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Quantitative Systems Pharmacology (QSP)-Based Dose Selection for Minimum Anticipated Biological Effect Level (MABEL) in First-in-Human Trials; Draft Guidance for Industry; Availability

🏛 Food and Drug Administration (FDA)FDA-2026-D-6539
Biomedical ResearchPharmaceutical Policy
Documents
3
Total comments
17
16 awaiting analysis
Comment status
Open
Last activity
Jul 24, 2026
In this docket

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Rules, notices, and supporting material — the primary rule pinned first.

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📄 Primary document
OtherJun 24, 2026
Quantitative Systems Pharmacology (QSP)-Based Dose Selection for Minimum Anticipated Biological Effect Level (MABEL) in First-inHuman (FIH) Trials; Guidance for Industry; Draft Guidance
Closed on Jul 25, 2026💬 6 comments · 5 awaiting analysis
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