FDA Issues Draft Guidance on QSP Modeling for First-In-Human Trial Dose Selection
June 27, 2026
June 27, 2026
WASHINGTON, June 27 (TNSFR) -- The U.S. Department of Health and Human Services Food and Drug Administration has issued draft guidance recommending quantitative systems pharmacology modeling for selecting starting doses in first-in-human trials.
The guidance, announced in a Federal Register, is intended to help drug and biological product developers apply quantitative systems pharmacology (QSP) modeling when determining the minimum anticipated biological effect level (MABEL) for pha . . .
The guidance, announced in a Federal Register, is intended to help drug and biological product developers apply quantitative systems pharmacology (QSP) modeling when determining the minimum anticipated biological effect level (MABEL) for pha . . .