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Article History

Accepted: 14 May 2025

First Online: 12 August 2025

Declarations

:

: Dr. Dunlap was supported by the National Institute of General Medical Sciences of the National Institutes of Health under award number T32GM086330. Dr. Zhu was supported by the NHLBI under award number T32HL007148. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.

: Dr. Weiner is an independent member of the Board of Directors and a member of the Scientific Advisory Board for Simulations Plus (Nasdaq:SLP). All other authors report no conflicts of interest related to this research. At the time of study conception and execution, Dr. Dunlap, Dr. Zhu, Dr. DeVane, Dr. Nguyen, Dr. Patel, Dr. Riches, and Dr. Ptachcinski were all employed at the University of North Carolina. However, currently Dr. Dunlap is employed by Metrum Research Group, Dr. Zhu by Pfizer, Dr. DeVane by Immatics, Dr. Nguyen by Biogen, Dr. Patel by Bristol Myers Squibb, Dr. Riches by Kura Oncology, and Dr. Ptachcinski by Johnson & Johnson.

: All research activities were performed in accordance with the ethical standards of the responsible committee on human experimentation or with the Helsinki Declaration of 1975. Both studies =received approval from the University of North Carolina Institutional Review Board (UNC IRB) prior to subject enrollment and data collection (UNC16-1480 and UNC19-3328). UNC16-1480 was originally approved on July 21, 2016, and UNC19-3328 was originally approved on June 16, 2020. Both studies were renewed in 2025 by the UNC IRB.

: All research subjects from both studies (UNC16-1480 and UNC19-3328) provided informed consent to participate in their respective studies, for their genetic material to be used in our pharmacogenetics experiments and in the pharmacometric modeling and simulation, and all subjects provided consent to publish study results.

: Deidentified individual data that supports the results will be shared beginning 9–36 months following publication, provided the investigator who proposes to use the data has approval from an institutional review board (IRB), independent ethics committee (IEC), or research ethics board (REB), as applicable, and executes a data use/sharing agreement with UNC.

: Designed research—T.C.D., D.Z., J.R.P., P.M.A., D.L.W., and D.J.C. Performed research—all authors. Analyzed data—T.C.D., D.Z., D.L.W., R.M.K., and D.J.C. Wrote manuscript—all authors. Approved content for publication—all authors. Contributed new reagents/analytical tools—NA.

: NONMEM control stream is in the supplemental.