Quantitative methods are increasingly used to analyse spontaneous reports. We describe
the core concepts behind the most common methods, the proportional reporting ratio (PRR) …

Robust tools for monitoring the safety of marketed therapeutic products are of paramount
importance to public health. In recent years, innovative statistical approaches have been …

Background: Disproportionality analysis of spontaneous reporting is increasingly used, but it
may be influenced in unknown ways by safety alerts (notoriety bias). Objective: To explore …

Background Most pharmacovigilance departments maintain a system to identify adverse
drug reactions (ADRs) through analysis of spontaneous reports. The signal detection …

Pharmacovigilance studies based on spontaneous reporting systems use disproportionality
analysis methods to identify drug‐event combinations with higher‐than‐expected reporting …

Spontaneous reporting is a crucial component of post-marketing drug safety surveillance
despite its significant limitations. The size and complexity of some spontaneous reporting …

Due to their specific properties and pharmacokinetics, nanomedicinal products (NMPs) may
present different toxicity and side effects compared to non-nanoformulated, conventional …

The objective of this article is to review the application of informatics-driven approaches in
the pharmacovigilance field with focus on drug-drug interaction (DDI) safety signal discovery …

In various real-world applications, it is very useful mining unanticipated episodes where
certain event patterns unexpectedly lead to outcomes, eg, taking two medicines together …

Background: The Food and Drug Administration (FDA) in the United States and the
European Medicines Agency (EMA) have recognized social media as a new data source to …