Unpublished conference/Abstract (Scientific congresses and symposiums)
Optimization of ligand-binding assay in a QbD environment. Use of Bayesian non-linear regression to set up probability profile as quality response
Lebrun, Pierre; Boulanger, Bruno; Hubert, Philippe
2010Non clinical statistics conference
 

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Keywords :
Ligand-biding assay; Bayesian; Optimization; Prediction; Design Space; Quality by Design
Abstract :
[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.
Research center :
CIRM - Centre Interdisciplinaire de Recherche sur le Médicament - ULiège
Disciplines :
Mathematics
Author, co-author :
Lebrun, Pierre ;  Université de Liège - ULiège > Département de pharmacie > Chimie analytique
Boulanger, Bruno ;  Université de Liège - ULiège > Département de pharmacie > Analyse des médicaments
Hubert, Philippe  ;  Université de Liège - ULiège > Département de pharmacie > Chimie analytique
Language :
English
Title :
Optimization of ligand-binding assay in a QbD environment. Use of Bayesian non-linear regression to set up probability profile as quality response
Publication date :
28 September 2010
Event name :
Non clinical statistics conference
Event organizer :
Emmanuel Pham
Event place :
Lyon, France
Event date :
27-29 septembre 2010
Audience :
International
Funders :
DGTRE - Région wallonne. Direction générale des Technologies, de la Recherche et de l'Énergie [BE]
Arlenda S.A.
ULiège - Université de Liège [BE]
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