FDA posts draft guidance "Quantitative Systems Pharmacology (QSP)-Based Dose Selection for Minimum Anticipated Biological Effect Level (MABEL) in First-in-Human (FIH) Trials"

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1. FDA posts draft guidance "Quantitative Systems Pharmacology (QSP)-Based Dose Selection for Minimum Anticipated Biological Effect Level (MABEL) in First-in-Human (FIH) Trials"

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Mark Arnold

Posted an hour ago

The Agency frames this 10-page guidance in the Introduction as

"The focus of this guidance is on drugs for which the MABEL approach is recommended to guide starting doses for FIH trials. This can, but does not necessarily, include drugs that cause T-cell activation and subsequent cytokine release. Here, we provide recommendations for leveraging mechanistic QSP as a model-based approach to improve FIH dose estimation."

Along with the various considerations for QSP-based dose selection for MABEL, there is a section that I'm seeing in more draft guidance: REGULATORY INTERACTIONS, which in this case covers Sponsor Meetings and IND Submissions.

If you are interested in commenting, you have less than a month - only until 24Jul26.

#fda #DoseSelection #MABEL #QSP#FIH

Guidance for Industry

U.S. Food and Drug Administration

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Guidance for Industry

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

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Mark Arnold Ph.D., FAAPS
Westampton, NJ
[email protected]
Bioanalytical Solution Integration
LinkedIn: https://www.linkedin.com/in/markearnoldphd/
Website & Blog: Bioanalysis & Biomarkers <bioanalysisandbiomarkers.blogspot.com>
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