review-bioanalytical-planlisted

Reviews a bioanalytical plan before samples are collected - which analytes will be measured, in what matrix, over what calibration range, and whether that range covers the concentrations the study will actually produce. It derives required analytes from the objectives before reading the plan, compares the lower limit against predicted terminal concentrations rather than peak, checks long-term stability against the interval to the last analysis rather than the first, and flags points where the plan requires a judgment it does not constrain. Use it for a draft plan, a calibration range check, or a reanalysis plan. Example: "Please a draft plan, a calibration range check." Do not use for the bioanalytical report and its validation results, for sampling times, for multi-analyte conjugate strategy, or to accept the method.
malekokour/clinpharm-pmx-skills · ★ 6 · AI & Automation · score 77

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

# Bioanalytical plan review ## Who this is for A clinical pharmacologist reviewing the bioanalytical plan for a study — what will be measured, in what matrix, over what range, and whether that range covers the concentrations the study will actually produce. ## When to use this skill - Reviewing a bioanalytical plan before samples are collected. - Checking the calibration range against predicted concentrations. - Confirming every analyte the objectives require will be measured. - Reviewing sample handling and stability coverage against the study's logistics. - Checking an incurred-sample-reanalysis plan. ## When NOT to use this skill - **The bioanalytical report and its validation results** — use `review-bioanalytical-report`. That reviews what the method achieved; this reviews what is planned. - **Sampling times** — use `review-pkpd-sampling-schedule`. The two constrain each other and are reviewed separately. - **Multi-analyte strategy for conjugated products** — use `review-adc-analyte-strategy`. - **Accepting the method.** Refused. ## Operating modes | Mode | Question it answers | Minimum inputs | |---|---|---| | `ANALYTES` | Is everything the objectives require being measured? | plan, objectives | | `RANGE` | Does the calibration range cover expected concentrations? | plan, predicted profile | | `HANDLING` | Do stability and handling cover the study's real logistics? | plan, study logistics | | `ISR` | Is the reanalysis plan adequate and pre-specified? | plan