What ICH M12 - Drug Interaction Studies: In Vitro and In Vivo Assessment, Clinical Pharmacokinetic Studies and Product Labelling Recommendations requires
This regulation requires sponsors to conduct in vitro and in vivo drug interaction studies, as outlined in Article 3…
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Pillar: Pharmaceuticals & Life Sciences · Authority: International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use · Version: 1.0.1 · Last updated:
Primary source: https://www.ich.org/page/multidisciplinary-guidelines
SHA-256 integrity: dc5ca4ed0123697970b85fe38621b4cebea98a47d073ce55c4819f0d0c8c09a2
Primary Citations — 5 traced to source
- ICH M12, Article 3 - In Vitro Drug Interaction Studies
- ICH M12, Article 4 - In Vivo Drug Interaction Studies
+ 3 more citations (full bibliography, deterministic workflow, actionable schema and crosswalks) included in the vault unlock — $0.01 via Skyfire / L402 / Direct Base USDC.
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