review-clinical-ddi-studylisted

Reviews clinical drug-interaction study reports for design adequacy, result integrity and coverage against in-vitro triggers. It records the mechanism and index drug and flags mismatches, assesses whether the design could detect the effect it sought, extracts every geometric mean ratio with its confidence interval and classifies it against magnitude bands transcribed from the guidance in force, and separates inconclusive studies from negative ones. Use it to review a dedicated interaction study, check which triggered signals received a study, or reconcile a reported ratio against a summary or label. Example: "Review a dedicated interaction study, check which triggered signals received a study." Do not use for in-vitro package review, for management strategy or label wording, for re-analysing individual data, or to judge whether an exposure change is clinically significant.
malekokour/clinpharm-pmx-skills · ★ 6 · Data & Documents · score 77

Install: claude install-skill malekokour/clinpharm-pmx-skills

# 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