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

Source: https://www.keypedia.com/guidances/guidance-document/quantitative-systems-pharmacology-qsp-based-dose-selection-for-minimum-anticipated-biological-effect-level-mabel-in-first-in-human-fih-trials/994ae4f9-15eb-4cb0-9f01-39f7e22daee5

> FDA guidance document: Quantitative Systems Pharmacology (QSP)-Based Dose Selection for Minimum Anticipated Biological Effect Level (MABEL) in First-in-Human (FIH) Trials. Issue date: June 24, 2026. Get complete insights and analysis.

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## Details

- Title: Quantitative Systems Pharmacology (QSP)-Based Dose Selection for Minimum Anticipated Biological Effect Level (MABEL) in First-in-Human (FIH) Trials
- Communication Type: Guidance Document
- Product Type: drugs
- Office Name: Center for Drug Evaluation and Research
- Office URL: /offices/center-for-drug-evaluation-and-research/cd980d74-1cbf-4226-ba9a-9045324c236c
- Issue Date: 2026-06-24
- Last Changed: 2026-06-22
- Docket Number: <a href="https://www.regulations.gov/docket/FDA-2026-D-6539">FDA-2026-D-6539</a>

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