Showing results 41 to 60 of 86
 Intérêt du profil d'exactitude dans le cadre de la validation des méthodes analytiquesHubert, Philippe  ; Chiap, Patrice ; et alPoster (2004) Detailed reference viewed: 25 (1 ULg)The use of total error to validate analytical method : examples of applications; ; Dewé, Walthère et alConference (2004) Detailed reference viewed: 9 (1 ULg)Validation of quantitation methodsBoulanger, Bruno ; Dewé, Walthère ; Hubert, Philippe Conference (2004) Detailed reference viewed: 6 (1 ULg)Towards a better use of statistics in method validationDewé, Walthère ; Boulanger, Bruno ; Hubert, Philippe Conference (2004) Detailed reference viewed: 9 (2 ULg)Use of accuracy profiles as efficient decision tool for the validation of quantitative analytical methodsChiap, Patrice ; Dewé, Walthère ; Boulanger, Bruno et alPoster (2004) Detailed reference viewed: 17 (2 ULg)Objectives of analytical methods and objectives of validation. How to reconcile them ?Boulanger, Bruno ; Dewé, Walthère ; Hubert, Philippe Conference (2004) Detailed reference viewed: 8 (1 ULg) An analysis of the SFSTP guide on validation of chromatographic bioanalytical methods: progresses and limitationsBoulanger, Bruno ; Chiap, Patrice ; Dewé, Walthère et alin 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 ▲] Detailed reference viewed: 40 (4 ULg)LC method for the simultaneous determination of R-timolol and other closely related impurities in S-timolol maleate: Optimization by use of an experimental designMarini Djang'Eing'A, Roland ; Chiap, Patrice ; Boulanger, Bruno et alin 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 ▲] Detailed reference viewed: 22 (2 ULg)Development of response models for optimizing HPLC methodsDewé, Walthère ; Marini Djang'Eing'A, Roland ; Chiap, Patrice et alPoster (2003, June) Detailed reference viewed: 8 (2 ULg)Validation des procédures analytiques quantitatives, Harmonisation des démarchesHubert, Philippe ; ; Boulanger, Bruno et alin STP Pharma Pratiques (2003), 13(3), 101-138 Detailed reference viewed: 329 (43 ULg)Separation énatiomérique de substances médicamenteuses basiques par électrophorèse capillarie en milieu non aqueux : effet de l’utilisation simul-tanée d’une cyclodextrine anionique et d’un agent d’appariement d’ionsServais, Anne-Catherine ; Dewé, Walthère ; Chiap, Patrice et alConference (2003) Detailed reference viewed: 10 (1 ULg)Enantiomeric separation of basic pharmaceuticals in non-aqueous capillary electrophoresis using an anionic cyclodextrin in combination with an ion-pairing reagentCrommen, Jacques ; Servais, Anne-Catherine ; Dewé, Walthère et alConference (2003) Detailed reference viewed: 2 (0 ULg)Harmonisation des démarches de validation, est-elle possible ?Hubert, Philippe ; Chiap, Patrice ; et alConference (2003) Detailed reference viewed: 19 (1 ULg)Development of response models for optimising HPLC methodsDewé, Walthère ; Marini Djang'Eing'A, Roland ; Chiap, Patrice et alPoster (2003) Detailed reference viewed: 10 (5 ULg)Intérêt du profil d’exactitude dans le cadre de la validation d’une méthode de dosage par chromatographie liquide du miconazole, de l’éconazole et du sor-bate dans les préparations à usage dermatologieChiap, Patrice ; Crommen, Jacques ; et alPoster (2003) Detailed reference viewed: 33 (2 ULg)Objectives of analytical methods and objectives of validation : how to reconciliate them ?Boulanger, Bruno ; Marini Djang'Eing'A, Roland ; Chiap, Patrice et alConference (2003) Detailed reference viewed: 10 (3 ULg)Statistical analysis of validation method revisited : the need to use the total error. Proceeding 9th international congress of the european association for Veterinary Pharmacology and Toxicology; Boulanger, Bruno ; Dewé, Walthère et alin Journal of Veterinary Pharmacology & Therapeutics (2003), 26 Detailed reference viewed: 8 (2 ULg)Harmonization of validation strategies for analytical methodsHubert, Philippe ; Chiap, Patrice ; Dewé, Walthère et alConference (2003) Detailed reference viewed: 13 (2 ULg)Statistical analysis of validation method revisited : the need to use the total error; Boulanger, Bruno ; Dewé, Walthère et alConference (2003) Detailed reference viewed: 5 (1 ULg)Objectives of analytical methods and objectives of validationBoulanger, Bruno ; Dewé, Walthère ; Chiap, Patrice et alConference (2003) Detailed reference viewed: 14 (1 ULg) |
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