Statements in which the resource exists as a subject.
PredicateObject
rdf:type
lifeskim:mentions
pubmed:issue
1-2
pubmed:dateCreated
2008-4-18
pubmed:abstractText
The transfer of analytical methods from a sending laboratory to a receiving one requires to guarantee that this last laboratory will obtain accurate results. Undeniably method transfer is the ultimate step before routine implementation of the method at the receiving site. The conventional statistical approaches generally used in this domain which analyze separately the trueness and precision characteristics of the receiver do not achieve this. Therefore, this paper aims first at demonstrating the applicability of two recent statistical approaches using total error-based criterion and taking into account the uncertainty of the true value estimate of the sending laboratory, to the transfer of bioanalytical methods. To achieve this, they were successfully applied to the transfer of two fully automated liquid chromatographic method coupled on-line to solid-phase extraction. The first one was dedicated to the determination of three catecholamines in human urine using electrochemical detection, and the second one to the quantitation of N-methyl-laudanosine in plasma using fluorescence detection. Secondly, a risk-based evaluation is made in order to understand why classical statistical approaches are not sufficient to provide the guarantees that the analytical method will give most of the time accurate results during its routine use. Finally, some recommendations for the transfer studies are proposed.
pubmed:language
eng
pubmed:journal
pubmed:citationSubset
IM
pubmed:chemical
pubmed:status
MEDLINE
pubmed:month
May
pubmed:issn
0021-9673
pubmed:author
pubmed:issnType
Print
pubmed:day
2
pubmed:volume
1189
pubmed:owner
NLM
pubmed:authorsComplete
Y
pubmed:pagination
32-41
pubmed:dateRevised
2009-1-15
pubmed:meshHeading
pubmed:year
2008
pubmed:articleTitle
Risk-based approach for the transfer of quantitative methods: bioanalytical applications.
pubmed:affiliation
Laboratory of Analytical Chemistry, Bioanalytical Chemistry Research Unit, University of Liège, B-4000 Liège 1, Belgium. Eric.Rozet@ulg.ac.be
pubmed:publicationType
Journal Article, Research Support, Non-U.S. Gov't