Reference : Harmonization of strategies for the validation of quantitative analytical procedures ...
Scientific journals : Article
Physical, chemical, mathematical & earth Sciences : Chemistry
Human health sciences : Pharmacy, pharmacology & toxicology
http://hdl.handle.net/2268/6170
Harmonization of strategies for the validation of quantitative analytical procedures - A SFSTP proposal - Part II
English
Hubert, Philippe mailto [Université de Liège - ULg > > Chimie analytique >]
Nguyen-Huu, J.-J. [Aventis >]
Boulanger, Bruno [Université de Liège - ULg > Département de pharmacie > Analyse des médicaments >]
Chapuzet, Eric [QUALILAB (Olivet) >]
Chiap, Patrice mailto [Université de Liège - ULg > Département de pharmacie > Analyse des médicaments >]
Cohen, N. [EXPANSCIENCE (Epernon) >]
Compagnon, Pierre-Albert [Agence française de sécurité sanitaire des produits de santé - AFSSAPS > Unité physico-chimie >]
Dewé, Walthère [Université de Liège - ULg > > Analyse des médicaments >]
Feinberg, Max [Institut national de la recherche agronomique - INRA >]
Lallier, M. [INNOTHERA (Arcueil, France) >]
Laurentie, Michel [Agence française de sécurité sanitaire des produits de santé - AFSSAPS >]
Mercier, N. [QUALILAB (Olivet, France) >]
Muzard, G. [> > > >]
Nivet, C. [> > > >]
Valat, L. [> > > >]
Rozet, Eric mailto [Université de Liège - ULg > > Chimie analytique >]
21-Sep-2007
Journal of Pharmaceutical & Biomedical Analysis
Pergamon-Elsevier Science Ltd
45
1
70-81
Yes (verified by ORBi)
International
0731-7085
Oxford
[en] analytical procedure ; validation ; harmonization ; quantitative analysis ; accuracy profile ; total error ; experimental protocol
[en] As reported in a previous paper[1], the main objective of the new commission of the Societe Francaise des Sciences et Techniques Pharmaceutiques (SFSTP) was the harmonisation of approaches for the validation of quantitative analytical procedures. In a series of meetings, members of this Commission have first tried to review the objectives of analytical methods and the objectives of validation methods and to recommend the use of two-sided beta-expectation tolerance intervals for total error of validation samples (accuracy profile) in the acceptance/rejection of analytical method in validation phase. In the context of the harmonization, the other objectives were: (i) to propose a consensus on the norms usually recognized, while widely incorporating the ISO terminology; (ii) to recommend to validate the analytical procedure accordingly to the way it will be used in routine; (iii) to elaborate a rational, practical and statistically reliable strategy to assure the quality of the analytical results generated. This strategy has been formalised in a guide and the three latter objectives made by the Commission are summarised in the present paper which is the second part of summary report of the SFSTP commission. The SFSTP guide has been produced to help analysts to validate their analytical methods. It is the result of a consensus between professionals having expertise in analytical and/or statistical fields. The suggestions presented in this paper should therefore help the analyst to design and perform the minimum number validation experiments needed to obtain all the required information to establish and demonstrate the reliability of its analytical procedure. (C) 2007 Elsevier B.V. All rights reserved.
http://hdl.handle.net/2268/6170
10.1016/j.jpba.2007.06.013

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