References of "Boulanger, Bruno"
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See detailUsing total error as decision criterion in analytical method transfer
Dewé, Walthère ULg; Govaerts, Bernadette; Boulanger, Bruno ULg et al

in Chemometrics and Intelligent Laboratory Systems (2007), 85(2), 262-268

An analytical transfer is a complete process that consists in transferring a validated analytical method from a sending laboratory (called sender) to a receiving laboratory (called receiver) after having ... [more ▼]

An analytical transfer is a complete process that consists in transferring a validated analytical method from a sending laboratory (called sender) to a receiving laboratory (called receiver) after having experimentally demonstrated that it also masters the method. The decision to transfer an analytical method is usually taken based on the combination of two criteria: one about systematic error and one about random errors. These usual criteria, their combination and their limitations are described in this paper. As it is for method validation, total error-based approaches should be also considered in method transfer. Two approaches are proposed in order to have a total error-based criterion and to take into account the precision of the true value estimate. In the first approach, a beta-expectation tolerance interval similar to the one used in method validation is calculated and then compared to acceptance limits around the estimate of the true value. The second approach, found as slightly more powerful than the first one, consists in estimating the probability to have a result outside these acceptance limits. (c) 2006 Elsevier B.V. All rights reserved. [less ▲]

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See detailHarmonization of strategies for the validation of quantitative analytical procedures - A SFSTP proposal - Part III
Hubert, Philippe ULg; Nguyen-Huu, J. J.; Boulanger, Bruno ULg et al

in Journal of Pharmaceutical & Biomedical Analysis (2007), 45(1), 82-96

In the first two documents [Ph. Hubert, J.J. Nguyen-Huu, B. Boulanger, E. Chapuzet, P. Chiap, N. Cohen, P.A. Compagnon, W. Dewe, M. Feinberg. M. Lallier, M. Laurentie, N. Mercier, G. Muzard, C. Nivet, L ... [more ▼]

In the first two documents [Ph. Hubert, J.J. Nguyen-Huu, B. Boulanger, E. Chapuzet, P. Chiap, N. Cohen, P.A. Compagnon, W. Dewe, M. Feinberg. M. Lallier, M. Laurentie, N. Mercier, G. Muzard, C. Nivet, L. Valat, J. Pharm. Biomed. Anal. 36 (2004) 579-586; Ph. Hubert, J.J. Nguyen-Huu. B. Boulanger, E. Chapuzet, P. Chiap, N. Cohen, P.A. Compagnon, W. Dewe, M. Feinberg, M. Lallier, M. Laurentie, N. Mercier, G. Muzard. C. Nivet, L. Valat, E. Rozet, J. Pharm. Biomed. Anal., in press], a recent SFSTP Commission on the validation of analytical procedure has introduced a harmonized approach for the validation of analytical procedures. In order to complete this guide, the statistical methodology allowing to correctly conclude about the validity of a procedure is proposed in this third part of the guide. Indeed all the steps to obtain the decision tool namely the accuracy profile are described and illustrated step by step by a numerical example. This tool, based on the concept of total error (bias + standard deviation) build with a P-expectation tolerance interval, allows to easily take the right decision and simultaneously minimizing the risk of the future use of the analytical procedure. (C) 2007 Elsevier B.V. All rights reserved. [less ▲]

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See detailAnalysis of recent pharmaceutical regulatory documents on analytical method validation.
Rozet, Eric ULg; Ceccato, Attilio ULg; Hubert, Cédric ULg et al

in Journal of Chromatography. A (2007), 1158(1-2), 111-25

All analysts face the same situations as method validation is the process of proving that an analytical method is acceptable for its intended purpose. In order to resolve this problem, the analyst refers ... [more ▼]

All analysts face the same situations as method validation is the process of proving that an analytical method is acceptable for its intended purpose. In order to resolve this problem, the analyst refers to regulatory or guidance documents, and therefore the validity of the analytical methods is dependent on the guidance, terminology and methodology, proposed in these documents. It is therefore of prime importance to have clear definitions of the different validation criteria used to assess this validity. It is also necessary to have methodologies in accordance with these definitions and consequently to use statistical methods which are relevant with these definitions, the objective of the validation and the objective of the analytical method. The main purpose of this paper is to outline the inconsistencies between some definitions of the criteria and the experimental procedures proposed to evaluate those criteria in recent documents dedicated to the validation of analytical methods in the pharmaceutical field, together with the risks and problems when trying to cope with contradictory, and sometimes scientifically irrelevant, requirements and definitions. [less ▲]

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See detailGESTION DU RISQUE LORS DU TRANSFERT DE METHODES ANALYTIQUES – CAS D’UNE METHODE BIOANALYTIQUE
Rozet, Eric ULg; Dewe, W.; Morello, R. et al

Conference (2007)

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See detailGuide for validation of analytical procedures
Oprean, R.; Rozet, Eric ULg; Dewé, Walthère ULg et al

Book published by Medicala Universitara “Iuliu Hatieganu” (2007)

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See detailRobustness testing of a chiral NACE method for R-timolol determination in S-timolol maleate and uncertainty assessment from quantitative data.
Marini Djang'Eing'A, Roland ULg; Rozet, Eric ULg; Vanderheyden, Yvan et al

in Journal of Pharmaceutical & Biomedical Analysis (2007), 44(3), 640-51

A robustness test of a capillary electrophoresis method for the chiral separation of timolol in nonaqueous acidified media was performed. A two-level Plackett-Burman design was applied in which one ... [more ▼]

A robustness test of a capillary electrophoresis method for the chiral separation of timolol in nonaqueous acidified media was performed. A two-level Plackett-Burman design was applied in which one qualitative and six quantitative factors were examined. Resolution, migration times and relative migration times to pyridoxine (selected as internal standard) were examined as qualitative responses to evaluate electrophoretic performance. A quantitative response, the content of R-timolol in S-timolol maleate sample, was also considered. Even though some significant factor effects were observed on the qualitative responses, it was still possible to quantify the R-timolol in the S-timolol maleate samples properly. The quantitative response was not significantly affected by the selected factors, demonstrating the robustness of the procedure. However, the use of different HDMS-beta-CD batches seemed to affect both types of responses necessitating to introduce a warning in the procedure. Since the experiments of the Plackett-Burman design can be assimilated to laboratories in an interlaboratory study, uncertainty can be evaluated using the robustness test data. The robustness test was set-up in such a way that the required variances could be estimated. [less ▲]

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See detailTotal Error-Based Criterion for Analytical Method Transfer Experiments
Rozet, Eric ULg; Dewe, W.; Boulanger, Bruno ULg et al

Conference (2007)

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See detailEvaluation of Analytical Method Transfer on a Risk Based Methodology using Total Error
Rozet, Eric ULg; Dewe, W.; Govaerts, B. et al

Conference (2007)

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See detailShort Course on Method validation
Boulanger, Bruno ULg; Hubert, Philippe ULg

Conference (2007)

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