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Results: The scaled-up PBPK model provided an good prediction tacrolimus concentration-time data obtained after the administration of single and multiple oral doses in human patients on the waiting list for kidney transplantation.

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Groups of patients that underwent analysis included a safety population (patients who received at least one dose of a study drug) and an intention-to-treat population (patients who received at least one dose of a study drug and underwent transplantation).

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