Table 1.
Credibility evidence categories from the FDA CM&S Credibility Guidance (14).
No. | Category |
---|---|
① | Code verification results |
② | Model calibration evidence |
③ | Bench test validation results |
④ | In vivo validation results |
⑤ | Population-based validation results |
⑥ | Emergent model behavior |
⑦ | Model plausibility evidence |
⑧ | Calculation verification/UQ results using COU simulations |