21/03/2025
This chapter proposes a general framework for development and application of quantitative systems pharmacology (QSP) workflows, addressing the need for clarity, transparency, and reproducibility in model-informed drug development via physiologically-based mathematical models. It outlines a high-level, language-agnostic workflow that formalizes common QSP tasks – such as systematic literature review, structural model development, parameter estimation, forward simulations and virtual population generation – into modular, repeatable components. Rather than focusing on specific tools or programming languages, the framework emphasizes consistent data handling, workflow definition, and interface design, enabling modelers to document and automate their processes more effectively. The chapter serves as a conceptual guide for organizing QSP modeling efforts, aiming to improve communication among stakeholders and support best practices in model validation and regulatory submission, and offers a blueprint for scalable and standardized QSP model execution in diverse project settings.
