Article (Scientific journals)
Using tolerance intervals in pre-study validation of analytical methods to predict in-study results - The fit-for-future-purpose concept
Rozet, Eric; Hubert, Cédric; Ceccato, Attilio et al.
2007In Journal of Chromatography. A, 1158 (1-2), p. 126-137
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Keywords :
validation; beta-expectation tolerance interval; accuracy profile; fitness for purpose; quality control; prediction; in-study results
Abstract :
[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.
Research center :
C.I.R.M.
Disciplines :
Chemistry
Pharmacy, pharmacology & toxicology
Author, co-author :
Rozet, Eric ;  Université de Liège - ULiège > Département de pharmacie > Chimie analytique
Hubert, Cédric  ;  Université de Liège - ULiège > Département de pharmacie > Chimie analytique
Ceccato, Attilio ;  Université de Liège - ULiège > Département de pharmacie > Chimie anlytique
Dewé, Walthère ;  Université de Liège - ULiège > Département de pharmacie > Chimie analytique
Ziemons, Eric  ;  Université de Liège - ULiège > Département de pharmacie > Chimie analytique
Moonen, François
Michail, Karim
Wintersteiger, Reinhold
Streel, Bruno
Boulanger, Bruno ;  Université de Liège - ULiège > Département de pharmacie > Chimie analytique
Hubert, Philippe  ;  Université de Liège - ULiège > Département de pharmacie > Chimie analytique
Language :
English
Title :
Using tolerance intervals in pre-study validation of analytical methods to predict in-study results - The fit-for-future-purpose concept
Publication date :
27 July 2007
Journal title :
Journal of Chromatography. A
ISSN :
0021-9673
eISSN :
1873-3778
Publisher :
Elsevier Science Bv, Amsterdam, Netherlands
Special issue title :
Data analysis in chromatography
Volume :
1158
Issue :
1-2
Pages :
126-137
Peer reviewed :
Peer Reviewed verified by ORBi
Available on ORBi :
since 02 December 2008

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