References of "Dewé, Walthère"
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See detailThe use of total error to validate analytical method : examples of applications
Laurentie, M.; Manceau, J.; Dewé, Walthère ULg et al

Conference (2004)

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See detailValidation of quantitation methods
Boulanger, Bruno ULg; Dewé, Walthère ULg; Hubert, Philippe ULg

Conference (2004)

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See detailAn analysis of the SFSTP guide on validation of chromatographic bioanalytical methods: progresses and limitations
Boulanger, Bruno ULg; Chiap, Patrice ULg; Dewé, Walthère ULg et al

in Journal of Pharmaceutical & Biomedical Analysis (2003), 32(4-5), 753-765

The Societe Francaise des Sciences et Techniques Pharmaceutiques (SFSTP) published in 1997 a guide on the validation of chromatographic bio-analytical methods, which introduces new concepts in three ... [more ▼]

The Societe Francaise des Sciences et Techniques Pharmaceutiques (SFSTP) published in 1997 a guide on the validation of chromatographic bio-analytical methods, which introduces new concepts in three different areas: stages of the validation, test of acceptability of a method and design of experiments to perform. In 'stages of validation', the SFSTP guide requires two phases to validate a method. The first phase, called 'prevalidation', is intended to (1) identify the model to use for the calibration curve; (2) evaluate the limits of quantitation; and (3) provide good estimates of the precision and bias of the method before designing the 'validation' phase per se. In the 'test of acceptability', the use of the interval hypotheses is envisaged by the SFSTP guide, not on the parameters of bias and precision, but on individual results by mixing mean bias and intermediate precision in a single test. The SFSTP guide also avoids the use of Satterthwaite's df for testing the acceptability. The reasons for those choices are discussed extensively. In 'design of experiments', much effort has been devoted to improving the quality of results by optimally designing and sizing the experiments to perform in validation. The rationale for using near D-optimal designs for the calibration curve is demonstrated and sample sizes are proposed to correctly size the validation experiments. (C) 2003 Elsevier Science B.V. All rights reserved. [less ▲]

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See detailLC method for the simultaneous determination of R-timolol and other closely related impurities in S-timolol maleate: Optimization by use of an experimental design
Marini Djang'Eing'A, Roland ULg; Chiap, Patrice ULg; Boulanger, Bruno ULg et al

in Journal of Separation Science (2003), 26(9-10), 809-817

A liquid chromatography (LC) method using cellulose tris(3,5-dimethylphenylcarbamate) (5 mum) as chiral stationary phase (CSP) and a mixture of hexane, 2-propanol, and diethylamine as mobile phase was ... [more ▼]

A liquid chromatography (LC) method using cellulose tris(3,5-dimethylphenylcarbamate) (5 mum) as chiral stationary phase (CSP) and a mixture of hexane, 2-propanol, and diethylamine as mobile phase was developed for the simultaneous determination of R-timolol and other potential related substances in S-timolol maleate samples. An experimental design was elaborated in order to test the effects of the different selected factors. Three factors were studied simultaneously, namely the concentrations of 2-propanol and diethylamine as well as the column temperature. The effects of these factors were evaluated statistically. Optimal LC conditions were then deduced by applying a multicriteria decision making approach, namely Derringer's desirability function, for the responses of interest. The developed LC method was compared to the European Pharmacopoeia method and was applied to the determination of R-timolol and other related substances in several samples of S-timolol maleate from different sources. [less ▲]

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See detailValidation des procédures analytiques quantitatives, Harmonisation des démarches
Hubert, Philippe ULg; Nguyen-Huu, J. J.; Boulanger, Bruno ULg et al

in STP Pharma Pratiques (2003), 13(3), 101-138

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See detailHarmonisation des démarches de validation, est-elle possible ?
Hubert, Philippe ULg; Chiap, Patrice ULg; Laurentie, M. et al

Conference (2003)

Detailed reference viewed: 21 (1 ULg)