ABSTRACT

Pharmacodynamic (PD) modeling has been presented as a means of “improving the scientific knowledge base for early decision making in developing new drugs” (1). This chapter illustrates the use of integrated pharmacokinetic-pharmacodynamic (PK/PD) modeling of multiple physiological responses in order to predict

drug response in patients based on a model established in healthy volunteers. This application of PK/PD modeling is especially relevant to early clinical development, particularly during transition from phase 1 to phase 2.