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rdf:type |
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lifeskim:mentions |
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pubmed:issue |
4
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pubmed:dateCreated |
2008-10-1
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pubmed:abstractText |
To facilitate and improve clinical research within Europe, the European Union (EU) adopted in 2001 the Clinical Trials Directive (EUCTD). The aim of this study was to compare duration between submission of a clinical drug trial application and approval by regulatory authorities in EU countries regulated by EUCTD vs. EU countries regulated by local legislation and, second, to compare the duration of regulatory approval in Europe vs. the USA and Australia.
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pubmed:commentsCorrections |
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pubmed:language |
eng
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pubmed:journal |
|
|
pubmed:citationSubset |
IM
|
|
pubmed:status |
MEDLINE
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|
pubmed:month |
Oct
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|
pubmed:issn |
1365-2125
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pubmed:author |
|
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pubmed:issnType |
Electronic
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pubmed:volume |
66
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pubmed:owner |
NLM
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pubmed:authorsComplete |
Y
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pubmed:pagination |
546-50
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pubmed:dateRevised |
2009-11-18
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pubmed:meshHeading |
pubmed-meshheading:18662290-Australia,
pubmed-meshheading:18662290-Clinical Trials as Topic,
pubmed-meshheading:18662290-Drug Approval,
pubmed-meshheading:18662290-Drug Industry,
pubmed-meshheading:18662290-Ethics Committees, Research,
pubmed-meshheading:18662290-Europe,
pubmed-meshheading:18662290-European Union,
pubmed-meshheading:18662290-Humans,
pubmed-meshheading:18662290-Time Factors,
pubmed-meshheading:18662290-United States
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|
pubmed:year |
2008
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pubmed:articleTitle |
Does the European clinical trials directive really improve clinical trial approval time?
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|
pubmed:affiliation |
Department of Clinical Pharmacology, University Medical Centre Groningen, University of Groningen, Groningen, The Netherlands. h.j.lambers.heerspink@med.umcg.nl
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pubmed:publicationType |
Journal Article,
Research Support, Non-U.S. Gov't,
Multicenter Study,
Evaluation Studies
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