The 146th Annual Meeting of the Pharmaceutical Society of Japan (Osaka)

Organizer: Hiroshi Arakawa (Grad. Sch. Pharm. Sci., Nagoya City Univ.), Satoshi Yokota (NIHS)

Amid growing interest in promoting the 3Rs in animal testing, New Approach Methodologies (NAMs) that do not rely on conventional animal studies are being actively explored as alternative tools for drug safety assessment. Although expectations for NAMs are increasing, accurate prediction of human safety requires a clear definition of the applicability domain of each method. In addition, rather than depending on a single approach, integrated strategies such as Integrated Approaches to Testing and Assessment (IATA) are essential. The need to develop NAMs aligned with the Concept of Use (CoU) required by end users, including pharmaceutical companies, has also been emphasized. In regulatory science, international discussions are progressing on how these technologies should be incorporated into regulatory frameworks. This symposium will begin with an overview of the current status and challenges of NAMs. Academic researchers will introduce advanced initiatives, including AI- and machine learning–based safety evaluations of drugs and chemicals, as well as new in vitro models for assessing biliary excretion. Furthermore, industry researchers will present applications such as drug disposition prediction using humanized-liver chimeric animals and iPS cell–based systems, along with approaches to embryo–fetal developmental toxicity assessment. Through these presentations, we aim to deepen the discussion on the potential and challenges of NAMs in drug safety research.