review-blq-and-time-deviation-ruleslisted

Reviews the data-handling rules that determine what an analysis dataset contains - BLQ method, actual-versus-nominal times, and exclusions. It records the censored proportion alongside the BLQ method because the choice only matters in proportion to it, checks the quantification limit in the plan against the bioanalytical report, requires sampling and dosing deviations to be handled by distinct rules, classifies each exclusion by whether it can be applied without seeing the result, and reconciles collected minus excluded against analysed. Use it for an analysis plan before derivation, or afterwards to establish what was actually applied. Example: "Please an analysis plan before derivation." Do not use for NCA parameter verification, for NCA dual-control oversight, for the modelling plan as a whole, for assay validation, or to decide which handling method is correct.
malekokour/clinpharm-pmx-skills · ★ 6 · Code & Development · score 77

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

# BLQ and time-deviation rules review ## Who this is for A clinical pharmacologist or pharmacometrician checking the data-handling rules that determine what an analysis dataset contains — before the analysis runs, or afterwards to establish what was actually applied. ## When to use this skill - Reviewing BLQ handling, time-deviation and exclusion rules in an analysis plan. - Checking that the rules applied match the rules specified. - Establishing which analysis conclusions depend on a data-handling choice. - Reviewing a dataset specification before derivation. - Assessing whether exclusions were analysis decisions presented as data cleaning. ## When NOT to use this skill - **NCA parameter verification** — use `verify-nca-outputs`. - **NCA oversight and dual control** — use `oversee-nca-dual-control-qc`. - **The modelling analysis plan as a whole** — use `review-model-analysis-plan-and-report`. - **Bioanalytical assay validation** — the lower limit of quantification comes from there; use `review-bioanalytical-report`. - **Deciding which handling method is correct for a compound.** Refused here — the choice has consequences a human owns. ## Operating modes | Mode | Question it answers | Minimum inputs | |---|---|---| | `SPECIFIED` | Are the rules specific enough to apply without judgment? | analysis plan | | `APPLIED` | Do the rules applied match the rules specified? | plan and dataset documentation | | `IMPACT` | Which conclusions depend on these choices? | plan