References
Bibliographic references:

  • Minois-Offroy F., Appriou Y., Brousset V., Chapuzet E., de Fontenay G., Dewé W., Dumas E., Ellie C., Galiay M., Lefebvre N., Mottu P., Quint M.P. et Schoeffter F., Transfert des méthodes analytiques: méthodologie, Rapport d’une Commission SFSTP, STP Pharma Pratiques, 12 (6), 337-343, 2002.
  • Food and Drug Administration, Process Analytical Technology (PAT) Initiative, 2004, http://www.fda.gov/cder/guidance/6419fnl.htm
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  • Johnson Y. An FDA Perspective on Method Transfer of Chromatographic Analytical Methods in the Pharmaceutical Industry, The Chromatography Forum of Delaware Valley, October meeting, 2004
  • Hubert P., N’guyen-Huu J.J., Boulanger B., Chapuzet E., Chiap P., Cohen N., Compagnon P.A., Dewé W., Feinberg M., Lallier M., Laurentie M., Mercier N., Muzard G., Nivet C. et Valat L., Validation des procédures analytiques quantitatives : Harmonisation des démarches, Rapport d’une Commission SFSTP, STP Pharma Pratiques, 13(3), 101-138, 2003.
  • Hubert Ph., Nguyen-Huu J.-J., Boulanger B., Chapuzet E., Chiap P., N. Cohen N., Compagnon P.-A., Dewe W., Feinberg M., Lallier M., Laurentie M., Mercier N., Muzard G., Nivet C. et Valat L. Journal of Pharmaceutical and Biomedical Analysis. 36, 579-586, 2004.
  • Schuirmann D.J. A comparison of the two one-sided tests procedure and the power approach for assessing the equivalence of average bioavaiability. Journal of Pharmacokinetics and Biopharmaceutics, 15(6), 657-680, 1987.
  • Dewé W., Govaerts B., Boulanger B., Rozet E., Yapi D., Mertens B., Chiap P. et Hubert Ph. Application de l’erreur totale au transfert des méthodes analytiques. Proceedings du congrès Chimiométrie 2004, France, Paris.
  • Dewé W., Boulanger B., Govaerts B., Rozet E., Chiap P. et Hubert Ph. Approches par l’erreur totale en transfert de méthodes analytiques. Proceedings du congrès Forum Labo 2006, France, Paris.
  • Dewé W., Govaerts B., Boulanger B., Rozet E., Chiap P. et Hubert Ph. Using total error as decision criterion in method transfer, Chemometrics and Intelligent Laboratory Systems, 85, 262-268, 2007.
  • Boulanger B., Dewé W., Gilbert A., Govaerts B. and Maumy-Bertrand M. Risk management for analytical methods based on the total error concept: Conciliating the objectives of the pre-study and in-study validation phases, Chemometrics and Intelligent Laboratory Systems, 86, 198-2007 ,2007.
  • Kringle R., Khan-Malek R., Snikeris F., Munden P., Agut C. and Bauer M, A unified approach for design and analysis of transfer studies for analytical methods, Drug Information Journal, 35, 1271-1288, 2001.
  • Rozet E., Mertens B., Dewe W., Ceccato A., Govaerts B., Boulanger B., Chiap P., Streel B., Crommen J., Hubert Ph. The transfer of a LC-UV method for the determination of fenofibrate and fenofibric acid in Lidoses: use of total error as decision criterion. Journal of Pharmaceutical and Biomedical Analysis, 42, 64-70, 2006.
  • Rodriguez S.A., Kubiak R., Mulcey M., Tamblyn T., Tougas T. Method Transfer from R&D to Quality Control of an RP-IPC Method with ELSD for the Analysis of an Excipient in a Pharmaceutical Drug Product. American Laboratory, 37(24), 9-14, 2005.
  • Schepers U., Wätzig H. Application of the equivalence test according to a concept for analytical method transfers from the International Society for Pharmaceutical Engineering (ISPE). Journal of Pharmaceutical and Biomedical Analysis, 39, 310-314, 2005.
  • Chambers D., Kelly G., Limentani G., Lister A., Lung R., Warner E. Analytical method equivalency, an acceptable analytical practice. Pharmaceutical Technology, September, 64-80, 2005.
  • Ment W., Technology transfer of analytical methods, FDA News and Information, vol. 2, N°3, 1-3, 17 August 2001.
  • Analytical procedure/Technology transfer, ISPE Guideline, pp. 23-34, 2003.
  • Satterthwaite F., Synthesis of variance, Psychometrika, 6, pp. 309-316
  • Food and Drug Administration : International Conference on Harmonization : guideline on validation of analytical procedures : definitions and terminology, Fed. Regist., 60, 11260-11262 (1995).
  • Food and Drug Administration : International Conference on Harmonization : guideline on validation of analytical procedures : methodology, Fed. Regist., 62, 27463-27467 (1997).
  • Eurachem guide, The Fitness for Purpose of Analytical Methods, A Laboratory Guide to Method Validation and Related Topics, 1st Edition, UK, 1998.
  • Guidance for Industry : Analytical Procedures and Methods Validation (Draft guidance), U.S. Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (CDER), Center for Biologics Evaluation and Research (CBER), August 2000.
  • ISO 5725-1, Application de la statistique - Exactitude (justesse et fidélité) des résultats et méthodes de mesure - Partie 1 : Principes généraux et définitions.
  • ISO 5725-2, Application de la statistique - Exactitude (justesse et fidélité) des résultats et méthodes de mesure - Partie 2 : Méthodes de base pour la détermination de la répétabilité et de la reproductibilité d’une méthode de mesure normalisée.
  • ISO 5725-3, Application de la statistique - Exactitude (justesse et fidélité) des résultats et méthodes de mesure - Partie 3 : Mesures intermédiaires de la fidélité d’une méthode de mesure normalisée.
  • ISO 5725-4, Application de la statistique - Exactitude (justesse et fidélité) des résultats et méthodes de mesure - Partie 4 : Méthodes de base pour la détermination de la justesse d’une méthode de mesure normalisée.
  • ISO 5725-6, Application de la statistique - Exactitude (justesse et fidélité) des résultats et méthodes de mesure - Partie 6 : Utilisation dans la pratique des valeurs d’exactitude.
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  • V. Shah, K. Midha, J. Findlay, H. Hill, J. Hulse, I. McGilveray, G. McKay, K. Miller, R. Patnaik, M. Powell, A. Tonelli, C. Viswanathan, A. Yacobi, Bioanalytical Method Validation - A revisit with a decade of progress. Pharmaceutical Research, Vol. 17, No. 12, 2000.
  • J. C. Miller, J. N. Miller, Statistics for Analytical Chemistry, 3rd edn, Elli Horwood, New York, 1993.
  • D. Derringer, R. Suich, Simultaneous optimization of several response variables, Journal of quality technology, 12 (1980) 214-219.
  • Eurachem/CITAC guide, Quantifying Uncertainty in Analytical Measurement, UK, 2000.
  • R. Burdik, F. Graybill, Confidence interval on variance components, Marcel Dekker, Inc., New-York, NY, 1992.
  • M. Feinberg, B. Boulanger, W. Dewe, P. Hubert, New advances in method validation and measurement uncertainty aimed at improving the quality of chemical data, Analytical and Bioanalytical Chemistry, 2004.

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