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GUIDANCE DOCUMENT

Quantitative Systems Pharmacology (QSP)-Based Dose Selection for Minimum Anticipated Biological Effect Level (MABEL) in First-in-Human (FIH) Trials June 2026

Download the Draft Guidance Document Read the Federal Register Notice
Draft Level 1 Guidance

Not for implementation. Contains non-binding recommendations.

This guidance is being distributed for comment purposes only.

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Submit Comments Online

Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the FDA considers your comment on a draft guidance before it begins work on the final version of the guidance, submit either online or written comments on the draft guidance before the close date.

If unable to submit comments online, please mail written comments to:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-2026-D-6539

Docket Number:
FDA-2026-D-6539
Issued by:
Guidance Issuing Office
Center for Drug Evaluation and Research

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.

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