ABSTRACT

This chapter utilizes representative cytokines, including interferon (IFN)-α, IFN-γ, and interleukin-2 to demonstrate the importance of cytokine pharmacology in optimal cytokine administration for biologic activity and development. This includes the conceptual need for chronic immunoaugmentation to foster optimal therapeutic activity, the need to consider the pharmacokinetics of administration to optimize drug delivery, and the nonlinear dose–response relationship, which can result in a bell-shaped dose response. The strategies for combination chemotherapy and immunotherapy, although they hold great promise, require close attention to the pharmacodynamics of protein administration to enhance the likelihood for failure-free and overall survival. The chapter discusses the pharmacodynamics of recombinant proteins that are either licensed or in active clinical trials in the United States, and these biopharmaceuticals are presented in the context of the strategies used for their development. Recombinant granulocyte-macrophage-Colony Stimulating Factor is a multipotent growth factor active on progenitors of both the myeloid and monocytic lineage