References of "Boulanger, Bruno"
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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 detailValidation des procédures analytiques quantitatives :harmonisation des démarches - Partie III. Exemples d’application
Hubert, Philippe ULg; Nguyen-Huu, Jean-Jacques; Boulanger, Bruno ULg et al

in STP PHARMA PRATIQUES (2006), 16(2), 87-121

A harmonized approach for the validation of analytical methods based on accuracy profile was introduced by a SFSTP commission on the validation of analytical procedure. This third and last document aims ... [more ▼]

A harmonized approach for the validation of analytical methods based on accuracy profile was introduced by a SFSTP commission on the validation of analytical procedure. This third and last document aims at illustrating this methodology and the statistics used. Therefore the validation of real case methods are proposed such as methods for the quality control of drugs, for the quantitation of impurities in drug substances, for bioanalysis or for the determination of nutriments. Furthermore, different types of analytical methods are used in order to demonstrate the applicability of the proposed approach to a wide range of methods such as liquid chromatography (LC-UV, LC-MS), spectrophotometry or ELISA. [less ▲]

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See detailValidation des procédures analytiques quantitatives :Partie II - Statistiques
Hubert, Philippe ULg; Nguyen-Huu, Jean-Jacques; Boulanger, Bruno ULg et al

in STP PHARMA PRATIQUES (2006), 16(1), 28-58

In a first document, a 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 ... [more ▼]

In a first document, a 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 second part of the guide. Indeed all the steps to obtain the decision tool namely the accuracy profile are described. This tool, based on the concept of total error (bias + standard deviation), allows to easily take the right decision and simultaneously minimizing the risk of the future use of the analytical procedure. [less ▲]

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See detailLC method for the determination of R-timolol in S-timolol maleate: Validation of its ability to quantify and uncertainty assessment.
Marini Djang'Eing'A, Roland ULg; Chiap, Patrice ULg; Boulanger, Bruno ULg et al

in Talanta (2006), 68(4), 1166-1175

This article presents the validation results of a chiral liquid chromatographic (LC) method previously developed for the quantitative determination of R-timolol in S-timolol maleate samples. A novel ... [more ▼]

This article presents the validation results of a chiral liquid chromatographic (LC) method previously developed for the quantitative determination of R-timolol in S-timolol maleate samples. A novel validation strategy based on the accuracy profiles was used to select the most appropriate regression model, to assess the method accuracy within well defined acceptance limits and to determine the limits of quantitation as well as the concentration range. The validation phase was completed by the investigation of the risk profiles of various acceptable regression models in order to ensure the risk of obtaining the future measurements outside the acceptance limits fixed a priori. On the other hand, the present paper also shows how data used in this validation approach can be used to estimate the measurement uncertainty. The uncertainty derived from beta-expectation tolerance interval (sigma(Tol)(2)), which is equal to the uncertainty of measurements as well as the expanded uncertainty (U(x)) using a coverage factor k=2 was estimated. The uncertainty estimates obtained from validation data were finally compared with those obtained from interlaboratory and robustness studies. [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)

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See detailApproches par l'erreur totale en transfert analytique
Dewé, Walthère ULg; Boulanger, Bruno ULg; Govaerts, B. et al

Conference (2006)

Detailed reference viewed: 49 (3 ULg)
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See detailAccuracy and precision : total error vs 4-6-30
Boulanger, Bruno ULg; Dewé, Walthère ULg; Hubert, Philippe ULg et al

Conference (2006)

Detailed reference viewed: 33 (3 ULg)
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See detailLes laboratoires accrédités saisis par l'incertitude
Feinberg, Max; Laurentie, M.; Hubert, Philippe ULg et al

Conference (2006)

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See detailSynchronization of validation and estimation strategies of doubt associated as part of the accreditation in trial laboratories
Hubert, Philippe ULg; Rozet, Eric ULg; Boulanger, Bruno ULg et al

in Acta Clinica Belgica (2006), 61(Suppl. 1), 54-56

In order to achieve the harmonization of validation strategies, the interpretation of several validation criteria is proposed. Furthermore, a simple and visual decision tool to assess the validity of an ... [more ▼]

In order to achieve the harmonization of validation strategies, the interpretation of several validation criteria is proposed. Furthermore, a simple and visual decision tool to assess the validity of an analytical procedure is described: the accuracy profile based on the estimation of the total error of the measurements. This profile build with beta-expectation tolerance intervals can also compute with efficiency the uncertainty related to the results of a laboratory, which is an essential parameter for the accreditation of laboratories under ISO 17025. [less ▲]

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See detailHarmonisation des strategies de validation et estimation de l'incertitude associee dans le cadre de l'accreditation des laboratoires d'essais
Hubert, Philippe ULg; Rozet, Eric ULg; Boulanger, Bruno ULg et al

in Acta Clinica Belgica. Supplementum (2006), S1(1), 53-55

In order to achieve the harmonization of validation strategies, the interpretation of several validation criteria is proposed. Furthermore, a simple and visual decision tool to assess the validity of an ... [more ▼]

In order to achieve the harmonization of validation strategies, the interpretation of several validation criteria is proposed. Furthermore, a simple and visual decision tool to assess the validity of an analytical procedure is described: the accuracy profile based on the estimation of the total error of the measurements. This profile build with beta-expectation tolerance intervals can also compute with efficiency the uncertainty related to the results of a laboratory, which is an essential parameter for the accreditation of laboratories under ISO 17025. [less ▲]

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See detailComparaison de trois approches pour l'estimation de l'incertitude.
Marini Djang'Eing'A, Roland ULg; Chiap, Patrice ULg; Boulanger, Bruno ULg et al

in Acta Clinica Belgica. Supplementum (2006), (1), 60-2

Three different approaches for the estimation of uncertainty measurements using the same analytical method were compared, namely validation, robustness and inter-laboratory studies. The uncertainty ... [more ▼]

Three different approaches for the estimation of uncertainty measurements using the same analytical method were compared, namely validation, robustness and inter-laboratory studies. The uncertainty obtained with the robustness study! predicted well the uncertainty of the inter-laboratory study. On the other hand, the uncertainty estimation obtained with the validation study is lower than those obtained with the two other approaches but is still acceptable as long as the analytical method will be used in a single laboratory. [less ▲]

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