Harmonization of strategies for the validation of quantitative analytical procedures. A SFSTP proposal--part III.
In the first two documents [Ph. Hubert, J.J. Nguyen-Huu, B. Boulanger, E. Chapuzet, P. Chiap, N. Cohen, P.A. Compagnon, W. Dewé, 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. Dewé, 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.
Hubert
Ph
P
Laboratory of Analytical Chemistry, Bioanalytical Chemistry Research Unit, Institute of Pharmacy, University of Liège, CHU, B36, B-4000 Liège, Belgium. Electronic address: ph.Hubert@ulg.ac.be.
Nguyen-Huu
J-J
JJ
Sanofi-Aventis, quai Jules Guesde, B.P. 14, F-94403 Vitry sur Seine, France.
Boulanger
B
B
UCB Pharma SA, Chemin du Foriest, B-1420 Braine-L'alleud, Belgium.
Chapuzet
E
E
Qualilab, rue de la Bergeresse, F-45160 Olivet (Orléans), France.
Cohen
N
N
Expanscience, rue des quatre Filles, B.P. 25034, F-28231 Epernon, France.
Compagnon
P-A
PA
French Agency for Health Products Safety (AFSSAPS), boulevard Anatole France, Les Portes de Pleyel, F-93285 St Denis, France.
Dewé
W
W
GlaxoSmithKline Biologicals, 89 Rue de l'Institut, B-1330 Rixensart, Belgium.
Feinberg
M
M
Met@risk, National Institute for Agricultural Research (INRA), rue Claude Bernard, F-75231 Paris, France.
Laurentie
M
M
LERMDV, French Food Safety Agency (AFSSA), B.P. 90203, F-35032 Fougères, France.
Mercier
N
N
Qualilab, rue de la Bergeresse, F-45160 Olivet (Orléans), France.
Muzard
G
G
Merck-Theramex, avenue Prince Héréditaire Albert, F-98007 Monaco, France.
Valat
L
L
Viatris-Manufacturing, avenue J.F. Kennedy, B.P. 100, F-33701 Mérignac, France.
Rozet
E
E
Laboratory of Analytical Chemistry, Bioanalytical Chemistry Research Unit, Institute of Pharmacy, University of Liège, CHU, B36, B-4000 Liège, Belgium.
D002138:Calibration; D002623:Chemistry Techniques, Analytical / Q000379:methods / Q000592:standards / Q000706:statistics & numerical data; D002626:Chemistry, Pharmaceutical / Q000379:methods / Q000592:standards / Q000706:statistics & numerical data; D019411:Clinical Laboratory Techniques / Q000379:methods / Q000592:standards / Q000706:statistics & numerical data; D005602:France; D012015:Reference Standards; D015203:Reproducibility of Results; D012955:Societies, Medical