Introduction to Biopharmaceutics 111 What is Biopharmaceutics

In the world of drug development, the meaning of the term "biopharmaceutics" often evokes confusion, even among scientists and professionals who work in the field. "Pharmaceutics" narrowly defined is a field of science that involves the preparation, use, or dispensing of medicines (Woolf, 1981). Addition of the prefix "bio," coming from the Greek "bios," relating to living organisms or tissues (Woolf, 1981), expands this field into the science of preparing, using, and administering drugs to living organisms or tissues. Inherent in the concept of biophar-maceutics as discussed here is the interdependence of biological aspects of the living organism (the patient) and the physical-chemical principles that govern the preparation and behavior of the medicinal agent or drug product. This philosophy was pioneered in the mid-twentieth century by the first generation of what we refer to now as biopharmaceutical scientists: those who recognized the importance of absorption, distribution, metabolism, and elimination (ADME) on the clinical performance of medicinal agents as well as the impact of the physical-chemical properties of the materials on their in vivo performance. As a result, biopharma-ceutics has evolved into a broad-based discipline that encompasses fundamental principles from basic scientific and related disciplines, including chemistry, physiology, physics, statistics, engineering, mathematics, microbiology, enzymology, and cell biology. The biopharmaceutical scientist, therefore, must have sufficient understanding of all of these scientific fields in order to be most effective in a drug development role. A scientist educated in the field of biopharmaceutics or biophar-maceutical sciences could have expertise in a number of interrelated specialty disciplines including formulation, pharmacokinetics (PK), cell-based transport, drug delivery, or physical pharmacy. For the subsequent discussion we will look broadly at the areas of physical pharmacy (pharmaceutics) and PK and their roles and inter-dependencies in the drug development process.

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