Discussion of points to consider in creating nSDRG of SEND datasets

Abstract

SEND datasets from certain types of nonclinical safety studies are required for new drug development in US. nSDRG is an important document to explain the summary of SEND datasets. PhUSE guideline and template are very informative in preparing the nSDRG; but it is not easy to understand the details due to its complexity. The nSDRG subteam of CJUG SEND team picked up the issues in preparing nSDRG and discussed how to deal with them. In this presentation, we will introduce such issues and provide some points to consider for solving them.