Recommendations for statistical designs of in vivo mutagenicity tests with regard to subsequent statistical analysis

Mutation Research - Genetic Toxicology and Environmental Mutagenesis

Volumn 417, Issue 1, 1998, Pages 19-30

  Adler, Ilse Dore ^a   Bootman, James ^b   Favor, John ^a   Hook, Graham ^c   Schriever Schwemmer, Gerlinde ^a   Welzl, Gerhard ^a   Whorton, Elbert ^d   Yoshimura, Isao ^e   Hayashi, Makoto ^f  

^a INSTITUTE OF EPIDEMIOLOGY   (Germany)

^b Pharmaco LSR Ltd   (United Kingdom)

^c NATIONAL INSTITUTE OF ENVIRONMENTAL HEALTH SCIENCES   (United States)

^d UNIVERSITY OF TEXAS MEDICAL BRANCH   (United States)

^e TOKYO UNIVERSITY OF SCIENCE   (Japan)

^f NATIONAL INSTITUTE OF HEALTH SCIENCES   (Japan)

Author keywords

Chromosomal aberration test in mouse bone marrow differentiating spermatogonia; Experimental design; Micronucleus test in mouse bone marrow peripheral blood; Mouse dominant lethal test; Statistical analysis

Indexed keywords

ANIMAL CELL; BONE MARROW CELL; CHROMOSOME ABERRATION; HUMAN; HUMAN CELL; MICRONUCLEUS TEST; MOUSE; MUTAGEN TESTING; MUTAGENICITY; NONHUMAN; PRIORITY JOURNAL; SHORT SURVEY; STATISTICAL ANALYSIS;

EID: 0031658881     PISSN: 13835718     EISSN: None     Source Type: Journal    
DOI: 10.1016/S1383-5718(98)00091-6     Document Type: Article

References (37)

1. D. Hauschke, M. Hayashi, K.K. Lin, D.P. Lovell, W.D. Robinson, I. Yoshimura, Recommendations for biostatistics in mutagenicity studies, Drug Information J. 31 (1997) 323-326.
2. D.O. Chanter, A. Bateman, A.K. Palmer, M. Richold, D. Anderson, D.P. Lovell, M.T. Stevens, Statistical methods for the dominant lethal assay, in: D. Kirkland (Ed.), Statistical Evaluation of Mutagenicity Test Data, Cambridge University Press, Cambridge, 1989, pp. 233-250.
3. J.T. MacGregor, J.A. Meddle, M. Hite, B.H. Margolin, C. Ramel, M.F. Salamone, R.R. Tice, D. Wild, Guidelines for the conduct of micronucleus assays in mammalian bone marrow erythrocytes, Mutation Res. 189 (1987) 103-112.
4. D.P. Lovell, D. Anderson, R. Albanese, G.E. Amphlett, G. Clare, R. Ferguson, M. Richold, D.G. Papworth, J.R.K. Savage, Statistical analysis of in vivo cytogenetic assays, in: D.J. Kirkland (Ed.), Statistical Evaluation of Mutagenicity Test Data, Cambridge University Press, Cambridge, 1989, pp. 184-232.
5. B.H. Margolin, K.J. Risko, The statistical analysis of in vivo genotoxicity data: case studies of the rat hepatocyte UDS and mouse bone marrow micronucleus assays, in: J. Ashby, F.J. de Serres, M.D. Shelby, B.H. Margolin, M. Ishidate, Jr., G.C. Becking (Eds.), Evaluation of Short-term Tests for Carcinogens: Report of the International Programme on Chemical Safety's Collaborative Study on In Vivo Assays, Cambridge University Press, Cambridge, 1988, 1.29-1.42.
6. J. Ashby, H. Tinwell, A sequential approach to testing with the rodent bone marrow micronucleus assay-obviation of the need for statistical analysis of the data, Mutation Res. 327 (1995) 49-55.
7. M.F.W. Festing, D.P. Lovell, The need for statistical analysis of rodent micronucleus test data. Comment on the paper by Ashby and Tinwell, Mutation Res. 329 (1995) 221-224.
8. M. Hayashi, T. Sofuni, A reaction to 'A sequential approach to testing with the rodent bone marrow micronucleus assay', Mutation Res. 331 (1995) 173-174.
9. M.F.W. Festing, The scope for improving the design of laboratory animal experiments, Lab. Animal 26 (1992) 256-267.
10. B.H. Margolin, K.J. Risko, The use of historical data in laboratory studies, in: Proceedings of the International Biometrics Conference, Vol. 12, 1984, pp. 21-30.
11. M. Hayashi, T. Sofuni, The need for three dose levels to detect genotoxic chemicals in in vivo rodent assays, Mutation Res. 327 (1995) 247-251.
12. M. Hayashi, I. Yoshimura, T. Sofuni, M. Ishidate Jr., A procedure for data analysis of the rodent micronucleus test involving a historical control, Environ. Mol. Mutagen. 13 (1989) 347-356.
13. M. Hayashi, S. Hashimoto, Y. Sakamoto, C. Hamada, T. Sofuni, I. Yoshimura, Statistical analysis of data in mutagenicity assays: rodent micronucleus assay, Environ. Health Perspect. 102 (1994) 49-52, Suppl. 1.
14. R.J. Simes, An improved Bonferroni procedure for multiple tests of significance, Biometrics 73 (1986) 751-754.
15. S. Green, K.S. Lavappa, M. Manadhar, C. Sheu, E. Whorton, J.A. Springer, A guide for mutagenicity testing using the dominant lethal assay, Mutation Res. 189 (1987) 167-174.
16. A.-M.C. Lockhart, W.W. Piegorsch, J.B. Bishop, Assessing overdispersion and dose-response in the male dominant lethal assay, Mutation Res. 272 (1992) 35-58.
17. J.K. Piegorsch, W.W. Haseman, Statistical methods for analysing developmental toxicity data, Teratogen., Carcinogen., Mutagen. 11 (1991) 115-133.
18. D.M. Smith, D.A. James, A comparison of alternative distributions of postimplantation death in the dominant lethal assay, Mutation Res. 128 (1984) 195-206.
19. J. Vollmar, Statistical problems in mutagenicity tests, Arch. Toxicol. 38 (1977) 13-25.
20. E.B. Whorton Jr., Parametric statistical methods and sample size considerations for dominant lethal experiments. The use of clustering to achieve approximate normality, Teratogen., Carcinogen., Mutagen. 1 (1981) 353-360.
21. D. Anderson, The dominant lethal test in rodents, in: S. Venitt, J.M. Parry (Eds.), Mutagenicity Testing. A Practical Approach, IRL Press, Oxford, 1984, pp. 307-335.
22. A.J. Bateman, S.S. Epstein, Dominant lethal mutations in mammals, in: A. Hollaender (Ed.), Chemical Mutagens, Principles and Methods of Their Detection, Vol. 2, Plenum, New York, 1971, pp. 541-568.
23. U.H. Ehling, L. Machemer, W. Buselmaier, J. Dycka, H. Frohberg, J. Kratochvilova, R. Lang, D. Lorke, D. Müller, J. Peh, G. Röhrborn, R. Roll, M. Schulze-Schenking, H. Wiemann, Standard protocol for the dominant lethal test on male mice, Arch. Toxicol. 39 (1978) 173-185.
24. A.-M.C. Lockhart, J.B. Bishop, W.W. Piegorsch, Issues regarding data acquisition and analysis in the dominant lethal assay, Proc. Biopharm. Sect. Amer. Stat. Association (1991) 234-237.
25. E.B. Whorton Jr., T.G. Pullin, A.F. Frost, A. Onofre, M.S. Legator, D.S. Folse, Dominant lethal effects of n-butyl glycidyl ether in mice, Mutation Res. 124 (1983) 225-233.
26. J. Ashby, Rodent mutation assay data presentation and statistical assessment, Mutation Res. 331 (1995) 233-235.
27. J. Ashby, M.J.L. Clapp, The rodent dominant lethal assay: a proposed format for data presentations that alerts to pseudo-dominant lethal effects, Mutation Res. 320 (1995) 209-218.
28. W.M. Generoso, W.W. Piegorsch, Dominant lethal tests in male and female mice, Methods in Toxicology, Vol. 3A, Acad. Press, 1993, pp. 124-141.
29. M.F. Salamone, K.H. Mavournin, Bone marrow micronucleus assay: a review of the mouse stocks used and their published mean spontaneous micronucleus frequencies, Environ. Mol. Mutagen. 23 (1994) 239-273.
30. P. Armitage, Tests for linear trends in proportions and frequencies, Biometrics 11 (1955) 375-386.
31. W.G. Cochran, Some methods forstrengthening the common chi-square tests, Biometrics 10 (1954) 417-451.
32. Y.I. Chen, D.A. Wolfe, Nonparametric procedures for comparing umbrella pattern treatment effects with a control in a one-way layout, Biometrics 49 (1992) 455-465.
33. D. Krewski, B.G. Leroux, S.R. Bleuer, L.H. Broekhoven, Modeling the Ames Salmonella/Microsome assay, Biometrics 49 (1993) 499-510.
34. W.W. Piegorsch, Nonparametric methods to assess non-monotone dose response: application to genetic toxicology, in: P.K. Sen, I.A. Salama (Eds.), Order Statistics and Non-parametrics: Theory and Application, Elsevier, Amsterdam, 1992, pp. 419-430.
35. S. Schmoor, M. Schumacher, Adaptive statistical procedures for the analysis of non-monotone dose-response relationships, Biometrie und Informatik in Medizin und Biologie 23 (1992) 113-126.
36. D.G. Simpson, B.H. Margolin, Recursive nonparametric testing for dose-response relationships subject to downturn at high dose, Biometrika 73 (1986) 586-596.
37. D.G. Simpson, B.H. Margolin, Nonparametric testing for dose-response curves subject to downturns. Asymptotic power considerations, Annals Statistics 18 (1990) 373-390.