review-cmc-change-ba-be-assessment

# Review CMC Change BA BE Assessment CMC change BA/BE assessment evidence pack — bounded review / prepare / structure workflow for the L3 task **CMC change BA/BE assessment** (Band B · Post-approval stewardship). **Skills review, reconcile, verify, structure and flag. **Qualified humans decide, approve, sign off, submit and act.**** ## Four-box contract | Box | Content | |---|---| | **Trigger** | Please review the materials for CMC change BA/BE assessment and produce a sourced finding register — do not decide the clinical or regulatory outcome. | | **Input** | Primary package for CMC change BA/BE assessment plus the supporting pack in Required inputs | | **Output** | Source-linked finding register with denominators; gap / contradiction flags; refuse list | | **Refuses** | Decide the outcome of CMC change BA/BE assessment; approve or submit related documents; select or adjust a dose; speak for the sponsor to an agency | ## Who this is for Clinical pharmacology or pharmacometrics practitioners working on **Post-approval stewardship** who need a repeatable, sourced pass over **CMC change BA/BE assessment** — not a decision and not a filing. ## When to use this skill - "Please review the materials for CMC change BA/BE assessment and produce a sourced finding register — do not decide the clinical or regulatory outcome." - "What is evidenced, missing, or inconsistent for: CMC change BA/BE assessment?" - "Trace every material statement about CMC change BA/BE assessment to a ...