Program
Pre-conference workshop
Tuesday, 23 September 2008 |
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13:45 - 14:00 |
Welcome - Pre-Conference Workshop |
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Chair : G. Verbeke Katholieke Universiteit Leuven, Belgium |
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14:00 - 17:30 |
An Introduction to Nonlinear Mixed-Effects Models |
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M. Davidian, North Carolina State University, Raleigh NC, USA |
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17:30 |
City tour of Leuven |
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19:00 |
Drink at the Town Hall |
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Main Conference
Wednesday, 24 September 2008 |
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08:15 - 08:30 |
Welcome - Main Conference |
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L Bijnens, Janssen Pharma, Beerse, Belgium |
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Session1 |
Model Based Drug Development |
Chair : F. De Ridder, Janssen Pharma, Beerse, Belgium |
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08:30 - 09:15 |
Some principles of modelling and simulation in preclinical research and development |
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Ph. Jacqmin, Exprimo NV, Mechelen, Belgium |
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09:15 - 10:30 |
Contributed papers |
09:15 - 9:35 |
Using desirability indices for decision making in drug development |
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Didier Renard, Novartis Pharma AG - Basel - Switzerland |
09:35 - 9:55 |
Adaptive model-based dose selection methods |
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François Vandenhende, Clinbay, Genappe, Belgium |
09:55 - 10:15 |
Clinical relevance of dissolution specifications |
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Tom Jacobs, Center for Statistics, Hasselt University, Diepenbeek, Belgium |
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10:15 - 10:45 |
Coffee Break & poster session |
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Session 2 |
Methodology I |
Chair : Bruno Boulanger, UCB Pharma SA, Braine-L'alleud, Belgium |
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10:45 - 12:05 |
Contributed papers |
10:45 - 11:05 |
Statistics in high-content biology |
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Rebecca Walls, AstraZeneca, Loughborough, UK |
11:05 - 11:25 |
Combination of independent component analysis and statistical modelling for the identification of metabonomic biomarkers in H-NMR spectroscopy |
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Réjane Rousseau, Université Catholique de Louvain, Belgium |
11:25 - 11:45 |
Expected and credible design space for analytical methods: a new perspective based on modeling and prediction |
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Pierre Lebrun, Université de Liège, Belgium |
11:45 - 12:05 |
Symmetric and Asymmetric Sigmoid Curves: a close look at their statistical, numerical and mathematical properties |
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Charles Tan, Merck, West Point - USA |
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12:05 - 13:30 |
Lunch & Poster Session |
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Session 3 |
Translational Medicine & Biomarkers |
Chair : L. Bijnens, Janssen Pharma, Beerse, Belgium |
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13:30 - 14:15 |
Unified approaches for surrogate marker evaluation from multiple randomized trials |
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G. Molenberghs, Censtat, Hasselt University, Belgium |
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14:15 - 15:15 |
Contributed papers |
14:15 - 14:35 |
Fit for purpose limits and tolerance intervals: connecting the biomarker assay performance to the clinical trial |
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Astrid Jullion, UCB Pharma SA, Braine-L'alleud, Belgium |
14:35 - 14:55 |
Investigating association between behavior, corticosterone, heart rate, and blood pressure in rats using surrogate marker evaluation methodology |
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Abel Tilahun, Center for Statistics, Hasselt University, Diepenbeek, Belgium |
14:55 - 15:15 |
Genomic biomarkers for a binary response in early drug development microarray experiments |
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Suzy Van Sanden, Center for Statistics, Hasselt University, Diepenbeek, Belgium |
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15:15 - 15:45 |
Coffee Break & Poster Session |
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Session 4 |
Methodology II |
Chair : P. Lambert, Université de Liège, Belgium |
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15:45 - 16:30 |
Estimation of nonlinear mixed effects models in pharmacokinetics with the SAEM algorithm implemented in MONOLIX |
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France Mentré, Université Paris-7, France |
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16:30 - 17:50 |
Contributed papers |
16:30 - 17:50 |
A framework for estimation of area under the concentration versus time curves (AUC's) in complete and incomplete sampling designs |
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Thomas Jaki, Lancaster University, Lancaster, UK |
16:50 - 17:10 |
Assessing repeatability and reproducibility of dose-response experiments |
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Marc Weimer, German Cancer Research Centre, Heidelberg, Germany |
17:10 - 17:30 |
Mixed modeling using the SAS® PROC MIXED procedure: A simulation based approach to assess sample sizes and deal with a daily biostatistician dilemma for preclinical trialsv |
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Lisa Maiofiss, SFdS, Suresnes, France |
17:30 - 17:50 |
Modeling Spatial Learning in rats based on morris water maze experiments |
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Christel Faes, Center for Statistics, Hasselt University, Diepenbeek, Belgium |
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20:00 |
Conference Dinner at Salon Georges |
Thursday, 25 September 2008 |
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Session 5 |
Chemical Manifacturing & Control |
Chair : B.Govaerts Université Catholique de Louvain, Belgium |
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08:30 - 09:15 |
Application of the tolerance interval concept in quality assurance assessment of pharmaceutical products |
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Y. Tsong, Office of Biometrics, Center for Drug Evaluation, FDA, USA |
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09:15 - 10:30 |
Contributed papers |
09:15 - 09:35 |
Reconsidering shelf life: An update from the PQRI stability shelf life working group |
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James Schwenke, Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, U.S.A. |
09:35 - 9:55 |
Evaluation tolerance interval estimates: to capture or not to capture |
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Michelle Quinlan, University of Nebraska-Lincoln, Lincoln, U.S.A. |
09:55 - 10:15 |
Development of statistical tools to test the equivalence between two measurement methods |
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Bernard Francq, Université Catholique de Louvain, Belgium |
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10:15 - 10:40 |
Coffee Break & poster session |
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Session 6 |
Toxicology |
Chair : L. A. Hothorn, Leibniz University Hannover |
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10:40 - 10:55 |
Semi- and non-parametric approaches to concentration-response modelling |
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C. Ritz, University of Copenhagen, Denmark |
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10:55 - 11:20 |
Evaluation of the in vitro mutagenicity assays |
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D. Gerhard, Leibniz University Hannover, Germany |
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11:20 - 11:45 |
Invitrostat: An open-source R-GUI for the statistical evaluation of in vitro assays in toxicology |
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F. Schaarschmidt, Leibniz University Hannover, Germany |
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11:45 - 12:30 |
Contributed papers |
11:45 - 12:00 |
The algae growth inhibition test - robust initial values for parameter estimation |
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Anke Schulz, Bayer Schering Pharma AG - Berlin, Germany |
12:00 - 12:15 |
Assessing the similarity of bioanalytical methods |
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Jason Liao, Merck, USA |
12:15 - 12:30 |
Dose-response evaluation using a combined parametric/non-parametric approach |
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John-Philip Lawo, Baxter BioScience, Vienna, Austria |
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12:30 - 14:00 |
Lunch & Poster Session |
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Session 7 |
Omics |
Chair : Z. Shkedy, Censtat, Hasselt University, Belgium |
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14:00-14:45 |
Tentacular analysis of high throughput omics data |
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D. Amaratunga, Johnson & Johnson Pharmaceutical Research & Development LLC, Raritan, NJ, USA |
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14:45-16:05 |
Contributed papers |
14:45 - 15:05 |
Estimation of power and analysis of qPCR data with normal mixed models |
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Auli Partanen, Orion Corporation ORION PHARMA, Turku - Finland |
15:05 - 15:25 |
Order restricted clustering for dose-response microarray experiments |
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Adetayo Kasim, Center for Statistics, Hasselt University, Diepenbeek, Belgium |
15:25 - 15:45 |
FARMS: a probabilistic latent variable model for summarizing Affymetrix array data at probe level |
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Djork-Arné Clevert, Institute of Bioinformatics, Johannes Kepler Universität Linz, Austria |
15:45 - 16:05 |
A flexible probe level approach to improving the quality and relevance of affymetrix microarray Data |
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Chris Harbron, AstraZeneca, Macclesfield, UK |
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16:05-16:20 |
Closing and concluding remark |
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Bruno Boulanger, UCB Pharma SA, Braine-L'alleud, Belgium |
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Download the Program in PDF :
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