[en] Two new statistical approaches based on the total error of measurements were applied to the transfer of an automated method for the determination of noradrenalin in human urine by LC-ECD coupled on-line to SPE. They showed that the receiving laboratory was mastering the analytical procedure allowing it to use the method in routine. Furthermore the risk based approach gave guarantee that the risk to have future measurements out of specification in the receiving laboratory was smaller than 5%, therefore being a risk management tool.
Disciplines :
Laboratory medicine & medical technology
Author, co-author :
Rozet, Eric ; Université de Liège - ULiège > Chimie analytique
Dewé, Walthère ; Université de Liège - ULiège > Analyse des médicaments
Chiap, Patrice ; Université de Liège - ULiège > Département de pharmacie > Analyse des médicaments
Minois-Offroy F., Appriou Y, Broussset V., Chapuzet E., De Fontenay G., Dewé W., Dumas E., Ellie C., Galiay M., Lefebvre N., Mottu P., Quint M.P., Schoeffter F. Transfert des méthodes analytiques: méthodologie. STP Pharma Pratiques. 2002, 12, 337-43.
ISPE Good Practice Guide: Technology Transfer. 2003.
Kringle R., Khan-Malek R., Snikeris F., Munden P., Agut C., Bauer M. A unified approach for design and analysis of transfer studies for analytical methods. Drug Information Journal. 2001, 35, 1271-88.
Hubert Ph., Nguyen 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. Harmonization of strategies for the validation of quantitative analytical procedures A SFSTP proposal-part I. J. Pharm. Biomed. Anal. 2004, 36, 579-86.
