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Case Studies

Using Existing Pediatric Data to Guide a New Study

Background & Problem The Sponsor’s drug had been approved in Europe for decades, but had not been developed in the US.  The Sponsor wanted to bridge the studies that were conducted in Europe with a few additional studies conducted in the US to gain approval… Read more

A Unique Modeling and Simulation Strategy

Background & Problem The pharmacokinetics (PK) of a Sponsor’s candidate has been studied in a pediatric population, but is relatively unknown in an adult population. Due to the desired PK characteristics of the treatment (rapid onset of efficacy, sustained concentrations throughout the majority of the… Read more

Human AME Study: Silk Purse from a Sow’s Ear

Background & Problem A Sponsor came to Nuventra requesting a noncompartmental analysis (NCA) and clinical study report sections for a human AME study. Normally, these analyses are fairly straightforward, however this study was unique in that their radiolabeled drug stayed in the subject’s system longer… Read more