A novel workflow integrating whole-body PET microdosing data and therapeutic-dose pharmacokinetics across species to inform first-in-human dose selection
This study demonstrates that integrating whole-body PET microdosing data with therapeutic-dose pharmacokinetics in non-human primates within a PBPK framework successfully predicts first-in-human exposure and tissue distribution for dolutegravir, validating a novel workflow to inform dose selection.