Statistical evaluation of the Local Lymph Node Assay

Regulatory Toxicology and Pharmacology

Volumn 56, Issue 3, 2010, Pages 352-356

  Hothorn, Ludwig A ^a,c   Vohr, Hans Werner ^b  

^a LEIBNIZ UNIVERSITY HANNOVER   (Germany)

^b Bayer HealthCare AG Wuppertal   (Germany)

^c SCRIPPS RESEARCH INSTITUTE   (United States)

Author keywords

Inference for ratios; LLNA; Proof of hazard; Proof of safety; Software; Statistical evaluation

Indexed keywords

ARTICLE; BAGG ALBINO MOUSE; CELL COUNT; CELL PROLIFERATION; FALSE POSITIVE RESULT; LOCAL LYMPH NODE ASSAY; NONHUMAN; ORGAN WEIGHT; PRIORITY JOURNAL; SKIN SENSITIZATION; STATISTICAL ANALYSIS;

ANIMALS; HAZARDOUS SUBSTANCES; LOCAL LYMPH NODE ASSAY; SOFTWARE; STATISTICS AS TOPIC;

ANIMALIA;

EID: 77249098262     PISSN: 02732300     EISSN: 10960295     Source Type: Journal    
DOI: 10.1016/j.yrtph.2009.10.007     Document Type: Article

References (20)

1. A Language and Environment for Statistical Computing R Foundation for Statistical Computing, 2007.
2. Altman D.G., and Bland J.M. Statistics notes - absence of evidence is not evidence of absence. British Medical Journal 311 (1995) 485
3. Bretz F., and Hothorn L.A. Statistical analysis of monotone or non-monotone dose-response data from in vitro toxicological assays. ATLA-Alternatives to Laboratory Animals 31 (2003) 81-96
4. Bretz F., Hothorn T., and Westfall P. On multiple comparisons in R. R News 2 (2002) 14-17
5. Cariello N.F., and Piegorsch W.W. The Ames test: the two-fold rule revisited mutation research-genetic. Toxicology 369 1-2 (1996) 23-31
6. Dilba G., Bretz E., Guiard V., and Hothorn L.A. Simultaneous confidence intervals for ratios with applications to the comparison of several treatments with a control. Methods of Information in Medicine 43 5 (2004) 465-469
7. Dilba G., Schaarschmidt F., and Hothorn L.A. Inferences for ratios of normal means. R News 7 (2007) 20-23
8. Dunnett C.W. A Multiple comparison procedure for comparing several treatments with a control. Journal of the American Statistical Association 50 272 (1955) 1096-1121
9. Ehling G., Hecht M., Heusener A., Huesler J., Gamer A.O., van Loveren H., Maurer T., Riecke K., Ullmann L., Ulrich P., Vandebriel R., and Vohr H.W. An European inter-laboratory validation of alternative endpoints of the murine Local Lymph Node Assay - 2nd round. Toxicology 212 1 (2005) 69-79
10. Gerberick G.F., Ryan C.A., Dearman R.J., and Kimber I. Local Lymph Node Assay (LLNA) for detection of sensitization capacity of chemicals. Methods 41 1 (2007) 54-60
11. Gomes M.L., de Mattos D.M.M., Freitas R.D., Bezerra R.J.A.C., and Bernardo-Filho M. Study of the toxicological effect of mitomycin C in mice: alteration on the biodistribution of radiopharmaceuticals used for renal evaluations. Human & Experimental Toxicology 20 4 (2001) 193-197
12. Haneke K.E., Tice R.R., Carson B.L., Margolin B.H., and Stokes W.S. ICCVAM evaluation of the murine Local Lymph Node Assay, III. Data analyses completed by the national toxicology program interagency center for the evaluation of alternative toxicological methods. Regulatory Toxicology and Pharmacology 34 (2001) 274-286
13. Lovell, D.P., Yoshimura, I., Hothorn, L.A., Margolin, B.H., Soper, K., 2000. Report and summary of the major conclusions from statistics in genotoxicity testing working group from the International Workshop on Genotoxicity Test Procedures (IWGTP), March 1999 Environmental And Molecular Mutagenesis. 35(3), 260-263.
14. Millard S.P. Proof of safety vs. proof of hazard. Biometrics 43 3 (1987) 719-725
15. OECD Guideline for Testing of Chemicals: Skin Sensitisation: Local Lymph Node Assay OECD/OCDE 429, 2002.
16. Ryan T.P., and Woodall W.H. The most-cited statistical papers. Journal of Applied Statistics 32 5 (2005) 416-474
17. Takeyoshi M., Sawaki M., Yamasaki K., and Kimber I. Assessment of statistic analysis in non-radioisotopic Local Lymph Node Assay (non-RI-LLNA) with alpha-hexylcinnamic aldehyde as an example. Toxicology 191 2-3 (2003) 259-263
18. The Murine Local Lymph Node Assay: A Test Method for Assessing the Allergic Contact Dermatitis Potential of Chemicals/Compounds, 1999. NIH Publication N 99-4494.
19. Vohr, H.-W., 2007. Local Lymph Node Assay study report about validation catch-up trial. Report: Bayer HealthCare AG.
20. Williams D.A. Test for differences between treatment means when several dose levels are compared with a zero dose control. Biometrics 27 1 (1971) 103-117