Statements in which the resource exists as a subject.
PredicateObject
rdf:type
lifeskim:mentions
pubmed:issue
2
pubmed:dateCreated
2006-6-26
pubmed:abstractText
In Vitro toxicology methods are being validated and adopted by regulatory agencies for use as alternatives to animal testing. Such methods may use ex vivo tissues or bioconstructs, some of which may be proprietary. Users of the data from these methods need to be reassured that the assays or assay components used in their studies provide consistent, good quality data over time, matching the standards achieved during the validation process. This paper presents an overview of approaches currently used by representatives of a manufacturer and a contract testing laboratory to ensure that the results from in vitro alternative methods are reproducible and of high quality over time. These approaches include full characterization of cells or tissues, sampling of each lot of manufactured bioconstructs for performance, and regular use of controls and benchmark chemicals to provide assurance of consistency of assay performance.
pubmed:language
eng
pubmed:journal
pubmed:citationSubset
IM
pubmed:status
MEDLINE
pubmed:month
Jul
pubmed:issn
0273-2300
pubmed:author
pubmed:issnType
Print
pubmed:volume
45
pubmed:owner
NLM
pubmed:authorsComplete
Y
pubmed:pagination
97-103
pubmed:dateRevised
2007-11-15
pubmed:meshHeading
pubmed:year
2006
pubmed:articleTitle
Ensuring quality of in vitro alternative test methods: Current practice.
pubmed:affiliation
US Environmental Protection Agency, Office of Pesticide Programs (7506C), Washington, DC, USA. amy.rispin@epa.gov
pubmed:publicationType
Journal Article, Review