- 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
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Novel Treatment Strategies for Secondary Prevention of Cardiovascular Disease: A Systematic Review of Cost-Effectiveness
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233
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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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Latest publications
Medicines safety information from regulators in clinical practice guidelines: a mixed-method case study
Research output: Contribution to journal › Journal article › Research › peer-review
Challenges in the implementation of EU risk minimization measures for medicinal products in clinical practice guidelines: mixed methods multi-case study
Research output: Contribution to journal › Journal article › Research › peer-review
The Work 'Digital' Does in Pharmaceutical Markets
Research output: Chapter in Book/Report/Conference proceeding › Book chapter › Research › peer-review