[en] The transfer of analytical methods from a sending laboratory to a receiving one requires to guarantee that this last laboratory will obtain accurate results. Undeniably method transfer is the ultimate step before routine implementation of the method at the receiving site. The conventional statistical approaches generally used in this domain which analyze separately the trueness and precision characteristics of the receiver do not achieve this. Therefore, this paper aims first at demonstrating the applicability of two recent statistical approaches using total error-based criterion and taking into account the uncertainty of the true value estimate of the sending laboratory, to the transfer of bioanalytical methods. To achieve this, they were successfully applied to the transfer of two fully automated liquid chromatographic method coupled on-line to solid-phase extraction. The first one was dedicated to the determination of three catecholamines in human urine using electrochemical detection, and the second one to the quantitation of N-methyl-laudanosine in plasma using fluorescence detection. Secondly, a risk-based evaluation is made in order to understand why classical statistical approaches are not sufficient to provide the guarantees that the analytical method will give most of the time accurate results during its routine use. Finally, some recommendations for the transfer studies are proposed.
Disciplines :
Pharmacie, pharmacologie & toxicologie
Auteur, co-auteur :
Rozet, Eric ; Université de Liège - ULiège > Chimie analytique
Dewé, Walthère ; Université de Liège - ULiège > Analyse des médicaments
Morello, R.
Chiap, Patrice ; Université de Liège - ULiège > Département de pharmacie > Analyse des médicaments
Hubert Ph., N'guyen-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
Rozet E., Ceccato A., Hubert C., Ziemons E., Oprean R., Rudaz S., Boulanger B., and Hubert Ph. J. Chromatogr. A 1158 (2007) 111
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 parts 1-6, Accuracy (trueness and precision) of measurement methods and results, International Organization for Standardization (ISO), Geneva, 1994.
Guidance for Industry: Bioanalytical Method Validation, US Department of Health and Human Services, US Food and Drug Administration (FDA), Center for Drug Evaluation and Research (CDER), Center for Biologics Evaluation and Research (CBER), Rockville, May 2001.
Analytical Procedure/Technology Transfer, International Society for Pharmaceutical Engineering (ISPE) Guideline, 2003, pp. 23-24.
Minois-Offroy F., Appriou Y., Brousset V., Chapuzet E., de Fontenay G., Dewé W., Dumas E., Ellie C., Galiay M., Lefebvre N., Mottu P., Quint M.P., and Schoeffter F. STP Pharma. Pratiques 12 (2002) 337
Kringle R., Khan-Malek R., Snikeris F., Munden P., Agut C., and Bauer M. Drug Inf. J. 35 (2001) 1271
Rodriguez S.A., Kubiak R., Mulcey M., Tamblyn T., and Tougas T. Am. Lab. 37 (2005) 9
Schepers U., and Wätzig H. J. Pharm. Biomed. Anal. 39 (2005) 310
Chambers D., Kelly G., Limentani G., Lister A., Lung R., and Warner E. Pharm. Technol. September (2005) 64-80
A.J. DeStefano, Issues in the Transfer of Methods to Analysts and Laboratories, AAPS Third Bioanalytical Workshop: Quantitative Bioanalytical Methods Validation and Implementation - Best Practices for Chromatographic and Ligand Binding Assays, Arlington, VA, May 1-3, 2006, http://www.aapspharmaceutica.com/meetings/meeting.asp?id=64.
Lukulay P.H. Considerations for a Successful Analytical Method Transfer for Pharmaceuticals, Institute of Validation Technology (IVT) Conferences on Method Validation. Dublin, Ireland, May 16-19 (2006)
Schepers U., and Wätzig H. J. Pharm. Biomed. Anal. 41 (2006) 290
Feng S., Liang Q., Kinser R.D., Newland K., and Guilbaud R. Anal. Bioanal. Chem. 385 (2006) 975
Vial J., Jardy A., Anger P., Brun A., and Menet J.M. J. Chromatogr. A 815 (1998) 173
Ramond B., Gaillandre A., Gibelin N., Michalski C., Nabet P., Niewiaski C., Poirault D., and Rigal H. STP Pharma. Pratiques 17 (2007) 67
Dewé W., Govaerts B., Boulanger B., Rozet E., Chiap P., and Hubert Ph. Chemom. Intell. Lab. Syst. 85 (2007) 262
Rozet E., Mertens B., Dewe W., Ceccato A., Govaerts B., Boulanger B., Chiap P., Streel B., Crommen J., and Hubert Ph. J. Pharm. Biomed. Anal. 42 (2006) 64
Hubert Ph., Nguyen-Huu J.-J., Boulanger B., Chapuzet E., Chiap P., Cohen N., Compagnon P.-A., Dewe W., Feinberg M., Lallier M., Laurentie M., Mercier N., Muzard G., Nivet C., and Valat L. STP Pharma. Pratiques 13 (2003) 101
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'Brian P.J., Sailstad J., Khan M., Ray C., and Wagner J.A. Pharm. Res. 23 (2006) 312
DeSilva B., Smith W., Weiner R., Kelley M., Smolec J., Lee B., Khan M., Tacey R., Hill H., and Celniker A. Pharm. Res. 20 (2003) 1885
B. Boulanger, W. Dewe, Ph. Hubert, B. Govaerts, C. Hammer, F. Moonen, Accuracy and Precision (Total error vs. 4/6/30), AAPS Third Bioanalytical Workshop: Quantitative Bioanalytical Methods Validation and Implementation - Best Practices for Chromatographic and Ligand Binding Assays, Arlington, VA, May 1-3, 2006, http://www.aapspharmaceutica.com/meetings/meeting.asp?id=64.
Boulanger B., Dewe W., Gilbert A., Govaerts B., and Maumy-Bertrand M. Chemom. Intell. Lab. Syst. 86 (2007) 198
Findlay J.W.A., Smith W.C., Lee J.W., Nordblom G.D., Das I., DeSilva B.S., Khan M.N., and Bowsher R.R. J. Pharm. Biomed. Anal. 21 (2000) 1249
Feinberg M., Boulanger B., Dewé W., and Hubert Ph. Anal. Bioanal. Chem. 380 (2004) 502
Hubert Ph., Lagorce P., Lallier M., Laparra M.C., Laurentie M., Nivet J.C., Chiap P., and Grandjean D. Anal. Chim. Acta 391 (1999) 135
Chiap P., Hubert Ph., Boulanger B., and Crommen J. Anal. Chim. Acta 391 (1999) 227
Rozet E., Wascotte V., Lecouturier N., Préat V., Dewé W., Boulanger B., and Hubert Ph. Anal. Chim. Acta 591 (2007) 239
International Conference on Harmonization (ICH): Quality Risk Management Q9, Geneva, 2005, http://www.emea.eu.int/Inspections/docs/ICHQ9Step4QRM.pdf.
Process Analytical Technology (PAT), Initiative, US Food and Drugs Administration, Rockville, MD, 2004, http://www.fda.gov/cder/OPS/PAT.htm.
Graulich A., Mercier F., Scuvée-Moreau J., Seutin V., and Liégeois J.-F. Bioorg. Med. Chem. 13 (2005) 1201
Rozet E., Morello R., Lecomte F., Martin G.B., Chiap P., Crommen J., Boos K.S., and Hubert Ph. J. Chromatogr. B 844 (2006) 251
Morello R., Boos K.-S., and Seidel D. GIT Lab. J. Eur. 6 (2004) 30
Hartmann C., Massart D.L., and McDowall R.D. J. Pharm. Biomed. Anal. 12 (1994) 1337
Boulanger B., Chiap P., Dewe W., Crommen J., and Hubert Ph. J. Pharm. Biomed. Anal. 32 (2003) 753
Burdick R.K., and Graybill F.A. Confidence Intervals on Variance Components (1992), Marcel Dekker, New York
Hubert Ph., N'guyen-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., Valat L., and Rozet E. J. Pharm. Biomed. Anal. 45 (2007) 82
Viswanathan C.T., Bansal S., Booth B., DeStefano A.J., Rose M.J., Sailstad J., Shah V.P., Skelly J.P., Swann P.G., and Weiner R. AAPS J. 9 (2007) E30. http://www.aapsj.org
