Using total error as decision criterion in analytical method transfer
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Philippe Hubert | Patrice Chiap | Walthère Dewé | Bruno Boulanger | Eric Rozet | Bernadette Govaerts | B. Govaerts | P. Chiap | P. Hubert | E. Rozet | B. Boulanger | W. Dewé
[1] Christophe Agut,et al. A Unified Approach for Design and Analysis of Transfer Studies for Analytical Methods , 2001 .
[2] P. Chiap,et al. An analysis of the SFSTP guide on validation of chromatographic bioanalytical methods: progress and limitations. , 2003, Journal of pharmaceutical and biomedical analysis.
[3] David Hoffman,et al. TWO-SIDED TOLERANCE INTERVALS FOR BALANCED AND UNBALANCED RANDOM EFFECTS MODELS , 2005, Journal of biopharmaceutical statistics.
[4] Robert W. Mee. β-Expectation and β-Content Tolerance Limits for Balanced One-Way ANOVA Random Model@@@b-Expectation and b-Content Tolerance Limits for Balanced One-Way ANOVA Random Model , 1984 .
[5] H. Wätzig,et al. Application of the equivalence test according to a concept for analytical method transfers from the International Society for Pharmaceutical Engineering (ISPE). , 2005, Journal of pharmaceutical and biomedical analysis.
[6] M Laurentie,et al. Harmonization of strategies for the validation of quantitative analytical procedures. A SFSTP proposal--part II. , 2004, Journal of pharmaceutical and biomedical analysis.
[7] Donald J. Schuirmann. A comparison of the Two One-Sided Tests Procedure and the Power Approach for assessing the equivalence of average bioavailability , 1987, Journal of Pharmacokinetics and Biopharmaceutics.
[8] Robert W. Mee. Estimation of the percentage of a normal distribution lying outside a specified interval , 1988 .
[9] B. Govaerts,et al. The transfer of a LC-UV method for the determination of fenofibrate and fenofibric acid in Lidoses: use of total error as decision criterion. , 2006, Journal of pharmaceutical and biomedical analysis.
[10] Robert W. Mee. β-Expectation and β-Content Tolerance Limits for Balanced One-Way ANOVA Random Model , 1984 .
[11] Jérôme Vial,et al. Methodology for transfer of liquid chromatography methods based on statistical considerations , 1998 .
[12] F. Minois-Offroy,et al. Transfert des méthodes analytiques: Méthodologie , 2002 .
[13] Y. Heyden,et al. Reappraisal of hypothesis testing for method validation : detection of systematic error by comparing the means of two methods or of two laboratories , 1995 .