Zobrazeno 1 - 10 of 107 pro vyhledávání: '"Christine C Gispen-de Wied"'
1
Akademický článek
Sex Proportionality in Pre-clinical and Clinical Trials: An Evaluation of 22 Marketing Authorization Application Dossiers Submitted to the European Medicines Agency
Autor: Marieke J. H. J. Dekker, 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
Publikováno v: Frontiers in Medicine, Vol 8 (2021)
This study assessed to what extent women were included in all phases of drug development; whether the clinical studies in the marketing authorization application dossiers include information per sex; and explored whether there are differences between
Externí odkaz: https://doaj.org/article/a5e7cdfb136d43a79f4ae6dc16dd8b7c
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2
Akademický článek
Oncologic orphan drugs approved in the EU – do clinical trial data correspond with real-world effectiveness?
Autor: Yvonne Schuller, Marieke Biegstraaten, Carla E. M. Hollak, Heinz-Josef Klümpen, Christine C. Gispen-de Wied, Violeta Stoyanova-Beninska
Publikováno v: Orphanet Journal of Rare Diseases, Vol 13, Iss 1, Pp 1-11 (2018)
Abstract Background Evaluation of evidence for efficacy of orphan medicinal products (OMPs) for rare malignancies may be hampered by the use of tumor measurements instead of clinical endpoints. This may cause efficacy data to not always match effecti
Externí odkaz: https://doaj.org/article/54c1406d95344772a624b2f11cf50998
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3
Akademický článek
Alignment of European Regulatory and Health Technology Assessments: A Review of Licensed Products for Alzheimer's Disease
Autor: Marieke J. H. J. Dekker, Jacoline C. Bouvy, Diana O'Rourke, Robin Thompson, Amr Makady, Pall Jonsson, Christine C. Gispen-de Wied
Publikováno v: Frontiers in Medicine, Vol 6 (2019)
Aims: To facilitate regulatory learning, we evaluated similarities and differences in evidence requirements between regulatory and health technology assessment (HTA) bodies of Alzheimer's disease (AD) approved products.Methods: The European marketing
Externí odkaz: https://doaj.org/article/ddb542f1dac448c5b5ebf4e76cca4fb4
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4
Akademický článek
A standardised framework to identify optimal animal models for efficacy assessment in drug development.
Autor: 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
Publikováno v: PLoS ONE, Vol 14, Iss 6, p e0218014 (2019)
IntroductionPoor translation of efficacy data derived from animal models can lead to clinical trials unlikely to benefit patients-or even put them at risk-and is a potential contributor to costly and unnecessary attrition in drug development.Objectiv
Externí odkaz: https://doaj.org/article/0f14ca084e9b487cb8a1f7e01b4a38f6
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6
Gender differences in the response to antipsychotic medication in patients with schizophrenia: An individual patient data meta-analysis of placebo-controlled studies
Autor: Bram W.C. Storosum, Taina Mattila, Tamar D. Wohlfarth, Christine C. Gispen-de Wied, Kit C.B. Roes, Wim van den Brink, Lieuwe de Haan, Damiaan A.J.P. Denys, Jasper B. Zantvoord
Publikováno v: Psychiatry research, 320. Elsevier Ireland Ltd
Psychiatry Research, 320
Psychiatry research, 320:114997. Elsevier Ireland Ltd
Contains fulltext : 291389.pdf (Publisher’s version ) (Open Access) OBJECTIVE: To determine whether gender and menopausal status moderate the response to antipsychotic medication in patients with schizophrenia. METHODS: We analyzed data of 22 short
Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::1b9e87144925089575d8f46721c207bb
https://pure.knaw.nl/portal/en/publications/a58eae0c-484c-4225-9cc3-2785050a4d15
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7
Akademický článek
Drug Shortages From the Perspectives of Authorities and Pharmacy Practice in the Netherlands: An Observational Study
Autor: Doerine J. Postma, Peter A. G. M. De Smet, Christine C. Gispen-de Wied, Hubert G. M. Leufkens, Aukje K. Mantel-Teeuwisse
Publikováno v: Frontiers in Pharmacology, Vol 9 (2018)
Background: Drug shortages are a potential threat to public health. Reliable data on drug shortages is limited. The objective was to examine the extent and nature of potential drug shortages signaled by authorities and pharmacy practice in the Nether
Externí odkaz: https://doaj.org/article/7460d039dbe54308acff4a90ab8f48b1
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8
Run‐in periods and clinical outcomes of antipsychotics in dementia: A meta‐epidemiological study of placebo‐controlled trials
Autor: Hendrika J Luijendijk, Tessa A. Hulshof, Christine C. Gispen-de Wied, Sytse U Zuidema
Publikováno v: Pharmacoepidemiology and Drug Safety
Purpose Run‐in periods are used to identify placebo‐responders and washout. Our aim was to assess the association of run‐in periods with clinical outcomes of antipsychotics in dementia. Methods We searched randomized placebo‐controlled trials
Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::652f9fc4a7c6d517cad99d403a8ce391
http://europepmc.org/articles/PMC7027584
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9
Akademický článek
Regulatory scientific advice on non-inferiority drug trials.
Autor: 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
Publikováno v: PLoS ONE, Vol 8, Iss 9, p e74818 (2013)
The active-controlled trial with a non-inferiority design has gained popularity in recent years. However, non-inferiority trials present some methodological challenges, especially in determining the non-inferiority margin. Regulatory guidelines provi
Externí odkaz: https://doaj.org/article/41f4581e6bd243c9827bd962f70ffa8c
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10
Oncologic orphan drugs approved in the EU - do clinical trial data correspond with real-world effectiveness?
Autor: Christine C. Gispen-de Wied, Carla E. M. Hollak, Yvonne Schuller, Violeta Stoyanova-Beninska, Heinz-Josef Klümpen, Marieke Biegstraaten
Publikováno v: Orphanet Journal of Rare Diseases
Orphanet Journal of Rare Diseases, Vol 13, Iss 1, Pp 1-11 (2018)
Orphanet journal of rare diseases, 13(1):214. BioMed Central
Orphanet Journal of Rare Diseases, 13(1):214. BioMed Central
Schuller, Y, Biegstraaten, M, Hollak, C E M, Klümpen, H-J, Gispen-de Wied, C C & Stoyanova-Beninska, V 2018, ' Oncologic orphan drugs approved in the EU-Do clinical trial data correspond with real-world effectiveness? ', Orphanet Journal of Rare Diseases, vol. 13, no. 1, 214 . https://doi.org/10.1186/s13023-018-0900-9
Background Evaluation of evidence for efficacy of orphan medicinal products (OMPs) for rare malignancies may be hampered by the use of tumor measurements instead of clinical endpoints. This may cause efficacy data to not always match effectiveness in
Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::3f5a0f5dd39833986a83556b4da85f21
https://pubmed.ncbi.nlm.nih.gov/30486835
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