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.
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References
Albertsson-Wikland K (1987). Clinical trial with authentic recombinant somatropin in Sweden and Finland. Acta Paediatrica Scandinavica (Suppl), 331: 28–34.
Bierich JR (1986). Treatment of pituitary dwarfism with biosynthetic growth hormone. Acta Paediatrica Scandinavica (Suppl), 325: 13–18.
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.
Milner RDG (1986). Clinical experience of somatrem: UK preliminary report. Acta Paediatrica Scandinavica (Suppl), 325: 25–28.
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.
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.
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.
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.
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© 1998 Springer Science+Business Media Dordrecht
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Morton, D.M. (1998). Designing non-clinical safety evaluation programmes for colony stimulating factors, growth factors and hormones: A personal view. In: Griffiths, S.A., Lumley, C.E. (eds) Safety Evaluation of Biotechnologically-derived Pharmaceuticals. CMR International Workshop Series. Springer, Dordrecht. https://doi.org/10.1007/978-94-011-4876-4_7
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DOI: https://doi.org/10.1007/978-94-011-4876-4_7
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