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Regul Toxicol Pharmacol. 2010 Apr;56(3):352-6. doi: 10.1016/j.yrtph.2009.10.007. Epub 2009 Nov 14.

Statistical evaluation of the Local Lymph Node Assay.

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1
Institute of Biostatistics, Leibniz University Hannover, Germany. hothorn@biostat.uni-hannover.de

Abstract

In the Local Lymph Node Assay measured endpoints for each animal, such as cell proliferation, cell counts and/or lymph node weight should be evaluated separately. The primary criterion for a positive response is when the estimated stimulation index is larger than a specified relative threshold that is endpoint- and strain-specific. When the lower confidence limit for ratio-to-control comparisons is larger than a relevance threshold, a biologically relevant increase can be concluded according to the proof of hazard. Alternatively, when the upper confidence limit for ratio-to-control comparisons is smaller than a tolerable margin, harmlessness can be concluded according to a proof of safety.

PMID:
19922754
DOI:
10.1016/j.yrtph.2009.10.007
[Indexed for MEDLINE]
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