Translational and Clinical Science Community

Back to discussions
Expand all | Collapse all

FDA Guidance on QSP- based dose selection for MABEL First-in-Human (FIH) Trials

  • 1.  FDA Guidance on QSP- based dose selection for MABEL First-in-Human (FIH) Trials

    Community Leadership
    Posted 3 hours ago

    This guidance is intended to provide the Agency’s recommendations on the appropriate use of a quantitative systems pharmacology (QSP)-based approach for determining minimum anticipated biological effect level (MABEL) dose in first-in-human (FIH), phase 1 trials.

    U.S. Food and Drug Administration remove preview
    Guidance for Industry
    Quantitative Systems Pharmacology (QSP)-Based Dose Selection for Minimum Anticipated Biological Effect Level (MABEL) in First-in-Human (FIH) Trials
    View this on U.S. Food and Drug Administration >