Facilitating Drug Discovery and Development with Mechanistic Physiological Models that are "Fit for Purpose": Introducing a Model Qualification Method.

Mechanistic physiological models are powerful tools that leverage scientific knowledge and data to improve decision-making in drug discovery and development. While similar types of mechanistic models have been used in other disciplines and industries for decades, their use in drug discovery and development is in its relative infancy, and no standard method exists for ensuring that such models are qualified for their intended use. We propose here a broadly applicable model qualification method to ensure that mechanistic physiological models are fit for purpose. The proposed criteria address issues of relevance to the research context, dealing with uncertainty and variability, and ensuring that model results are qualitatively and quantitatively consistent with test data. Use of the model qualification method brings structure to model-based research and creates a common language and improved buy-in for cross-functional teams faced with making decisions at every step of the drug development process.