FDA draft guidance seeks clearer, more flexible QSP dose selection for first-in-human trials

Industry groups have asked the FDA for more clarity in a draft guidance that outlines how sponsors can use quantitative systems pharmacology (QSP) to select doses for first-in-human studies.

The request emphasizes the need for regulatory flexibility to adjust dose selections during early-phase development and to align U.S. expectations with international standards.

The FDA’s forthcoming guidance could shape how companies design phase-1 trials, potentially affecting timelines and resource allocation across the sector.