Review by Joseph Ross – 05/11/2020 – 4:09pm

Data Request Number: 2020-4305 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?: Unsure, further clarification from requestor is needed Please use this space to provide any comments, feedback or concerns (optional):

This is a clearly written proposal to investigate sources of pharmacokinetic variability for risperidone and its active metabolite, 9-hydroxy (OH)-risperidone, and examine associations with clinical outcomes. However, two aspects of the proposal may be an issue. First, I am unsure whether pharmacokinetic data were available for patients in these two trials, which could be used to estimate concentration-time profiles. Second, the authors are requesting to download certain aspects of the pharmacokinetic data, including dose, frequency of administered dose, and plasma concentrations of risperidone and 9-OH-risperidone, for non-linear mixed effects based modelling using Monolix software. Special approval would need to be secured to allow for downloading of data. Further clarification is needed.

Recommendation for this data request: Not Approve

See above