{
  "node_id": "ich-m12-drug-interaction-studies-2023",
  "title": "ICH M12 - Drug Interaction Studies: In Vitro and In Vivo Assessment, Clinical Pharmacokinetic Studies and Product Labelling Recommendations",
  "domain": "Pharmaceuticals & Life Sciences",
  "version": "1.0.1",
  "last_updated": "2026-04-30",
  "bluf": "This regulation requires sponsors to conduct in vitro and in vivo drug interaction studies, as outlined in Article 3…",
  "paywall": {
    "status": "LOCKED",
    "unlock_cost_usd": "0.01",
    "skyfire_id": "41779894-ece2-4163-9761-b3b1b76e19b0"
  },
  "crosswalks": {
    "_available_keys": [
      "nist_framework",
      "iso_standard",
      "industry_mapping",
      "ai_overlay_2026"
    ],
    "_note": "Full crosswalk values included in vault response"
  },
  "dependencies": [
    "iso-37301-compliance-2021"
  ],
  "primary_citations_count": 5,
  "workflow_steps_count": 10,
  "schema_fields_count": 9,
  "citation_preview": [
    "ICH M12, Article 3 - In Vitro Drug Interaction Studies",
    "ICH M12, Article 4 - In Vivo Drug Interaction Studies"
  ]
}