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

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
	To cite this reference:	http://hdl.handle.net/2268/41022

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 > Département de pharmacie > 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 > Département de pharmacie > Analyse des médicaments - Département de mathématique >]
	Feinberg, M. [> > > >]
	Laurentie, M. [> > > >]
	Mercier, N. [> > > >]
	Muzard, G. [> > > >]
	Valat, L. [> > > >]
	Rozet, Eric [Université de Liège - ULg > Département de pharmacie > Chimie analytique >]
Publication date :	2007
Journal title :	Journal of Pharmaceutical & Biomedical Analysis
Publisher :	Elsevier Science
Volume :	45
Issue/season :	1
Pages :	82-96
Peer reviewed :	Yes (verified by ORBi)
Audience :	International
ISSN :	0731-7085
City :	Oxford
Country :	United Kingdom
Keywords :	[en] Calibration ; Chemistry, Analytical/methods/standards/statistics & numerical data ; Chemistry, Pharmaceutical/methods/standards/statistics & numerical data ; Clinical Laboratory Techniques/methods/standards/statistics & numerical data ; France ; Reference Standards ; Reproducibility of Results ; Societies, Medical
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 beta-expectation tolerance interval, allows to easily take the right decision and simultaneously minimizing the risk of the future use of the analytical procedure.
Target :	Researchers ; Professionals ; Students
Permalink :	http://hdl.handle.net/2268/41022
DOI :	10.1016/j.jpba.2007.06.032

File(s) associated to this reference

Fulltext file(s):

	File	Commentary	Version	Size	Access
Restricted access	articlephhJPBAPartIII_2007.pdf		Publisher postprint	545.77 kB	Request copy

All documents in ORBi are protected by a user license.

Dspace v1.5