Issue Date: June 24, 2026
Issued by: Center for Drug Evaluation and Research
Topic(s): Clinical – Pharmacology
Status: Draft
Quantitative Systems Pharmacology (QSP)-Based Dose Selection for Minimum Anticipated Biological Effect Level (MABEL) in First-in-Human (FIH) Trials
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can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the FDA considers your comment on a draft guidance before it begins work on the final version of the guidance, submit either online or written comments on the draft guidance before the close date.
Download the Guidance Document
