analytical method transfer; transfer methodology; tolerance interval; risk; statistical approaches
Abstract :
[en] Two new statistical approaches to assess the validity of the transfer of a LC-UV method for the determination of fenofibrate and fenofibric acid were investigated and compared to the conventional approaches generally used in this domain. These new approaches, namely the Tolerance Interval and the Risk approaches, are based on the simultaneous evaluation of the systematic (or trueness) and random (or precision) errors of the transfer into a single criterion called total error (or accuracy). The results of the transfer showed that only the total error based approaches fulfilled the objective of an analytical method transfer, i.e. to give guarantees that each future measurement made by the receiving laboratory will be close enough to the true value of the analyte in the sample. Furthermore the Risk approach was the most powerful one and allowed the estimation of the risk to have future measurements out of specification in the receiving laboratory, therefore being a risk management tool. (c) 2006 Elsevier B.V. All rights reserved.
Disciplines :
Chemistry Pharmacy, pharmacology & toxicology
Author, co-author :
Rozet, Eric ; Université de Liège - ULiège > Chimie analytique
Mertens, Bénédicte; Galephar
Dewé, Walthère ; Université de Liège - ULiège > Analyse des médicaments
Ceccato, Attilio ; Université de Liège - ULiège > Département de pharmacie > Analyse des médicaments
Govaerts, Bernadette; Université Catholique de Louvain - UCL > Institute of Statistics
Boulanger, Bruno ; Université de Liège - ULiège > Département de pharmacie > Analyse des médicaments
Chiap, Patrice ; Université de Liège - ULiège > Département de pharmacie > Analyse des médicaments
Streel, Bruno; Galephar
Crommen, Jacques ; Université de Liège - ULiège > Département de pharmacie > Analyse des médicaments
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