Abstract
AbstractThe aim of this paper is to give a high level introduction into pharmacokinetic (PK) data and analysis for programmers new to PK, or who require a refresher. Key theoretical concepts will be covered, such as: absorption, distribution, metabolism, and elimination (ADME), derived PK parameters, including area under the curve (AUC), Cmax (maximum concentration observed), tmax (time of maximum concentration observed), and t1/2 (half-life), and steady state. The data flow from CRF to tables, figures and listings (TFLs) will also be covered. We shall also briefly discuss the use of PK in the drug development process including types of clinical studies, e.g. single ascending dose (SAD), multiple ascending dose (MAD), bioavailability, mass balance, food effect, and drug–drug interaction (DDI) studies, and how this relates to the PK of the drug.
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