Background & Problem
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 study drug in pediatrics. However, the data seemed to be very sparse and it was difficult to justify that a pediatric DDI study was not needed.
Even though the Sponsor’s available data was sparse, they sought Nuventra’s help to see if there were any solutions other than conducting the DDI study. Nuventra conducted a regression-based modeling analysis of three Sponsor studies. Using the analysis, Nuventra generated a short report describing the pharmacokinetics, exposure and DDI potential of the study drug in pediatrics.
Together, with Nuventra’s expertise and creative thinking, Nuventra and the Sponsor were able to construct an argument that the agency found acceptable in order to avoid the DDI study in pediatric patients. In the end, the Sponsor did not have to conduct the DDI study with pediatric subjects and was able to use a modeling and regression-based analysis to determine their study drug’s DDI potential in pediatrics.
The primary reason why I enjoy working with Nuventra is because of their focus on clinical pharmacology. They are able to manage all aspects of clinical pharmacology projects including protocol writing, data analysis etc. The benefit of working with Nuventra is that they are a one-stop clinical pharmacology shop. I have had many positive experiences with them.
– Director of Clinical Pharmacology, Pharma Client