Best Practices in Drug Development Modeling and Simulation

The use of modeling and simulation (M&S) in drug development has evolved from being a research nicety to a regulatory necessity. Today, modeling and simulation is leveraged to some extent, across most development programs to understand and optimize key decisions related to safety, efficacy, dosing, special populations, and others. Further, the use of M&S as a percentage of an entire drug development program is growing, as the advances in both computing power and our understanding of biological sciences increases, thus propelling both the need and value of the technology.

This paper provides a compilation of best practices to systematically leverage the many benefits of M&S across a drug development program.