ABSTRACT

INTRODUCTION The term Biopharmaceutics is the study of the influence of formulation on the biological activity of a drug product, including its in vitro properties such as its physicochemical characteristics, formulation, and delivery technology (1). Pharmacokinetics (PK) is used to define the science of in vivo performance of a drug such as its bioavailability/absorption and systemic disposition, and is an important marker of the likely intensity and duration of the biological activity of the drug. Therefore, an understanding of the underlying processes governing drug absorption and disposition within the human body, methods of analyzing the characterizing the concentration-time profile, and the temporal relation between the measured concentration-time profile and the efficacy and safety time profiles are all critical elements in the design of appropriate dosage forms. This chapter has been designed to provide an overview of these topics.