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

  • John Lipani
Part of the CMR International Workshop Series book series (CMRW)


1. Experience with biotechnologically derived pharmaceuticals to treat auto-immune diseases provides an example of the pharmacological and safety information pertinent to first entry into man, and the relevance of animal data in support of early clinical trials.


Protein Agent Soluble Cytokine Receptor Preclinical Toxicology Model Hypothesis Testing Multiple Animal Species 
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  1. Bugelski P, Griswold D et al. (1996). Pharmacology and safety of anti-CD4 antibody IDEC-CE9.1 in HuCD4 transgenic mice. Arthritis & Rheumatism, 39(9): 5247.Google Scholar

Copyright information

© Springer Science+Business Media Dordrecht 1998

Authors and Affiliations

  • John Lipani

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