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Designing non-clinical safety evaluation programmes for monoclonal antibodies for therapeutic use: A personal view

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

Abstract

1. Since the activity of monoclonal antibodies (MAbs) is, in general, limited to the epitopes which they bind, it is often possible to anticipate (and sometimes predict) the effects which such molecules will have in treated animals. By taking a mechanistic approach, a rational and tailored programme of non-clinical safety assessment of MAbs can be adopted.

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© 1998 Springer Science+Business Media Dordrecht

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Bugelski, P. (1998). Designing non-clinical safety evaluation programmes for monoclonal antibodies for therapeutic use: 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_9

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  • DOI: https://doi.org/10.1007/978-94-011-4876-4_9

  • 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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