References of "Lebrun, Pierre"
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See detailHow can QbD be used and implemented to optimize method development and validation?
Lebrun, Pierre ULg; Boulanger, Bruno ULg; Hubert, Philippe ULg

Conference (2010, November 04)

Through an example, the way to apply Design of Experiments and the Bayesian modeling to develop robust optimal ligand-binding assays (LBA) will be presented. The objectives of a LBA will be re-examined ... [more ▼]

Through an example, the way to apply Design of Experiments and the Bayesian modeling to develop robust optimal ligand-binding assays (LBA) will be presented. The objectives of a LBA will be re-examined and response of interest derived (precision profile). The concept of Design Space specific for LBA will be introduced in relation with validation, routine and transfer [less ▲]

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See detailPlans expérimentaux
Boulanger, Bruno ULg; Govaerts, B.; Le Boulengé, E. et al

Learning material (2010)

Vidéos du cours intitulé "Plans expérimentaux"

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See detailRISK MANAGMENT IN THE VALIDATION OF ANALYTICAL METHODS
Hubert, Philippe ULg; Ziemons, Eric ULg; Mantanus, Jérôme ULg et al

Conference (2010, October)

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See detailOptimization of ligand-binding assay in a QbD environment. Use of Bayesian non-linear regression to set up probability profile as quality response
Lebrun, Pierre ULg; Boulanger, Bruno ULg; Hubert, Philippe ULg

Conference (2010, September 28)

For ligan-binding assay, different parameters are controlled in routine. In a development phase, we will show how design of experiment can be used to select these parameters to obtain reliable results in ... [more ▼]

For ligan-binding assay, different parameters are controlled in routine. In a development phase, we will show how design of experiment can be used to select these parameters to obtain reliable results in the future use of the ELISA test. Uncertainties of measurements and models should be taken into account in a predictive manner. Bayesian modelling and MCMC simulations are well suited for this purpose and are flexible enough to include random effects on the parameters on non-linear model. We will focus on 4PL regression as it is encountered in most applications. We will also show that deriving a quality response such as a precision profile is clear and direct in the Bayesian setting. The approach is fully compliant with QbD guidelines and Design Space definition. [less ▲]

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See detailTransfer of a conventional LC method for the screening of conterfeit antimalarial medicines to UHPLC
Nistor, Iolanda ULg; Lecomte, Frédéric ULg; Mbinze Kindenge, Jérémie et al

Poster (2010, September)

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See detailAnalytical tools to fight against counterfeit medicines
Marini Djang'Eing'A, Roland ULg; Mbinze Kindenge, J.; Montes, M. L. A. et al

in Chimica Oggi = Chemistry Today (2010), 28(5), 10-14

Counterfeiting has been dramatically increasing this last decade throughout the world and particularly in developing countries, with many consequences such as adverse impacts on public health, economics ... [more ▼]

Counterfeiting has been dramatically increasing this last decade throughout the world and particularly in developing countries, with many consequences such as adverse impacts on public health, economics and negative reputation for the pharmaceutical industry. Recognizing the magnitude of the issue, health authorities at national, regional and international levels are trying to fight against this scourge using various strategies including the setting-up of effective quality control that need to be reinforced through generic, fast and specific detection methods. To illustrate this topic, we will present several analytical tools, including liquid chromatography, low cost capillary electrophoresis and near infrared spectroscopy, developed and applied to the detection and quantification of counterfeit drugs. [less ▲]

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See detailOptimisation and validation of a fast HPLC method for the quantitation of sulindac and its impurities
Krier, Fabrice ULg; Brion, Michaël; Debrus, Benjamin ULg et al

Poster (2010, September)

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See detailContribution to fight against counterfeit medecines applying several analytical tools
Marini Djang'Eing'A, Roland ULg; Mbinze Kindenge, Jérémie; Montes, M. L. A. et al

Poster (2010, September)

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See detailLa contrefaçon des médicaments : outils pour lutter contre ce fléau
Marini Djang'Eing'A, Roland ULg; Mbinze Kindende, Jérémie; Lecomte, Frédéric et al

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 ▲]

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See detailBayesian hierarchical linear regression for the validation of analytical methods
Lebrun, Pierre ULg; Boulanger, Bruno ULg; Rozet, Eric ULg et al

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 ▲]

Detailed reference viewed: 101 (9 ULg)