Reference : The transfer of a LC-UV method for the determination of fenofibrate and fenofibric acid ...
Scientific journals : Article
Physical, chemical, mathematical & earth Sciences : Chemistry
Human health sciences : Pharmacy, pharmacology & toxicology
http://hdl.handle.net/2268/6027
The transfer of a LC-UV method for the determination of fenofibrate and fenofibric acid in Lidoses: Use of total error as decision criterion
English
Rozet, Eric mailto [Université de Liège - ULg > > Chimie analytique >]
Mertens, Bénédicte [Galephar >]
Dewé, Walthère [Université de Liège - ULg > > Analyse des médicaments >]
Ceccato, Attilio mailto [Université de Liège - ULg > Département de pharmacie > Analyse des médicaments >]
Govaerts, Bernadette [Université Catholique de Louvain - UCL > Institute of Statistics >]
Boulanger, Bruno [Université de Liège - ULg > Département de pharmacie > Analyse des médicaments >]
Chiap, Patrice mailto [Université de Liège - ULg > Département de pharmacie > Analyse des médicaments >]
Streel, Bruno [Galephar >]
Crommen, Jacques mailto [Université de Liège - ULg > Département de pharmacie > Analyse des médicaments >]
Hubert, Philippe mailto [Université de Liège - ULg > > Chimie analytique >]
11-Sep-2006
Journal of Pharmaceutical & Biomedical Analysis
Pergamon-Elsevier Science Ltd
42
1
64-70
Yes (verified by ORBi)
International
0731-7085
Oxford
[en] analytical method transfer ; transfer methodology ; tolerance interval ; risk ; statistical approaches
[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.
Researchers ; Professionals ; Students
http://hdl.handle.net/2268/6027
10.1016/j.jpba.2005.12.037

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