Tacrolimus is the cornerstone of immunosuppressive therapy after pediatric liver transplantation. However, reliance on the physician's experience for dose titration, coupled with tacrolimus's narrow therapeutic window and inter and intra-patient variability, often results in frequent under or over-dosing with detrimental patient outcomes. Existing predictive dose personalization models are not readily feasible for clinical implementation, as they require multiple measurements each day while the standard frequency is once daily. We developed CURATE.AI, a small-data artificial intelligence-derived platform, as a clinical decision support system to personalize doses using the patient's own data obtained once a day. Retrospective dose personalization with CURATE.AI on 16 patients' data demonstrated potential to enable patients to stay in the therapeutic range longer and reach the therapeutic range significantly earlier. Our findings support the testing of CURATE.AI in a prospective controlled trial as an aid for the physician's decision on tacrolimus dose personalization after pediatric liver transplantation.

A.B. and D.H. are co-inventors or previously filed pending patents on artificial intelligence-based therapy development. E.K.-H.C., and D.H. are shareholders of KYAN Therapeutics, which has licensed intellectual property pertaining to AI-based oncology drug development. The findings from this study are being made available for public benefit, and no intellectual property rights arising from the work reported here are being pursued. D.H., A.B., K.S.K., S.-B.T., A.T.L.T., L.W.J.T. are co-inventors of previously filed pending patents on artificial intelligence-based therapy development. The remaining authors declare no competing interests.

This study was funded by the National Research Foundation Singapore under its AI Singapore Programme (Award Number:AISG-GC-2019-002), Singapore Ministry of Health's National Medical Research Council under its Open Fund-Large Collaborative Grant ("OF-LCG") (MOH-OFLCG18May-0028), and the Ministry of Education Tier 1 FRC Grant.

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Centralised Institutional Review Board D of SingHealth gave ethical approval for this work

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The data used in this study are available from the corresponding authors upon reasonable request.