Zobrazeno 1 - 10
of 11
pro vyhledávání: '"Michelle Putzeist"'
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
Publikováno v:
Rare Diseases ISBN: 9781351278409
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_________::bf2045a0d0f570167a0c408d3b2d4f26
https://doi.org/10.4324/9781351278409-6
https://doi.org/10.4324/9781351278409-6
Autor:
Michelle Putzeist, Giovanni Tafuri, Pieter Stolk, M. De Allegri, Hubert G. M. Leufkens, Richard Laing, Francesco Trotta
Publikováno v:
Annals of Oncology. 25:265-269
Background The process leading to a regulatory outcome is guided by factors both related and unrelated to the data package, defined in this analysis as ‘formal and informal factors’, respectively. The aim of this qualitative study was to analyse
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::cdd144ab25392d2e36391bc34e2d2dec
https://doi.org/10.1093/annonc/mdt512
https://doi.org/10.1093/annonc/mdt512
Autor:
Michelle Putzeist, C.C. Gispen-De Wied, J. Llinares, Arno W. Hoes, Hubert G. M. Leufkens, Aukje K. Mantel-Teeuwisse
Publikováno v:
Drug Discovery Today. 18:1001-1006
Marketing authorization application dossiers of 17 orphan drugs (ODs) and 51 non-ODs evaluated by the European Medicines Agency (EMA) in the period 2009-2010 were compared. We aimed to identify whether any differences existed between ODs and non-ODs
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::8e16de12eb5b60b220e92535583d0da7
https://doi.org/10.1016/j.drudis.2013.06.012
https://doi.org/10.1016/j.drudis.2013.06.012
Autor:
Aukje K. Mantel-Teeuwisse, Remco L A de Vrueh, Arno W. Hoes, Michelle Putzeist, Hubert G. M. Leufkens, Christine C. Gispen-de Wied
Publikováno v:
Orphanet Journal of Rare Diseases
Background We studied to what extent the level of scientific knowledge on exceptionally rare metabolic inherited diseases and their potential orphan medicinal products is associated with sponsors deciding to apply for an orphan designation at the US
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::84a1debfa1ebe0d2f31a7b26ded90405
https://pubmed.ncbi.nlm.nih.gov/24237580
https://pubmed.ncbi.nlm.nih.gov/24237580
Autor:
Arno W. Hoes, Michelle Putzeist, Grace Wangge, Christine C. Gispen-de Wied, Olaf H. Klungel, Mirjam J. Knol, Aukje K. Mantel-Teeuwisse, Hubert G. M. Leufkens, Antonius de Boer
Publikováno v:
PLoS ONE, Vol 8, Iss 9, p e74818 (2013)
PLoS ONE
PLoS ONE
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://explore.openaire.eu/search/publication?articleId=doi_dedup___::ecfb68142d2054eb2b51c3aeaada4692
https://www.ncbi.nlm.nih.gov/pmc/articles/pmid/24040346/?tool=EBI
https://www.ncbi.nlm.nih.gov/pmc/articles/pmid/24040346/?tool=EBI
Autor:
Jordi Llinares Garcia, Christine C. Gispen-de Wied, Aukje K. Mantel-Teeuwisse, Michelle Putzeist, Arno W. Hoes, Hubert G. M. Leufkens, Harald E. Heemstra
Publikováno v:
Drug discovery today. 17(7-8)
In 2010, the European Regulation for Orphan Medicinal Products (OMPs) was in force for ten years. In this study we assessed possible determinants of applications for OMPs in the EU since 2000 that are associated with a successful marketing authorisat
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::2b857bfea4a657960bff8756d5120a0f
https://pubmed.ncbi.nlm.nih.gov/22094244
https://pubmed.ncbi.nlm.nih.gov/22094244
Autor:
Arno W. Hoes, Christine C. Gispen-de Wied, Aukje K. Mantel-Teeuwisse, Michelle Putzeist, Hubert G. M. Leufkens
Publikováno v:
European Journal of Clinical Pharmacology
Purpose To assess whether the content of Scientific Advice (SA) questions addressed to a national drug regulatory agency is associated with company size. This may help to increase understanding about the knowledge, strategic, and regulatory gaps comp
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::71727ff81ea6adf5bcf2f3cbaba04567
https://pubmed.ncbi.nlm.nih.gov/21049297
https://pubmed.ncbi.nlm.nih.gov/21049297
Autor:
Christine C. Gispen-de Wied, Spiros Vamvakas, Malcolm Rowland, Michelle Putzeist, Hans-Georg Eichler, Aukje K. Mantel-Teeuwisse, Hubert G. M. Leufkens, Bo Aronsson, Arno W. Hoes
Publikováno v:
Nature Reviews Drug Discovery. 11:903-904
An analysis of recent approved and failed marketing applications for new drugs evaluated by the European Medicines Agency highlights the factors that are most likely to be associated with non-approval.
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_________::eabe66446243592cf9bbd608730d7990
https://doi.org/10.1038/nrd3894
https://doi.org/10.1038/nrd3894