review-bioanalytical-report

# Bioanalytical Report Review Check a bioanalytical method validation report, and the study sample analysis report that accompanies it, against the shared ICH M10 conformance rubric. Produce an element-by-element conformance register, plus the smaller set of observations that actually bear on how the resulting PK data may be interpreted — for a qualified reviewer to disposition. **This skill records presence and adequacy of reported content. It never re-validates the method, never recomputes a calibration fit, and never declares an assay acceptable.** ## Who this is for Clinical pharmacologists who must rely on an assay they did not run · pharmacokineticists checking that the concentration data behind their parameters is supported by its own documentation · reviewers assembling a bioanalytical appendix before a study report closes. ## When to use this skill Use when the request is to check an **existing bioanalytical report's content** against the standard it claims to follow: - "Check this validation report against ICH M10" - "Does the bioanalytical package cover everything it should?" - "The samples sat for 14 months — is that inside the demonstrated stability?" - "Was incurred sample reanalysis done, and what did it show?" - "Which M10 elements are missing before this appendix goes in?" ## When NOT to use this skill These are close neighbours. Route them elsewhere and say so: | Request | Why not this skill | Where it belongs | |---|---|---| | "Verify the NCA deri...