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EU decision-making for marketing authorization of advanced therapy medicinal products: a case study
Wilde, S. de; Coppens, D.G.M.; Hoekman, J.; Bruin, M.L. de; Leufkens, H.G.M.; Guchelaar, H.J.; Meij, P. 2018
EU decision-making for marketing authorization of advanced therapy medicinal products: a case study
Article / Letter to editor
open access
A decade of marketing approval of gene and cell-based therapies in the United States, European Union and Japan: An evaluation of regulatory decision-making
Coppens, D.G.M.; Wilde, S. de; Guchelaar, H.J.; Bruin, M.L. de; Leufkens, H.G.M.; Meij, P.; Hoekman, J. 2018
A decade of marketing approval of gene and cell-based therapies in the United States, European Union and Japan: An evaluation of regulatory decision-making
Article / Letter to editor
metadata only
The possibility of obtaining marketing authorization of orphan pharmaceutical compounding preparations: 3,4-DAP for Lambert-Eaton Myasthenic Syndrome
Wilde, S. de; Jong, M.G.H. de; Lipka, A.F.; Guchelaar, H.J.; Schimmel, K.J.M. 2018
The possibility of obtaining marketing authorization of orphan pharmaceutical compounding preparations: 3,4-DAP for Lambert-Eaton Myasthenic Syndrome
Article / Letter to editor
metadata only
Unlicensed pharmaceutical preparations for clinical patient care: Ensuring safety
Wilde, S. de; Jong, M.G.H. de; Brun, P.P.H. le; Guchelaar, H.J.; Schimmel, K.J.M. 2018
Unlicensed pharmaceutical preparations for clinical patient care: Ensuring safety
Article / Letter to editor
metadata only
Understanding clinical development of chimeric antigen receptor T cell therapies
Wilde, S. de; Guchelaar, H.J.; Zandvliet, M.L.; Meij, P. 2017
Understanding clinical development of chimeric antigen receptor T cell therapies
Article / Letter to editor
metadata only
Clinical development of gene- and cell-based therapies: overview of the European landscape
Wilde, S. de; Guchelaar, H.J.; Zandvliet, M.L.; Meij, P. 2016
Clinical development of gene- and cell-based therapies: overview of the European landscape
Article / Letter to editor
metadata only
Development of cell therapy medicinal products by academic institutes
Wilde, S. de; Guchelaar, H.J.; Herberts, C.; Lowdell, M.; Hildebrandt, M.; Zandvliet, M.; Meij, P. 2016
Development of cell therapy medicinal products by academic institutes
Article / Letter to editor
metadata only
Hurdles in clinical implementation of academic advanced therapy medicinal products: A national evaluation
Wilde, S. de; Veltrop-Duits, L.; Hoozemans-Strik, M.; Ras, T.; Blom-Veenman, J.; Guchelaar, H.J.; ... ; Meij, P. 2016
Hurdles in clinical implementation of academic advanced therapy medicinal products: A national evaluation
Article / Letter to editor
metadata only