Currently, drug applications to US regulatory authorities must comply with standards established by the Clinical Data Interchange Standards Consortium (CDISC) and electronic data must be submitted. Some nonclinical toxicity studies comply with the Standard for the Exchange of Nonclinical Data (SEND), an exchange standard for nonclinical studies. Standard-compliant electronic data is easy to use with programs. For example, data visualization makes it easy to visually understand drug reactivity.
We have created a JMP add-in tool that converts, processes, and visualizes SEND-compliant XPORT files. For SEND-compliant continuous value data (BW, FW, LB, OM, CV, VS, PC, PP, EG, and RE domains), we create scatter plots, individual trend graphs, trend graphs of summary statistics, and a list of summary statistics for each domain. Although SEND is an exchange standard, SEND data has storage variability between studies. This add-in also addresses this variability. In addition, it includes custom-calculated variables (difference from control group, difference from baseline, difference from previous measurement point) that are not usually included in SEND data, allowing for more practical evaluation of nonclinical toxicity study data.
