The authors propose a tiered reporting framework for QSP models aligned with PBPK practices and ICH M15 to improve regulatory transparency and review.
Quantitative systems pharmacology: Landscape analysis of regulatory submissions to the US Food and Drug Administration
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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.