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The duration of toxicity studies required to support repeated dosing in clinical investigation — a toxicologist’s opinion

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The Timing of Toxicological Studies to Support Clinical Trials

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References

  • Contrera JF, Aub D, Barbehenn E et al. (1993). A retrospective comparison of the results of six and twelve month non-rodent toxicity studies. Adverse Drug Reactions and Toxicological Reviews, 12(1), 63–76.

    PubMed  CAS  Google Scholar 

  • Igarashi T (1992). Is the 12-month treatment essential for the repeated dose study? In D’ Arcy PF and Harron DWG (eds.) Proceedings of the First International Conference on Harmonisation, Brussels, 1991. Belfast: Queens University Press. pp. 248–250.

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  • Igarashi T (1993). A review of the Japanese Pharmaceutical Manufacturers’ Association database currently established to examine retrospectively the value of long-term animal toxicology studies. Adverse Drug Reactions and Toxicological Reviews, 12(1), 35–52

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  • JPMA (1993). Nonclinical Evaluation Committee Report, JPMA Documentation No. 61 (in Japanese)

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  • JPMA (1994). Nonclinical Evaluation Committee Report, JPMA Documentation No. 65 (in Japanese)

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  • Lumley CE, Parkinson C and Walker SR (1993). The value of the dog in long-term toxicity studies. The CMR International Toxicology Database. Adverse Drug Reactions and Toxicological Reviews, 12(1), 53–61

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Authors
  1. Toshiji Igarashi
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Editors and Affiliations

  1. Centre for Medicines Research, Carshalton, Surrey, UK

    Christopher Parkinson , Neil McAuslane , Cyndy Lumley  & Stuart Walker , ,  & 

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© 1994 Springer Science+Business Media Dordrecht

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Igarashi, T. (1994). The duration of toxicity studies required to support repeated dosing in clinical investigation — a toxicologist’s opinion. In: Parkinson, C., McAuslane, N., Lumley, C., Walker, S. (eds) The Timing of Toxicological Studies to Support Clinical Trials. Springer, Dordrecht. https://doi.org/10.1007/978-94-011-1424-0_7

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  • DOI: https://doi.org/10.1007/978-94-011-1424-0_7

  • Publisher Name: Springer, Dordrecht

  • Print ISBN: 978-94-010-4623-7

  • Online ISBN: 978-94-011-1424-0

  • eBook Packages: Springer Book Archive

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