The 145th Annual Meeting of the Pharmaceutical Society of Japan (Fukuoka)

Organizer: Satoshi Yokota (NIHS), Arakawa Hiroshi (Fac. of Pharm. Sci., Kanazawa Univ)

In the view point of animal welfare (The 3R Principle), New Approached Methodologies (NAMs) are being explored and investigated as alternative methods to animal toxicity testing. On the other hand, it is necessary to set unique experimental conditions in NAMs compared to conventional animal experiments for the in vitro evaluation of drug-induced toxicity (i.e. device characteristics such as drug adsorption, oxygen permeability, setting of drug concentration extrapolated to human events, and selection of cell culture systems according to the purpose) Therefore, toxicologists need to collaborate with researchers who have expertise in pharmacokinetics, devices, and biology to improve the accuracy of prediction of drug-induced toxicity in humans. In this symposium, we will introduce reproductive toxicity assessment as well as safety methods for intestinal, hepatic, and renal toxicology using NAMs in beyond the framework of pharmaceutical science. Furthermore, we would like to discuss the perspective of a novel non-clinical toxicity evaluation using NAMs.