- 2020
- 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
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
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
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
Media coverage of drug regulatory agencies' safety advisories: A case study of citalopram and denosumab
Fabbri, A., O'Keeffe, M., Moynihan, R., Møllebæk, Mathias, Mohammad, A., Bhasale, A., Puil, L. & Mintzes, B., 2020, In: British Journal of Clinical Pharmacology. 86, 7, p. 1416-1429Research output: Contribution to journal › Journal article › Research › peer-review
- Published
Preparation of Direct Healthcare Professional Communication: An Exploratory Study on the Experiences and Perceptions of European Pharmaceutical Companies and the EMA
Fanø, A. B., Møllebæk, Mathias & Kaae, Susanne, May 2020, In: Therapeutic Innovation & Regulatory Science. 54, 3, p. 631-639Research output: Contribution to journal › Journal article › Research › peer-review
- Published
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
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
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
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
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247
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Novel Treatment Strategies for Secondary Prevention of Cardiovascular Disease: A Systematic Review of Cost-Effectiveness
Research output: Contribution to journal › Review › Research › peer-review
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237
downloads
MEDICINES AUTHORITY REGULATOR AND INDUSTRY PERCEPTIONS OF BIOSIMILAR INTERCHANGEABILITY
Research output: Contribution to conference › Conference abstract for conference › Research › peer-review
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177
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Cancer risk among insulin users: comparing analogues with human insulin in the CARING five-country cohort study
Research output: Contribution to journal › Journal article › Research › peer-review
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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