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Case Studies

Complex Concentration-QT Analysis

A Concentration-QT (C-QT) Analysis is a modeling and simulation technique used to help establish the risk of prolonging the QT interval. C-QT analysis can sometimes eliminate the need for a TQT study, which is more expensive and time-consuming. In a C-QT analysis, pharmacokinetic data (concentration… Read more

Developing an Anti-Ebola Intervention

In March 2014, the World Health Organization reported a major Ebola outbreak in West Africa. In September of that year, the first Ebola case was confirmed in the United States. Ebola outbreaks continue in the World to this day and the need for pharmaceutical intervention… Read more

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