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Preclinical safety evaluation of biotechnology-derived pharmaceuticals

Nature Reviews Drug Discovery volume 1, pages 469–475 (2002)Cite this article

Abstract

Although the principles of preclinical safety evaluation are similar between conventional pharmaceuticals and biotechnology-derived pharmaceuticals (biotech products), the difference lies in the way that these principles are put into practice. The biggest challenge in the preclinical assessment of biotech products has been coping with species specificity and the associated detection and implications of altered immune status. The choice of animal model and study design should depend on the question being asked. This article explores to what extent animal toxicity studies can lead to safer drugs in humans?

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Acknowledgements

The author acknowledges fellow members of the ICH S6 'relevant' Expert Working Group — G. Vicari, J. Sims, J. Carstensen, W. Neumann, T. Inoue, M. Nakadate, E. Maki, M. Kawai and J. Green, and colleagues C. Klingbeil, J. Stoudemire, M. Serabian, A. Pilaro, M. Papaluca-Amati, P. Spindler, D. Kornbrust, P. Smith, T. Hayes, T. Anderson, R. Tyler and others for staying on “Dr Zbinden's track”.

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Cavagnaro, J. Preclinical safety evaluation of biotechnology-derived pharmaceuticals. Nat Rev Drug Discov 1, 469–475 (2002). https://doi.org/10.1038/nrd822

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