Quantitative Systems Pharmacology (QSP)-Based Dose Selection for Minimum Anticipated Biological Effect Level (MABEL) in First-in-Human (FIH) Trials; Draft Guidance for Industry; Availability
FDA_FRDOC_0001-14302Notice
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Closed on Jul 25, 2026
Closed Jul 25, 2026
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- Title
- Quantitative Systems Pharmacology (QSP)-Based Dose Selection for Minimum Anticipated Biological Effect Level (MABEL) in First-in-Human (FIH) Trials; Draft Guidance for Industry; Availability
- Posted
- Jun 24, 2026
- Comment period
- Jun 24, 2026 – Jul 25, 2026
- FR Doc
- 2026-12619
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