Completed projects
Description
CORS funded project that monitored and explored the conditions for the development of FDC’s taking into account the differences in the available data for categories.
Collaboration between the University of Copenhagen departments of Pharmacy; Drug Design and Pharmacology; Public Health (Health and Medical Sciences), and Contera Pharma. Funding CORS partner:Novo Nordisk. PhD candidate: Asbjørn Nøhr-Nielsen.
CORS staff involved: Marie L. De Bruin
Outputs
Read the final PhD Thesis
Body of evidence and approaches applied in the clinical development program of fixed‐dose combinations in the European Union from 2010‐2016
A.Nøhr‐Nielsen, M.L.De Bruin, M.Thomsen, C.B.Pipper, T.Lange, O.J.Bjerrum, T.M.Lund
British Journal of Clinical Pharmacology. 2019; 85: 1829– 1840.
https://doi.org/10.1111/bcp.13986
Demonstrating Contribution of Components of Fixed-Dose Drug Combinations Through Longitudinal Exposure-Response Analysis
Nøhr-Nielsen, A., Lange, T., Forman, J.L. et al.
AAPS J (2020) 22: 32
https://doi.org/10.1208/s12248-020-0414-y
Pharmacodynamic modelling reveals synergistic interaction between docetaxel and SCO-101 in a docetaxel-resistant triple negative breast cancer cell line.
Nøhr-Nielsen A, Bagger SO, Brünner N, Stenvang J, Lund TM.
Eur J Pharm Sci. 2020;148:105315.
doi:10.1016/j.ejps.2020.105315
CORS funded project that aimed to identify and understand the factors that determine the effectiveness of drug safety communication such as Direct to Healthcare Professional Communication and educational materials, and set out to present suggestions on how to improve the existing communication process.
Collaboration between the University of Copenhagen departments of Pharmacy (Health and Medical Sciences), Media, Cognition and Communication (Humanities) and Ferring Pharmaceuticals. Funding CORS partner: Ferring Pharmaceuticals. PhD candidate: Mathias Møllebæk.
CORS staff involved: Christine E. Hallgreen.
Outputs
Read the final PhD Thesis.
The effectiveness of direct to healthcare professional communication – A systematic review of communication factor studies
Møllebæk M, Kaae S, De Bruin ML, Callréus T, Jossan S, Hallgreen CE.
Research in Social and Administrative Pharmacy. 2019 May;15(5):475-482.
https://doi.org/10.1016/j.sapharm.2018.06.015
Why do general practitioners disregard direct to healthcare professional communication? A user-oriented evaluation to improve drug safety communication
Mollebaek M, Kaae S
Basic Clinical Pharmacology Toxicology. 2020
https://doi.org/10.1111/bcpt.13516
Are Drug Safety Advisories Compatible with Physicians’ Information Behavior? Semi-Structured Interviews with GPs about Safety Information for Direct Oral Anticoagulants.
Therapeutic Advances in Drug Safety. 2020 aug 4. Pending review.
This CORS-funded project aimed to explore how different stakeholders interpret “similar,” and how these views impact the approval, development, and use of biosimilars.
Collaboration between the University of Copenhagen department of Pharmacy (Health and Medical Sciences) and the Centre for Advanced studies in Bio-medical Innovation Law (Faculty of Law). Funding CORS partner: LEO Pharma. PhD candidate: Louise C. Druedahl.
CORS staff involved: Marie L. De Bruin.
Outputs
Read the final PhD Thesis.
Published papers:
A qualitative study of biosimilar manufacturer and regulator perceptions on intellectual property and abbreviated approval pathways
LC. Druedahl, A. Birna Almarsdóttir, S. Kälvemark Sporrong, ML. De Bruin, H. Hoogland, T. Minssen, M. van de Weert, AS. Kesselheim, A. Sarpatwari
Nature Biotechnology 38, 1253–1256 (2020).
https://doi.org/10.1038/s41587-020-0717-7
Description
As the importance of personalized medicine is increasingly being recognized, there is a need to re-think the way in which medicines are currently being produced. Pharmacoprinting with 2D and 3D printers is a relatively new technology for producing/compounding medicine. Especially 3D printing of medicine comes with many new opportunities for creating personalized pills or capsules with different doses and delivery mechanisms, and even individualized polypills that combine two or more APIs. However, it can also present some challenges such as legal, regulatory, organizational and societal changes.
Our aim is to understand the different aspects in which this new technology would influence the current manufacturing/compounding practices, in order to assess the feasibility and future success of implementing the pharmacoprinting of personalized medicine. We plan to achieve this aim by conducting in-depth interviews with different stakeholders who are expected to be affected by the implementation of this new technology, including regulators, suppliers, the pharmaceutical industry, pharmacies, prescribers and patients.
CORS staff involved: Marie L. De Bruin.
Social and Clinical Pharmacy group staff involved: Natali N. Beer (principal investigator), Susanne Kaae, Sofia Sporrong.
Additional researchers: Natalja Genina.