ABSTRACT
INTRODUCTION As discussed in previous chapters, pharmacokinetics (PK) is the study of the processes that are responsible for the time course of the level of an exogenous compound in the body. The processes involved are absorption (A), distribution (D), metabolism (M), and excretion (E). The PK of peptides, proteins, and other biotechnology products are an important factor in their pharmacodynamics (PD), that is, the time course of their pharmacological effect. Therefore, knowledge of PK of a pharmaceutical drug in humans and laboratory animals is required when selecting dose levels and dose regimens. Similarly, the toxicokinetics (PK in toxicology studies, including higher doses than used clinically) are important for the design of toxicology studies (dose levels and dose regimens) as well as in determining safety margins and extrapolating toxicological data to humans.
