prepare-escalation-committee-package
SolidAssembles the exposure content a safety or escalation committee decides from, derived from the governing rule rather than from whatever data happens to be available. It reports subjects dosed, evaluable, and with the parameter as three distinct denominators, presents every parameter with its precision at the current sample size, states the implication for the next dose level rather than leaving the committee to extrapolate from the current one, and makes what the pack cannot show a named section rather than a footnote. Use it to assemble or review an escalation pack before committee. Example: "Please assemble or review an escalation pack before committee." Do not use for the escalation design itself, for interim look permissions, for committee minutes, or to make or recommend the escalation decision.
Install
Quality Score: 84/100
Skill Content
Details
- Author
- malekokour
- Repository
- malekokour/clinpharm-pmx-skills
- Created
- 1 weeks ago
- Last Updated
- 6 days ago
- Language
- Python
- License
- MIT
Similar Skills
Semantically similar based on skill content — not just same category
prepare-safety-committee-exposure-input
Prepares the exposure contribution to a safety signal review - whether an event tracks exposure, and what the available data could have shown either way. It justifies the exposure metric against the event mechanism rather than defaulting, counts affected subjects lacking PK data and states the bias direction since those cases are usually the sickest, reports stratum event counts before any rate because a rising percentage across two three and four events is not a relationship, and reports the observed exposure range alongside any negative finding so no relationship observed is distinguished from could not have observed one. Use it for a signal review or periodic safety discussion. Example: "Please a signal review or periodic safety discussion." Do not use for escalation decision packs, for submission exposure-safety sections, for nonclinical margins, for committee documentation, or to judge causality or recommend a dose change.
document-safety-committee-decisions
Records or reviews a safety or escalation committee decision so it can be understood a year later or by an inspector. It requires the decision to name exactly one action and flags wording that permits more than one, verifies quorum against the charter rather than inferring it from attendance, keeps decision date and data cut-off as separate fields, and traces every fact in the stated basis back to the pack the committee actually saw so knowledge drawn from outside the record is flagged rather than lost. It also preserves dissent and names who verifies each condition. Use it immediately after a meeting, before filing, or to reconstruct a past decision. Example: "Please assembling the pack, for the escalation design, for agency meeting minutes." Do not use for assembling the pack, for the escalation design, for agency meeting minutes, or to make or endorse the decision.
prepare-midd-engagement-package
Assembles and reviews the clinical pharmacology content of a Model-Informed Drug Development (MIDD) regulatory engagement package — the modelling question, the model context of use, the qualification or fitness-for-purpose argument, the key assumptions with their sensitivity analyses, and the decision the model output informs — structured so that every element traces to its source and no model-derived conclusion is stated as a fact. Use this skill when someone asks to assemble or review a MIDD engagement package, check that a modelling position is fit-for-purpose-ready, or map model assumptions to their evidence. Example: "Please to assemble or review a MIDD engagement package, check that a modelling position is fit-for-purpose-ready." Do not use for running or fitting a model, for writing the model analysis plan, for reviewing one PopPK or PBPK report for internal consistency, or for any request to decide whether a model is qualified or whether its output justifies a dose.