Predicting the Addition of Information Regarding Clinically Significant Adverse Drug Reactions to Japanese Drug Package Inserts Using a Machine-Learning Model.
Takashi WatanabeKaori AmbeMasahiro TohkinPublished in: Therapeutic innovation & regulatory science (2023)
Our model accurately predicted PI revisions using information on ADR cases that occurred 6 months before. This is the first ML model that can predict the necessary safety measures and is an efficient method for guiding the decision to adopt additional safety measures early.