Level: Intermediate
(using machine translation)
Post-market safety monitoring of drugs and therapeutic biologics is critical to protecting the public health. To facilitate the safety monitoring process, FDA maintains the FDA Online Label Repository ( Forp FOLP collects the latest drug listing information submitted by companies to the FDA. However, navigating hundreds of drug labels and extracting meaningful information can be challenging. An easy-to-use software solution can help.
Drug-induced liver injury (DILI) is the single most frequent cause of safety-related drug withdrawal from the market over the past 50 years. In this presentation, JMP Text Explorer is used to analyze 462 drug labels for DILI indicators. Terms and phrases in the "Warnings and Precautions" section of drug labels are matched to DILI keywords and MedDRA terms. The XGBoost add-in for JMP Pro is utilized to predict DILI indicators through cross-validation of XGBoost prediction models with a term matrix. Results demonstrate that a similar approach can readily be used to analyze other drug safety concerns.
To watch this presentation with a Japanese transcript, please click here .
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English subtitles are available in the video below.
