Host: The Japanese Society of Toxicology
Name : The 51st Annual Meeting of the Japanese Society of Toxicology
Date : July 03, 2024 - July 05, 2024
While the evaluation of the safety and efficacy of candidate compounds in nonclinical studies has been primarily conducted in animal models, the FDA Modernization Act 2.0, approved in 2022, now allows the use of cell based assays. Microphysiological Systems are discussed as one of the methods. In recent years, examples of their applications in Investigational New Drug Applications (IND applications) have been reported. In accepting such MPS data into the regulatory situations, it is important to establish the Context of Use (CoU) of the test method using MPS. In the MPS-RS project being conducted by the AMED program: Research on Regulatory Science of Pharmaceuticals and Medical Devices, the "first-pass effect" in the small intestine and liver is one example of such a CoU. The MPS-RS project is preparing to propose a test guideline to the OECD. I would like to introduce the background of the CoU for first pass effect test and discuss the status of development of "points to consider" and issues derived from the CoU. In addition, I will introduce the roadmap to the OECD test guideline proposal. I would appreciate your interest in the development of this test guideline.
