Details
| Original language | English |
|---|---|
| Pages (from-to) | 352-356 |
| Number of pages | 5 |
| Journal | Regulatory Toxicology and Pharmacology |
| Volume | 56 |
| Issue number | 3 |
| Early online date | 14 Nov 2009 |
| Publication status | Published - Apr 2010 |
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.
Keywords
- Inference for ratios, LLNA, Proof of hazard, Proof of safety, Software, Statistical evaluation
ASJC Scopus subject areas
- Pharmacology, Toxicology and Pharmaceutics(all)
- Toxicology
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In: Regulatory Toxicology and Pharmacology, Vol. 56, No. 3, 04.2010, p. 352-356.
Research output: Contribution to journal › Article › Research › peer review
}
TY - JOUR
T1 - Statistical evaluation of the Local Lymph Node Assay
AU - Hothorn, Ludwig A.
AU - Vohr, Hans Werner
PY - 2010/4
Y1 - 2010/4
N2 - 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.
AB - 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.
KW - Inference for ratios
KW - LLNA
KW - Proof of hazard
KW - Proof of safety
KW - Software
KW - Statistical evaluation
UR - http://www.scopus.com/inward/record.url?scp=77249098262&partnerID=8YFLogxK
U2 - 10.1016/j.yrtph.2009.10.007
DO - 10.1016/j.yrtph.2009.10.007
M3 - Article
C2 - 19922754
AN - SCOPUS:77249098262
VL - 56
SP - 352
EP - 356
JO - Regulatory Toxicology and Pharmacology
JF - Regulatory Toxicology and Pharmacology
SN - 0273-2300
IS - 3
ER -