Host: The Japanese Society of Toxicology
Name : The 51st Annual Meeting of the Japanese Society of Toxicology
Date : July 03, 2024 - July 05, 2024
Results of nonclinical toxicity studies play an important role in risk management for subjects in clinical trials. It is important to verify and improve the predictability of adverse events through toxicity studies to minimize risks to subjects.
Regarding the correlation between clinical and non-clinical test results, the results of a survey conducted by the Japan Pharmaceutical Manufacturers Association were presented at this annual meeting in 2012. Now, more than 10 years have been passed since this survey, and many new drugs have been launched on the market. Therefore, we are researching information on drugs approved in Japan in recent years and verify the predictability of adverse events.
As a method, based on the approval information, we have selected new drugs (small molecule, biopharmaceuticals) from the drug area for anticancer, autoimmune disease, diabetes and central nervous system disease. And we extracted adverse events related to the investigational drug from the CTD, interview forms, RMP materials, etc., and investigated whether similar findings had been observed in toxicity studies. In this annual meeting, we focused analysis on toxicity and adverse events in the intestinal tract, which is the theme of this symposium.
In this symposium, I would like to share the issues of toxicity study by presenting the results of a multifaceted analysis of the predictability of gastrointestinal adverse events by non-clinical toxicity studies, including whether it is a small molecule or a biopharmaceutical, route of administration and drug indications.
