Current Edition

Pharmacokinetic and Statistical Considerations in Firstin-human Clinical Trials – Case Study Article

The purpose of first-in-human (FIH) studies is to evaluate the pharmacology, tolerability, and safety of the drug or investigational medicinal product in humans for the first time. They are designed to reveal the best dose and dose regimen to be used in later Phase II studies. Given the exploratory nature of FIH studies, the question of what statistical analysis is required for pharmacokinetics (PK) data has long been a contentious topic. Joanna Magielse at SGS seeks to explore the topic in more depth.