Industry urges FDA to clarify and broaden QSP guidance for first-in-human dose selection

Industry stakeholders have asked the U.S. Food and Drug Administration for more detailed guidance on using quantitative systems pharmacology (QSP) to select first-in-human doses in phase-1 studies.

They argue that clearer criteria would help sponsors design dose-selection strategies with greater confidence and reduce uncertainty in early-stage trials.

The group also seeks regulatory flexibility to adjust dosing decisions as data emerge and calls for alignment of the FDA’s draft guidance with international standards.