Impact of pharmacokinetic-pharmacodynamic modelling in early clinical drug development

Abstract

Early clinical pharmacology studies in healthy subjects are often dissociated from patient studies. In this review we encourage the use of modelling and simulation techniques to generate valuable information at an early stage of clinical development. We illustrate these principles by presenting 5 different case studies from a spectrum of therapeutic drug classes. Their application leads to a better understanding of drug characteristics early on, thereby facilitating the design of dose-finding studies in the target patient population and saving resources.

Keywords: Clinical pharmacology; Drug development; Modelling; Pharmacodynamics; Pharmacokinetics.