This Article Free Full Text (Free PDF) Free Alert me when this article is cited Alert me if a correction is posted Citation Map Services Email this article to a friend Similar articles in this journal Similar articles in PubMed Alert me to new issues of the journal Add to Saved Citations Download to citation manager Request Permissions Request Reprints Add to My Marked Citations Citing Articles Citing Articles via HighWire Citing Articles via Google Scholar Citing Articles via Scopus Google Scholar Articles by Leblanc, B. Search for Related Content PubMed PubMed Citation Articles by Leblanc, B. Social Bookmarking                         What's this?

Pathology and Tissue Sampling Protocols for Rodent Carcinogenicity Studies: Time for Revision

Drug Safety Evaluation, Pfizer Central Research-B.P. 109, 37401 Amboise Cedex, France

References

• Bahnemann R., Jacobs M., Karbe E., Kaufmann W., Morawietz G., Nolte T., Rittinghausen S. (1995). RITA—Registry of industrial toxicology animal-data. Guides for organ sampling and trimming procedures in rats. Exp Toxicol Pathol 47: 247-266.[Medline] [Order article via Infotrieve]
• Boorman GA, Montgomery CA Jr, Eustis SL, Wolfe MJ, McConnell EE, Hardisty JF (1985). Quality assurance in pathology for rodent carcinogenicity studies. In: Handbook of Carcinogen Testing, Milman HA, Weisburger EK (eds). Noyes Publications, New Jersey, pp 345-357.
• Chhabra RS, Huff JE, Schwetz BS, Selkirk J. (1990). An overview of prechronic and chronic toxicity/carcinogenicity experimental study design and criteria used by the National Toxicology Program. Environ Health Perspect 86: 313-321.[Web of Science][Medline] [Order article via Infotrieve]
• Contrera JF, Jacobs AC, DeGeorge JJ (1997). Carcinogenicity and the evaluation of regulatory requirements for pharmaceuticals. Regul Toxicol Pharmacol 25: 130-145.[CrossRef][Web of Science][Medline] [Order article via Infotrieve]
• Devor DE, Henneman JR, Kurata Y., Rehm S., Weghorst CM, Ward JM ( 1994). Pathology procedures in laboratory animal carcinogenesis studies. In: Carcinogenesis, Waalkes MP, Ward JM (eds). Raven Press, New York, pp 429-466.
• Dua PN, Jackson BA (1988). Review of pathology data for regulatory purposes. Toxicol Pathol 16: 443-450.[Web of Science][Medline] [Order article via Infotrieve]
• European Community Commission (1989). 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 107-112.
• Faccini JM, Butler WR, Friedmann JC, Hess R., Reznik GK, Ito N., Hayashi Y., Williams GM (1992). IFSTP guidelines for the design and interpretation of the chronic rodent carcinogenicity bioassay. Exp Toxicol Pathol 44: 443-456.[Web of Science][Medline] [Order article via Infotrieve]
• Frith CH, Boothe AD, Greenmann DL, Farmer JH (1979). Correlations between gross and microscopic lesions in carcinogenic studies in mice. J Environ Pathol Toxicol 3: 139-153.
• Gold LS, Zeiger E. (1997). Carcinogenic Potency and Genotoxicity Databases. CRC Press, New York.
• Greaves P. (1990). Histopathology of Preclinical Toxicity Studies: Interpretation and Relevance in Drug Safety Evaluation. Elsevier, Amsterdam.
• Hardisty JF (1985). Factors influencing laboratory animal spontaneous tumor profiles. Toxicol Pathol 13: 95-104.[Medline] [Order article via Infotrieve]
• Haseman JK, Boorman GA, Huff J. ( 1997). Value of historical control data and other issues related to the evaluation of long-term rodent carcinogenicity studies. Toxicol Pathol 20: 524-527.
• Haseman JK, Hailey JR, Morris RW (1998). Spontaneous neoplasm incidences in Fisher 344 rats and B6C3F mice in two-year carcinogenicity studies: A National Toxicology Program update. Toxicol Pathol 26: 428-441.[Abstract/Free Full Text]
• Haseman JK, Huff JE, Rao GN, Eustis SL (1989). Sources of variability in rodent carcinogenicity studies. Fundam Appl Toxicol 12: 793-804.[CrossRef][Web of Science][Medline] [Order article via Infotrieve]
• International Conference on Harmonisation. Guidelines S1A, S1B, S1C, S1C(R). In: Proceedings of the Fourth International Conference on Harmonisation, 1997: Brussels, Belgium, D'Arcy PF, Harron DWG (eds). Queen's University Press, Belfast, pp 941-970. 17. Japanese Ministry of Health and Welfare (1997 ). Pharmaceutical and Medical Safety Bureau. In: Guidelines for Toxicity Studies of Drugs. Yakuji Nippo, Tokyo, pp 147-175.
• Kulwich BA, Hardisty JF, Gilmore CE, Ward JM ( 1980). Correlation between gross obversations of tumors and neoplasms diagnosed microscopically in carcinogenesis bioassays in rats. J Environ Pathol Toxicol 3: 281-287.[Web of Science]
• Long PH, Elwell M., Harris RK, Leininger JR, McKinney LA, Moch RW, Slayter MV (1992). Guides for toxicologic pathology. In: Standardized System of Nomenclature and Diagnostic Criteria. STP/ARP / AFIP, Washington, DC, p 3.
• Maronpot RR (1991). Chemical carcinogenesis. In: Handbook of Toxicologic Pathology, Haschek WM, Rousseaux CG (eds). Academic Press, San Diego, pp 91-129.
• McConnell EE (1983). Pathology requirements for two-year rodent studies. I—A review of current procedures. Toxicol Pathol 11: 60-64.[Abstract/Free Full Text]
• McConnell EE (1983). Pathology requirements for two-year rodent studies. II—Alternative approaches. Toxicol Pathol 11: 65-76.[Abstract/Free Full Text]
• Mohr U., Capen CC, Dungworth DL, Griesemer RA, Ito N., Turusov VS (1992-1993). International classification of rodent tumours part I—The rat. IARC Scientific Publication No 122, Lyon, France.
• Monro AM (1996). Are lifespan rodent carcinogenicity studies defensible for pharmaceutical agents? Exp Toxicol Pathol 48: 155-166.[Web of Science][Medline] [Order article via Infotrieve]
• Monro AM, MacDonald JS (1998). Evaluation of the carcinogenic potential of pharmaceuticals. Opportunities arising from the International Conference on Harmonisation. Drug Safety 18: 309-319.
• Organization for Economic Cooperation and Development (1993). Guidelines for testing of chemicals, section 4—Health effects. Carcinogenicity Studies 451. Publications Service, OECD, Paris.
• Physicians Desk Reference (1999). Medical Economics Company, Montvale, New Jersey.
• Robens JF, Calabrese EJ, Piegorsch WW, Schueler RL, Hayes AW (1994). Principles of testing for carcinogenicity. In: Principles and Methods of Toxicology, Hayes AW (ed). Raven Press, New York, pp 697-728.
• Society of Toxicologic Pathologists (1997). Documentation of pathology peer review. Toxicol Pathol 25: 655.[Free Full Text]
• Sontag JM, Page NP, Saffiotti U. (1976). Guidelines for Carcinogen Bioassay in Small Rodents. NCI-CG-TR-1, DHEW (NIH) 76-801, National Cancer Institute, Bethesda, Maryland.
• Soule NW (1987). Gut rolls: A better technique for GI tumor assessment. Toxicol Pathol 15: 374.
• Squire R. (1989). The interpretation of equivocal or marginal animal carcinogenic tests. Cell Biol Toxicol 5: 371-376.[CrossRef][Web of Science][Medline] [Order article via Infotrieve]
• Thompson SW, Hunt RD (1963). Spontaneous tumors in the Sprague-Dawley rat. Ann NY Acad Sci 108: 832-845.[CrossRef][Web of Science]
• US Environmental Protection Agency (1989). Health effects test guidelines. Pesticides and Toxic Substances (H-7504C). Subdivision F Guideline Ref 83-2. EPA 560/09-90-078, Washington, DC.
• US Food and Drug Administration. Bureau of Foods (1982). Toxicological principles for the safety assessment of direct food additives and color additives used in food. National Technical Information Service, Springfield, Virginia.
• US Food and Drug Administration. Bureau of Foods (Draft revision 1996). Toxicological principles for the safety assessment of direct food additives and color additives used in food.
• van Oosterhout Jpj, van Der Laan JW, De Waal EJ, Olejniczak K., Hilgenfeld M., Schmidt V., Bass R. (1997). The utility of two rodent species in carcinogenic risk assessment of pharmaceuticals in Europe. Regul Toxicol Pharmacol 25: 6-17.[CrossRef][Web of Science][Medline] [Order article via Infotrieve]
• Ward JM (1983). Background data and variations in tumor rates of control rats and mice. Prog Exp Tumor Res 26: 241-258.[Web of Science][Medline] [Order article via Infotrieve]
• Ward JM, Reznik G. (1983). Refinements of rodent pathology and the pathologist's contribution to evaluation of carcinogenesis bioassays. Prog Exp Tumor Res 26: 266-291.[Web of Science][Medline] [Order article via Infotrieve]
• Weisburger JH, Weisburger EK (1967). Tests for chemical carcinogens. In: Methods in Cancer Research, Busch H (ed). Academic Press, New York, pp 307-387.
• Woutersen RA, van Garderen-Hoetmer A., Slootweg PJ, Feron VJ (1994). Upper respiratory tract carcinogenesis in experimental animals and in humans. In: Carcinogenesis, Waalkes MP, Ward JM (eds). Raven Press, New York, pp 215-264.

Toxicologic Pathology, Vol. 28, No. 4, 628-633 (2000)
DOI: 10.1177/019262330002800417


CiteULike    Complore    Connotea    Del.icio.us    Digg    Reddit    Technorati    Twitter    What's this?

This article has been cited by other articles:

				J. I. Goodman A Perspective on Current and Future Uses of Alternative Models for Carcinogenicity Testing Toxicol Pathol, January 1, 2001; 29(1_suppl): 173 - 176. [Abstract] [PDF]

This Article Free Full Text (Free PDF) Free Alert me when this article is cited Alert me if a correction is posted Citation Map Services Email this article to a friend Similar articles in this journal Similar articles in PubMed Alert me to new issues of the journal Add to Saved Citations Download to citation manager Request Permissions Request Reprints Add to My Marked Citations Citing Articles Citing Articles via HighWire Citing Articles via Google Scholar Citing Articles via Scopus Google Scholar Articles by Leblanc, B. Search for Related Content PubMed PubMed Citation Articles by Leblanc, B. Social Bookmarking                         What's this?