ORBi: Hubert Philippe - Harmonization of strategies for the validation of quantitative analytical procedures - A SFSTP proposal

Reference : Harmonization of strategies for the validation of quantitative analytical procedures - A...


	Document type :	Scientific journals : Article
	Discipline(s) :	Physical, chemical, mathematical & earth Sciences : Chemistry Human health sciences : Pharmacy, pharmacology & toxicology
	To cite this reference:	http://hdl.handle.net/2268/6187

Title :	Harmonization of strategies for the validation of quantitative analytical procedures - A SFSTP proposal - Part III
Language :	English
Author, co-author :	Hubert, Philippe [Université de Liège - ULg > > Chimie analytique >]
	Nguyen-Huu, J. J. [> > > >]
	Boulanger, Bruno [Université de Liège - ULg > Département de pharmacie > Analyse des médicaments >]
	Chapuzet, E. [> > > >]
	Cohen, N. [> > > >]
	Compagnon, P.-A. [> > > >]
	Dewé, Walthère [Université de Liège - ULg > > Analyse des médicaments >]
	Feinberg, M. [> > > >]
	Laurentie, Michel [> > > >]
	Mercier, N. [> > > >]
	Muzard, G. [> > > >]
	Valat, L. [> > > >]
	Rozet, Eric [Université de Liège - ULg > > Chimie analytique >]
Publication date :	21-Sep-2007
Journal title :	Journal of Pharmaceutical & Biomedical Analysis
Publisher :	Pergamon-Elsevier Science Ltd
Volume :	45
Issue/season :	1
Pages :	82-96
Audience :	International
ISSN :	0731-7085
City :	Oxford
Keywords :	[en] analytical validation ; statistics ; total error ; risk ; accuracy profile
Abstract :	[en] In the first two documents [Ph. Hubert, J.J. Nguyen-Huu, B. Boulanger, E. Chapuzet, P. Chiap, N. Cohen, P.A. Compagnon, W. Dewe, M. Feinberg. M. Lallier, M. Laurentie, N. Mercier, G. Muzard, C. Nivet, L. Valat, J. Pharm. Biomed. Anal. 36 (2004) 579-586; Ph. Hubert, J.J. Nguyen-Huu. B. Boulanger, E. Chapuzet, P. Chiap, N. Cohen, P.A. Compagnon, W. Dewe, M. Feinberg, M. Lallier, M. Laurentie, N. Mercier, G. Muzard. C. Nivet, L. Valat, E. Rozet, J. Pharm. Biomed. Anal., in press], a recent SFSTP Commission on the validation of analytical procedure has introduced a harmonized approach for the validation of analytical procedures. In order to complete this guide, the statistical methodology allowing to correctly conclude about the validity of a procedure is proposed in this third part of the guide. Indeed all the steps to obtain the decision tool namely the accuracy profile are described and illustrated step by step by a numerical example. This tool, based on the concept of total error (bias + standard deviation) build with a P-expectation tolerance interval, allows to easily take the right decision and simultaneously minimizing the risk of the future use of the analytical procedure. (C) 2007 Elsevier B.V. All rights reserved.
Permalink :	http://hdl.handle.net/2268/6187
DOI :	10.1016/j.jpba.2007.06.032

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