Host: The Japanese Society of Toxicology
Name : The 50th Annual Meeting of the Japanese Society of Toxicology
Date : June 19, 2023 - June 21, 2023
Although mid-molecular peptide drugs have the potential to address an unmet need for drugs, approaches to the evaluation of middle molecular peptide drugs have not yet been established at the global level. ICH S2(R1) Guidance on Genotoxicity Testing and Data Interpretation for Pharmaceuticals Intended for Human Use is considered to be a useful for genotoxicity assessment of mid-molecular peptide drugs containing non-natural amino acids. However, molecular properties such as the molecular weight should be taken into account in evaluation for genotoxicity of the drugs. Especially, since the bacterial reverse mutation assay which is known as the Ames test has been mainly used for detection of mutagenicity caused by small molecule compounds, it is also necessary to confirm whether the Ames test is accepted for genotoxicity testing for the drug development. In addition, it is important for considering the concepts for the toxicological assessment of genotoxic impurities in the drug substances. In this presentation, I would like to discuss the points to be considered for genotoxicity evaluation of the drugs in order to properly evaluate the safety of drugs based on scientific knowledge.
