The authors propose a tiered reporting framework for QSP models aligned with PBPK practices and ICH M15 to improve regulatory transparency and review.
Consideration of a Credibility Assessment Framework in Model-Informed Drug Development: Potential Application to Physiologically-Based Pharmacokinetic Modeling and Simulation
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Best Practices on QSP Model Reporting for Regulatory Use: perspectives from ISoP QSP SIG Working Group
The authors propose a tiered reporting framework for QSP models aligned with PBPK practices and ICH M15 to improve regulatory transparency and review.