Reference : Using tolerance intervals in pre-study validation of analytical methods to predict in-st...
Scientific journals : Article
Physical, chemical, mathematical & earth Sciences : Chemistry
Human health sciences : Pharmacy, pharmacology & toxicology
http://hdl.handle.net/2268/1810
Using tolerance intervals in pre-study validation of analytical methods to predict in-study results - The fit-for-future-purpose concept
English
Rozet, Eric mailto [Université de Liège - ULg > Département de pharmacie > Chimie analytique > > >]
Hubert, Cédric mailto [Université de Liège - ULg > Département de pharmacie > Chimie analytique >]
Ceccato, Attilio mailto [Université de Liège - ULg > Département de pharmacie > Chimie anlytique > >]
Dewé, Walthère [Université de Liège - ULg > Département de pharmacie > Chimie analytique > >]
Ziemons, Eric mailto [Université de Liège - ULg > Département de pharmacie > Chimie analytique > > >]
Moonen, François mailto [> > > >]
Michail, Karim [> > > >]
Wintersteiger, Reinhold [> > > >]
Streel, Bruno mailto [> > > >]
Boulanger, Bruno [Université de Liège - ULg > Département de pharmacie > Chimie analytique > >]
Hubert, Philippe mailto [Université de Liège - ULg > Département de pharmacie > Chimie analytique > >]
27-Jul-2007
Journal of Chromatography. A
Elsevier Science Bv
1158
1-2
Data analysis in chromatography
126-137
Yes (verified by ORBi)
International
0021-9673
Amsterdam
The Netherlands
[en] validation ; beta-expectation tolerance interval ; accuracy profile ; fitness for purpose ; quality control ; prediction ; in-study results
[en] It is recognized that the purpose of validation of analytical methods is to demonstrate that the method is suited for its intended purpose. Validation is not only required by regulatory authorities, but is also a decisive phase before the routine use of the method. For a quantitative analytical method the objective is to quantify the target analytes with a known and suitable accuracy. For that purpose, first, a decision about the validity of the method based on prediction is proposed: a method is declared proper for routine application if it is considered that most of the future results generated will be accurate enough. This can be achieved by using the "beta-expectation tolerance interval" (accuracy profile) as the decision tool to assess the validity of the analytical method. Moreover, the concept of "fit-for-purpose" is also proposed here to select the most relevant response function as calibration curve, i.e. choosing a response function based solely on the predicted results this model will allow to obtain. This paper reports four case studies where the results obtained with quality control samples in routine were compared to predictions made in the validation phase. Predictions made using the "beta-expectation tolerance interval" are shown to be accurate and trustful for decision making. It is therefore suggested that an adequate way to conciliate both the objectives of the analytical method in routine analysis and those of the validation step consists in taking the decision about the validity of the analytical method based on prediction of the future results using the most appropriate response function curve, i.e. the fit-for-future-purpose concept.
C.I.R.M.
Researchers ; Professionals ; Students
http://hdl.handle.net/2268/1810
10.1016/j.chroma.2007.03.102
http://www.sciencedirect.com/science?_ob=ArticleURL&_udi=B6TG8-4NCR97W-1&_user=532038&_coverDate=07%2F27%2F2007&_alid=834606660&_rdoc=3&_fmt=high&_orig=search&_cdi=5248&_sort=d&_docanchor=&view=c&_ct=4&_acct=C000026659&_version=1&_urlVersion=0&_userid=532038&md5=1c25a625a959d8a64b562e9633d2b705

File(s) associated to this reference

Fulltext file(s):

FileCommentaryVersionSizeAccess
Restricted access
Fit for purpose final.pdfPublisher postprint1.26 MBRequest copy

Bookmark and Share SFX Query

All documents in ORBi are protected by a user license.