Linked Life Data

19171505

Source:http://linkedlifedata.com/resource/pubmed/id/19171505

Statements in which the resource exists as a subject.
PredicateObject
rdf:type
lifeskim:mentions
pubmed:issue
23
pubmed:dateCreated
2009-7-20
pubmed:abstractText
Due to the high variability inherent of experimental recipients, validating biological methods is often a complex exercise, and following ICH Q2R1 recommendations is not always feasible and/or meaningful. Linking systematic error and random error to obtain a unique criterion, as defined in ISO guideline, could be of interest to capture the total variability in biological assays. In this paper, the use of Total Error concept in the validation of biological assays was for the first time investigated and compared to a conventional interpretation of the ICH guideline. Both decision methodologies concluded that the assay was valid from 2.13 to 5.83 log(10)(CCID(50)/ml). However, only the Total Error approach using accuracy profile as decision tool allowed to guarantee that accurate and reliable results will be obtained during the future routine application of the assay. In addition, the risk to obtain out of acceptance limits results was estimated using this approach and was found out to be at the most 3.1% irrespective of the concentration level, thus demonstrating the reliability of the biological assay.
pubmed:language
eng
pubmed:journal
pubmed:citationSubset
IM
pubmed:status
MEDLINE
pubmed:month
Aug
pubmed:issn
1873-376X
pubmed:author
pubmed:issnType
Electronic
pubmed:day
1
pubmed:volume
877
pubmed:owner
NLM
pubmed:authorsComplete
Y
pubmed:pagination
2407-11
pubmed:meshHeading
pubmed:year
2009
pubmed:articleTitle
Use of Total Error concept in the validation of viral activity in cell cultures.
pubmed:affiliation
Analytical Services, Global Quality, sanofi pasteur, 2 avenue pont Pasteur, 69367 Lyon cedex 07, France. nicole.gibelin@sanofipasteur.com
pubmed:publicationType
Journal Article, Research Support, Non-U.S. Gov't, Validation Studies