The utility of two rodent species in carcinogenic risk assessment of pharmaceuticals in Europe

Regulatory Toxicology and Pharmacology

Volumn 25, Issue 1, 1997, Pages 6-17

  Van Oosterhout, J P J ^a   Van Der Laan, J W ^a   De Waal, E J ^a   Olejniczak, K ^b   Hllgenfeld, M ^b   Schmidt, V ^c   Bass, R ^b  

^a NATIONAL INSTITUTE FOR PUBLIC HEALTH AND THE ENVIRONMENT   (Netherlands)

^b Fed Inst for Drugs/Medical Devices   (Germany)

^c NONE

Author keywords

[No Author keywords available]

Indexed keywords

ADENOSINE TRIPHOSPHATASE INHIBITOR; ALPHA ADRENERGIC RECEPTOR BLOCKING AGENT; ANABOLIC AGENT; ANALGESIC AGENT; ANTIANGINA PECTORIS AGENT; ANTICONVULSIVE AGENT; ANTIDEPRESSANT AGENT; ANTIEMETIC AGENT; ANTIFUNGAL AGENT; ANTIHYPERTENSIVE AGENT; ANTILIPEMIC AGENT; ANTIVIRUS AGENT; BETA 2 ADRENERGIC RECEPTOR STIMULATING AGENT; BETA ADRENERGIC RECEPTOR BLOCKING AGENT; CALCIUM ANTAGONIST; CORTICOSTEROID; DIURETIC AGENT; DOPAMINE RECEPTOR STIMULATING AGENT; DRUG; GONADOTROPIN DERIVATIVE; HISTAMINE H1 RECEPTOR ANTAGONIST; HYPNOTIC AGENT; NEUROLEPTIC AGENT; OPIATE; ORAL ANTIDIABETIC AGENT; PEPTIDE HORMONE; SEDATIVE AGENT; SEX HORMONE; SPASMOLYTIC AGENT; UNINDEXED DRUG;

ANIMAL EXPERIMENT; ARTICLE; CANCER INCIDENCE; CANCER RISK; CARCINOGEN TESTING; CARCINOGENICITY; DATA BASE; FEMALE; MALE; MOUSE; NONHUMAN; PRIORITY JOURNAL; RAT; RISK ASSESSMENT; RODENT; SPECIES DIFFERENCE;

ANIMALIA; RODENTIA;

EID: 0031080023     PISSN: 02732300     EISSN: None     Source Type: Journal    
DOI: 10.1006/rtph.1996.1077     Document Type: Article

References (26)

1. Alison, R. H., Capen, C. C., and Prentice, D. E. (1994). Neoplastic lesions of questionable significance to humans. Toxicol. Pathol. 22, 165-186.
2. Ashby, J., and Morrod, R. S. (1991). Detection of human carcinogens. Nature 352, 185-186.
3. Barbacid, M. (1987). Ras genes. Annu. Rev. Biochem. 56, 779-829.
4. Boorman, G. A., Maronpot, R. R., and Eustis, S. L. (1994). Rodent carcinogenicity bioassay: Past, present, and future. Toxicol. Pathol. 22, 105-111.
5. Butterworth, B. E. (1990). Consideration of both genotoxic and non-genotoxic mechanisms in predicting carcinogenic potential. Mut. Res. 239, 117-132.
6. Contrera, J. F., Jacobs, A. C., DeGeorge, J. J., Chen, C., Choudary, J., DeFelice, A., Fairweather, W., Farrelly, J., Fitzgerald, G., Goheer, A., Jordan, A., Lin, D., Lin, K., Kelly, R., Meyers, L., Osterberg, R., Prasanna, H. R., Resnick, C., Sheevers, H., and Sun, J. (1996). Carcinogenicity Testing and the Evaluation of Regulatory Requirements for Pharmaceuticals. Federal Register, U.S. Department of Health and Human Sciences, Public Health Service, Docket No. 96D-0235.
7. Counts, J. L., and Goodman, J. I. (1994). Hypomethylation of DNA: An epigenetic mechanism involved in tumor promotion. Mol. Carcinogen. 11, 185-188.
8. Davies, T. S., and Monro, A. M. (1995). Marketed human pharmaceuticals reported to be tumorigenic in rodents. J. Am. Coll. Toxicol. 14, 90-107.
9. DeGeorge, J. J., and Contrera, J. F. (1996). A regulatory perspective of the guidance on the utility of two rodent species. In Proceedings, Third International Conference on Harmonisation, Yokohama, 1995 (P. F. D'Arcy and D. W. G. Harron, Eds.), pp. 274-277. Greystone Books Ltd., Antrim, N. Ireland.
10. Drinkwater, N. R., and Ginsler, J. J. (1986). Genetic control of hepatocarcinogenesis in C57/B1/6J and C3H/HeJ inbred mice. Carcinogenesis 7, 1701-1707.
11. EEC (1983). Note for Guidance Concerning the Application of Chapter I(E) of Part 2 of the Annex to Directive 75/318/EEC, with a View to the Granting of a Marketing Authorization of a New Drug, pp. 107-111.
12. Faccini, J. M., Butler, W. R., Friedmann, J. C., Hess, R., Reznik, G. K, Ito, N., Hayashi, Y., and Williams, G. M. (1992). IFSTP guideline for the design and interpretation of the chronic rodent carcinogenicity bioassay. Exp. Toxicol. Pathol. 44, 443-456.
13. Gold, L. S., Bernstein, L., Magaw, R., and Slone, T. H. (1989). Interspecies extrapolation in carcinogenesis: Prediction between rats and mice. Environ. Health Perspect. 81, 211-219.
14. Goodman, J. I., Ward, J. M., Popp, J. A., Klaunig, J. E., and Fox, T. R. (1991). Mouse liver carcinogenesis: Mechanisms and relevance. Fundam. Appl. Toxicol. 17, 651-665.
15. Haseman, J. K. (1990). Use of statistical decision rules for evaluating laboratory animal carcinogenicity studies. Fundam. Appl. Toxicol. 14, 637-648.
16. Lai, D. Y., Baetcke, K. P., Vu, V. T., Cotruvo, J. A., and Eustis, S. L. (1994). Evaluation of reduced protocols for carcinogenicity testing of chemicals: Report of a joint EPA/NIEHS workshop. Regul. Toxicol. Pharmacol. 19, 183-201.
17. Marselos, M., and Vainio, H. (1991). Carcinogenic properties of pharmaceutical agents evaluated in the IARC Monographs programme. Carcinogenesis 12, 1751-1766.
18. McAuslane, J. A. N., Lumley, C. E., and Walker, S. R. (Eds.) (1992). The Carcinogenicity Debate. Quay Publishing, Lancaster.
19. Monro, A. (1994). Utility of two rodent species: Some arguments for and against: In Proceedings, Second International Conference on Harmonisation, Orlando, 1993, (P. F. D'Arcy and D. W. G. Harron, Eds.), pp. 293-300. Greystone Books, Antrim, N. Ireland.
20. Monro, A. (1996). Are lifespan rodent carcinogenicity studies defensible for pharmaceutical agents? Exp. Toxicol. Pathol. 48, 155-166.
21. Oda, T., Tsuda, H., and Scarpa, A. (1992). p53 gene mutation spectrum on hepatocellular carcinoma. Cancer Res. 52, 6358-6364.
22. Ozturk, M. (1991). p53 mutation in hepatocellular carcinoma after aflatoxin exposure. Lancet 338, 1356-1359.
23. Scales, M. D. C., and Griffin, J. (1992). Use of two matched strains: Can they improve sensitivity? In The Carcinogenicity Debate (J. A. N. McAuslane, C. E. Lumley, and S. R. Walker, Eds.), pp. 129-139. Quay Publishing, Lancaster.
24. Schach von Wittenau, M., and Estes, P. C. (1983). The redundancy of mouse carcinogenicity bioassays. Fundam. Appl. Toxicol. 3, 631-639.
25. Tennant, R. W. (1993). Stratification of rodent carcinogenicity bioassay results to reflect relative human hazard. Mutat. Res. 286, 111-118.
26. Usui, T., Griffiths, S. A., and Lumley, C. E. (1996). Industry viewpoint: The utility of the mouse for the assessment of the carcinogenic potential of pharmaceuticals. In Proceedings, Third International Conference on Harmonisation, Yokohama, 1995 (P. F. D'Arcy and D. W. G. Harron, Eds.), pp. 279-284, Greystone Books, Antrim, N. Ireland.