Articles
A Dynamic Approach To Models In Phase I
March 4, 2008
•Article: A Dynamic Approach To Models In Phase I
Written and compiled by Dr. John Connell, Director, Clinical Pharmacodynamics & Project Management, ICON Development Solutions
Pharmacodynamic models are contributing to the effort to develop treatments more quickly and cost-effectively. Dr. John Connell explains how such models can aid the investigation of a range of therapeutic targets.
The primary focus in Phase I clinical trials has traditionally been the assessment of safety, tolerability, and pharmacokinetics. However, there has been increasing interest over the last decade in the application of biomarkers and surrogate endpoints in healthy volunteer studies to provide information on 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 whilst at the same time there is a clear need to recognize and to terminate non-viable compounds at an earlier stage.
Click Here To Download:•Article: A Dynamic Approach To Models In Phase I
