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(QSP)-Based Dose Selection for Minimum Anticipated Biological Effect Level (MABEL) in First-in-Human (FIH) Trials; Draft Guidance for Industry; Availability

Official abstract: The Food and Drug Administration (FDA, Agency, or we) is announcing the availability of a draft guidance for industry entitled "Quantitative Systems Pharmacology (QSP)-Based Dose Selection for Minimum Anticipated Biological Effect Level (MABEL) in First-in-Human (FIH) Trials." The guidance is intended to provide recommendations in the application of quantitative systems pharmacology (QSP) modeling when a minimum anticipated biological effect level (MABEL) in first-in- human (FIH), phase 1 trials for drugs and biological products is recommended. This guidance focuses on drugs and biological products for which the MABEL approach can be used to guide starting doses for FIH trials. This includes, but is not limited to, drugs and biological products that may cause cytokine release, T-cell activation, or other potent pharmacological reactions.