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Population pharmacokinetics of tacrolimus in paediatric systemic lupus erythematosus based on real‐world study
Author(s) -
Wang D.D.,
Lu J.M.,
Li Q.,
Li Z.P.
Publication year - 2018
Publication title -
journal of clinical pharmacy and therapeutics
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.622
H-Index - 73
eISSN - 1365-2710
pISSN - 0269-4727
DOI - 10.1111/jcpt.12707
Subject(s) - tacrolimus , medicine , nonmem , volume of distribution , pharmacokinetics , population , systemic lupus erythematosus , pharmacology , transplantation , disease , environmental health
Summary What is known and objectives Different population pharmacokinetics ( PPK ) models of tacrolimus have been established in various populations. However, the tacrolimus PPK model in paediatric systemic lupus erythematosus ( PSLE ) is still undefined. This study aimed to establish the tacrolimus PPK model in Chinese PSLE . Methods A total of nineteen Chinese patients with PSLE from real‐world study were characterized with nonlinear mixed‐effects modelling ( NONMEM ). The impact of demographic features, biological characteristics, and concomitant medications was evaluated. Model validation was assessed by bootstrap and prediction‐corrected visual predictive check ( VPC ). Results A one‐compartment model with first‐order absorption and elimination was determined to be the most suitable model in PSLE . The typical values of apparent oral clearance ( CL /F) and the apparent volume of distribution (V/F) in the final model were 2.05 L/h and 309 L, respectively. Methylprednisolone and simvastatin were included as significant. What is new and conclusion The first validated tacrolimus PPK model in patients with PSLE is presented.