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Article
Open AccessA Novel Method for Deriving Adverse Event Prevalence in Randomized Controlled Trials: Potential for Improved Understanding of Benefit-Risk Ratio and Application to Drug Labels
Adverse event (AE) data in randomized controlled trials (RCTs) allow quantification of a drug’s safety risk relative to placebo and comparison across medications. The standard US label for Food and Drug Admini...
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Article
Pharmacokinetic Correlates of Once-Monthly Paliperidone Palmitate-Related Adverse Drug Reactions
The objective of this study was to investigate associations between pharmacokinetic correlates and once-monthly paliperidone palmitate (PP1M)-related adverse drug reactions (ADRs).