Review by Joseph Ross – 09/29/2020 – 4:31pm

Data Request Number: 2020-4423 Is the scientific purpose of the research proposal clearly described?: Yes Will request create or materially enhance generalizable scientific and/or medical knowledge to inform science and public health?: Yes Can the proposed research be reasonably addressed using the requested data?: Yes, or it’s highly likely Please use this space to provide any comments, feedback or concerns (optional):

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).

Recommendation for this data request: Approve