ABSTRACT

This chapter discusses how pharmacokinetic-pharmacodynamic (PK/PD) modeling can be applied to the data obtained or obtainable during drug development, with the specific objective of answering critical questions at various stages of this process. It outlines the key questions in various stages of drug development and discussing how PK/PD modeling is needed to effectively address these questions. The chapter presents a discussion of PK/PD modeling considerations for the development of new dosage forms. It also presents the studies that represent the current state of affairs, and indicates that there are numerous opportunities in drug development to apply PK/PD modeling. PK data collected in animal models of activity taken in concert with human kinetic data suggested that a dose of up to 15 mg/kg/d in man would be necessary to achieve effective concentrations. The use of logistic regression analysis in PD analysis may be illustrated by the alprazolam treatment of panic disorder.