Oncologic orphan drugs approved in the EU – do clinical trial data correspond with real-world effectiveness?

by Yvonne Schuller, Marieke Biegstraaten, Carla E. M. Hollak, Heinz-Josef Klümpen, Christine C. Gispen-de Wied, Violeta Stoyanova-Beninska
Published 2018-11-01

Alignment of European Regulatory and Health Technology Assessments: A Review of Licensed Products for Alzheimer's Disease

by Marieke J. H. J. Dekker, Jacoline C. Bouvy, Diana O'Rourke, Robin Thompson, Amr Makady, Pall Jonsson, Christine C. Gispen-de Wied
Published 2019-05-01

A standardised framework to identify optimal animal models for efficacy assessment in drug development.

by Guilherme S Ferreira, Désirée H Veening-Griffioen, Wouter P C Boon, Ellen H M Moors, Christine C Gispen-de Wied, Huub Schellekens, Peter J K van Meer
Published 2019-01-01

Correction: A standardised framework to identify optimal animal models for efficacy assessment in drug development.

by Guilherme S Ferreira, Désirée H Veening-Griffioen, Wouter P C Boon, Ellen H M Moors, Christine C Gispen-de Wied, Huub Schellekens, Peter J K van Meer
Published 2019-01-01

Regulatory scientific advice on non-inferiority drug trials.

by Grace Wangge, Michelle Putzeist, Mirjam J Knol, Olaf H Klungel, Christine C Gispen-De Wied, Antonius de Boer, Arno W Hoes, Hubert G Leufkens, Aukje K Mantel-Teeuwisse
Published 2013-01-01

Drug Shortages From the Perspectives of Authorities and Pharmacy Practice in the Netherlands: An Observational Study

by Doerine J. Postma, Doerine J. Postma, Peter A. G. M. De Smet, Peter A. G. M. De Smet, Christine C. Gispen-de Wied, Hubert G. M. Leufkens, Aukje K. Mantel-Teeuwisse
Published 2018-10-01

Sex Proportionality in Pre-clinical and Clinical Trials: An Evaluation of 22 Marketing Authorization Application Dossiers Submitted to the European Medicines Agency

by Marieke J. H. J. Dekker, Sieta T. de Vries, Sieta T. de Vries, Carolien H. M. Versantvoort, Ellen G. E. Drost-van Velze, Mansi Bhatt, Peter J. K. van Meer, Ineke K. Havinga, Christine C. Gispen-de Wied, Peter G. M. Mol, Peter G. M. Mol
Published 2021-03-01