Reference : Comments on “Uncertainty profiles for the validation of analytical methods” by Saffaj an...
Scientific journals : Letter to the editor
Human health sciences : Pharmacy, pharmacology & toxicology
http://hdl.handle.net/2268/101440
Comments on “Uncertainty profiles for the validation of analytical methods” by Saffaj and Ihssane
English
Rozet, Eric mailto [Université de Liège - ULg > Département de pharmacie > Chimie analytique >]
Ziemons, Eric mailto [Université de Liège - ULg > Département de pharmacie > Département de pharmacie >]
Marini Djang'Eing'A, Roland mailto [Université de Liège - ULg > Département de pharmacie > Chimie analytique >]
Boulanger, Bruno [ > > ]
Hubert, Philippe mailto [Université de Liège - ULg > Département de pharmacie > Chimie analytique >]
Jan-2012
Talanta
Elsevier Science
88
769-771
Yes (verified by ORBi)
International
0039-9140
1873-3573
Amsterdam
The Netherlands
[en] analytical method validation ; expectation tolerance interval ; confidence content tolerance interval ; false compliance and false non compliance risks ; method validation sample size
[en] Saffaj et al., recently proposed an uncertainty profile for evaluating the validity of analytical methods using the statistical methodology of γ-confidence β-content tolerance intervals. This profile assesses the validity of the method by comparing the method measurement uncertainty to a pre defined acceptance limit stating the maximum uncertainty suitable for the method under study. Several years earlier as stated by these authors a SFSTP (Société Française des Sciences et Techniques Pharmaceutique) commission has developed a similar profile called accuracy profile used to assess the validity of analytical methods. This accuracy profile also uses the methodology of statistical tolerance intervals, but β-expectation tolerance intervals. The uncertainty profile of Saffaj et al. and the accuracy profile of the SFSTP commission are both fulfilling the same final purpose. The core question is finally what statistical tolerance interval to use ? The aim of this letter to the editor is to discuss this question and provide arguments that β-expectation tolerance intervals should be prefered to assess the validity of the method as this type of interval give the guarantee that each future results has high probability to fall within pre-specified acceptance limits.
Researchers ; Professionals ; Students
http://hdl.handle.net/2268/101440

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