Bottom-up modeling and simulation of tacrolimus clearance: Prospective investigation of blood cell distribution, sex and CYP3A5 expression as covariates and assessment of study power

Biopharmaceutics and Drug Disposition

Volumn 32, Issue 9, 2011, Pages 498-506

  Ohtani, Hisakazu ^a   Barter, Zoe ^b   Minematsu, Tsuyoshi ^c   Makuuchi, Masatoshi ^d   Sawada, Yasufumi ^e   Rostami Hodjegan, Amin ^b,f  

^a KEIO UNIVERSITY   (Japan)

^b CERTARA UK LIMITED   (United Kingdom)

^c ASTELLAS PHARMA INC   (Japan)

^d JAPANESE RED CROSS MEDICAL CENTER   (Japan)

^e UNIVERSITY OF TOKYO   (Japan)

^f UNIVERSITY OF MANCHESTER   (United Kingdom)

Author keywords

covariate analysis; haematocrit; in vitro in vivo extrapolation (IVIVE); modeling and simulation; population pharmacometrics

Indexed keywords

CYTOCHROME P450 3A5; TACROLIMUS;

ADULT; ARTICLE; BLOOD CELL; COMPUTER PROGRAM; COVARIANCE; DRUG CLEARANCE; DRUG METABOLISM; FEMALE; GENDER; GENOTYPE; HEMATOCRIT; HUMAN; JAPANESE; MALE; MODEL; POPULATION RESEARCH; PROTEIN EXPRESSION; REPRODUCIBILITY; SEX DIFFERENCE; SIMULATION; SIMULATOR; VALIDATION PROCESS;

ADULT; ASIAN CONTINENTAL ANCESTRY GROUP; COMPUTER SIMULATION; CYTOCHROME P-450 CYP3A; FEMALE; GENOTYPE; HEMATOCRIT; HUMANS; IMMUNOSUPPRESSIVE AGENTS; LIVER TRANSPLANTATION; MALE; METABOLIC CLEARANCE RATE; MIDDLE AGED; MODELS, BIOLOGICAL; SEX FACTORS; TACROLIMUS;

EID: 82155166249     PISSN: 01422782     EISSN: 1099081X     Source Type: Journal    
DOI: 10.1002/bdd.777     Document Type: Article

References (26)

1. Sam WJ, Aw M, Quak SH, et al,. Population pharmacokinetics of tacrolimus in Asian paediatric liver transplant patients. Br J Clin Pharmacol 2000; 50: 531-541. (Pubitemid 32010014)
2. Fukatsu S, Yano I, Igarashi T, et al,. Population pharmacokinetics of tacrolimus in adult recipients receiving living-donor liver transplantation. Eur J Clin Pharmacol 2001; 57: 479-484.
3. Staatz CE, Willis C, Taylor PJ, Lynch SV, Tett SE,. Toward better outcomes with tacrolimus therapy: population pharmacokinetics and individualized dosage prediction in adult liver transplantation. Liver Transpl 2003; 9: 130-137. (Pubitemid 36204563)
4. Antignac M, Hulot JS, Boleslawski E, et al,. Population pharmacokinetics of tacrolimus in full liver transplant patients: modelling of the post-operative clearance. Eur J Clin Pharmacol 2005; 61: 409-416. (Pubitemid 41569318)
5. Sam WJ, Tham LS, Holmes MJ, et al,. Population pharmacokinetics of tacrolimus in whole blood and plasma in Asian liver transplant patients. Clin Pharmacokinet 2006; 45: 59-75. (Pubitemid 43145015)
6. Fukudo M, Yano I, Masuda S, et al,. Population pharmacokinetic and pharmacogenomic analysis of tacrolimus in pediatric living-donor liver transplant recipients. Clin Pharmacol Ther 2006; 80: 331-345. (Pubitemid 44479749)
7. Li D, Lu W, Zhu JY, Gao J, Lou YQ, Zhang GL,. Population pharmacokinetics of tacrolimus and CYP3A5, MDR1 and IL-10 polymorphisms in adult liver transplant patients. J Clin Pharm Ther 2007; 32: 505-515. (Pubitemid 47404287)
8. Musuamba FT, Mourad M, Haufroid V, Delattre IK, Verbeeck RK, Wallemacq P,. Time of drug administration, CYP3A5 and ABCB1 genotypes, and analytical method influence tacrolimus pharmacokinetics: a population pharmacokinetic study. Ther Drug Monit 2009; 31: 734-742.
9. Zhao W, Elie V, Roussey G, et al,. Population pharmacokinetics and pharmacogenetics of tacrolimus in de novo pediatric kidney transplant recipients. Clin Pharmacol Ther 2009; 86: 609-618.
10. Minematsu T, Sugiyama E, Kusama M, et al,. Effect of hematocrit on pharmacokinetics of tacrolimus in adult living donor liver transplant recipients. Transplant Proc 2004; 36: 1506-1511. (Pubitemid 38903017)
11. Johnson TN, Kerbusch T, Jones B, Tucker GT, Rostami-Hodjegan A, Milligan PA,. Assessing the efficiency of mixed effects modelling in quantifying metabolism based drug-drug interactions: using in vitro data as an aid to assess study power. Pharm Stat 2009; 8: 186-202.
12. Dickinson GL, Rezaee S, Proctor NJ, Lennard MS, Tucker GT, Rostami-Hodjegan A,. Incorporating in vitro information on drug metabolism into clinical trial simulations to assess the effect of CYP2D6 polymorphism on pharmacokinetics and pharmacodynamics: dextromethorphan as a model application. J Clin Pharmacol 2007a; 47: 175-186. (Pubitemid 46146483)
13. Dickinson GL, Lennard MS, Tucker GT, Rostami-Hodjegan A,. The use of mechanistic DM-PK-PD modelling to assess the power of pharmacogenetic studies -CYP2C9 and warfarin as an example. Br J Clin Pharmacol 2007b; 64: 14-26. (Pubitemid 46934416)
14. Waxman DJ, Holloway MG,. Sex differences in the expression of hepatic drug metabolizing enzymes. Mol Pharmacol 2009; 76: 215-228.
15. Barter ZE, Perrett HF, Yeo KR, Allorge D, Lennard MS, Rostami-Hodjegan A,. Determination of a quantitative relationship between hepatic CYP3A5*1/*3 and CYP3A4 expression for use in the prediction of metabolic clearance in virtual populations. Biopharm Drug Dispos 2010; 31: 516-532.
16. Dai Y, Hebert MF, Isoherranen N, et al,. Effect of CYP3A5 polymorphism on tacrolimus metabolic clearance in vitro. Drug Metab Dispos 2006; 34: 836-847.
17. Proctor NJ, Tucker GT, Rostami-Hodjegan A,. Predicting drug clearance from recombinantly expressed CYPs: intersystem extrapolation factors. Xenobiotica 2004; 34: 151-178. (Pubitemid 38299716)
18. Zahir H, Nand RA, Brown KF, Tattam BN, McLachlan AJ,. Validation of methods to study the distribution and protein binding of tacrolimus in human blood. J Pharmacol Toxicol Methods 2001; 46: 27-35. (Pubitemid 34260893)
19. Howgate EM, Rowland Yeo K, Proctor NJ, Tucker GT, Rostami-Hodjegan A,. Prediction of in vivo drug clearance from in vitro data. I: impact of inter-individual variability. Xenobiotica 2006; 36: 473-497. (Pubitemid 43890728)
20. Inoue S, Howgate EM, Rowland-Yeo K, et al,. Prediction of in vivo drug clearance from in vitro data. II: potential inter-ethnic differences. Xenobiotica 2006; 36: 499-513. (Pubitemid 43890729)
21. Marcos A, Fisher RA, Ham JM, et al,. Liver regeneration and function in donor and recipient after right lobe adult to adult living donor liver transplantation. Transplantation 2000; 69: 1375-1379. (Pubitemid 30238727)
22. Akamatsu N, Sugawara Y, Tamura S, Imamura H, Kokudo N, Makuuchi M,. Regeneration and function of hemiliver graft: right versus left. Surgery 2006; 139: 765-772. (Pubitemid 43902911)
23. Kashuba AD, Bertino JS Jr, Rocci ML Jr, Kulawy RW, Beck DJ, Nafziger AN,. Quantification of 3-month intraindividual variability and the influence of sex and menstrual cycle phase on CYP3A activity as measured by phenotyping with intravenous midazolam. Clin Pharmacol Ther 1998; 64: 269-277. (Pubitemid 28462287)
24. Todo S, Furukawa H, Jin MB, Shimamura T,. Living donor liver transplantation in adults: outcome in Japan. Liver Transpl 2000; 6 (Suppl 2): S66-S72.
25. Saeki M, Saito Y, Nakamura T, et al,. Single nucleotide polymorphisms and haplotype frequencies of CYP3A5 in a Japanese population. Hum Mutat 2003; 21: 653.
26. Rostami-Hodjegan A, Tucker GT,. Simulation and prediction of in vivo drug metabolism in human populations from in vitro data. Nat Rev Drug Discov 2007; 6: 140-148. (Pubitemid 46745341)