Pharmacology

Abstract

Overview The biology and clinical indications relevant to systemic anticancer therapies are covered extensively in other chapters in this book. In this chapter, we will focus on the principles of clinical pharmacology as they apply to systemic anticancer therapies and will attempt to illustrate how an understanding of clinical pharmacokinetics and pharmacodynamics can optimize the therapeutic index of these agents. The United States Food and Drug Administration (FDA) conducts a question‐based clinical pharmacology and biopharmaceutics review for each approved drug ( http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/StaffPoliciesandProcedures/ucm073007.pdf ). Their reviews are publicly available on the FDA website ( http://www.accessdata.fda.gov/scripts/cder/drugsatfda/ ) by searching for the drug name, and often include details that are not included in the product label. We will use their standard questions to introduce the principles of clinical pharmacology and will highlight examples that illustrate these principles.