FP7 logo euThe ESNATS project has received funding from the European Community's Seventh Framework Programme (FP7/2007-2013) under grant agreement n° HEALTH-F5-2008-201619

Embryonic Stem cell-based Novel Alternative Testing Strategies

Partners: Gottfried Wilhelm Leibniz Universität Hannover (LUH)

The Department of Biostatistics of Leibniz University of Hannover is particularly specialised on inference in dose-response studies as well as design and evaluation of pre-clinical experiments, including toxicology. Two projects related to pre-validation and validation of in vivo and in vitro toxicity assays were worked out: i) Validation and inter-laboratory comparison of an immuno-toxicity study (Federal Ministry of Health, bgvv), ii) Statistical analysis of in vitro validation studies INVITROSTAT (European Community, Research Centre Ispra, Italy, Contract no. 17159-2000-11F1ED ISP DE). Recently, the next project sponsored by JRC, ECVAM was started: Quality assessment and novel statistical analysis techniques for toxicological data (lot 2: ANOVA technique for ratios). The three major contributions of the biostatistics group are: i) estimation of assay's accuracy (sensitivity, specificity) with or without the availability of a gold standard (validation phase), ii) design and evaluation of assay-specific inter-laboratory studies, and iii) design and evaluation of high-throughput CNS and reprotox assays using concentration-response relationships.

Key staff involved in the project

Ludwig A. HothornLudwig A. Hothorn, Prof. Dr. Dr., PhD in Engineering TU Dresden (1974), Dr. habil. in Biostatistics University of Halle (1990). Working experience in biostatistics in toxicology (e.g. Toxikologie Graupa, German Cancer Research Centre, Boehringer Mannheim) and teaching biostatistics at Leibniz University of Hannover since 1993 (head of institute). 77 original publications in biostatistics and some textbook chapters. Three topics will be the contributions to ESNATS: i) Statistical evaluation of a typical in-vitro assay on repeated microtiter plates with robust estimation of ED50 (and its confidence intervals), ii) estimation of accuracy of in-vitro assays in comparison of a gold standard library (sensitivity, specificity, predictive values), iii) p>n problem for bead arrays.

Further information: www.biostat.uni-hannover.de

Top ^