Articles
ICON Insight: Pharmacodynamic Models In Phase I Clinical Trials — A Dynamic Approach
October 1, 2008
•ICON Insight: Pharmacodynamic Models In Phase I Clinical Trials — A Dynamic Approach
By 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 controlled laboratory conditions so that they can be more fully examined and quantified. Such models are increasingly being incorporated into first-in-man packages, to provide pivotal information to the pharmaceutical industry.
Pharmacodynamic models enable the investigation of how compounds can modulate the elicited symptoms and can be applied in both patients and healthy volunteers. The models can also give an indication of a compound's activity and the dose level that is likely to be effective at an early stage, and can potentially eliminate the time and expense involved in Phase I and II clinical trials.
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