The authors propose a tiered reporting framework for QSP models aligned with PBPK practices and ICH M15 to improve regulatory transparency and review.
Using Quantitative Approaches to Optimize Dosages for New Combinations and Subsequent Indications for Oncology Drugs
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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.