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  1. Article

    Open Access

    A 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...

    Daria Piacentino, Ajay Ogirala, Robert Lew, Gregory Loftus in Advances in Therapy (2024)

  2. No Access

    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).

    Georgios Schoretsanitis, Ekkehard Haen, Daria Piacentino in Clinical Pharmacokinetics (2021)