Abstract
The objective of this chapter is to provide an overview of the most common modeling and simulation approaches used in drug discovery and development to understand and predict pharmacokinetic and pharmacodynamic relationship of small molecule and biologic drug candidates. The chapter will first discuss some basic pharmacokinetic modeling concepts to perform absorption, distribution and clearance predictions as well as time course of PK profiles for small molecule and biologics. A few examples of how those models can be applied to predict oral small molecule drug absorption and disposition as well as biologic drug clearance will be discussed. Subsequently, a general overview of pharmacodynamic modeling will be discussed in the context of two specific examples covering CNS and oncology drug development. These examples will highlight the impact of modeling can have on facilitating the preclinical and clinical development of drug candidates.
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