Federal Register #FDA-2026-D-6539

FDA Draft Guidance on QSP-Based Dose Selection for First-in-Human Trials

This opportunity is an informational notice from the Food and Drug Administration (FDA) regarding draft guidance for industry on dose selection in first-in-human (FIH) trials: - Government Buyer: - Department of Health and Human Services (HHS) - Food and Drug Administration (FDA) - No OEMs or vendors are mentioned, as this is not a procurement or award notice - No products or services are being requested - The draft guidance focuses on: - Using Quantitative Systems Pharmacology (QSP) modeling to determine the Minimum Anticipated Biological Effect Level (MABEL) for starting doses in FIH trials - Addressing drugs and biological products that may cause cytokine release, T-cell activation, or other potent pharmacological reactions - Providing recommendations for developing and applying QSP models to improve dose selection and patient safety - The notice invites public comment on the draft guidance - No purchase quantities, part numbers, or unique procurement requirements are included

Description

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry titled "Quantitative Systems Pharmacology (QSP)-Based Dose Selection for Minimum Anticipated Biological Effect Level (MABEL) in First-in-Human (FIH) Trials." This guidance provides recommendations on applying QSP modeling to determine starting doses in FIH trials for drugs and biological products, especially those that may cause cytokine release, T-cell activation, or other potent pharmacological reactions. It addresses the limitations of traditional dose selection methods and outlines how QSP models can be developed and used to estimate a MABEL for drugs and biological products entering FIH trials. The guidance is intended to assist industry in dose selection for FIH trials using QSP modeling.

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