ABSTRACT

INTRODUCTION In this chapter, we aim to provide an outline of the pharmacokinetics (PK) that would normally be part of new drug development for an oral formulation. We discuss the in vitro evaluation of the metabolism of drugs as a means of identifying potential routes of metabolism in vivo and predicting potential drug-drug interactions (DDIs). The integration of PK and pharmacodynamics (PD) as a means of understanding the dose-concentration-response relationship and the application of population PK and PD will be addressed.