An Introduction to Biopharmaceutics

This chapter aims to introduce biopharmaceutics and to define some key terms used within biopharmaceutics, and introduces where biopharmaceutics sits in the drug development process. In modern parlance, the term biopharmaceutics encompasses the science associated with the physical/chemical properties of the drug product and the interactions of this product with parameters linked to the route of administration that affect the rate and extent of drug uptake or presence at the site for local action. Biopharmaceutics was part of clinical pharmacology and pharmaceutical chemistry, only becoming its own scientific discipline in the 1970s. Pharmacokinetics measures the concentration of drug at a site in the body versus time. Understanding the biopharmaceutics will influence the pharmacokinetic profile observed. Biopharmaceutics is integral to the phases of clinical testing as predictive models to understand absorption and consequences of bridging are critical to the success of the interpretation of clinical data.