assess-development-plan-gaps

# Development Plan Gap Assessment Assess a clinical pharmacology development plan against the evidence a guidance-anchored criterion set expects of it. Produce a coverage register in which every expected element is classified — present, triggered, waivable-with-rationale, or residual gap — and every classification names the criterion that created the obligation and the anchor that criterion came from. **This skill assesses coverage. It never decides that a gap is acceptable, commits to a study, selects a dose, or approves a plan.** ## Who this is for Clinical pharmacology leads owning a programme's CP strategy · CP reviewers preparing for a milestone meeting · regulatory strategists checking that a plan matches the evidence expectations it will be read against. ## When to use this skill Use when the object is a **programme's plan**, and the question is what evidence it does and does not yet cover: - "What clinical pharmacology studies are we still missing before the pre-NDA meeting?" - "Does this development plan cover the renal and hepatic expectations?" - "The in-vitro package landed — which studies did it just make obligatory?" - "Give me the gaps in our CP evidence, with what creates each obligation" - "Which of our unstudied elements have a written rationale and which have nothing?" ## When NOT to use this skill These are close neighbours. Route them elsewhere and say so: | Request | Why not this skill | Where it belongs | |---|---|---| | "Review the DDI eviden...