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Designing non-clinical safety evaluation programmes: The view of the toxicologist

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Safety Evaluation of Biotechnologically-derived Pharmaceuticals

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

Abstract

1. Biotechnologically-derived pharmaceuticals possess unique and often species-specific biological characteristics. Their preclinical safety evaluation therefore presents unusual challenges that often preclude strict adherence to regulatory guidelines established for small-molecular-weight compounds.

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References

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© 1998 Springer Science+Business Media Dordrecht

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Dempster, M. (1998). Designing non-clinical safety evaluation programmes: The view of the toxicologist. 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_2

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  • DOI: https://doi.org/10.1007/978-94-011-4876-4_2

  • Publisher Name: Springer, Dordrecht

  • Print ISBN: 978-94-010-6043-1

  • Online ISBN: 978-94-011-4876-4

  • eBook Packages: Springer Book Archive

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