Level: Intermediate
【Presenter】
Wenjun Bao, Chief Scientist, Sr. Manager, JMP Life Sciences, SAS Institute Inc
Fang Hong, Dr., National Center for Toxicological Research, FDA
Zhichao Liu, Dr., National Center for Toxicological Research, FDA
Weida Tong, Dr., National Center for Toxicological Research, FDA
Russ Wolfinger, Director of Scientific Discovery and Genomics, JMP Life Sciences, SAS
[Announcement summary] (Using automatic translation)
Monitoring the post-marketing safety of pharmaceuticals and therapeutic biologics is critical to the protection of public health. To facilitate the safety monitoring process, the FDA has launched the FDA Online Label Repository ( Fold ). FOLP collects up-to-date drug list information submitted by companies to the FDA. However, it is difficult to navigate hundreds of drug labels and extract meaningful information. An easy-to-use software solution will help.
The most frequent single cause of safety-related drug withdrawal from the market over the last 50 years is drug-induced liver injury (DILI). In this presentation, we will use the JMP Text Explorer to analyze 462 drug labels with the DILI indicator. The terms and phrases in the Warning and Caution section of the drug label match the DILI keywords and MedDRA terminology. JMP Pro's XGBoost add-in is used to predict DILI indicators through mutual validation of XGBoost prediction models using a term matrix. The results show that a similar approach can be easily used to analyze other drug safety concerns.
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English subtitles are available in the video below.
