CORS Publications – University of Copenhagen

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Department of Pharmacy > Research > CORS > Publications

CORS Publications

List of scientific publications by CORS affiliated authors

Sorted by publication date, most recent.

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. and Hoekman, J.
Clin. Pharmacol. Ther. 2017 Oct 6.
doi: 10.1002/cpt.894

When more is less - An exploratory study of the precautionary reporting bias and its impact on safety signal detection.
Klein K, Scholl JH, De Bruin ML, van Puijenbroek EP, Leufkens HG, Stolk P.
Clin Pharmacol Ther. 2017 Sep 15.
doi: 10.1002/cpt.879. [Epub ahead of print]   

Breast Cancer Risk After Radiation Therapy for Hodgkin Lymphoma: Influence of Gonadal Hormone Exposure.
Krul IM, Opstal-van Winden AWJ, Aleman BMP, Janus CPM, van Eggermond AM, De Bruin ML, Hauptmann M, Krol ADG, Schaapveld M, Broeks A, Kooijman KR, Fase S, Lybeert ML, Zijlstra JM, van der Maazen RWM, Kesminiene A, Diallo I, de Vathaire F, Russell NS, van Leeuwen FE.
Int J Radiat Oncol Biol Phys. 2017 Jul 18.
pii: S0360-3016(17)33598-8. doi: 10.1016/j.ijrobp.2017.07.016. [Epub ahead of print]

Risk Perceptions in Diabetic Patients Who Have Experienced Adverse Events: Implications for Patient Involvement in Regulatory Decisions.
Mikkel Lindskov Sachs, Sofia Kälvemark Sporrong, Morten Colding-Jørgensen, Sven Frokjaer, Per Helboe, Katarina Jelic, Susanne Kaae.
Pharm Med. 2017 July 18.
doi: 10.1007/s40290-017-0200-z.

Infradiaphragmatic irradiation and high procarbazine doses increase colorectal cancer risk in Hodgkin lymphoma survivors.
van Eggermond AM, Schaapveld M, Janus CP, de Boer JP, Krol AD, Zijlstra JM, van der Maazen RW, Kremer LC, van Leerdam ME, Louwman MW, Visser O, De Bruin ML,  Aleman BM, van Leeuwen FE.
Br J Cancer. 2017 June 20.
doi: 10.1038/bjc.2017.177. [Epub ahead of print]

Cancer risk among insulin users: comparing analogues with human insulin in the CARING five-country cohort study.
Anna But, Marie L. De Bruin, Marloes T. Bazelier, Vidar Hjellvik, Morten Andersen, Anssi Auvinen, Jakob Starup-Linde, Marjanka K. Schmidt, Kari Furu, Frank de Vries, Øystein Karlstad, Nils Ekström, Jari Haukka.
Diabetologia. 2017 June 01.
doi:10.1007/s00125-017-4312-5.

Evaluating the effectiveness of risk minimisation measures: the application of a conceptual framework to Danish real-world dabigatran data.
Nyeland ME, Laursen MV, Callréus T.
Pharmacoepidemiol Drug Saf. 2017 Apr 11.
doi: 10.1002/pds.4203.

Registries in European post-marketing surveillance: a retrospective analysis of centrally approved products, 2005-2013.
Bouvy JC, Blake K, Slattery J, De Bruin ML, Arlett P, Kurz X.
Pharmacoepidemiol Drug Saf. 2017 Mar 26. 
doi:10.1002/pds.4196. [Epub ahead of print]

Trends in breast cancer incidence among women with type-2 diabetes in British general practice.
Bronsveld HK, Peeters PJ, de Groot MC, de Boer A, Schmidt MK, De Bruin ML.
Prim Care Diabetes. 2017 Feb 22. pii: S1751-9918(17)30024-4.
doi: 10.1016/j.pcd.2017.02.001. [Epub ahead of print] 

Lessons learned on the design and the conduct of Post-Authorization Safety Studies: review of 3 years of PRAC oversight.
Engel P, Almas MF, De Bruin ML, Starzyk K, Blackburn S, Dreyer NA.
Br J Clin Pharmacol. 2017 Apr;83(4):884-893.
doi: 10.1111/bcp.13165. 

Serious adverse events reported for antiobesity medicines: postmarketing experiences from the EU adverse event reporting system EudraVigilance.
Aagaard L, Hallgreen CE, Hansen EH.
Int J Obes (Lond). 2016 Nov;40(11):1742-1747.
doi: 10.1038/ijo.2016.135. 

A Paradigm Shift Towards Patient Involvement in Medicines Development and Regulatory Science: Workshop Proceedings and Commentary.
Borup G, Bach KF, Schmiegelow M, Wallach-Kildemoes H, Bjerrum OJ, Westergaard N.
Ther Innov Regul Sci. 2016 May;50(3):304-311. 
doi: 10.1177/2168479015622668.  

Recommendations for benefit-risk assessment methodologies and visual representations.
Hughes D, Waddingham E, Mt-Isa S, Goginsky A, Chan E, Downey GF, Hallgreen CE, Hockley KS, Juhaeri J, Lieftucht A, Metcalf MA, Noel RA, Phillips LD, Ashby D, Micaleff A; PROTECT Benefit-Risk Group.
Pharmacoepidemiol Drug Saf. 2016 Mar;25(3):251-62.
doi: 10.1002/pds.3958. 

Innovation of Medical Products: The Evolution of Regulatory Science, Research, and Education.
Spindler P, Bach KF, Schmiegelow M, Bedlington N, Eichler HG.
Ther Innov Regul Sci. 2016 Jan; 50(1):44-48.
doi: 10.1177/2168479015599810.