Quantitative Systems Pharmacology (QSP)-Based Dose Selection for Minimum Anticipated Biological Effect Level (MABEL) in First-in-Human (FIH) Trials
Detailed guidance document from FDA and regulatory agencies.
Document Details
Guidance Document
June 24, 2026
June 22, 2026
994ae4f9-15eb-4cb0-9f01-39f7e22daee5
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