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Case Studies

Avoiding a DDI Study in Pediatric Populations

The FDA requested that a Sponsor perform a drug-drug interaction (DDI) study for pediatric populations. In an effort to avoid having to conduct a full pediatric DDI study, the Sponsor tried to utilize available adult data to assess systemic exposure and DDI potential of their… Read more

Unconventional Drug-Drug Integration Study Design

The sponsor’s drug had a very long half-life. It also had three metabolites, one of which was active, that also had very long half-lives. These PK characteristics of the drug made a typical Drug-Drug Integration study design infeasible. Nuventra helped the sponsor design a study… Read more

Using Existing Data to Guide a New Study

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 of the drug… Read more

A Unique Modeling and Simulation Strategy

The 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 day, but drop in… Read more

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

A sponsor came to Nuventra requesting a noncompartmental analysis 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 than expected. Consequently, there… Read more