Host: The Japanese Society of Toxicology
Recently, modality in drug development has become diverse. Since current toxicity test guidelines do not completely cover the new modalities, consultation with PMDA is important. However, there is a “gap” in view or thinking between companies and PMDA due to their different positions, which sometimes leads to reconsider the development. Mutual understanding of the “gap” may be important to activate drug development in Japan.
I would discuss “peptides with non-natural amino acids” as a virtual drug for the theme of this session, and also pick up the questions came up from the questionnaire.
