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/2268/41022
Harmonization of strategies for the validation of quantitative analytical procedures - A SFSTP proposal - Part III
English
Hubert, Philippe mailto [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 mailto [Université de Liège - ULg > > Chimie analytique >]
2007
Journal of Pharmaceutical & Biomedical Analysis
Pergamon-Elsevier Science Ltd
45
1
82-96
Yes (verified by ORBi)
International
0731-7085
Oxford
United Kingdom
[en] analytical validation ; Calibration ; Chemistry, Analytical/methods/standards/statistics & numerical data ; Chemistry, Pharmaceutical/methods/standards/statistics & numerical data ; Clinical Laboratory Techniques/methods/standards/statistics & numerical data ; statistics ; total error ; risk ; accuracy profile
[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.
Researchers ; Professionals ; Students
http://hdl.handle.net/2268/41022
also: http://hdl.handle.net/2268/6187
10.1016/j.jpba.2007.06.032

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