Strategy in Regulatory Decision-Making for Management of Progressive Multifocal Leukoencephalopathy

Autor: Segec, A, Keller-Stanislawski, B, Vermeer, N S, Macchiarulo, C, Straus, S M, Hidalgo-Simon, A, De Bruin, M L, Sub Pharmacoepidemiology, Pharmacoepidemiology and Clinical Pharmacology

Publikováno v: Clinical Pharmacology and Therapeutics, 98(5), 502. Nature Publishing Group
Europe PubMed Central

Progressive multifocal leukoencephalopathy (PML) has been observed after the use of several medicines, including monoclonal antibodies. As these drugs play important roles in the therapeutic armamentarium, it is important to address the challenges th

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::ce8c38e4772fd999282653656a84adb3
https://dspace.library.uu.nl/handle/1874/330056

Development of safety concerns within RMPs after approval: A cohort study of biologicals

Autor: Vermeer, N. S., Duijnhoven, R. G., Straus, S. M. J. M., Blackburn, S., Hoogendoorn, W. E., Mantel-Teeuwisse, A. K., Egberts, A. C. G., Leufkens, H. G. M., Marie Louise (Marieke) De Bruin

Publikováno v: ResearcherID

Background: Risk management plans (RMPs) form an integral part of the regulatory approval of new drugs in Europe. The RMP details all safety concerns and associated pharmacovigilance activities, facilitating postapproval knowledge increase. The proce

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=dedup_wf_001::93f8b933b24d5ac62600dd479200f265
https://dspace.library.uu.nl/handle/1874/330041

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Drug-induced progressive multifocal leukoencephalopathy: Lessons learned from contrasting natalizumab and rituximab.

Autor: Vermeer NS; Utrecht Institute for Pharmaceutical Sciences (UIPS), Division of Pharmacoepidemiology and Clinical Pharmacology, Utrecht University, Utrecht, The Netherlands.; Medicines Evaluation Board, Utrecht, The Netherlands., Straus SM; Medicines Evaluation Board, Utrecht, The Netherlands.; Medical Informatics, Erasmus Medical Center, Rotterdam, The Netherlands., Mantel-Teeuwisse AK; Utrecht Institute for Pharmaceutical Sciences (UIPS), Division of Pharmacoepidemiology and Clinical Pharmacology, Utrecht University, Utrecht, The Netherlands., Hidalgo-Simon A; European Medicines Agency, London, United Kingdom., Egberts AC; Utrecht Institute for Pharmaceutical Sciences (UIPS), Division of Pharmacoepidemiology and Clinical Pharmacology, Utrecht University, Utrecht, The Netherlands.; Department of Clinical Pharmacy, University Medical Center Utrecht, Utrecht, The Netherlands., Leufkens HG; Utrecht Institute for Pharmaceutical Sciences (UIPS), Division of Pharmacoepidemiology and Clinical Pharmacology, Utrecht University, Utrecht, The Netherlands.; Medicines Evaluation Board, Utrecht, The Netherlands., De Bruin ML; Utrecht Institute for Pharmaceutical Sciences (UIPS), Division of Pharmacoepidemiology and Clinical Pharmacology, Utrecht University, Utrecht, The Netherlands.; Medicines Evaluation Board, Utrecht, The Netherlands.

Publikováno v: Clinical pharmacology and therapeutics [Clin Pharmacol Ther] 2015 Nov; Vol. 98 (5), pp. 542-50. Date of Electronic Publication: 2015 Sep 08.