A model qualification method for mechanistic physiological QSP models to support model‐informed drug development

Mechanistic physiological modeling is a scientific method that combines available data with scientific knowledge and engineering approaches to facilitate better understanding of biological systems, improve decision‐making, reduce risk, and increase efficiency in drug discovery and development. It is a type of quantitative systems pharmacology (QSP) approach that places drug‐specific properties in the context of disease biology. This tutorial provides a broadly applicable model qualification method (MQM) to ensure that mechanistic physiological models are fit for their intended purposes.