Reference : Optimization of ligand-binding assay in a QbD environment. Use of Bayesian non-linear...
Scientific congresses and symposiums : Unpublished conference
Physical, chemical, mathematical & earth Sciences : Mathematics
http://hdl.handle.net/2268/75749
Optimization of ligand-binding assay in a QbD environment. Use of Bayesian non-linear regression to set up probability profile as quality response
English
Lebrun, Pierre mailto [Université de Liège - ULg > Département de pharmacie > Chimie analytique >]
Boulanger, Bruno [Université de Liège - ULg > Département de pharmacie > Analyse des médicaments >]
Hubert, Philippe mailto [Université de Liège - ULg > Département de pharmacie > Chimie analytique >]
28-Sep-2010
Yes
No
International
Non clinical statistics conference
27-29 septembre 2010
Emmanuel Pham
Lyon
France
[en] Ligand-biding assay ; Bayesian ; Optimization ; Prediction ; Design Space ; Quality by Design
[en] 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.
CIRM
Région wallonne : Direction générale des Technologies, de la Recherche et de l'Energie - DGTRE ; Arlenda S.A. ; Université de Liège
Researchers ; Professionals ; Students
http://hdl.handle.net/2268/75749

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