Advani, S. M., Agrawal, A., Ahmadian, E., Alahdab, F., Aljunid, S. M., Altirkawi, K. A., Alvis-Guzman, N., Anber, N. H., Andrei, C. L., Anjomshoa, M., Ansari, F., Antó, J. M., Arabloo, J. & 232 others, , 2020, In: The Lancet Respiratory Medicine. 8, 6, p. 585-596 12 p.Research output: Contribution to journal › Journal article › 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
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
- Published
Rhetoric and STS
Møllebæk, Mathias, 2020, Communicating about Risks and Safe Use of Medicines: Real Life and Applied Research. Bahri, P. (ed.). Springer, p. 267-284Research output: Chapter in Book/Report/Conference proceeding › Book chapter › Research
- 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
The Frequency of, and Factors Associated with Prolonged Hospitalization: A Multicentre Study in Victoria, Australia
Ofori-Asenso, R., Liew, D., Martensson, J. & Jones, D., 2020, In: Journal of Clinical Medicine. 9, 9, 14 p., 3055.Research output: Contribution to journal › Journal article › 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
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
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
- 2019
- 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
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
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
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
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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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