Stephan Schaller, PhD: No financial relationships to disclose
The Open Systems Pharmacology Suite (OSP Suite) V12 introduces groundbreaking features for physiologically-based quantitative systems pharmacology (PB-QSP) modeling, with a focus on model modularization and automated qualification. As regulatory agencies increasingly require the qualification of intended-use scenarios, the complexity and lifecycle of models necessitate innovative technical solutions. This presentation will demonstrate the implementation of the new modular architecture in MoBi, which enables model reuse and exchange while simplifying model extension. We will also present the automated requalification framework, which ensures continuous quality control and facilitates regulatory submissions by streamlining model validation processes.