| Автор | Betton, G. |
| Автор | Cockburn, A. |
| Автор | Harpur, E. |
| Автор | Hopkins, J. |
| Автор | Illing, P. |
| Автор | Lumley, C. |
| Автор | Connors, T. |
| Дата выпуска | 1994 |
| dc.description | This review indicates that for the detection of non-neoplastic toxic effects:1 Four decades of accumulated literature provide no lead as to the optimum duration of repeat dose toxicity testing required for all classes of chemicals, although 6 months repeated administration appears adequate for pharmaceuticals.2 Three month studies predicted the 2 year outcome for 70% of the compounds evaluated in this pilot study using data published by the US National Toxicology Program.3 In spite of the limitations of this pilot study, this finding is considered encouraging as it is close to that generated previously on more detailed confidential pharmaceutical data.<sup>1,2</sup> This suggests that the exercise should now be expanded using confidential surveys of industrial data to determine the concordance resulting from the evaluation of a larger group of chemicals. |
| Издатель | Sage Publications |
| Название | A Critical Review of the Optimum Duration of Chronic Rodent Testing for the Determination of Non-Tumourigenic Toxic Potential: A Report by the BTS Working Party on Duration of Toxicity Testing |
| Тип | Reviews |
| DOI | 10.1177/096032719401300401 |
| Print ISSN | 0960-3271 |
| Журнал | Human and Experimental Toxicology |
| Том | 13 |
| Первая страница | 221 |
| Последняя страница | 232 |
| Аффилиация | Betton, G., Zeneca Pharmaceuticals, Alderley Park, Macclesfield, SK10 4TG |
| Аффилиация | Cockburn, A., Schering Agrochemicals Limited, Chesterford Park Research Station, Saffron Walden, Essex, CB10 1XL |
| Аффилиация | Harpur, E., Sterling Winthrop Pharmaceuticals Research Division, Sterling Winthrop Research Centre, Alnwick, Northumberland, NE66 2JH |
| Аффилиация | Hopkins, J., BIBRA Toxicology International, Woodmansterne Road, Carshalton, Surrey, SM5 4DS |
| Аффилиация | Illing, P., HSE, Magdalen House, Bootle, Merseyside, L20 3QZ |
| Аффилиация | Lumley, C., CMR, Woodmansterne Road, Carshalton, Surrey, SM5 4DS |
| Аффилиация | Connors, T., Former Director, MRC Toxicology Unit, Woodmansterne Road, Carshalton, Surrey, SM5 4DS, UK |
| Выпуск | 4 |
| Библиографическая ссылка | Lumley CE, Parkinson C. & Walker SR An international appraisal of the minimum duration of chronic animal toxicity studies. Human and Experimental Toxicology 1992; 11: 155-62. |
| Библиографическая ссылка | Lumley CE & Walker SR A critical appraisal of the duration of chronic animal toxicity studies. Regulatory Toxicology and Pharmacology 1986; 6: 66-72. |
| Библиографическая ссылка | Bein HJRational and irrational numbers in toxicology. Proceedings of theEuropean Societies for Study of Drug Toxicity1963; 2: 15-26. |
| Библиографическая ссылка | Hayes WJTests detecting and measuring long-term toxicity. Essays in Toxicology 1972; 3: 65-77. |
| Библиографическая ссылка | Hayes WJThe 90-dose LD50 and a chronicity factor as measures of toxicity . Toxicology and Applied Pharmacology 1967 ; 11: 327-35. |
| Библиографическая ссылка | McNamara BPConcepts in health evaluation of commercial and industrial chemicals. In: New Concepts in Safety Evaluation, eds M.A. Mehlman, R.E. Shapiro & H. Blumenthal. New York, Wiley, 1976, pp. 61-140. |
| Библиографическая ссылка | McCollister DDSociety of Toxicology Ad Hoc Committee Comments on Health Research Group Petitions. Society of Toxicology Newsletter1974, p. 2. |
| Библиографическая ссылка | Weil CS & McCollister DD Relationship between short and long-term feeding studies in designing an effective toxicity test. Journal of Agricultural and Food Chemistry 1963; 11: 486-491. |
| Библиографическая ссылка | Salsburg DSStatistics and toxicology: An overview. In: Scientific Considerations in Monitoring and Evaluating Toxicological Research, ed. E.J. Gralla.New York: Hemisphere Publishing Corp, 1981, pp. 123-136. |
| Библиографическая ссылка | Heywood R.Long-term toxicity. In Animals and Alternatives in Toxicity Testing, eds M. Balls, R.J. Riddell & A.N. Worden. London: Academic Press Inc, FRAME, 1983, pp. 79-93. |
| Библиографическая ссылка | Barnes JM & Denz FA Experimental methods used in determining chronic toxicity. A critical review . Pharmacological Review 1954; 6: 191-242. |
| Библиографическая ссылка | Noel, Prb.Traditional animal screening tests. Meeting on Pharmacological Models to Assess Toxicity and Side Effects of Fertility Regulating Agents. Geneva, 17-20 September 1973 ; pp. 17-33. |
| Библиографическая ссылка | Paget, G.E.Standards for the laboratory evaluation of the toxicity of a drug. Proceedings of theEuropean Societies for Study of Drug Toxicity1963; 2: 7-12. |
| Библиографическая ссылка | Igarashi, T.Is the 12 month treatment essential for the repeated dose study? In Proceedings of the First International Conference on Harmonisation , Brussels 1991. eds P.F. D'Arcy and D.W.G. Harron. Belfast: Queens University Press, 1992; pp. 248-51. |
| Библиографическая ссылка | Peck HMAn appraisal of drug safety evaluation in animals and the extrapolation of results to man. In: Importance of Fundamental Principles in Drug Evaluation, eds D.H. Tedeschi & R.E. Tedeschi. New York : Raven Press, 1968, pp. 449-71. |
| Библиографическая ссылка | Gross FHThe scientific basis of drug safety regulations. In: Drug Safety: Progress and Controversies, eds M. Auriche , J. Burke & J. Duchier. Oxford: Pergamon Press, 1982, pp. 9-18. |
| Библиографическая ссылка | Griffin JPRepeated-dose long-term toxicity studies. In: Animals and Alternatives in Toxicity Testing, eds M. Balls, R.J. Riddell & A.N. Worden. London: Academic Press Inc, FRAME, 1983, pp. 98-104. |
| Библиографическая ссылка | Worden ANThe evidence supporting 6 month animal studies. In: Long-Term Animal Studies- Their Predictive Value for Man, eds S.R. Walker & A.D. Dayan. Lancaster: MTP Press Ltd., CMR Workshop Series, 1986, pp. 83-86. |
| Библиографическая ссылка | Worden ANToxicological methods. Toxicology1974; 2: 359-70. |
| Библиографическая ссылка | Worden AN & Walker SR Animal models of long-term toxic effects. In: The Future of Predictive Safety Evaluation, eds A.N. Worden , D.V. Parke & J. Marks. Lancaster: MTP Press Ltd., 1987, pp. 57-64. |
| Библиографическая ссылка | Lumley CE & Walker SR The value of chronic animal toxicology studies of pharmaceutical compounds: A retrospective analysis. Fundamental and Applied Toxicology 1985; 5: 1007-1024. |
| Библиографическая ссылка | Lumley CE & Walker SR What is the value of animal toxicology studies beyond 6 months? British Journal of Pharmacology 1985; 84: 117. |
| Библиографическая ссылка | Walker SRA retrospective analysis of chronic toxicity studies on pharmaceutical compounds . In: Long-Term Animal Studies - Their Predictive Value for Man, eds S.R. Walker & A.D. Dayan. Lancaster: MTP Press Ltd., CMR Workshop Series, 1986, pp. 53-62. |
| Библиографическая ссылка | Walker SR, Schuetz E., Schuppan D. & Gelzer J. A comparative retrospective analysis of data from short and long-term animal toxicity studies on 40 pharmaceutical compounds. Archives of Toxicology 1984; Suppl 7: 485-487. |
| Библиографическая ссылка | Walker SRIs there an alternative? In: Animals and Alternatives in Toxicity Testing, eds M. Balls, R.J. Riddell & A.N. Worden. London: Academic Press Inc. , FRAME, 1983, pp. 93-7. |
| Библиографическая ссылка | Speid LH, Lumley CE & Walker SR Harmonisation of guidelines for toxicity testing of pharmaceuticals by 1992 . Regulatory Toxicology and Pharmacology 1990 ; 12: 179-211. |
| Библиографическая ссылка | European Community's Committee on Proprietary Medicinal Products Working Party on Safety Requirements. Com. (80) 789 (final). Reported in Griffin, J.P. Repeat dose long-term toxicity studies. In: Animals and Alternatives in Toxicity Testing, eds M. Balls, R.J. Riddell & A.N. Worden. London: Academic Press Inc., FRAME, 1983, pp. 98-104. |
| Библиографическая ссылка | Contrera JFRepeated dose toxicity testing: the FDA database. In: Proceedings of the First International Conference on Harmonisation, Brussels, 1991, eds P.F. D'Arcy and D.W.G. Harron. Belfast: Queens University Press, 1992, pp. 245-8. |
| Библиографическая ссылка | Emmerson JLLetters to the Editor. Fundamental and Applied Toxicology1987; 8: 134. |
| Библиографическая ссылка | Glocklin VCJustification for 12 month animal studies. In: Long-Term Animal Studies - Their Predictive Value for Man, eds S.R. Walker & A.D. Dayan. Lancaster: MTP Press Ltd., CMR Workshop Series, 1986, pp. 77-82. |
| Библиографическая ссылка | Ecetoc.Recommendations for the harmonisation of international guidelines for toxicity studies. Monograph No. 7. Brussels : ECETOC, 1985. |
| Библиографическая ссылка | Frederick GLThe evidence supporting 18 month animal studies. In: Long-Term Animal Studies- Their Predictive Value for Man, eds. S.R. Walker & A.D. Dayan. Lancaster: MTP Press Ltd., CMR Workshop Series, 1986, pp. 65-76. |
| Библиографическая ссылка | Frederick GLThe necessary minimum duration of final long-term tests of drugs. Fundamental and Applied Toxicology1986; 6: 385-94. |
| Библиографическая ссылка | Frederick GLLetters to the Editor: Reply. Fundamental and Applied Toxicology1987; 8: 135-8. |
| Библиографическая ссылка | Lehman AJProof of safety: Some interpretations. Journal of the American Pharmaceutical Association1951; 40: 305-8. |
| Библиографическая ссылка | Boyd EM100 day LD50 index of chronic toxicity. Clinical Toxicity1971; 4: 205-13. |
| Библиографическая ссылка | Rao GN & Huff J. Refinement of long-term toxicity and carcinogenesis studies. Fundamental and Applied Toxicology 1990; 15: 33-43. |
| Библиографическая ссылка | Who.Principles and methods for evaluating the toxicity of chemicals. Part 1. Experimental Health Criteria 6. Geneva: WHO, 1978. |
| Библиографическая ссылка | Grahame-Smith DGWhat is expected from repeated-dose studies by the regulatory authorities. In: Long-Term Animal Studies - Their Predictive Value for Man, eds S.R. Walker & A.D. Dayan. Lancaster: MTP Press Ltd., CMR Workshop Series, 1986, pp. 23-27. |
| Библиографическая ссылка | OecdGuidelines for Testing of Chemicals. Paris: OECD, 1981. |
| Библиографическая ссылка | D'Arcy PF & Harron Dwg. Proceedings of the First International Conference on Harmonisation, Brussels 1991. Belfast: Queen's University Press, 1992: 544. |
| Библиографическая ссылка | Bach, PH, Cockburn, A., Esdaile, DJ, Grasso, P. & Lumley, CE Chronic toxicity testing: present perspectives and the way toward shorter screening, decreased use of resources and better risk assessment. In Animals and Alternatives in Toxicology: Present Status and Future Prospects, eds M. Balls, J. Bridges, J. Southee. Basingstoke: Macmillan Press, 1991 , pp. 53-77. |
| Библиографическая ссылка | EC Commission .The Rules Governing Medicinal Products in theEuropean Community. Vol. III. Guidelines on the Quality, Safety and Efficacy of Medicinal Products for Human Use. Luxembourg: EC Commission, 1989 . |
| Библиографическая ссылка | Kesterson JWDrug safety evaluation: Animal toxicity studies and their interpretations. Drug Information Journal, 1982; Jan/Jun: 22-34. |
| Библиографическая ссылка | Japanese Ministry of Health and Welfare.Guidelines for Toxicity Studies of Drugs Manual. Tokyo : Yakuji-Nippo, 1990. |
| Библиографическая ссылка | Control of Pesticide Registration. SI 1986, No 1510. London: HMSO, 1986. |
| Библиографическая ссылка | Pesticide Assessment Guidelines, Subdivision F, Hazard Evaluation: Human and Domestic Animals, November 1984. Washington, DC: US Environmental Protection Agency, 1984. |
| Библиографическая ссылка | Agricultural Chemicals Laws and Regulations, Society of Agricultural Chemical Industry, Japan, 1985. |
| Библиографическая ссылка | EC Commission.Council Directive 79/831/EEC. Official Journal of the European Community , No L259. 1979: 10. |
| Библиографическая ссылка | EC Commission.Commission Directive 87/302/EEC. Official Journal of the European Community , No L133. 1988:1. |
| Библиографическая ссылка | Revised Japanese Chemical Substances Control Law. Jetoc Newsletter No. 5. October 1987. |
| Библиографическая ссылка | Scf.Reports of the Scientific Committee for Food: Tenth Series. Commission of the European Community, 1980. |
| Библиографическая ссылка | Fda.Toxicological Principles for the Safety Assessment of Direct Food Additives and Color Additives used in Food. FDA, 1982. |
| Библиографическая ссылка | Food Sanitation Law.Food Additives in Japan. Edition for 1981. The Federation of Food Additives Associations in Japan. |
| Библиографическая ссылка | Huff JE, McConnell EE, Haseman JK et al. Carcinogenesis studies: Results of 398 experiments on 104 chemicals from the U.S. National Toxicology Programme. Annals of the New York Academy of Sciences 1988; 534: 1. |
| Библиографическая ссылка | Haseman JK & Seilkop SK An examination of the association between maximum-tolerated dose and carcinogenicity in 326 long-term studies in rats and mice. Fundamental and Applied Toxicology 1992; 19: 207-13. |
