ABSTRACT
Biomarker development is a very active area in drug development for their utility in screening, diagnosing, monitoring disease, as well as for predicting treatment modulated clinical outcome. Of these, pharmacodynamic (PD) biomarkers are used from early phase human pharmacology stage studies to late phase studies to obtain pharmacological information of drugs interacting with the physical systems under study. Biomarkers can be biological properties or molecules that can be detected and measured in parts of the body like the blood or tissue. Biomarkers can be specific cells, molecules, or genes, gene products, enzymes, or hormones. Complex organ functions or general characteristic changes in biological structures can also serve as biomarkers. Several PD biomarkers over several phases of clinical development may be needed to constitute a complete picture of the drug’s mechanism in the body from minutes to hours and days of drug administration. The chapter also presents an overview of the key concepts discussed in this book.
