Article (Scientific journals)
Harmonization of strategies for the validation of quantitative analytical procedures - A SFSTP proposal - Part III
Hubert, Philippe; Nguyen-Huu, J. J.; Boulanger, Bruno et al.
2007In Journal of Pharmaceutical and Biomedical Analysis, 45 (1), p. 82-96
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Keywords :
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
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.
Disciplines :
Pharmacy, pharmacology & toxicology
Chemistry
Author, co-author :
Hubert, Philippe  ;  Université de Liège - ULiège > Chimie analytique
Nguyen-Huu, J. J.
Boulanger, Bruno ;  Université de Liège - ULiège > Département de pharmacie > Analyse des médicaments
Chapuzet, E.
Cohen, N.
Compagnon, P.-A.
Dewé, Walthère ;  Université de Liège - ULiège > Analyse des médicaments
Feinberg, M.
Laurentie, Michel
Mercier, N.
Muzard, G.
Valat, L.
Rozet, Eric ;  Université de Liège - ULiège > Chimie analytique
More authors (3 more) Less
Language :
English
Title :
Harmonization of strategies for the validation of quantitative analytical procedures - A SFSTP proposal - Part III
Publication date :
2007
Journal title :
Journal of Pharmaceutical and Biomedical Analysis
ISSN :
0731-7085
eISSN :
1873-264X
Publisher :
Pergamon-Elsevier Science Ltd, Oxford, United Kingdom
Volume :
45
Issue :
1
Pages :
82-96
Peer reviewed :
Peer Reviewed verified by ORBi
Available on ORBi :
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