Topic: Model Qualification and Credibility Assessment

Worked PBPK Qualification Case for Renal Impairment

Setting Credibility Goals Before Reviewing Evidence

Model Risk From Decision Consequence and Model Influence

Managing PBPK Limitations and Assumptions

Mapping Evidence to PBPK Model Components

Interpreting Prediction Evidence for Its Intended Use

Graded Credibility Conclusions and Residual Risk

Diagnosing Discordant Evidence in PBPK Qualification

Decision-Relevant Acceptance Criteria for PBPK

Decision Robustness to Credibility Gaps