Dose Response Evaluation

Abstract

This paper suggests that pharmacokinetic data might provide a rational basis to improve dose-response trials. Construction of plasma concentration confidence intervals may be a tool to predict optimal drug dose ratios for dose-response studies and, for some drugs, may point to the need for plasma concentration measurement in clinical practice. An important task now is to integrate pharmacokinetic knowledge into the design of clinical trials. To facilitate this, studies on clinical pharmacokinetics should report individual plasma AUC or clearance values or give the 95% confidence intervals of the observation.