review-clinical-ddi-study

# Clinical DDI study review ## Who this is for A clinical pharmacologist or reviewer holding one or more clinical interaction study reports and asking whether each study answers the question it was run to answer, and whether its result is being carried forward faithfully. ## When to use this skill - Reviewing a dedicated clinical DDI study report before it supports a label statement. - Checking whether the index perpetrator or victim was appropriate for the mechanism. - Assessing whether the design could detect the effect size that matters. - Reconciling a reported geometric mean ratio against what a summary or label claims. - Gap-checking which triggered in-vitro signals actually received a clinical study. ## When NOT to use this skill - **In-vitro packages and triggers** — use `review-in-vitro-ddi-package`. That skill decides which studies the programme owes; this one reviews the studies it ran. - **Management strategy and label wording** — use `review-ddi-evidence`. - **Deciding whether an exposure change matters clinically.** Refused here. - **Recomputing a ratio from individual data.** This skill reviews reported statistics against the design that produced them; it does not re-analyse. - **Modality where the framework does not apply** — for a therapeutic protein, see `contexts/modality/mab.md`. The cytokine-mediated question replaces the enzyme question, and a clean enzyme study answers neither. ## Operating modes One mode per invocation. Say which was us...