Level: Beginner
【Presenter】
Takumi Information Technology Co., Ltd.
Business Planning Office Planning Support Group Kaoru Nakano
[Presentation summary]
Currently, applications for pharmaceutical products to US regulatory authorities must comply with standards established by the Clinical Data Interchange Standards Consortium (CDISC) and submit electronic data. Some non-clinical toxicity studies will comply with SEND (Standard for the Exchange of Nonclinical Data), an exchange standard for non-clinical studies. Electronic data that complies with standards can be easily used by programs. For example, visual understanding of drug reactivity is easily possible through data visualization.
This time, we created a JMP add-in tool that converts, processes, and visualizes SEND-compliant XPORT files. For continuous value data compliant with SEND (BW, FW, LB, OM, CV, VS, PC, PP, EG, RE domains), scatter plots, individual transition diagrams, summary statistics transition diagrams, summary statistics for each domain Create a list of quantities. Although SEND is an exchange standard, there are variations in storage of SEND data between tests. This add-in also accommodates this variation. In addition, it includes uniquely calculated variables (difference from control group, difference from baseline, difference from previous measurement point) that are not normally included in SEND data, allowing for more practical evaluation of non-clinical toxicity test data. It is possible.
[Presenter profile]
After graduating from university, he engaged in the development of safety test support systems at an IT vendor. After that, he joined Takumi Information Technology Co., Ltd. and mainly worked on system development, operation and maintenance for the non-clinical department. Currently, he is developing the SENDVT series, which visualizes SEND datasets using the JMP scripting language (JSL).
[Co-presenter]
Kyowa Kirin Co., Ltd. Kenji Kamimori, Yuta Sakakibara
Takumi Information Technology Co., Ltd. Shinji Fukushima, Sanae Ikeda, Jun Hamada
