| Ethical, legal, and social implications (ELSI) of microdose clinical trials. | |
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MedLine Citation:
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PMID: 21251940 Owner: NLM Status: Publisher |
Abstract/OtherAbstract:
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A "microdose clinical trial" (microdosing) is one kind of early phase exploratory clinical trial, administering the compound at doses estimated to have no pharmacological or toxicological effects, aimed at screening candidates for further clinical development. This article's objective is to clarify the ethical, legal, and social implications (ELSI) of such an exploratory minimum-risk human trial. The definition and non-clinical study requirements for microdosing have been harmonized among the European Union (EU), United States (US), and Japan. Being conducted according to these regulations, microdosing seems to be ethically well justified in terms of autonomy, beneficence, justice, human dignity, and animal welfare. Three big projects have been demonstrating the predictability of therapeutic dose pharmacokinetics from microdosing. The article offers suggestions as how microdosing can become a more useful and socially accepted strategy. |
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Authors:
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Chieko Kurihara |
Publication Detail:
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Type: JOURNAL ARTICLE Date: 2011-1-18 |
Journal Detail:
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Title: Advanced drug delivery reviews Volume: - ISSN: 1872-8294 ISO Abbreviation: - Publication Date: 2011 Jan |
Date Detail:
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Created Date: 2011-1-28 Completed Date: - Revised Date: - |
Medline Journal Info:
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Nlm Unique ID: 8710523 Medline TA: Adv Drug Deliv Rev Country: - |
Other Details:
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Languages: ENG Pagination: - Citation Subset: - |
Copyright Information:
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Copyright © 2011 Elsevier B.V. All rights reserved. |
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From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
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