Host: The Japanese Society of Toxicology
Name : The 47th Annual Meeting of the Japanese Society of Toxicology
Date : 2020 -
Medium-sized peptide (MP) has recently emerged as a promising new modality of drug platform. MP is composed of various amino acids other than the 20 amino acids composing human proteins, which enables numerous structural variations to achieve intended chemical property. MP is similar partially to biopharmaceuticals and partially to low molecular drugs. Therefore, the safety guidelines based on the accumulated knowledge with existing therapeutics are not directly applicable to MP. Preparation of AMED guidance document is underway and has not yet been published. Here, I’ll discuss the safety and quality issues which toxicologists are confronting under the current situation.