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Designing non-clinical safety evaluation programmes for colony stimulating factors, growth factors and hormones: A personal view

  • Douglas M. Morton
Chapter
Part of the CMR International Workshop Series book series (CMRW)

Abstract

1. Colony stimulating factors, growth factors and hormones developed for human therapy may belong to one of three groups: (1) substances used for replacement therapy which are identical to human endogenous proteins (homologues), (2) analogues, which have minor changes to the amino acid sequence of endogenous proteins, and (3) pharmacologically active peptide fragments. Studies considered necessary for their safety evaluation vary accordingly.

Keywords

Human Insulin Human Growth Hormone Toxicology Study Safety Evaluation Insulin Analogue 
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. Albertsson-Wikland K (1987). Clinical trial with authentic recombinant somatropin in Sweden and Finland. Acta Paediatrica Scandinavica (Suppl), 331: 28–34.PubMedCrossRefGoogle Scholar
  2. Bierich JR (1986). Treatment of pituitary dwarfism with biosynthetic growth hormone. Acta Paediatrica Scandinavica (Suppl), 325: 13–18.PubMedCrossRefGoogle Scholar
  3. Dideriksen LH, Jorgensen LN and Drejer K (1992). Carcinogenic effect on female rats after 12 months administration of the insulin analogue BIO Asp (Abstract 507). Diabetes, 41 (Suppl 1): 143A.Google Scholar
  4. Milner RDG (1986). Clinical experience of somatrem: UK preliminary report. Acta Paediatrica Scandinavica (Suppl), 325: 25–28.PubMedCrossRefGoogle Scholar
  5. Ottesen L, Nilsson P, Jami J, Weilguny D, Duhrkop M, Bucchini D, Havelund S and Fogh JM (1994). The potential immunogenicity of human insulin and insulin analogues evaluated in a transgenic mouse model. Diabetologia, 37: 1178–1185.PubMedCrossRefGoogle Scholar
  6. Robison RL and Myers LA (1993). Preclinical safety assessment of recombinant human GM-CSF in rhesus monkeys. In International Review of Experimental Pathology, 34, A. Cytokine-induced Pathology. Academic Press, Inc., pp. 149–172.PubMedGoogle Scholar
  7. Ryffel B (1996). Predictive value of carcinogenicity studies for protein and gene therapy. In Carcinogenicity Testing of Potential Medicines-Challenges and Changes. IBC Technical Services, London.Google Scholar
  8. Zwickl CM, Cocke KS, Tamura RN, Holzhausen LM, Brophy GT, Bick PH and Wierda D (1991). Comparison of the immunogenicity of recombinant and pituitary human growth hormone in rhesus monkeys. Fundamental and Applied Toxicology, 16: 275–287.PubMedCrossRefGoogle Scholar

Copyright information

© Springer Science+Business Media Dordrecht 1998

Authors and Affiliations

  • Douglas M. Morton

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