Designing non-clinical safety evaluation programmes for interferons and interleukins: Past experiences and recommendations for future products

  • Joy A. Cavagnaro
  • Timothy Anderson
Chapter
Part of the CMR International Workshop Series book series (CMRW)

Abstract

In general, the ICH Step 2* draft document on ’Safety Studies for Biotechnological Products’ captures the essence of a scientificallybased safety evaluation programme inclusive of interferons and interleukins.

Keywords

Safety Evaluation Tissue Distribution Study Safety Pharmacology Genotoxicity Study Safety Pharmacology Study 
These keywords were added by machine and not by the authors. This process is experimental and the keywords may be updated as the learning algorithm improves.

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Copyright information

© Springer Science+Business Media Dordrecht 1998

Authors and Affiliations

  • Joy A. Cavagnaro
  • Timothy Anderson

There are no affiliations available

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