Reference : Evaluating the reliability of analytical results using a probability criterion: a Bay...
Scientific journals : Article
Human health sciences : Pharmacy, pharmacology & toxicology
http://hdl.handle.net/2268/91261
Evaluating the reliability of analytical results using a probability criterion: a Bayesian perspective
English
Rozet, Eric mailto [Université de Liège - ULg > Département de pharmacie > Chimie analytique >]
Govaerts, B. [> >]
Lebrun, Pierre mailto [Université de Liège - ULg > Département de pharmacie > Chimie analytique >]
Michail, K. [> >]
Ziemons, Eric mailto [Université de Liège - ULg > Département de pharmacie > Département de pharmacie >]
Wintersteiger, R. [> >]
Rudaz, S. [> >]
Boulanger, B. [> >]
Hubert, Philippe mailto [Université de Liège - ULg > Département de pharmacie > Chimie analytique >]
2011
Analytica Chimica Acta
Elsevier
705
193-206
Yes (verified by ORBi)
International
0003-2670
1873-4324
Amsterdam
The Netherlands
[en] results reliability ; validation ; reliability profile ; Bayesian approach
[en] Methods validation is mandatory in order to assess the fitness of purpose of the developed analytical method. Of core importance at the end of the validation is the evaluation of the reliability of the individual results that will be generated during the routine application of the method. Regulatory guidelines provide a general framework to assess the validity of a method, but none address the issue of results reliability. In this study, a Bayesian approach is proposed to address this concern. Results reliability is defined here as “the probability of an analytical method to provide analytical results within predefined acceptance limits around their reference or conventional true concentration values over a defined concentration range and under given environmental and operating conditions.” By providing the minimum reliability probability needed for the subsequent routine application of the method, as well as specifications or acceptance limits , the proposed Bayesian approach provides the effective probability of obtaining reliable future analytical results over the whole concentration range investigated. This is summarized in a single graph: the reliability profile. This Bayesian reliability profile is also compared to two frequentist approaches, the first one derived from the work of Dewé et al. [Dewé W., Govaerts B., Boulanger B., Rozet E., Chiap P., Hubert Ph., Chemometr. Intell. Lab. Syst. 85 (2007) 262-268] and the second proposed by Govaerts et al. [B. Govaerts, W. Dewé, M. Maumy, B. Boulanger, Qual. Reliab. Engng. Int. 24 (2008) 667-680]. Furthermore, to illustrate the applicability of the Bayesian reliability profile, this approach is also applied here to a bioanalytical method dedicated to the determination of ketoglutaric acid (KG) and hydroxymethylfurfural (HMF) in human plasma by SPE-HPLC-UV.
Researchers ; Professionals ; Students
http://hdl.handle.net/2268/91261

File(s) associated to this reference

Fulltext file(s):

FileCommentaryVersionSizeAccess
Restricted access
FinalPublished_Proba.pdfPublisher postprint2.15 MBRequest copy

Bookmark and Share SFX Query

All documents in ORBi are protected by a user license.