Pharmacokinetic and Statistical Considerations in First-in-human Clinical Trials – Case Study
Given the exploratory nature of First-in-Human (FIH) studies, the question, "what, if any, statistical analysis is required for pharmacokinetics (PK) data?" has been asked before. This article investigates that question.
FIH studies can consist of different components: primary single ascending dose (SAD) and multiple ascending dose (MAD). Furthermore, other assessments such as food effects, formulation effect, gender differences, drug-drug interaction (DDI), and age effect can be explored in FIH studies. In this article, the emphasis is on the assessment of dose proportionality, steady state and food effect, as described in a case study. However, first, the attention is pointed towards several tasks that should be completed prior to performing the assessments.