Clinical Pharmacology Modeling Simulation

The role of Clinical Pharmacology Modeling and Simulation in drug development is to evaluate what the body does to the drug and what the drug does to the body, understand patient variability, and relate that back to benefit, risk, and dosing. Every in vitro, non-clinical, and clinical study is designed to answer key questions for development milestones with the purpose of understanding the value of the drug for patients.

The information from these studies at all phases of development along with relevant published data is integrated using model-informed approaches to provide quantitative information for dosing options, design features to enhance study efficiency, patient selection criteria, and PK/PD assessments to be evaluated to answer crucial questions for various patient and clinical scenarios along the entire development journey through candidate selection to regulatory approval and beyond.