Learnings from the Field: The Rosa Physiological Model Qualification Method

Mechanistic physiological or systems pharmacology modeling is employed by pharmaceutical companies to support decisions at every step of the drug development pipeline. Use of a quality standard such as the Model Qualification Method (MQM) is necessary to ensure impact and support the broad-scale adoption of this technology. Rosa has used the MQM in modeling projects in many disease areas ranging from early discovery to phase2 and 3 clinical work. With its continued application, it has become clear that principled use of the MQM keeps modeling projects focused, captures key model assumptions and insights, facilitates the conversation between modelers and scientists, and provides a useful mechanism for ensuring that such models are fit for purpose. In this webinar, we will review the principles of the MQM and highlight learnings from the field.