Pharmacodynamic Models in Phase I Clinical Trials:
A Dynamic Approach

John Connell, PhD • Senior Director, Scientific & Clinical Operations, ICON Development Solutions

The primary focus in Phase I clinical trials has traditionally been the assessment of safety, tolerability and pharmacokinetics. However, the past decade has seen increasing interest in the application of biomarkers and surrogate endpoints in healthy volunteer studies, to provide information on the putative efficacy, dose response and time effects of investigational drugs. This interest is being driven by the pharmaceutical industry itself, where there is growing pressure to develop medicines more rapidly and cost-effectively, and terminate non-viable compounds at an earlier stage.

Pharmacodynamic models are simulations of naturally occurring disease states that aim to elicit the symptoms of a disorder under