développement récent dans le domaine de la validation des méthodes analytiques

Conference (2006, September 28)

EVALUATION OF MOLECULARLY IMPRINTED POLYMERS BY MEANS OF EXPERIMENTAL DESIGN PRIOR TO THE DETERMINATION OF p-[18F]MPPF IN PLASMA

Poster (2006, September)

COMPARISON OF THREE DIFFERENT APPROACHES FOR UNCERTAINTY ESTIMATION CONSIDERING LC AND CE METHODS

Conference (2006, May)

LC method for the determination of R-timolol in S-timolol maleate: Validation of its ability to quantify and uncertainty assessment

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-timoloi 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-timoloi 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 P-expectation tolerance interval (sigma-(2)(Tol)), 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. (c) 2005 Elsevier B.V. All rights reserved. [less ▲]

Comparaison de différentes approches pour accepter un transfert de méthodes analytiques

Scientific conference (2006)

Approches par l'erreur totale en transfert analytique

Conference (2006)

Les laboratoires accrédités saisis par l'incertitude

Conference (2006)

Synchronization of validation and estimation strategies of doubt associated as part of the accreditation in trial laboratories

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 ▲]

LC method for the determination of R-timolol in S-timolol maleate: Validation of its ability to quantify and uncertainty assessment.

in Talanta (2006), 68(4), 1166-75

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 ▲]

Comparaison de trois approches pour l'estimation de l'incertitude.

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 ▲]