prepare-dose-justification-evidence

# Dose Justification Evidence Assemble everything that stands behind a proposed dose or regimen — the exposure-response analyses, the intrinsic and extrinsic factor coverage, the formulation-bridging chain, the dose-modification rules — into an indexed evidence package in which every claim carries its locator and every gap is named. Organised against the shape of question a clinical pharmacology reviewer asks, so the weak points surface before an agency finds them. ## The risk veto — read this first The research scoring for this skill recorded a **risk veto at 62.5**: its output sits one step from a registration-dose decision. That proximity is the whole reason the boundary below is structural rather than advisory. **This skill assembles and organises evidence. It never selects, recommends, adjusts or justifies a dose, and it never states that the evidence supports the proposed one.** Humans own the dose call — that is not a hedge, it is the condition under which this skill was allowed to ship at all. What that means in practice: | The skill does | The skill does not | |---|---| | Index each claim to the artefact and locator that carries it | Say whether the claim is true | | Report what an exposure-response analysis states | Say whether E-R supports the proposed dose | | Tabulate which factors are covered and which are not | Say whether the coverage is sufficient to file | | Preserve both sides of a contradiction | Decide which side is right | | Flag a dose-modificatio...