| 08:15 – 08:30 |
H. Geys, Janssen Pharma, Belgium |
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Welcome – Main Conference |
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| Session 1 |
Chair : O. Thas, Ghent University, Belgium |
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Translational Research |
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| 08:30 – 09:15 |
W. Van Criekinge, Ghent University, Belgium |
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Translational epigenomics |
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| Contributed papers |
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| 09:15 – 09:35 |
K. Gore, Pfizer, UK |
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Helping to Drive the Robustness of Preclinical Research
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| 09:35 – 09:55 |
R. Walley, UCB, UK |
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Demonstrating the impact of statistics in the preclinical area using Bayesian analysis with informative priors
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| 09:55 – 10:15 |
G. Chen, Merck, Netherlands |
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Bayesian tolerance interval
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| 10:15 – 10:45 |
Coffee Break & Poster Session |
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| Session 2 |
Chair : Pierre Lebrun, Arlenda, Belgium |
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Bioassays |
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| 10:45 – 11:30 |
C. Tan, Pfizer, USA |
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A Step in the Right Direction? the development of USP Chapter <1210>
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| Contributed papers |
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| 11:30 – 11:50 |
P. Sondag, B. Boulanger, E. Rozet, R. Rousseau, Arlenda, Belgium |
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Comparison of methodologies to assess the parallelism between two four parameters logistic curves
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| 11:50 – 12:10 |
J.-F. Michiels, T. Scherder, B. Boulanger, P. Lebrun, A. Jullion, Arlenda, Belgium |
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A Bayesian framework for conducting effective bridging between references under uncertainty
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| 12:10 – 12:30 |
A. Baclin, M-P. Malice, G. de Lannoy, M. Key Prato, GSK, Belgium |
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Control Chart to Monitor Quantitative Assay Consistency
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| 12:30 – 13:45 |
Lunch & Poster Session |
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| Session 3 |
Chair : B. Boulanger, Arlenda, Belgium |
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Chemical Manufacturing & Control Bioassays |
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| 13:45 – 14:30 |
H. Yang, MedImmune, USA |
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Using statistical innovation to impact regulatory thinking
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| Contributed papers |
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| 14:30 – 14:50 |
P. C. Ijzerman-Boon, E. R. van den Heuvel, Merck, Netherlands |
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Validation of qualitative microbiological test methods
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| 14:50 – 15:10 |
E. Talens, Merck, Netherlands |
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Stability of reference standards |
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| 15:10 – 15:30 |
T. Mzolo, G. Goris, A. Di Bucchianico, E. van den Heuvel, University Medical Center Groningen, Netherlands |
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An Evaluation of Several Statistical Methods for Monitoring the Bioactivity of an In-house Reference Standard |
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| 15:30 – 15:50 |
A. Baclin, C. Bievelet, G. de Lannoy, M. Key-Prato, M.-P. Malice, GSK, Belgium |
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A statistical method to demonstrate dilutional linearity for immunoassays
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| 15:50 – 16:20 |
Coffee Break & Poster Session |
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| Session 4 |
Chair : Z. Shkedy, Hasselt University |
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QSTAR- an integrated analysis of biological, chemical and gene expression data in drug discovery
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| 16:20 – 17:05 |
H. Goehlmann, Janssen Pharma, Belgium |
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ADA-Cutpoint estimation – using R: assumptions, solutions, problems |
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| Contributed papers |
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| 17:05 – 17:25 |
F. Mattiello, O. Thas, Ghent University, Belgium |
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Two Explorative Data Analysis Methods for Discovering Connections Between Three Data Sources, with Applications in Early Drug Development
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| 17:25 – 17:45 |
N. J. Perualila, Hasselt University, Belgium |
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Rationalizing CMap Gene Expression Readouts via Target Prediction
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| 17:45 – 18:05 |
M. Otava, Hasselt University, Belgium |
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Regression with Enriched random forest
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| 20:00 |
Conference Dinner at brewery Halve Maan |