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Case Studies

Successful Lactation Study Design for Single Dose PK Profile

Background & Problem The Sponsor was developing a therapy that could be administered to women undergoing childbirth via Caesarean section. Since the drug would have no benefit to the infant, the Sponsor was required to evaluate how much of the drug formulation could be passed… Read more

Complex Concentration-QT Analysis

Background & Problem 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,… Read more

Developing an Anti-Ebola Intervention

Background & Problem 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… Read more

Avoiding a DDI Study in Pediatric Populations

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… Read more

Unconventional Drug-Drug Interaction Study Design

Background & Problem The Sponsor’s drug had a long half-life. It also had three metabolites, one of which was active, that also had long half-lives. These pharmacokinetic (PK) characteristics of the drug made a typical Drug-Drug Interaction (DDI) study design infeasible. Nuventra helped the Sponsor… Read more