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

  • Maggie Dempster
Chapter
Part of the CMR International Workshop Series book 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.

Keywords

Toxicity Study Safety Evaluation Reproductive Toxicity Safety Pharmacology Preclinical Safety 
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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References

  1. Cowgill LD (1992). Pathophysiology and management of anemia in chronic progressive renal failure. Seminars in Veterinary and Medical Surgery (Small Animal), 7(3): 175–182.Google Scholar
  2. Dempster AM (1995). Pharmacological testing of recombinant human erythropoietin: implications for other biotechnology products. Drug Development Research, 35:173–178.CrossRefGoogle Scholar
  3. Raine AEG (1988). Hypertension, blood viscosity, and cardiovascular morbidity in renal failure: implications of erythropoietin therapy. Lancet, 1(8557): 97–100.PubMedCrossRefGoogle Scholar

Copyright information

© Springer Science+Business Media Dordrecht 1998

Authors and Affiliations

  • Maggie Dempster

There are no affiliations available

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