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The Questionable Value of Long-Term Animal Toxicity Studies: A Regulatory Dilemma

  • C. E. Lumley
  • S. R. Walker
Part of the Archives of Toxicology book series (TOXICOLOGY, volume 9)

Abstract

Recommendations for the minimum period of repeated dose administration to animals to support marketing authorisation of pharmaceuticals vary from 6 months in the EEC to 18 months in Canada. The value of studies lasting longer than 6 months has not, however, been established. In order to enable retrospective analyses to be carried out, the Centre for Medicines Research has established a toxicology databank containing comprehensive data from repeated dose animal safety evaluation studies on 124 compounds, provided by 21 pharmaceutical companies in Europe (Lumley and Walker 1985a). There are 214 case studies (1 compound tested in 1 species for 1 or more time periods), and in 100 of these tests lasted for longer than 6 months. In 88 longterm studies comparable short-term data are available and these have been analysed to determine what new findings, if any, became apparent after 6 months. The data do not support the need for animal toxicity studies of longer than 6 months, apart from those designed to investigate carcinogenicity. Safety evaluation studies should be of value in predicting adverse drug reactions for man. Unless it can be established that these longer-term studies more accurately define potential target organ effects, the scientific rationale for conventional long-term studies must be questioned.

Key words

Retrospective Analysis Pharmaceuticals Toxicology Databank Animal Safety Evaluation Studies Duration 

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References

  1. Health Protection Branch (1981) Pre-clinical toxicologic guidelines. Bureau of Human Prescription Drugs, Health Protection Branch, Health and Welfare CanadaGoogle Scholar
  2. Lumley CE, Walker SR (1985a) A toxicology databank based on animal safety evaluation studies of pharmaceutical compounds. Human Toxicol 4:447–460CrossRefGoogle Scholar
  3. Lumley CE, Walker SR (1985b) The value of chronic animal toxicology studies of pharmaceutical compounds — a retrospective analysis. Fund Appl Toxicol 5:1007–1024CrossRefGoogle Scholar

Copyright information

© Springer-Verlag 1986

Authors and Affiliations

  • C. E. Lumley
    • 1
  • S. R. Walker
    • 1
  1. 1.Centre for Medicines ResearchCarshalton, SurreyUK

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