Topic: Verification, Validation and Independent Validation

Limiting-Case Tests for Mechanistic Submodels

Invariant and Conservation Tests for Executable Models

Intended-Use Claims for QSP Model Qualification

Independent Validation by a Separate Team

Holdout Design and Leakage Prevention in QSP Validation

External Validation Across Laboratories and Assays

Dimensional, Positivity, and Boundary-Condition Assertions

Detecting Structural Discrepancy in Validation Residuals

Defining the Domain of Applicability from Validation Evidence

Convergence Diagnostics for Stiff QSP Simulations