"The immunogenic reaction affecting the systemic exposure and hence the toxicity profile, the NO(A)EL defined during the preclinical stage for PEG-IFNa-2B must be carefully interpreted and assessed given its importance in defining the Maximum Recommended Starting Dose(MRSD) in Phase I. In addition, the immunogenicity of PEG-IFNa-2B in non-human primates suggests a potential immunogenicity in humans that must be followed during the clinical trials.
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Citation: Maraschiello C (2014) The Relevance of Immunogenicity in Preclinical development. J Bioanal Biomed 6: 001-004."
Last date updated on April, 2024
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