Statistical evaluation of the Local Lymph Node Assay.
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.
Hothorn
Ludwig A
LA
Institute of Biostatistics, Leibniz University Hannover, Germany. hothorn@biostat.uni-hannover.de
Vohr
Hans-Werner
HW
D000818:Animals; D015386:Hazardous Substances / Q000145:classification; D023441:Local Lymph Node Assay; D012984:Software; D013223:Statistics as Topic
D015386:Hazardous Substances