Host: The Japanese Society of Toxicology
Name : The 49th Annual Meeting of the Japanese Society of Toxicology
Date : June 30, 2022 - July 02, 2022
Rodents, especially rats, are commonly used in non-clinical toxicology studies. In such studies, subsets of animals are often assigned to satellite groups to evaluate toxicokinetics (TK) because sampling a certain amount of blood for TK analysis can affect toxicological evaluation. However, recent improvements in the technology used to measure drug concentrations have enabled researchers to use very small blood samples, 50µL or less, for TK evaluation. This is called microsampling. Microsampling makes it possible to analyze TK and evaluate toxicity in the same animal and can contribute greatly to the 3Rs by reducing the number of animals needed and improving their welfare. The ICH S3A Q&A focused on microsampling was finalized in 2017 and microsampling is increasingly being used more often in non-clinical animal studies. However, although there are many reports that show the benefits of microsampling and explain how it can be used for TK evaluation, the number of GLP studies which use it still limited in Japan.
In this workshop, we will introduce two in-house GLP studies (a 4-week repeated study and a preliminary study on embryo-fetal development in rats). Before conducting these studies, we investigated the best methods, devices, and conditions for microsampling and we will share what we learned in designing and analyzing these studies.
