Clinical Pharmacology – Chemical
2019 PharmSci 360
Applications of modeling and simulation methodologies in pharmaceutical development have evolved considerably in the past couple of decades. However, opportunity remains to further improve the predictability of these approaches and consider alternative strategies for their application in addressing specific drug development challenges. Application of more than one complementary modeling and simulation methodology could be beneficial in assessing and reducing prediction uncertainty in dose determination and ultimately, in improving decision making. A brief overview of model-informed dose selection methodologies will be presented, with consideration of how the available data, compound properties, and the goals of the underlying analyses can influence the modeling and simulation approach. Case studies illustrating the use of two complementary modeling and simulation methods (e.g., PBPK and population PK) in addressing a specific clinical development program question will be discussed.