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See detailHarmonization of strategies for the validation of quantitative analytical procedures - A SFSTP proposal - Part III
Hubert, Philippe ULg; Nguyen-Huu, J. J.; Boulanger, Bruno ULg et al

in Journal of Pharmaceutical & Biomedical Analysis (2007), 45(1), 82-96

In the first two documents [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, L ... [more ▼]

In the first two documents [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, L. Valat, J. Pharm. Biomed. Anal. 36 (2004) 579-586; 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, L. Valat, E. Rozet, J. Pharm. Biomed. Anal., in press], a recent SFSTP Commission on the validation of analytical procedure has introduced a harmonized approach for the validation of analytical procedures. In order to complete this guide, the statistical methodology allowing to correctly conclude about the validity of a procedure is proposed in this third part of the guide. Indeed all the steps to obtain the decision tool namely the accuracy profile are described and illustrated step by step by a numerical example. This tool, based on the concept of total error (bias + standard deviation) build with a P-expectation tolerance interval, allows to easily take the right decision and simultaneously minimizing the risk of the future use of the analytical procedure. (C) 2007 Elsevier B.V. All rights reserved. [less ▲]

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See detailAnalysis of recent pharmaceutical regulatory documents on analytical method validation.
Rozet, Eric ULg; Ceccato, Attilio ULg; Hubert, Cédric ULg et al

in Journal of Chromatography. A (2007), 1158(1-2), 111-25

All analysts face the same situations as method validation is the process of proving that an analytical method is acceptable for its intended purpose. In order to resolve this problem, the analyst refers ... [more ▼]

All analysts face the same situations as method validation is the process of proving that an analytical method is acceptable for its intended purpose. In order to resolve this problem, the analyst refers to regulatory or guidance documents, and therefore the validity of the analytical methods is dependent on the guidance, terminology and methodology, proposed in these documents. It is therefore of prime importance to have clear definitions of the different validation criteria used to assess this validity. It is also necessary to have methodologies in accordance with these definitions and consequently to use statistical methods which are relevant with these definitions, the objective of the validation and the objective of the analytical method. The main purpose of this paper is to outline the inconsistencies between some definitions of the criteria and the experimental procedures proposed to evaluate those criteria in recent documents dedicated to the validation of analytical methods in the pharmaceutical field, together with the risks and problems when trying to cope with contradictory, and sometimes scientifically irrelevant, requirements and definitions. [less ▲]

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See detailGESTION DU RISQUE LORS DU TRANSFERT DE METHODES ANALYTIQUES – CAS D’UNE METHODE BIOANALYTIQUE
Rozet, Eric ULg; Dewe, W.; Morello, R. et al

Conference (2007)

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See detailGuide for validation of analytical procedures
Oprean, R.; Rozet, Eric ULg; Dewé, Walthère ULg et al

Book published by Medicala Universitara “Iuliu Hatieganu” (2007)

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See detailDevelopment of a mass spectrometry method for the determination of a melanoma biomarker, 5-S-cysteinyldopa, in human plasma using solid phase extraction for sample clean-up.
Martin, Gaëlle ULg; Chiap, Patrice ULg; Paquet, Philippe ULg et al

in Journal of Chromatography. A (2007), 1156(1-2), 141-8

5-S-cysteinyldopa is a well-known pigment intermediate and analysis of its plasma concentration is interesting for the early diagnosis, as well as for evaluation of treatment and follow-up of malignant ... [more ▼]

5-S-cysteinyldopa is a well-known pigment intermediate and analysis of its plasma concentration is interesting for the early diagnosis, as well as for evaluation of treatment and follow-up of malignant melanoma. A determination method of 5-SCD in human plasma was developed using solid phase extraction (SPE) on disposable cartridges and liquid chromatography electrospray mass spectrometry (LC-ESI-MS-MS). Compound's sensitivity to light and oxidation requires the addition of anti-oxidative agents (AO), to work in acidic media at 4 degrees C and to avoid light exposure of samples since blood collection. Different solid phases involving covalent binding to phenylboronic groups or dual retention mechanisms were evaluated and extraction cartridges containing both hydrophobic and strong cation exchange functionalities were finally selected. The LC separation of 5-SCD from endogenous catecholamines was achieved by gradient elution on a C18 stationary phase. 5-SCD was detected by multiple reaction monitoring (MRM) performed on ES(+) generated ions. Finally, the method was prevalidated in the lower ng/ml range. Good results with respect to accuracy, trueness and precision were obtained. [less ▲]

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See detailRobustness testing of a chiral NACE method for R-timolol determination in S-timolol maleate and uncertainty assessment from quantitative data.
Marini Djang'Eing'A, Roland ULg; Rozet, Eric ULg; Vanderheyden, Yvan et al

in Journal of Pharmaceutical & Biomedical Analysis (2007), 44(3), 640-51

A robustness test of a capillary electrophoresis method for the chiral separation of timolol in nonaqueous acidified media was performed. A two-level Plackett-Burman design was applied in which one ... [more ▼]

A robustness test of a capillary electrophoresis method for the chiral separation of timolol in nonaqueous acidified media was performed. A two-level Plackett-Burman design was applied in which one qualitative and six quantitative factors were examined. Resolution, migration times and relative migration times to pyridoxine (selected as internal standard) were examined as qualitative responses to evaluate electrophoretic performance. A quantitative response, the content of R-timolol in S-timolol maleate sample, was also considered. Even though some significant factor effects were observed on the qualitative responses, it was still possible to quantify the R-timolol in the S-timolol maleate samples properly. The quantitative response was not significantly affected by the selected factors, demonstrating the robustness of the procedure. However, the use of different HDMS-beta-CD batches seemed to affect both types of responses necessitating to introduce a warning in the procedure. Since the experiments of the Plackett-Burman design can be assimilated to laboratories in an interlaboratory study, uncertainty can be evaluated using the robustness test data. The robustness test was set-up in such a way that the required variances could be estimated. [less ▲]

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See detailTotal Error-Based Criterion for Analytical Method Transfer Experiments
Rozet, Eric ULg; Dewe, W.; Boulanger, Bruno ULg et al

Conference (2007)

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See detailEvaluation of Analytical Method Transfer on a Risk Based Methodology using Total Error
Rozet, Eric ULg; Dewe, W.; Govaerts, B. et al

Conference (2007)

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See detailPerformances of a multidimensional on-line SPE-LC-ECD method for the determination of three major catecholamines in native human urine: Validation, risk and uncertainty assessments
Rozet, Eric ULg; Morello, Rosa; Lecomte, Frédéric ULg et al

in Journal of Chromatography. B : Analytical Technologies in the Biomedical & Life Sciences (2006), 844(2), 251-260

A novel, multidimensional on-line SPE-LC method with electrochemical detection is described for the fully automated and direct analysis of the catecholamines norepinephrine, epinephrine and dopamine in ... [more ▼]

A novel, multidimensional on-line SPE-LC method with electrochemical detection is described for the fully automated and direct analysis of the catecholamines norepinephrine, epinephrine and dopamine in urine. The integrated extractive clean-up of the raw biofluid is based on a SPE-column packed with restricted access material (RAM) which is modified with the affinity ligand nitrophenylboronic acid. The method was fully validated according to a recent approach based on an accuracy profile. The acceptance limits were set at +/- 15% of the nominal concentration values. The method was found accurate over a concentration range from 15 to 500 mu g/l for norepinephrine, from 5 to 500 mu g/l for epinephrine and from 50 to 500 mu g/l for dopamine. The relative risk for the use of the validated method in routine analysis was also assessed based on this validation strategy. It was found that at most 3.5% of future sample measurements will fall outside the acceptance limits. This demonstrates the high reliability of the analytical method described. Moreover, the measurements uncertainties were deduced from the validation experiments without any additional effort. (c) 2006 Elsevier B.V. All rights reserved. [less ▲]

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See detailThe transfer of a LC-UV method for the determination of fenofibrate and fenofibric acid in Lidoses: Use of total error as decision criterion
Rozet, Eric ULg; Mertens, Bénédicte; Dewé, Walthère ULg et al

in Journal of Pharmaceutical & Biomedical Analysis (2006), 42(1), 64-70

Two new statistical approaches to assess the validity of the transfer of a LC-UV method for the determination of fenofibrate and fenofibric acid were investigated and compared to the conventional ... [more ▼]

Two new statistical approaches to assess the validity of the transfer of a LC-UV method for the determination of fenofibrate and fenofibric acid were investigated and compared to the conventional approaches generally used in this domain. These new approaches, namely the Tolerance Interval and the Risk approaches, are based on the simultaneous evaluation of the systematic (or trueness) and random (or precision) errors of the transfer into a single criterion called total error (or accuracy). The results of the transfer showed that only the total error based approaches fulfilled the objective of an analytical method transfer, i.e. to give guarantees that each future measurement made by the receiving laboratory will be close enough to the true value of the analyte in the sample. Furthermore the Risk approach was the most powerful one and allowed the estimation of the risk to have future measurements out of specification in the receiving laboratory, therefore being a risk management tool. (c) 2006 Elsevier B.V. All rights reserved. [less ▲]

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See detailComparaison de différentes approches pour accepter un transfert de méthodes analytiques
Rozet, Eric ULg; Dewe, W.; Boulanger, Bruno ULg et al

Scientific conference (2006, May 11)

Detailed reference viewed: 41 (11 ULg)