Characteristics of drugs safety signals that predict safety related product information update.
Widya N InsaniAlexandra C PacurariuAukje K Mantel-TeeuwisseLiana Gross-MartirosyanPublished in: Pharmacoepidemiology and drug safety (2018)
This study identified 4 characteristics of drug safety signals that have shown to be associated with PI changes as outcome of signal evaluation. These characteristics may be used as criteria for selection and prioritization of potential signals that are more likely to necessitate product information updates.