extract-embedded-ind-impd-cp-content
SolidLocate and inventory clinical-pharmacology-relevant mechanism and ADME disclosures embedded in an IND pharmacology/drug-disposition section or the Module-4/5-shaped summaries of an IMPD. Use this skill when a clinical pharmacologist or regulatory reviewer needs a source-located IND/CTA/IMPD content inventory. Example: "Please a clinical pharmacologist or regulatory reviewer needs a source-located IND/CTA/IMPD content inventory." Do not use it to decide trial-phase adequacy, filing readiness, approvability, dose selection, or regulatory acceptance.
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
check-investigators-brochure-pk-section
Check a supplied Investigator's Brochure for declared human pharmacokinetics/product-metabolism and related effects-in-humans content, then compare its version/date with a supplied DSUR citation register. Use this skill when a clinical pharmacologist and medical or regulatory reviewer need a source-located IB PK-section completeness and version reconciliation. Example: "Please a clinical pharmacologist and medical or regulatory reviewer need a source-located IB PK-section completeness and version reconciliation." Do not use it to approve medical content, decide live-study conduct, recommend a dose, or determine a filing obligation.
prepare-briefing-package-content
Drafts and reviews the clinical pharmacology portion of a regulatory briefing package — answerable questions to the agency, applicant positions with their supporting evidence, and validated annex cross-references — aligned to the public structure of clinical pharmacology review. Use this skill when someone asks to draft, structure, stress-test or QC the CP content of a briefing book or meeting package — for example "draft the clin pharm section of our pre-NDA briefing package", "which questions should we ask", or "check every position in this package is actually supported". Do not use for responding to questions an agency has already sent, for writing the meeting request itself, for CTD summary or labelling content, or for any request to decide whether a position will be accepted.
extract-doc
NOTE: this skill requires connected ~~docs MCPs (Notion, Google Docs, Confluence, Box, Egnyte), which are typically only present in Cowork — the Code variant exists for parity but most users will want the Cowork variant. Pull insights from a single doc or page (Notion, Google Doc, Confluence, etc.) into the standard intake backlog. Use when user says '/extract-doc', 'extract insights from this doc', 'pull learnings from this page', 'mine this Notion page for knowledge', 'extract from this Confluence'. Differs from /intake doc (which captures one structured doc artifact with reaction) — extract-doc decomposes a doc into multiple intake-backlog entries for audit routing. (Code port — ADR-094.)