Use of Phase I PK/PD results in design and analysis of Clinical trials with Sparse data

R.A.J.Wixley

In cardiovascular drug development it is important to acquire good insight into PK/PD relationships in healthy volunteers before proceeding to to clinical trials. These phase I trials should include intravenous and oral modes of administration. The plasma sampling times and measurement times of pharmacodynamic variables in phase I trials should be adequate to ensure good model identifiability and estimation.

This presentation show how phase I modelling has been useful in
1. design of clinical trials by scenario simulation based on phase I population models.
2. The PK/PD analysis of clinical trials with sparse measurements

Reference: PAGE 9 (2000) Abstr 122 [www.page-meeting.org/?abstract=122]

Poster: poster