Model extrapolation to a real-world dataset: evaluation of tacrolimus population pharmacokinetics and drug interaction in pediatric liver transplantation patients

References

• Agrawal YP, Cid M, Westgard S, et al. (2014). Transplant patient classification and tacrolimus assays: more evidence of the need for assay standardization. Ther Drug Monit 36:706–9.
   PubMed Web of Science ®Google Scholar
• Anderson BJ, Holford NH. (2008). Mechanism-based concepts of size and maturity in pharmacokinetics. Annu Rev Pharmacol Toxicol 48:303–32.
   PubMed Web of Science ®Google Scholar
• Anderson BJ, Holford NH. (2011). Tips and traps analyzing pediatric PK data. Paediatr Anaesth 21:222–37.
   PubMed Web of Science ®Google Scholar
• Fukudo M, Yano I, Masuda S, et al. (2006). Population pharmacokinetic and pharmacogenomic analysis of tacrolimus in pediatric living-donor liver transplant recipients. Clin Pharmacol Ther 80:331–45.
   PubMed Web of Science ®Google Scholar
• García Sanchez MJ, Manzanares C, Santos-Buelga D, et al. (2001). Covariate effects on the apparent clearance of tacrolimus in paediatric liver transplant patients undergoing conversion therapy. Clin Pharmacokinet 40:63–71.
   PubMed Web of Science ®Google Scholar
• Guy-Viterbo V, Scohy A, Verbeeck RK, et al. (2013). Population pharmacokinetic analysis of tacrolimus in the first year after pediatric liver transplantation. Eur J Clin Pharmacol 69:1533–42.
   PubMed Web of Science ®Google Scholar
• Hebert MF. (1997). Contributions of hepatic and intestinal metabolism and P-glycoprotein to cyclosporine and tacrolimus oral drug delivery. Adv Drug Deliv Rev 27:201–14.
   PubMed Web of Science ®Google Scholar
• Hesse CJ, Baan CC, Balk AH, et al. (2002). Evaluation of the new EMIT enzyme immunoassay for the determination of whole-blood tacrolimus concentrations in kidney, heart, and liver transplant recipients. Transplant Proc 34:2988–90.
   PubMed Web of Science ®Google Scholar
• Ho S, Clipstone N, Timmermann L, et al. (1996). The mechanism of action of cyclosporin A and FK506. Clin Immunol Immunopathol 80:S40–S45.
   PubMedGoogle Scholar
• Holford NH. (1996). A size standard for pharmacokinetics. Clin Pharmacokinet 30:329–32.
   PubMed Web of Science ®Google Scholar
• Jalil MH, Hawwa AF, McKiernan PJ, et al. (2014). Population pharmacokinetic and pharmacogenetic analysis of tacrolimus in paediatric liver transplant patients. Br J Clin Pharmacol 77:130–40.
   PubMed Web of Science ®Google Scholar
• Kassir N, Labbe L, Delaloye JR, et al. (2014). Population pharmacokinetics and Bayesian estimation of tacrolimus exposure in paediatric liver transplant recipients. Br J Clin Pharmacol 77:1051–63.
   PubMed Web of Science ®Google Scholar
• Kauffman RE, Kearns GL. (1992). Pharmacokinetic studies in paediatric patients. Clinical and ethical considerations. Clin Pharmacokinet 23:10–29.
   PubMed Web of Science ®Google Scholar
• Kay JE, Sampare-Kwateng E, Geraghty F, Morgan GY. (1991). Uptake of FK 506 by lymphocytes and erythrocytes. Transplant Proc 23:2760–2.
   PubMed Web of Science ®Google Scholar
• Lampen A, Christians U, Guengerich FP, et al. (1995). Metabolism of the immunosuppressant tacrolimus in the small intestine: cytochrome P450, drug interactions, and interindividual variability. Drug Metab Dispos 23:1315–24.
   PubMed Web of Science ®Google Scholar
• Passey C, Birnbaum AK, Brundage RC, et al. (2011). Dosing equation for tacrolimus using genetic variants and clinical factors. Br J Clin Pharmacol 72:948–57.
   PubMed Web of Science ®Google Scholar
• Piekoszewski W, Jusko WJ. (1993). Plasma protein binding of tacrolimus in humans. J Pharm Sci 82:340–1.
   PubMed Web of Science ®Google Scholar
• Qin XL, Bi HC, Wang CX, et al. (2010a). Study of the effect of Wuzhi tablet (Schisandra sphenanthera extract) on tacrolimus tissue distribution in rat by liquid chromatography tandem mass spectrometry method. Biomed Chromatogr 24:399–405.
   PubMed Web of Science ®Google Scholar
• Qin XL, Bi HC, Wang XD, et al. (2010b). Mechanistic understanding of the different effects of Wuzhi Tablet (Schisandra sphenanthera extract) on the absorption and first-pass intestinal and hepatic metabolism of Tacrolimus (FK506). Int J Pharm 389:114–21.
   PubMed Web of Science ®Google Scholar
• Sam WJ, Aw M, Quak SH, et al. (2001). Population pharmacokinetics of tacrolimus in Asian paediatric liver transplant patients. Br J Clin Pharmacol 50:531–41.
   Web of Science ®Google Scholar
• Staatz CE, Tett SE. (2004). Clinical pharmacokinetics and pharmacodynamics of tacrolimus in solid organ transplantation. Clin Pharmacokinet 43:623–53.
   PubMed Web of Science ®Google Scholar
• Tang JT, Andrews LM, van Gelder T, et al. (2016). Pharmacogenetic aspects of the use of tacrolimus in renal transplantation: recent developments and ethnic considerations. Expert Opin Drug Metab Toxicol 12:555–65.
   PubMed Web of Science ®Google Scholar
• Vadcharavivad S, Praisuwan S, Techawathanawanna N, et al. (2016). Population pharmacokinetics of tacrolimus in Thai kidney transplant patients: comparison with similar data from other populations. J Clin Pharm Ther 41:310–28.
   PubMed Web of Science ®Google Scholar
• Venkataramanan R, Swaminathan A, Prasad T, et al. (1995). Clinical pharmacokinetics of tacrolimus. Clin Pharmacokinet 29:404–30.
   PubMed Web of Science ®Google Scholar
• Vincent SH, Karanam BV, Painter SK, Chiu SH. (1992). In vitro metabolism of FK-506 in rat, rabbit, and human liver microsomes: identification of a major metabolite and of cytochrome P450 3A as the major enzymes responsible for its metabolism. Arch Biochem Biophys 294:454–60.
   PubMed Web of Science ®Google Scholar
• Wallin JE, Bergstrand M, Wilczek HE, et al. (2011). Population pharmacokinetics of tacrolimus in pediatric liver transplantation: early posttransplantation clearance. Ther Drug Monit 33:663–72.
   PubMed Web of Science ®Google Scholar
• Wang DD, Chen X, Li ZP. (2018a). Efficacy and safety of tacrolimus in treating pediatric refractory nephrotic syndrome: a meta-analysis. Int J Clin Exp Med 11:6436–44.
   Web of Science ®Google Scholar
• Wang DD, Lu JM, Li Q, Li ZP. (2018b). Population pharmacokinetics of tacrolimus in paediatric systemic lupus erythematosus based on real-world study. J Clin Pharm Ther 43:476–83.
   PubMed Web of Science ®Google Scholar
• Wei H, Tao X, Di P, et al. (2013). Effects of traditional Chinese medicine Wuzhi capsule on pharmacokinetics of tacrolimus in rats. Drug Metab Dispos 41:1398–403.
   PubMed Web of Science ®Google Scholar
• Xin HW, Li Q, Wu XC, et al. (2011). Effects of Schisandra sphenanthera extract on the blood concentration of tacrolimus in renal transplant recipients. Eur J Clin Pharmacol 67:1309–11.
   PubMed Web of Science ®Google Scholar
• Xin HW, Wu XC, Li Q, et al. (2007). Effects of Schisandra sphenanthera extract on the pharmacokinetics of tacrolimus in healthy volunteers. Br J Clin Pharmacol 64:469–75.
   PubMed Web of Science ®Google Scholar
• Yang JW, Liao SS, Zhu LQ, et al. (2015). Population pharmacokinetic analysis of tacrolimus early after Chinese pediatric liver transplantation. Int J Clin Pharmacol Ther 53:75–83.
   PubMed Web of Science ®Google Scholar
• Yasuhara M, Hashida T, Toraguchi M, et al. (1995). Pharmacokinetics and pharmacodynamics of FK 506 in pediatric patients receiving living-related donor liver transplantations. Transplant Proc 27:1108–10.
   PubMed Web of Science ®Google Scholar
• Zhao W, Kaguelidou F, Biran V, et al. (2013). External evaluation of population pharmacokinetic models of vancomycin in neonates: the transferability of published models to different clinical settings. Br J Clin Pharmacol 75:1068–80.
   PubMed Web of Science ®Google Scholar