QSP-based MABEL dose selection guidance for FIH trials
FDA issued guidance on using quantitative systems pharmacology to determine MABEL dose in first-in-human trials.
What this means
The FDA issued new advice for drugmakers on calculating safe starting doses for first human trials of experimental medicines, using computer models to predict biological effects. The draft guidance explains how to apply quantitative pharmacology modeling to estimate the lowest dose likely to show any effect in people, reducing risks in early testing. This could help streamline development of new treatments while protecting trial volunteers, with the agency seeking public feedback before finalizing the approach.
From the source
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.
Submit Comments
Submit Comments Online
You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))
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.
Reproduced from FDA Drugs (Whats New) · view original · public domain or open-licensed government work