An innovative approach to select the prediction model in the development of NIR spectroscopy methods

Poster (2010, September)

TOLERANCE INTERVALS AS CONTROL CHART: COMPARISON TO CLASSIC SHEWHART X̅-R CONTROL CHART

Poster (2010, September)

Total error as natural decision criteria for analytical methods validation and transfer

Conference (2010, September)

Quels paramètres cliniques et biologiques peuvent être considérés comme prédictifs des calcifications vasculaires chez le patient hémodialysé?

in Néphrologie & Thérapeutique (2010, September), 6(5), 296

Comparaison d'une méthode "acide" et enzymatique pour le dosage de l'inuline

in Néphrologie & Thérapeutique (2010, September), 6(5), 316

La contrefaçon des médicaments : outils pour lutter contre ce fléau

Scientific conference (2010, July 31)

The increase of counterfeit drug medicines is very remarkable all over the world and particulary in developing countries where many dramatic consequences on public health and economics have been reported ... [more ▼]

The increase of counterfeit drug medicines is very remarkable all over the world and particulary in developing countries where many dramatic consequences on public health and economics have been reported. Therefore, several tools to fight against counterfeit are presented including the simple ones such as organoleptic tools that can be applied by any one and the complex ones namely the analytical tools that belongs to the competence of laboratory. [less ▲]

Guidelines and Validation Issues in Pharmaceutical Analysis

Conference (2010, June 16)

Bayesian hierarchical linear regression for the validation of analytical methods

Conference (2010, May)

Analytical quantitative methods are widely used to quantify analytes of interest, for instance in pharmaceutical formulations, linking an observed response to the concentration of one compound of the ... [more ▼]

Analytical quantitative methods are widely used to quantify analytes of interest, for instance in pharmaceutical formulations, linking an observed response to the concentration of one compound of the formulation. Current methodologies to validate these analytical methods are based on one-way ANOVA random effect model in order to estimate repeatability and intermediate precision variances. This model is then applied several times at different concentration levels over a range of concentrations where the method is intended to be used, assuming independency between the levels. In this way, the capacity of the method to be able to quantify accurately is assessed at various concentration levels, and the method is said to be fitted for purpose (or valid) at the concentration level(s) where it shows trueness and precision that are fully acceptable, i.e. within predefined acceptance limits. Problem of such approach is the amount of data required and the time needed to collect them, while small sample sizes (small number of series and of replicates per series) are often preferred and practiced by laboratories. A better use of the data could then be envisaged. In this presentation, we take into account the response-concentration relationship that exists by the use of a hierarchical linear regression model. Instead of fitting a model at each concentration level that is assessed, only one model is studied. We show how the Bayesian framework is well adapted to this task. Also, as a predictive tool, we naturally derive beta-expectation and beta-gamma content tolerance intervals by means of MCMC simulations. The Bayesian modeling can also include informative prior information whenever justified, leading to reliable decisions given the domain knowledge. [less ▲]

Donor-Estimated Glomerular Filtration Rate as a Criterion for Allocation of Expended Criteria Donors Kidney into Single or Dual Transplantation : The Choice of the Estimating Equation Matters

in American Journal of Transplantation (2010, April), 10(sp Iss SI Suppl 4), 443

Estimation of uncertainty from the total error strategy: Application to internal and normative methods

in Acta Clinica Belgica (2010), 65

Based on the importance of uncertainty, another approach to estimate this parameter of performance considering the total error (systematic and random) was applied. The data were obtained from the two main ... [more ▼]

Based on the importance of uncertainty, another approach to estimate this parameter of performance considering the total error (systematic and random) was applied. The data were obtained from the two main steps of an analytical method lifecycle: validation and routine for levonorgestrel (LNG) assay and routine for oxygen assay. Results obtained allowed drawing suitable conclusion in terms of prediction of routine and establishment of norms. [less ▲]