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

CPT Pharmacometrics Syst Pharmacol. 2016 Feb;5(2):43-53. doi: 10.1002/psp4.12056. Epub 2016 Jan 26.


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.

MeSH terms

  • Drug Discovery / methods*
  • Humans
  • Models, Biological
  • Systems Biology / methods