Visualization Concepts to Enhance Quantitative Decision Making in Drug Development

Communication of analysis and simulation results via graphical presentation is a cornerstone of pharmacometric analysis. A modeling and simulation (M&S) project typically has 3 distinct phases: (1) exploratory data analysis, (2) model building, and (3) simulation. Each phase has unique requirements for presentation of graphics. In exploratory data analysis, initial considerations include examination of data quality and discovery of key relationships in the data leading to identification of a modeling approach. For model building, assessment of model fit and model qualification are the objectives of graphical analysis. In the simulation phase, graphical displays expose relevant implications of the relationships described by the models in order to guide decision making. This article describes general considerations to aid in communication via graphical displays, accompanied by example graphs that illustrate the principles for each phase of an M&S project.