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FDA Publishes Draft Guidance Entitled “Quantitative Systems Pharmacology (QSP)-Based Dose Selection for Minimum Anticipated Biological Effect Level (MABEL) in First-in-Human (FIH) Trials”
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The U.S. Food and Drug Administration (FDA) recently published the draft guidance entitled "Quantitative Systems Pharmacology (QSP)-Based Dose Selection for Minimum Anticipated Biological Effect Level (MABEL) in First-in-Human (FIH) Trials."
Selecting an appropriate initial dose for FIH trials is a critical step. In the past decade, QSP has emerged as a modeling approach that can be used in regulatory submissions to evaluate complex drug-biological system interactions. By integrating biology and exposure-response understanding, QSP can inform FIH dose selection and dose escalation. The use of QSP modeling for this purpose also aligns with FDA’s broader strategy to reduce reliance on animal studies.
FDA seeks feedback on this guidance document. Please refer to the notice in the Federal Register for submission information.
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This communication was prepared by the Office of Clinical Pharmacology, Office of Translational Sciences, CDER, FDA.
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