Improvement of the decision efficiency of the accuracy profile by means of a desirability function for analytical methods validation - Application to a diacetyl-monoxime colorimetric assay used for the determination of urea in transdermal iontophoretic extracts
[en] Validation of analytical methods is a widely used and regulated step for each analytical method. However, the classical approaches to demonstrate the ability to quantify of a method do not necessarily fulfill this objective. For this reason an innovative methodology was recently introduced by using the tolerance interval and accuracy profile, which guarantee that a pre-defined proportion of future measurements obtained with the method will be included within the acceptance limits. Accuracy profile is an effective decision tool to assess the validity of analytical methods. The methodology to build such a profile is detailed here. However, as for any visual tool it has a part of subjectivity. It was then necessary to make the decision process objective in order to quantify the degree of adequacy of an accuracy profile and to allow a thorough comparison between such profiles. To achieve this, we developed a global desirability index based on the three most important validation criteria: the trueness, the precision and the range. The global index allows the classification of the different accuracy profiles obtained according to their respective response functions. A diacetyl-monoxime colorimetric assay for the determination of urea in transdermal iontophoretic extracts was used to illustrate these improvements.
Disciplines :
Chemistry
Author, co-author :
Rozet, Eric ; Université de Liège - ULiège > Chimie analytique
Wascotte, Valentine; Université Catholique de Louvain - UCL > School of Pharmacy > Pharmaceutical Technology Department
Lecouturier, Nathalie; Université Catholique de Louvain - UCL > School of Pharmacy > Pharmaceutical Technology Department
Préat, Véronique; Université Catholique de Louvain - UCL > School of Pharmacy > Pharmaceutical Technology Department
Dewé, Walthère ; Université de Liège - ULiège > Analyse des médicaments
Boulanger, Bruno ; Université de Liège - ULiège > Département de pharmacie > Analyse des médicaments
Improvement of the decision efficiency of the accuracy profile by means of a desirability function for analytical methods validation - Application to a diacetyl-monoxime colorimetric assay used for the determination of urea in transdermal iontophoretic extracts
International Conference on Harmonization (ICH) of Technical Requirements for registration of Pharmaceuticals for Human Use, Topic Q2 (R1): Validation of Analytical Procedures: Text and Methodology, Geneva, 2005.
ISO 5725-1, Application of the statistics - Accuracy (trueness and precision) of the results and methods of measurement - Part 1: General principles and definitions. International Organization for Standardization (ISO), Geneva, 1994.
Commission Decision 2002/657/EC, Off. J. Eur. Commun., L 221 (2002) 8.
Guidance for industry: Bioanalytical Method Validation, US Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (CDER), Center for Biologics Evaluation and Research (CBER), Rockville, May 2001.
Hubert Ph., Chiap P., Crommen J., Boulanger B., Chapuzet E., Mercier N., Bervoas-Martin S., Chevalier P., Grandjean D., Lagorce Ph., Laparra M.C., Laurentie M., and Nivet J.C. Anal. Chim. Acta 391 (1999) 135-148
Karnes H.T., Shiu G., and Shah V.P. Pharm. Res. 8 (1991) 421-426
Hartmann C., Smeyers-Verbeke J., Massart D.L., and McDowall R.D. J. Pharm. Biomed. Anal. 17 (1998) 193-218
Shah V.P., Midha K.K., Findlay J.W.A., Hill H.M., Hulse J.D., McGilveray I.J., McLay G., Miller K.J., Patnaik R.N., Powell M.L., Tonelli A., Viswanathan C.T., and Yacobi A. Pharm. Res. 17 (2000) 1551-1557
Boulanger B., Dewe W., Chiap P., Crommen J., and Hubert Ph. J. Pharm. Biomed. Anal. 32 (2003) 753-765
Feinberg M., Boulanger B., Dewe W., and Hubert Ph. Anal. Bioanal. Chem. 380 (2004) 502-514
Boudreau S.P., McElvain J.S., Martin L.D., Dowling T., and Fields S.M. Pharm. Technol. (2004) 54-66
Lee J.W., Devanarayan V., Barrett Y.C., Weiner R., Allinson J., Fountain S., Keller S., Weinryb I., Green M., Duan L., Rogers J.A., Millham R., O'Brien P.J., Sailstad J., Khan M., Ray C., and Wagner J.A. Pharm. Res. 23 (2006) 312-328
Hubert Ph., Nguyen-Huu J.-J., Boulanger B., Chapuzet E., Chiap P., Cohen N., Compagnon P.-A., Dewé W., Feinberg M., Lallier M., Laurentie M., Mercier N., Muzard G., Nivet C., and Valat L. J. Pharm. Biomed. Anal. 36 (2004) 579-586
Process Analytical Technology (PAT) Initiative, US Food and Drug Administration, Rockville, MD, 2004; http://www.fda.gov/cder/OPS/PAT.htm.
Food and Drug Administration, International Conference on Harmonization (ICH): Quality Risk Management (Q9), Fed. Regist., vol. 71 (2006) 32105-32106.
The Fitness for Purpose of Analytical Methods, A Laboratory Guide to Method Validation and Related Topics, Eurachem, Teddington, 1998.
Mee R. Technometrics 26 (1984) 251-254
Gonzalez G., and Herrador M.A. Talanta 70 (2006) 896-901
Satterthwaite F. Psychometrika 6 (1941) 309-316
Miller J.C., and Miller J.N. Statistics for Analytical Chemistry. fifth ed. (2000), Ellis Horwood, New York p. 96
P. Dagnelie, Théorie et méthodes statistiques vol. 1 et 2, Les presses agronomiques de Gembloux, Gembloux, 1994.
Derringer G.C., and Suich R. J. Qual. Technol. 12 (1980) 214-219
