1 The sensitivity of long-term toxicity tests is impaired due to the 'background noise' of spontaneous lesions which are unrelated to treatment.
2 The need for a comprehensive source of computerized information concerning the occurrence and incidence of spontaneous lesions in control animals has been highlighted by initiatives in Europe and the USA. It is, however, essential to identify the potential users, and the type of information required for such a database to be of value.
3 This information has been acquired following an international survey of the pharmaceutical industry in Europe, Japan and the USA, including responses from 48 toxicologists and toxicopathologists representing 38 company groups.
4 Thirty-eight respondents indicated that they would use a historical control database that was regularly updated with the majority of respondents suggesting that they currently use external sources (Breeder's data, the literature, other companies) occasionally to acquire information on control animal pathology data.
5 The majority (94%) of the respondents indicated that a control animal database should contain information on both neoplastic and non-neoplastic lesions for use in evaluating long-term studies, in particular carcinogenicity studies.
6 The survey confirms the need for a historical control animal pathology database wider then those currently available.
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References
1.
Traina VMThe role of toxicology in drug research and development. Medicinal Research Reviews1983; 3: 43-72.
2.
Tucker MJFactors influencing carcinogenicity testing in rodents. Human Toxicology1987; 6: 107-9.
3.
Glaister JRLaboratory animal pathology. In: Principles of Toxicological Pathology, pp. 131-203. London: Taylor and Francis, 1986.
4.
EEC Directive 75/318/EEC. Annex 3, Carcinogenic potential. In: Commission of the European Communities. The Rules Governing Medicaments in the European Community, pp. 63-8. Brussels: EEC, 1984.
5.
U.S. Interagency Staff Group on Carcinogens.Chemical carcinogens: A review of the science and its associated principles. Environmental Health Perspective1986; 67: 201-82.
6.
Oecd.Carcinogenicity studies (451). In: OECD Guidelines for testing chemicals, Section 4: Health effects , 1981.
7.
Sher SP, Jensen RD & Bokelman DLSpontaneous tumors in control F344 and Charles River-CD rats and Charles River CD-1 and B6C3HF1 mice. Toxicology Letters1982; 11: 103-10.
8.
Jones TC, Mohr U & Hunt RD (eds). Monographs on pathology of laboratory animals: Urinary System. Berlin : Springer-Verlag, 1986.
9.
Altman PL & Fisher KDReview of data standards related to the laboratory animal data bank. Interim report. Federation of American Societies for Experimental Biology, 1980.
10.
Mohr U., Bader R., Ernst H. et al. Tumor registry data base. Suggestions for a systematized nomenclature of pre-neoplastic and neoplastic lesions in rats. Experimental Pathology1990; 38; 1-18.
11.
Lumley CE & Walker SRA critical appraisal of the duration of chronic animal toxicity studies. Regulatory Toxicology and Pharmacology1986; 6: 66-72.
12.
Thompson SW & Rac VSSome thoughts on attempts to correlate the occurrence of neoplastic and non-neoplastic spontaneous diseases in laboratory animals. Toxicologic Pathology1981; 9: 1-18.
13.
van Zwieten MJ , Majka JA, Peter CP & Burek JDThe value of historical control data. In: Carcinogenicity. The design, analysis and interpretation of long-term animal studies, eds HC Grice & JL Ciminera. pp. 39-52. New York: Springer-Verlag, 1986.
14.
Society of Toxicology Task Force of Past Presidents.Animal data in hazard evaluation: Paths and Pitfalls. Fundamental and Applied Toxicology1982; 2: 101-7.
