| Availability of comparative trials for the assessment of new medicines in the European Union at the moment of market authorization. | |
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MedLine Citation:
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PMID: 17166187 Owner: NLM Status: MEDLINE |
Abstract/OtherAbstract:
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AIMS: To investigate the availability of information about premarketing randomized active-control trials (RaCTs) involving medicines with a new active substance at the moment of market authorization in the European Union. METHODS: Information was obtained from the EMEA European Public Assessment Reports and the MEDLINE and EMBASE databases. RESULTS: Between 1999 and 2005, 48% of recently approved medicines (n = 122) had been studied in comparison with existing medicines at the moment of market authorization. About one-third of these trials were published and publicly available at that moment. CONCLUSIONS: For most new medicines evidence-based assessment of the (added) therapeutic value is not really possible at the moment of market authorization. |
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Authors:
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Johan C F van Luijn; Frank W J Gribnau; Hubert G M Leufkens |
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Publication Detail:
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Type: Journal Article Date: 2006-12-07 |
Journal Detail:
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Title: British journal of clinical pharmacology Volume: 63 ISSN: 0306-5251 ISO Abbreviation: Br J Clin Pharmacol Publication Date: 2007 Feb |
Date Detail:
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Created Date: 2007-02-05 Completed Date: 2007-05-21 Revised Date: 2009-11-18 |
Medline Journal Info:
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Nlm Unique ID: 7503323 Medline TA: Br J Clin Pharmacol Country: England |
Other Details:
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Languages: eng Pagination: 159-62 Citation Subset: IM |
Affiliation:
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Division of Pharmacoepidemiology and Pharmacotherapy, Utrecht Institute for Pharmaceutical Sciences (UIPS), Faculty of Science, Utrecht, The Netherlands. |
Export Citation:
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| MeSH Terms | |
Descriptor/Qualifier:
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Clinical Trials as Topic
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statistics & numerical data* Drug Approval / legislation & jurisprudence* European Union Evaluation Studies as Topic Humans Legislation, Drug* |
| Comments/Corrections | |
From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
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