"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.
OMICS Group International is one of the leading Open Access Publishers which is publishing 700+ peer-reviewed journals with the support of 50,000+ editorial board members as editorial team and aimed to disseminate the scholarly knowledge to the scientific society. OMICS Group also organizing 3000+ International Scientific Conferences and events yearly all over the world with the support of 1000+ Scientific associations worldwide.
Citation: Maraschiello C (2014) The Relevance of Immunogenicity in Preclinical development. J Bioanal Biomed 6: 001-004."
Last date updated on September, 2020