Moein, Anita
Jin, Jin Y.
Wright, Matthew R.
Alicke, Bruno
Wong, Harvey
Clinical trials referenced in this document:
Documents that mention this clinical trial
Retrospective Assessment of Translational Pharmacokinetic–Pharmacodynamic Modeling Performance: A Case Study with Apitolisib, a Dual PI3K/mTOR Inhibitor
https://doi.org/10.1007/s40268-024-00459-5
Documents that mention this clinical trial
Retrospective Assessment of Translational Pharmacokinetic–Pharmacodynamic Modeling Performance: A Case Study with Apitolisib, a Dual PI3K/mTOR Inhibitor
https://doi.org/10.1007/s40268-024-00459-5
Article History
Accepted: 7 March 2024
First Online: 3 May 2024
Declarations
:
: This work was supported by Genentech Inc., a member of the Roche group.
: A.M., J.Y.J., M.W., and B.A. are Genentech employees and Roche shareholders. H.W. is Faculty of Pharmaceutical Sciences at the University of British Columbia working under contract with Genentech.
: Qualified researchers may request access to individual patient-level data through the clinical study data request platform ().
: Clinical trials (NCT00854152 and NCT00854126) were conducted in accordance with Good Clinical Practice guidelines and the Declaration of Helsinki. Prior to enrollment, written informed consent was acquired from all patients, in alignment with the approved protocols from the ethics committees at each study site. All clinical trial information can be accessed through the following website. .
: All patients provided written informed consent.
: Codes provided in Supplementary Information.
: Wrote manuscript: A.M., J.Y.J., M.R.W., B.A., and H.W. Designed research: A.M. and H.W. Performed research: A.M. Analyzed data: A.M.