 |
| Risk management for analytical methods based on the total error concept: conciliating the objectives of the pre-study and in-study validation phases |
| BOULANGER B., DEWE W., GILBERT A., GOVAERTS B. AND MAUMY M. |
| Chemometrics and intelligent laboratory systems,
volume 86,
2007 , 198-207
|
|
| An Analysis of Recent Pharmaceutical Regulatory Documents on Analytical Method Validation |
| ROZET E., CECCATO A., HUBERT C., ZIEMONS E., OPREAN R., RUDAZ S., BOULANGER B., HUBERT P. |
| J. Chrom A,
volume 1158,
2007 , 111-125
|
|
| Validation of analytical methods based on accuracy profiles |
| MAX FEINBERG |
| J. Chrom A.,
volume 1158,
2007 , 174-183
|
|
| LC method for the determination of R-timolol in S-timolol maleate: Validation of the ability to quantify and uncertainty assessment |
| MARINI R.D., CHIAP P., BOULANGER B., RUDAZ S., ROZET E., CROMEN J., HUBERT P. |
| Talanta,
volume 68,
2007 , 1166-1175
|
|
| Using Tolerance Intervals in Pre-Study Validation of Analytical Methods to Predict In-Study Results. The Fit-for-Future-Purpose Concept. |
| ROZET E., HUBERT C., CECCATO A., DEWE W., ZIEMONS E., MOONEN F., MICHAIL F., WINTERSTEIGER R., STREEL B., BOULANGER B., HUBERT P. |
| J. Chrom A.,
volume 1158,
2007 , 126-137
|
|
| Improvement of the decision efficiency of the accuracy profile by means
of a desirability function for analytical methods validation
Application to a diacetyl-monoxime colorimetric assay used for the
Improvement of the decision efficiency of the a |
| E. ROZET, V. WASCOTTE, N. LECOUTURIER, V. PREAT, W. DEWE, B. BOULANGER, PH. HUBERT |
| Analytica Chimica Acta,
volume 591,
2007 , 239-247
|
|
| Statistical Considerations in the Validation of Analytical Methods |
| BOULANGER B., DEVANARYAN V., DEWE W., SMITH W. |
| SAS book on pre-clinical Statistics, A. Dimitrienko Editor,
2007
|
|
| Comparison of liquid chromatography and capillary electrophoresis methods for quantification of sodium residuals |
| W. BRIONE, C. HERBOTS, C. KOTTGEN, S. LOIX, M. GIBELLA, M. BERTRAND and A. CECCATO |
| Journal of Pharmaceutical and Biomedical Analysis,
volume "Available online",
2006 , "In press"
|
|
| A new validation approach applied to the GC determination of impurities in organic solvents |
| P. JACOBS, W. DEWE, A. FLAMENT, M. GIBELLA and A. CECCATO |
| Journal of Pharmaceutical and Biomedical Analysis,
volume 40,Issue 2,
2006 , 294-304
|
|
| Nonaqueous capillary electrophoresis method for the enantiomeric purity determination of S-timolol using heptakis(2,3-di-O-methyl-6-O-sulfo)- -cyclodextrin: Validation using the accuracy profile strategy and estimation of uncertainty |
| MARINI R.D., SERVAIS A.C., ROZET E., CHIAP P., BOULANGER B., RUDAZ S., CROMMEN J., HUBERT P., FILLET M. |
| Journal of Chromatography A,
volume 1120,
2006 , 102-111
|
|
| Risk management for analytical methods based on the total error concept: conciliating the objectives of the pre-study and in-study validation phases. |
| BOULANGER B., DEWE W., GILBERT A., GOVAERTS B. AND MAUMY M. |
| Discussion paper, UCL/IS,
volume June,
2006
|
|
| Quantitative Analytical procedures: Harmonization of the appraoches - Part II |
| HUBERT P., NGUYEN-HUU J.J., BOULANGER B., CHAPUZET E., COHEN N., COMPAGNON P.A., DEWE W., FEINBERG M., LAURENTIE M., MERCIER N., MUZARD G., VALAT L. |
| STP Pharma pratique,
volume 16 (1),
2006
|
|
| Quantitative Analytucal procedures: Harmonization of the appraoches - Part III |
| HUBERT P., NGUYEN-HUU J.J., BOULANGER B., CHAPUZET E., COHEN N., COMPAGNON P.A., DEWE W., FEINBERG M., LAURENTIE M., MERCIER N., MUZARD G., VALAT L. |
| STP Pharma pratique,
volume 16 (1),
2006
|
|
| Comparaison des trois approches pour l'estimation de l'incertitude |
| MARINI R.D., CHIAP P., BOULANGER B., RUDAZ S., ROZET E., CROMEN J., HUBERT P. |
| Acta Clinica Belgica,
volume 61-Suppl 1,
2006
|
|
| Les laboratoires accrédites saisis par l'incertitude |
| FEINBERG M., LAURENTIE M., HUBERT P., BOULANGER B., DEWE W. |
| Annales de Toxicologie Analytiques,
volume 18, n.1,
2006 , Suppl 1
|
|
| Approches par l'erreur totale en transfert analytique |
| DEWE W., BOULANGER B., GOVAERTS B., ROZET E., HUBERT P. |
| Annales de Toxicologie Analytiques,
volume 18, n.1,
2006 , Suppl 1
|
|
| Harmonisation des stratégies de validation et estimation de l'incertitude associée dans le cadre de l'acréditation des laboratoires d'essais |
| HUBERT P., ROZET E., BOULANGER B., LAURENTIE M., DUBOIS N., CHARLIER C., FEINBERG M. |
| Acta Clinica Belgica,
volume 61, Suppl 1,
2006
|
|
| Integrated on-line sample clean-up using cation exchange restricted access sorbent for the LC determination of atropine in human plasma coupled to UV detection |
| O. RBEIDA, B.CHRISTIAENS, Ph. HUBERT, D. LUBDA, K.S. BOOS, J. CROMMEN and P. CHIAP. |
| J. Pharm. Biomed. Anal.,
volume 36,
2005 , 947-954
|
|
| Development and validation of a fully automated LC method for the determination of cloxacillin in human plasma using anion exchange restricted access material for sample clean-up |
| O. RBEIDA, P. CHIAP, D. LUBDA, K.-S. BOOS, J. CROMMEN and Ph. HUBERT. |
| J. Pharm. Biomed. Anal.,
volume 36,
2005 , 961-968
|
|
| Validation of a LC/MS/MS method for the determination of Loperamide in human plasma |
| B. STREEL, A. CECCATO, R. KLINKENBERG and Ph. HUBERT. |
| J. Chromatogr. B,
volume 814,
2005 , 263-273
|
|
| Automated method for the determination of RO28-2653 in ovine plasma and serum by coupling of restricted access material for in-line sample clean-up to liquid chromatography |
| P. CHIAP, M. PIETTE, B. EVRARD, F. FRANKENNE, B. CHRISTIAENS, G. PIEL, D. CATALDO, J.M. FOIDART, L. DELATTRE, J. CROMMEN and Ph. HUBERT |
| J. Chromatogr. B,
volume 817,
2005 , 109-117
|
|
| A validated method for the quantification of pimarane and trachylobane diterpenes in the leaves of Croton Zambesicus by capillary gas chromatography |
| S. BLOCK, D. BRKIC, Ph. HUBERT et J. QUETIN-LECLERCQ. |
| Phytochemical Analysis,
2005 , In press
|
|
| New fully automated method for the LC-MS/MS determination of cyproterone acetate in human plasma using restricted access material for sample clean-up |
| B. CHRISTIAENS, P. CHIAP, M. FILLET, O. RBEIDA, A. CECCATO, B. STREEL, J. DE GRAEVE , J. CROMMEN and Ph. HUBERT. |
| J. Chromatogr. A,
volume 1056,
2004 , 105-110
|
|
| Development and validation of a high-performance liquid chromatographic method for the determination of cyproterone acetate in human skin |
| S. HENRY DE HASSONVILLE, P. CHIAP, J.F. LIEGEOIS, B. EVRARD, L. DELATTRE, J. CROMMEN, G. PIEL and Ph. HUBERT. |
| J. Pharm. Biomed. Anal.,
volume 36,
2004 , 133-143
|
|
| Determination of salbutamol enantiomers in human urine using heptakis(2,3-diacetyl-6-O-sulfo)-?-cyclodextrin in non-aqueous capillary electrophoresis |
| A.C. SERVAIS, M. FILLET, P. CHIAP, W. DEWE, Ph. HUBERT and J. CROMMEN. |
| Electrophoresis,
volume 25 (16),
2004 , 1632-1640
|
|
| Development and validation of a high-performance liquid chromatographic method for quantitative determination of aporphine alkaloids form different samples of Cassytha filiformis L |
| C. STEVIGNY, M.C. WAUTIER, J.L. HABIB JIWAN, P. CHIAP, Ph. HUBERT and J. QUETIN-LECLERCQ. |
| Planta Medica,
volume 70 (8),
2004 , 764-770
|
|
| Harmonization of strategies for the validation of quantitative analytical procedures. A SFSTP Proposal ? Part I. |
| 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 and L. VALAT. |
| J. Pharm. Biomed. Anal.,
volume 36(3),
2004 , 579-586
|
|
| New advances in chemical data quality: method validation and measurement uncertainty |
| M. FEINBERG, B. BOULANGER, W. DEWE and Ph. HUBERT. |
| Analytical Bioanalytical Chemistry, Special issue on Chemometrics,
volume 380(3),
2004 , 502-514
|
|
| Uncertainty assessment from robustness testing applied on an LC assay for R-timolol and other related substances in S-timolol maleate |
| R. D. MARINI, B. BOULANGER, Y. VANDER HEYDEN, P. CHIAP, J. CROMMEN and Ph. HUBERT. |
| Analytica Chimica Acta,
2004 , In press
|
|
| Optimal designs for inverse prediction in nonlinear calibration models |
| N. FRANÇOIS, B. GOVAERTS and B. BOULANGER. |
| Chem. Intel. Lab. Syst.,
volume 74,
2004 , 283-292
|
|
| Application de l’erreur totale au transfert des méthodes analytiques |
| W. DEWÉ, B. GOVAERTS, B. BOULANGER, E. ROZET, D. YAPI, B. MERTENS, P. CHIAP and Ph. HUBERT |
| Proceedings du congrès Chimiométrie 2004,
2004 , 71-75
|
|
| Development of response models for optimising HPLC methods |
| W. DEWE, R.D. MARINI, P. CHIAP, Ph. HUBERT, J. CROMMEN and B. BOULANGER. |
| Chem. Intel. Lab. Syst.,
volume 74 (2),
2004 , 263-268
|
|
| Validation of quantitative analytical procedures, Harmonization of approaches |
| Ph. HUBERT, JJ. N´GUYEN-HUU, B. BOULANGER, E. CHAPUZET, P. CHIAP, N. COHEN, PA. COMPAGNON, W. DEWE, M. FEINBERG, M. LALLIER, M. LAURENTIE, N. MERCIER, G. MUZARD, C. NIVET, L. VALAT. |
| STP Pharma Pratiques,
volume 13,
2003 , 101-138
|
|
| An analysis of the SFSTP guide on validation of bioanalytical methods : progress and limitations |
| B. BOULANGER, W. DEWE, P. CHIAP, J. CROMMEN and Ph. HUBERT. |
| J. Pharm. Biomed. Anal.,
volume 32,
2003 , 753-765
|
|
| Determination of uncertainty in analytical measurements from collaborative study results on the analysis of a phenoxymethylpenicillin sample |
| P. DEHOUCK, Y. VANDER HEYDEN, J. SMEYERS-VERBEKE, D. L. MASSART, J. CROMMEN, PH. HUBERT, R. D. MARINI, O. S. N. M. SMEETS, G. DECRISTOFORO, W. VAN DE WAUW, J. DE BEER, M. G. QUAGLIA, C. STELLA, J. -L. VEUTHEY, O. ESTEVENON, A. VAN SCHEPDAEL, E. ROETS |
| Analytica Chimica Acta,
volume 481 (2),
2003 , 261-272
|
|
| Interlaboratory study of a liquid chromatography method for erythromycin : determination of uncertainty |
| P. DEHOUCK, Y. VANDER HEYDEN, J. SMEYERS-VERBEKE, D.L. MASSART, R.D. MARINI, P. CHIAP, Ph. HUBERT, J. CROMMEN, W. VAN DE WAUW, J. DE BEER, R. COX, G. MATHIEU, J.C. REEPMEYER, B. VOIGT, O. ESTEVENON, A. NICOLAS, A. VAN SCHEPDAEL, E. ADAMS and J. HOOGM |
| J. Chromatogr. A,
volume 1010 (1),
2003 , 63-74
|
|
| Fully automated method for the determination of cyproterone acetate in plasma using restricted access materiel for sample pre-treatment |
| B. CHRISTIAENS, P. CHIAP, O. RBEIDA, D. CELLO, J. CROMMEN and PH. HUBERT. |
| J. Chromatogr. B,
volume 795,
2003 , 73-82
|
|
| Sensitive determination of buprenorphine and is N-dealkylated metabolite norbuprenorphine in human plasma by liquid chromatography coupled to tandem mass spectrometry |
| A. CECCATO, R. KLINKENBERG, Ph. HUBERT and B. STREEL. |
| J. Pharm. Biomed. Anal.,
volume 32,
2003 , 829-838
|
|
| Automated LC method for the determination of sotalol in plasma using a restrcited access material with cation exchange properties and flurometric detection |
| O. RBEIDA, B. CHRISTIAENS, P. CHIAP, Ph. HUBERT, D. LUBDA and J. CROMMEN. |
| J. Pharm. Biomed. Anal.,
volume 32,
2003 , 829-838
|
|
| Optimisation and validation of a generic method for the LC assay of six corticosteroids and salicylic acid in dermopharmaceutical forms |
| R. MARINI DJANG´EINGA, A. PANTELLA, M.A. BIMAZUBUTE, P. CHIAP, Ph. HUBERT and J. CROMMEN. |
| Chromatographia,
volume 55,
2002 , 263-269
|
|
| Development and validation of an automated method for the liquid chromatographic determination of sotalol in plasma using dialysis and thrace enrichment on a cation-exchange pre-column as on-line sample preparation |
| P. CHIAP, A. CECCATO, B. MIRALLES BURAGLIA, B. BOULANGER, PH. HUBERT and J. CROMMEN. |
| J. Pharm. Biomed. Anal.,
volume 24,
2001 , 801-814
|
|
| New strategy for the validation of chromatographic bio-analytical methods. Report of a SFSTP Commission |
| S. BERVOAS-MARTIN, B. BOULANGER, E. CHAPUZET, P. CHEVALIER, P. CHIAP, D. GRANDJEAN, Ph. HUBERT, Ph. LAGORCE, M. LALLIER, M-Ch. LAPARRA, M. LAURENTIE, N. MERCIER and C. NIVET. |
| STP Pharma Pratiques,
volume 10,
2000 , 12-27
|
|
| Example of application of the new strategy proposed for the validation of chromatographic bioanalytical methods |
| E. CHAPUZET, N. MERCIER, S. BERVOAS-MARTIN, B. BOULANGER, P. CHEVALIER, P. CHIAP, D. GRANDJEAN, Ph. HUBERT, Ph. LAGORCE, M. LALLIER, M-Ch. LAPARRA, M. LAURENTIE and C. NIVET. |
| STP Pharma Pratiques,
volume 10,
2000 , 79-101
|
|
| Quantitative analysis of N-acetylcystéine and its pharmacopeial impurities in a pharmaceutical formulation by liquid chromatography-UV detector - mass spectrometry |
| B. TOUSSAINT, Ch. PITTI, B. STREEL, A. CECCATO, Ph. HUBERT and J. CROMMEN. |
| J. Chromatogr. A,
volume 896,
2000 , 191-199
|
|
| Validation of an automated method for the liquid chromatographic determination of atenolol in plasma : application of a new validation strategy |
| P. CHIAP, Ph. HUBERT, B. BOULANGER and J. CROMMEN. |
| Anal. Chim. Acta,
volume 391,
1999 , 227-238
|
|
| The SFSTP Guide on the validation of chromatographic methods for drug bioanalysis : from the Washington Conference to the laboratory |
| Ph. HUBERT, P. CHIAP, J. CROMMEN, B. BOULANGER, E. CHAPUZET, N. MERCIER, S. BERVOAS-MARTIN, P. CHEVALIER, D. GRANDJEAN, Ph. LAGORCE, M.C. LAPARRA, M. LAURENTIE and J.C. NIVET. |
| Anal. Chim. Acta,
volume 391,
1999 , 135-148
|
|
| Méthodes chromatographiques de dosage dans les milieux biologiques : Exemple d´application |
| S. BERVOAS-MARTIN, B. BOULANGER, E. CHAPUZET, P. CHEVALIER, P. CHIAP, D. GRANDJEAN, Ph. HUBERT, Ph. LAGORCE, M. LALLIER, M-Ch. LAPARRA, M. LAURENTIE, N. MERCIER et C. NIVET. |
| STP Pharma Pratiques,
volume 8,
1998 , 81-107
|
|
| Méthodes chromatographiques de dosage dans les milieux biologiques : Stratégie de validation |
| S. BERVOAS-MARTIN, B. BOULANGER, E. CHAPUZET, P. CHEVALIER, P. CHIAP, D. GRANDJEAN, Ph. HUBERT, Ph. LAGORCE, M. LALLIER, M-Ch. LAPARRA, M. LAURENTIE, N. MERCIER et C. NIVET. |
| STP Pharma Pratiques,
volume 7,
1997 , 169-194
|
|
| Evalutation of Analytical Method Transfer on a Risk Based Methodology using Total Error |
| E. ROZET, W. DEWE, B. GOVAERTS, B. BOULANGER, A. CECCATO, P. CHIAP, J. CROMMEN, PH. HUBERT |
| HPLC 2007, Ghent - Belgium, June 2007 |
|
| Présentation des travaux de la commission "Validation des procédures analytiques quantitatives: Harmonisation des démarches" |
| HUBERT, NGUYEN-HUU J.J., BOULANGER B., CHAPUZET E., COHEN N., COMPAGNON M., DEWE W., FEINBERG M, LAURENTIE M, MERCIER N., MUZARD G., VALAT L. |
| Paris, March 2007 |
|
| Statistical considerations for the validation of an ELISA assay as biomarker |
| BOULANGER B., DEWE W., HUBERT P., MOONEN F. |
| Bioassays in Clinical development, London, February 2007 |
|
| Analytical method validation based on risk estimation. Comparison of alternative statistical approaches |
| GOVAERTS B., BOULANGER B., DEWE W., MAUMY M., HAMMER C |
| Chemométrie, Paris - Potsdam, December 2006 - September 2006 |
|
| Risk management for analytical methods: conciliating objectives of methods, validation phase and routine decision rules |
| BOULANGER B., MAUMY M., DEWE W., GILBERT A., HAMMER C., GOVAERTS B. |
| Statistical methodology in pre-clinical statistics, Potsdam, September 2006 |
|
| Analytical method validation based on the total error concept: Comparison of alternative statistical approaches. |
| GOVAERTS B., BOULANGER B., DEWE W., MAUMY M. |
| Statistical methodology in pre-clinical statistics, Potsdam, September 2006 |
|
| Accuracy and Precision: Total Error vs. 4-6-30. |
| BOULANGER B., DEWE W., HUBERT P., GOVAERTS B., HAMMER C. |
| AAPS 3rd Bioanalytical Workshop on Quantitative Methods Validation and implementation, Crystal City, USA, May 2006 |
|
| Conciliating objectives of analytical methods and objectives of validation: a statistical perspective |
| BOULANGER B., DEWE W., HUBERT P., GOVAERTS B. |
| IVT, Amsterdam, May 2006 |
|
| Towards a risk based methodology to assess the acceptability of an analytical method transfer: comparison of different approaches |
| ROZET E., DEWE W., GOVAERTS B., BOULANGER B., CECCATO A., CHIAP P., CROMMEN J., HUBERT PH. |
| Drug Analysis, Namur, Belgique, May 2006 |
|
| Simultaneous estimation of measurement uncertainty and implementation of control chart using quality control standards |
| ROZET E., DEWE W., BOULANGER B., HUBERT PH. |
| Drug Analysis, Namur, Belgique, May 2006 |
|
| Validation of a LC method for the determination of levonorgestrel released from a polymeric matrix. A two days protocol |
| HUBERT C., ROZET E., BOULANGER B., DEWE W., BREUER A., COLLARD L., EVRARD B., HUBERT P. |
| Drug Analysis, Namur, Belgique, May 2006 |
|
| Comparison of three different approaches for uncertainty estimation considering LC and CE methods |
| MARINI R., ROZET E., ZIEMONS E., CHIAP P., BOULANGER B., RUDAZ S., SERVAIS A.-C., FILLET M., CROMMEN J., HUBERT P. |
| Drug Analysis, Namur, Belgique, May 2006 |
|
| Applying statistics recommended by regulatory documents: A statistical Perspective |
| BOULANGER B., DEWE W., HUBERT P., E. ROZET, F. MOONEN. |
| Inst. Validation Tech., Philadelphia, December 2005 |
|
| Risk management for analytical methods: conciliating objectives of methods, validation phase and routine decision rules |
| MAUMY M., BOULANGER B., DEWE W., A. GILBERT, GOVAERTS B. |
| Chimiometrie, Lille, France, Decembre 2005 |
|
| Conciliating objectives of analytical methods and objectives of validation: A statistical perspective |
| BOULANGER B., DEWE W., HUBERT P., E. ROZET, F. MOONEN, GOVAERTS B., MAUMY M. |
| Inst. Validation Tech., Philadelphia, December 2005 |
|
| Harmonisation des stratégies de validation et estimation de l'incertitude associée dans le cadre de l'accréditation des laboratoires d'essais |
| HUBERT P., E. ROZET, BOULANGER B., DEWE W., M. LAURENTIE, N. DUBOIS, C. CHARLIER, M. FEINBERG. |
| 3&eagrave;mes Journées Internationales de Toxicologie Hospitali&eagrave;re, Paris, December 2005 |
|
| The usefullness of accuracy profile to validate the ability of an analytical method to quantify |
| ROZET, E., CHIAP, P., DEWE, W., BOULANGER, B., CROMMEN, J., HUBERT, P. |
| 2005. 11th Meeting on Recent Developments in Pharmaceutical Analysis - RDPA 2005, Rimini, Italy, September 2005 |
|
| Use of the accuracy profile for the validation of a diacetyl-monoxime colorimetric method for the determination of urea in transdermal iontophoretic extracts |
| ROZET, E., WASCOTTE, V., LECOUTURIER, N., PREAT, V., DEWE, W., BOULANGER, B., HUBERT, P. |
| 2005. 11th Meeting on Recent Developments in Pharmaceutical Analysis - RDPA 2005, Rimini, Italy, September 2005 |
|
| Recent trends in the validation of bioanalytical methods |
| CHIAP, BOULANGER B., DEWE W., CROMMEN J., HUBERT P. |
| PharmSciFair 2005, Nice, France, Juin 2005 |
|
| Validation of quantitation methods |
| BOULANGER B., DEWE W., AND P. HUBERT. |
| Bioforum, Li&eagrave;, Belgique, December 2004 |
|
| Towards a better use of statistics in method validation |
| DEWE W., BOULANGER B., HUBERT P. |
| Applied Statistics Workshop, UCL, Louvain, Belgique, December 2004 |
|
| The use of the total error to validate analytical method: Examples of applications |
| LAURENTIE M., MANCEAU J., DEWE W., BOULANGER B ., HUBERT P. |
| Ottawa, Canada, June 2004 |
|
| Objectives of analytical methods and objectives of validation. How to reconcile them? |
| BOULANGER B., DEWE W., HUBERT P. |
| 4th International Workshop on Statistical Methods in non-clinical R&D, Dublin, April 2004 |
|
| Intérêt du profile d'exactitude dans le cadre de la validation des méthodes analytiques |
| HUBERT P., CHIAP P., C. DORMAL, CROMMEN J., DEWE W., BOULANGER B. |
| LaboForum 2004, Paris, March 2004 |
|
| Setting acceptance criteria and total error criteria |
| BOULANGER B., DEWE W., HUBERT P. |
| Bioval2004, London, February 2004 |
|
| Harmonization of validation strategies for analytical methods |
| P. CHIAP, W. DEWE, B. BOULANGER, J. CROMMEN and Ph. HUBERT. |
| 4th International Symposium on Pharmaceutical Chemistry, Istanbul, September 17-19, 2003 |
|
| Objectives of analytical methods and objectives of validation |
| B. BOULANGER, W. DEWE, P. CHIAP, J. CROMMEN and Ph. HUBERT. |
| Land-O-lake conference, Wisconsin, USA, July 18, 2003 |
|
| Statistical analysis of validation method revisited: the need to use the total error |
| M. LAURENTIE, B. BOULANGER, W DEWE and Ph. HUBERT. |
| 9th International Congress of the European Association for Veterinary Pharmacology and Toxicology, Lisboa, July 13-18, 2003 |
|
| Objectives of analytical methods and objectives of validation : how to reconciliate them ? |
| B. BOULANGER, R.D. MARINI, P.CHIAP, W. DEWE, J. CROMMEN and Ph. HUBERT. |
| HPLC 2003 - 27th International Symposium on High Performance Liquid Phase Separations and Related Techniques, Nice, June 15-19, 2003 |
|
| 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 sorbate dans des préparations à usage dermatologique |
| P. CHIAP, Ph. HUBERT, Ch. DORMAL, W. DEWE, B. BOULANGER and J. CROMMEN. |
| SEP 2003, Lyon, May 13-15, 2003 |
|
| L'harmonisation des démarches de validation est-elle possible? |
| Ph. HUBERT, P. CHIAP, M. LAURENTIE, W. DEWE, B. BOULANGER and J. CROMMEN. |
| SEP 2003, Lyon, May 13-15, 2003 |
|
| 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 sorbate dans des préparations à usage dermatologique |
| Y. MARTIN, V. REYNDERS, P. CHIAP, Ch. DORMAL, Ph. HUBERT and J. CROMMEN. |
| SEP 2003, Lyon, May 13-15, 2003 |
|
| Validation of analytical methods |
| B. BOULANGER. |
| IRMM, Geel, February 21, 2003 |
|
| Objectifs des méthodes analytiques et objectifs de la validation. Comment les réconcilier pour garantir la qualité des résultats? |
| B. BOULANGER, W. DEWE, P. CHIAP, J. CROMMEN and Ph. HUBERT. |
| Chimiométrie 2002, Paris, December 4-5, 2002 |
|
| Intérèt du profil d'exactitude dans le cadre de la validation des méthodes analytiques |
| Ph. HUBERT, P. CHIAP, Ch. DORMAL, J. CROMMEN, W. DEWE and B. BOULANGER. |
| Club Chimiométrie et Assurance Qualité, INRA, Paris, November 15, 2002 |
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| Objectives of analytical methods and objectives of validation |
| B. BOULANGER, W. DEWE, P. CHIAP and Ph. HUBERT. |
| Barnett Conference, Philadelphia, Pennsylvania, USA, October 11, 2002 |
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| Aspects réglementaires liés à la validation des méthodes de contròles |
| PH. HUBERT. |
| VIIeme Journées scientifiques du ccCTA, Diablerets, September 12-13, 2002 |
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| Use of the accuracy profile for the validation of a generic LC method for the determination of miconazole, econazole and sorbate in dermatological forms |
| P. CHIAP, E. LAMBERT, Ch. DORMAL, Ph. HUBERT, W. DEWE, B. BOULANGER and J. CROMMEN. |
| 7th International Symposium on Drug Analysis, Bruges, April 21-25, 2002 |
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| Statistical analysis of the validation results: diagnostic or decision tools |
| Ph. HUBERT, P. CHIAP, Ch. DORMAL, W. DEWE, B. BOULANGER and J. CROMMEN. |
| 7th International Symposium on Drug Analysis, Bruges, April 21-25, 2002 |
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| Intérèt du profil d'exactitude dans le cadre de la validation des méthodes analytiques |
| Ph. HUBERT, P. CHIAP, Ch. DORMAL, J. CROMMEN, W. DEWE and B. BOULANGER. |
| Forum Labo 2002, Paris, March 26-29, 2002 |
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| Objectives of validation: the statistical rationale of the SFSTP |
| B. BOULANGER, W. DEWE, P. CHIAP and Ph. HUBERT. |
| BIOVAL 2002, London, February 28 - March 1, 2002 |
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| New trends in method validation strategies in the field of pharmaceutical and biomedical analysis |
| J. CROMMEN, P. CHIAP; B. BOULANGER, W. DEWE and Ph. HUBERT. |
| 3rd International Symposium on Pharmaceutical Chemistry, Istanbul, September 17-19, 2001 |
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| The usefulness of accuracy profiles in LC method validation |
| Ph. HUBERT, P. CHIAP, W. DEWE, B. BOULANGER and J. CROMMEN. |
| HPLC 2001 - 25th International Symposium on High Performance Liquid Phase Separations and Related Techniques, Maastricht, June 23-26, 2001 |
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| Développements récents dans le domaine de la validation de méthodes en analyse pharmaceutique et biomédicale |
| Ph. HUBERT, B. BOULANGER, P. CHIAP, W. DEWE and J. CROMMEN. |
| SEP 2001, Paris, June 12-14, 2001 |
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| Analyse statistique des résultats de validation de méthodes d'analyse chromatographiques |
| B. BOULANGER, P. CHIAP, W. DEWE, J. CROMMEN and Ph. HUBERT. |
| Les Journées du GMP, Bordeaux, November 14-15, 2000 |
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| Objectives of pre-validation and decision rules |
| B. BOULANGER, W. DEWE, P. CHIAP and Ph. HUBERT. |
| AAPS APQ Open Forum, Arlington, February 11, 2000 |
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