Run‐in periods and clinical outcomes of antipsychotics in dementia: A meta‐epidemiological study of placebo‐controlled trials

por Hulshof, Tessa A., Zuidema, Sytse U., Gispen‐de Wied, Christine C., Luijendijk, Hendrika J.
Publicado 2019

Future of the drug label: Perspectives from a multistakeholder dialogue

por Gispen‐de Wied, Christine C., Weemers, Just, Boon, Wouter, Mol, Peter G.M., Stolk, Pieter
Publicado 2019

Regulatory scientific advice in drug development: does company size make a difference?

por Putzeist, Michelle, Mantel-Teeuwisse, Aukje K., Gispen-De Wied, Christine C., Hoes, Arno W., Leufkens, Hubert G.
Publicado 2010

Dose‐Finding Studies Among Orphan Drugs Approved in the EU: A Retrospective Analysis

por Schuller, Yvonne, Gispen‐de Wied, Christine, Hollak, Carla E. M., Leufkens, Hubertus G. M., Stoyanova‐Beninska, Violeta
Publicado 2018

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

por Schuller, Yvonne, Biegstraaten, Marieke, Hollak, Carla E. M., Klümpen, Heinz-Josef, Gispen-de Wied, Christine C., Stoyanova-Beninska, Violeta
Publicado 2018

Baseline imbalances and clinical outcomes of atypical antipsychotics in dementia: A meta‐epidemiological study of randomized trials

por Hulshof, Tessa A., Zuidema, Sytse U., van Meer, Peter J.K., Gispen‐de Wied, Christine C., Luijendijk, Hendrika J.
Publicado 2018

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

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

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

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

Requirements for generic anti-epileptic medicines: a regulatory perspective

por Maliepaard, Marc, Hekster, Yechiel A., Kappelle, Arnoud, van Puijenbroek, Eugène P., Elferink, André J., Welink, Jan, Gispen-de Wied, Christine C., Lekkerkerker, Frits J. F.
Publicado 2009

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

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

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

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

Regulatory Scientific Advice on Non-Inferiority Drug Trials

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

Aggregated N-of-1 trials for unlicensed medicines for small populations: an assessment of a trial with ephedrine for myasthenia gravis

por Weinreich, Stephanie S., Vrinten, Charlotte, Kuijpers, Marja R., Lipka, Alexander F., Schimmel, Kirsten J. M., van Zwet, Erik W., Gispen-de Wied, Christine, Hekster, Yechiel A., Verschuuren, Jan J. G. M., Cornel, Martina C.
Publicado 2017

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

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