Investigators proposed using non-linear mixed effect modeling method to estimate darunavir and ritonavir concentrations among children based on PK data from 6 different data sources, after accounting for age, bodyweight, alpha-1 glycoprotein, and other cotreatments. 3 trials are being made available via the YODA Project. Just need to be clear that the 3 other data sources are being brought into the secure analytic environment (not that data are being downloaded and combined elsewhere).
Approve