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Titlebook: Safety Evaluation of Biotechnologically-derived Pharmaceuticals; Facilitating a Scien Susan A. Griffiths,Cyndy E. Lumley Book 1998 Springer

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Designing non-clinical safety evaluation programmes for colony stimulating factors, growth factors acement 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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Designing non-clinical safety evaluation programmes for monoclonal antibodies for therapeutic use: sometimes predict) the effects which such molecules will have in treated animals. By taking a mechanistic approach, a rational and tailored programme of non-clinical safety assessment of MAbs can be adopted.
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Designing non-clinical safety evaluation programmes for colony stimulating factors, growth factors acement 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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Designing non-clinical safety evaluation programmes for interferons and interleukins: A personal vimacologically active species have been able to predict most human toxicities. However, when design issues, such as early neutralisation of biological effects, limit the value of animal studies in responsive species, the use of homologous proteins in a species not sensitive to the recombinant human p
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