Points to be considered toward future SEND implementation of genotoxicity study data

Abstract

SEND is the standard for electric data of nonclinical studies developed by CDISC. Single/repeated dose toxicity studies, carcinogenicity study, and cardiovascular and respiratory safety pharmacology studies are the scope of SEND. For genotoxicity studies, SEND implementation guide (IG) is under development by CDISC. In this presentation, we will introduce the points to be considered for the future SEND implementation of genotoxicity studies, obtained from our activities such as mock dataset preparation according to the latest draft genotoxicity IG.