References on Regulation

  1. Cone M, D'Arcy PF, Harron DWG (1992) Harmonisation of international registration requirements for pharmaceuticals. In Griffin (ed) Medicines: Regulation, Research and Risk 2nd ed. Belfast: Queen's University Press, pp 515-524.
  2. D'Arcy P and Harron D (1992). Proceedings of the First International Conference on International Harmonisation Belfast: Queens University Press, pp 189-191.
  3. D'Arcy P and Harron D (1994). Proceedings of the Second International Conference on International Harmonisation Belfast: Queens University Press.
  4. D'Arcy P and Harron D (1996). Proceedings of the Third International Conference on International Harmonisation Belfast: Queens University Press.
  5. D'Arcy P and Harron D (1997). Proceedings of the Fourth International Conference on International Harmonisation Belfast: Queens University Press (in press)
  6. Cordier, A (1992) Single dose toxicity: industry perspectives. In D'Arcy P and Harron D Proceedings of the First International Conference on International Harmonisation Belfast: Queens University Press, pp 189-191.
  7. Lumley CE and Walker SR (1985a). The establishment of a computer-based toxicology databank. Medical Informatics 10(2):173-174.
  8. Lumley CE and Walker SR (1985b) The value of chronic animal toxicology studies of pharmaceutical compounds - a retrospective analysis. Fundamental and Applied Toxicology 5:1007-1024.
  9. Lumley CE, Parkinson C and Walker R (1992). An international appraisal of the minimum duration of chronic animal toxicity studies. Human & Experimental Toxicology 11:155-162; reprinted in D'Archy P and Harron D Proceedings of the First International Conference on International Harmonisation Belfast: Queens University Press, pp 236-245
  10. > Igarashi T (1992) Is the 12-month treatment essentialfor the repeated dose study? In D'Arcy P and Harron D Proceedings of the First International Conference on International Harmonisation Belfast: Queens University Press, pp 248-251.
  11. > Contrera J (1992) Repeated dose toxicity: the FDA database. In D'Arcy P and Harron D Proceedings of the First International Harmonisation. Belfast: Queens University Press, pp 245-248.
  12. Contrera J (1994) Emerging trends in nonclinical safety assessment for therapeutics. Toxicologic Pathology 22(2):89-94.
  13. Hayashi Y (1994). Safety:single-dose toxicity, repeat-dose toxicity and carcinogenicity, in D'Arcy P and Harron D Proceedings of the First International Conference on International Harmonisation. Belfast: Queens University Press, pp 31-33.
  14. Lumley CE, Parkingson C and Walker SR (1993). The value of the dog in long-term toxicology studies. The CMR international toxicology database. Adverse Drug Reactions and Toxicological Reviews 12(1):53-62.
  15. Igarashi T (1993). A review of the Japanese Pharmaceutical Manufacturers Association database currently established to examine retrospectively the value of long-term animal toxicity studies. Adverse Drug Reactions and Toxicological Reviews
    12(1):pp 35-52.
  16. Contrera J, Aud D, Barbehenn E et al (1993). A retrospective comparison of the results of six and 12 month non-rodent toxicity studies. Adverse Drug eactions and Toxicological Reviews
    12(1):pp 63-76.
  17. Tabimura T (1985). Guidelines for developmental toxicity testing of chemicals in Japan.Neurobehav. Toxicol. Teratol. 7:647-652.
  18. Khera KS, Grice HC and Clegg CJ (1989). Guidelines for reproductive toxicity tests in different countries with a proposal for international harmonisation. In Current Issues in Toxicology. New York: Springer Verlag, pp 115-133.
  19. Lumley CE (1991a) An overview of the international industry's approach to reproductive and developmental testing of pharmaceuticals. In Lumley CE, Walker SR (eds) Current Issues in Reproductive and Developmental Toxicology: Can an International Guideline be Achieved? Lancaster: Quay Publishing, pp101-112.
  20. Anon (1994a) ICH Harmonised Tripartite Guideline: Detection of Toxicity to Reproduction for Medicinal Products. In D'Arcy P and Harron D Proceedings of the Second International Conference on International Harmonisation. Belfast: Queens University Press, pp 557-577.
  21. Bass R (1994) Development of the reproductive toxicology guidelines to become one of the first to complete the ICH process. In D'Arcy and Harron D Proceedings of the Second International Conference on International Harmonisation. Belfast: Queens University Press, pp 33-38.
  22. Ulbrich B, Palmer AK and Bass R (1994) Reproductive toxicology. In Cartwright AC and Matthews BR, eds Internal Pharmaceutical Product Registration. Aspects of Quality, Safety and Efficacy Chichester: Ellis Horwood, pp 458-473.
  23. Scales MDC and Tweats D (1994) Progress with harmonisation of guidelines for human pharmaceuticals. TEN 1(4):113-116.
  24. Scales MDC and Mahoney K (1991) Animal toxicology studies on new medicines and their relationship to clinical exposure: A review of inter-nation recommendations. Adverse Drug Reactions and Toxicology Reviews 10:155-168.
  25. Scales MDC (1994) Toxicity testing. In Griffin JP, Wells FO (eds). The Textbook of Pharmaceutical Medicine. Belfast: The Queens' University Press, pp 53-80.
  26. DeGeorge J (1994) Proposal on dose selection for carcinogenicity studies of pharmaceuticals. In D'Arcy P and Harron D Proceedings of the Second International Conference on International Harmonisation. Belfast: Queens University Press, pp 268-273.
  27. Anon (1995a) International Conference on Harmonisation: Guideline on dose selection for carcinogenicity studies of pharmaceuticals. Federal Register Volume 60, No 040 Part XII 60 FR 11278, Wednesday, March 01, 1995.
  28. McAuslane JAN (1994) Is the use of the mouse as the second species in lifetime toxicology studies redundant? Toxicology and Ecotoxicology News 1(3):98-99.
  29. Contrera J, Jacobs AC, Prasanna HR et al (1995) A systemic exposure-based alternative to the maximum tolerated dose for carcinogenicity studies of human therapeutics. Journal of the American College of Toxicology 14(1):1-10.
  30. Griffiths SA, Parkinson C, McAuslane JAN and Lumley CE (1994) The utility of the second rodent species in the carcinogenicity testing of pharmaceuticals. The Toxicologist 14(1):214.
  31. McAuslane JAN, Griffiths SA, Parkinson C and Lumley CE (1994) Aspects of carcinogenicity tests: Results from 82 pharmaceutical compounds. The Toxicologist 14(1):214.
  32. DeGeorge J (1996) A regulatory perspective of the guidance on the utility of two rodent species. In D'Arcy P and Harron D Proceedings of the Third International Conference on International Harmonisation Belfast: Queens University Press, pp 274-277.
  33. Usui T, Griffiths SA and Lumley CE (1996). The utility of the mosue for the assessment of the carcinogenic potential of pharmaceuticals. In D'Arcy POF & Harron DWG (eds). Proceedings of the Third International Conference on Harmonisation. Queen's University Press, Belfast. pp 279-284.
  34. van Der Laan J-W (1996) Regulatory Viewpoint. In D'Arcy P and Harron D Proceedings of the Third International Conference on International Harmonisation Belfast: Queens University Press, pp 269-273.
  35. Casciano DA (1994) Report of the plenary session on the safety symposium. In D'Arcy P and Harron D Proceedings of the Second International Conference on International Harmonisation Belfast: Queens University Press, pp 515-524.
  36. Esber EC (1994) Review of the outcome of ICH2 and the implications for ICH3: FDA perspective. In D'Arcy P and Harron D Proceedings of the Second International Conference on International Harmonisation Belfast: Queens University Press, pp 538-541.
  37. Jones KH (1994) Review of the outcome of ICH2 and the implications for ICH3: EC regulatory perspective. In D'Arcy P and Harron D Proceedings of the Second International Conference on International Harmonisation Belfast: Queens University Press, pp 534-536.
  38. van Cauteren H (1997) Development and registration of new chemical compound: new approaches to non-clinical evaluation. In D'Arcy P and Harron D Proceedings of the Fourth International Conference on International Harmonisation Belfast: Queens University in Press (in press).