| The European and American use of exploratory approaches for first-in-human studies. | |
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MedLine Citation:
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PMID: 20443952 Owner: NLM Status: MEDLINE |
Abstract/OtherAbstract:
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Exploratory approaches for first-in-human clinical studies have evolved over the last few years and have stimulated the issuance of national regulatory guidances in some European countries as well as the United States. With the increasing implementation of these approaches and the recent preparation of a multiregional regulatory guidance (ICH M3 rev2), an exchange of experiences on the opportunities and challenges of exploratory clinical trials was desirable; thus, a workshop focusing on the use of this clinical approach was planned and conducted in Lisbon, Portugal, March 18-19, 2009 sponsored by the Portuguese Health Authority (INFARMED) and DIA. The structure of the workshop focused in three main areas. Regulatory representatives from Portugal, Belgium, Germany, the United Kingdom and the United States formally reviewed their experiences. This was followed by a discussion on issues from an ethics review perspective as well as an insight to the opportunities in the area of biologics. The industry perspective was presented by representatives from Merck, Pfizer, J&J, Novartis, Speedel, AstraZeneca, GSK, and Roche. Finally, through break out sessions, issues were identified to be addressed moving forward. It is the purpose of this paper to report on the outcome of this workshop. |
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Authors:
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Beatriz Silva-Lima; David Carlson; David R Jones; David Laurie; Elke Stahl; Vasco Maria; Walter Janssens; William T Robinson |
Publication Detail:
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Type: Journal Article |
Journal Detail:
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Title: Clinical and translational science Volume: 3 ISSN: 1752-8062 ISO Abbreviation: Clin Transl Sci Publication Date: 2010 Feb |
Date Detail:
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Created Date: 2010-05-06 Completed Date: 2010-08-09 Revised Date: - |
Medline Journal Info:
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Nlm Unique ID: 101474067 Medline TA: Clin Transl Sci Country: United States |
Other Details:
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Languages: eng Pagination: 38-41 Citation Subset: IM |
Affiliation:
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iMED, University of Lisbon, INFARMED, Lisbon, Portugal. beatrizlima@netcabo.pt |
Export Citation:
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APA/MLA Format Download EndNote Download BibTex |
| MeSH Terms | |
Descriptor/Qualifier:
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Biological Products
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therapeutic use Clinical Trials as Topic / ethics, legislation & jurisprudence, trends* Drug Industry Drugs, Investigational Ethics, Medical Europe Humans International Cooperation Treatment Outcome United States |
| Chemical | |
Reg. No./Substance:
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0/Biological Products; 0/Drugs, Investigational |
From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
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