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Designing non-clinical safety evaluation programmes for interferons and interleukins: A personal view

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Safety Evaluation of Biotechnologically-derived Pharmaceuticals

Part of the book series: CMR International Workshop Series ((CMRW))

Abstract

1. Toxicity of interferons and interleukins is produced only in animal models that are pharmacologically responsive to the molecule. Studies in a pharmacologically active species have been able to predict most human toxicities. However, when design issues, such as early neutralisation of biological effects, limit the value of animal studies in responsive species, the use of homologous proteins in a species not sensitive to the recombinant human protein may allow prediction of toxic effects.

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Authors
  1. Grushenka H. I. Wolfgang
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  2. Sharon Chen
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  3. Martin Giedlin
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  4. Rene Braeckman
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  5. Dale Johnson
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Editors and Affiliations

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

    Susan A. Griffiths  & Cyndy E. Lumley  & 

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© 1998 Springer Science+Business Media Dordrecht

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Wolfgang, G.H.I., Chen, S., Giedlin, M., Braeckman, R., Johnson, D. (1998). Designing non-clinical safety evaluation programmes for interferons and interleukins: A personal view. In: Griffiths, S.A., Lumley, C.E. (eds) Safety Evaluation of Biotechnologically-derived Pharmaceuticals. CMR International Workshop Series. Springer, Dordrecht. https://doi.org/10.1007/978-94-011-4876-4_8

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  • DOI: https://doi.org/10.1007/978-94-011-4876-4_8

  • Publisher Name: Springer, Dordrecht

  • Print ISBN: 978-94-010-6043-1

  • Online ISBN: 978-94-011-4876-4

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