Details
| Originalsprache | Englisch |
|---|---|
| Seiten (von - bis) | 352-356 |
| Seitenumfang | 5 |
| Fachzeitschrift | Regulatory Toxicology and Pharmacology |
| Jahrgang | 56 |
| Ausgabenummer | 3 |
| Frühes Online-Datum | 14 Nov. 2009 |
| Publikationsstatus | Veröffentlicht - 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.
ASJC Scopus Sachgebiete
- Pharmakologie, Toxikologie und Pharmazie (insg.)
- Toxikologie
Zitieren
- Standard
- Harvard
- Apa
- Vancouver
- BibTex
- RIS
in: Regulatory Toxicology and Pharmacology, Jahrgang 56, Nr. 3, 04.2010, S. 352-356.
Publikation: Beitrag in Fachzeitschrift › Artikel › Forschung › 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 -