| Dried blood spot sampling: practical considerations and recommendation for use with preclinical studies. | |
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MedLine Citation:
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PMID: 21585305 Owner: NLM Status: In-Data-Review |
Abstract/OtherAbstract:
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At present it is necessary to use animals to generate toxicokinetic data as part of preclinical safety studies. However, ethical standards require animal use to be carefully monitored and the principles of the 3Rs: replacement, reduction and refinement, to be considered and applied. Use of dried blood spot (DBS) samples, typically 10 to 20 µl, rather than the larger blood volumes required to obtain plasma samples, fully embraces the latter two principles of reduction and refinement. The use of DBS sampling enables the number of rodents per study to be reduced whilst also refining the way blood samples are taken from both rodents and non-rodents. The recent changes to the European Directive on the protection of animals used for scientific purposes favor DBS sampling becoming the standard for generation of toxicokinetic data, and imply that pharmaceutical companies will have to justify why plasma samples (and therefore larger blood volumes) are required for bioanalysis. Use of DBS samples has been, and is being, discussed widely within the pharmaceutical industry as the move away from taking large blood volumes becomes inevitable. |
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Authors:
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Josephine Ec Burnett |
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Publication Detail:
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Type: Journal Article |
Journal Detail:
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Title: Bioanalysis Volume: 3 ISSN: 1757-6199 ISO Abbreviation: Bioanalysis Publication Date: 2011 May |
Date Detail:
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Created Date: 2011-05-18 Completed Date: - Revised Date: - |
Medline Journal Info:
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Nlm Unique ID: 101512484 Medline TA: Bioanalysis Country: England |
Other Details:
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Languages: eng Pagination: 1099-107 Citation Subset: IM |
Affiliation:
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Covance Laboratories Ltd, Otley Road, Harrogate, North Yorkshire, HG3 1PY, UK. jo.burnett@covance.com. |
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From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
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