Designing non-clinical safety evaluation programmes for colony stimulating factors, growth factors and hormones: A personal view
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.
KeywordsHuman Insulin Human Growth Hormone Toxicology Study Safety Evaluation Insulin Analogue
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