Population pharmacokinetics of immediate‐ and prolonged‐release tacrolimus formulations in liver, kidney and heart transplant recipients
Aims Develop a population pharmacokinetics model of tacrolimus in organ transplant recipients receiving twice‐daily, immediate‐release (IR‐T; Prograf) and/or once‐daily, prolonged‐release (PR‐T; Advagraf or Astagraf XL) tacrolimus. Methods Tacrolimus concentration–time profiles were analysed from 8...
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Published in | British journal of clinical pharmacology Vol. 85; no. 8; pp. 1692 - 1703 |
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Main Authors | , , |
Format | Journal Article |
Language | English |
Published |
England
John Wiley and Sons Inc
01.08.2019
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Subjects | |
Online Access | Get full text |
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Abstract | Aims
Develop a population pharmacokinetics model of tacrolimus in organ transplant recipients receiving twice‐daily, immediate‐release (IR‐T; Prograf) and/or once‐daily, prolonged‐release (PR‐T; Advagraf or Astagraf XL) tacrolimus.
Methods
Tacrolimus concentration–time profiles were analysed from 8 Phase II studies in adult and paediatric liver, kidney and heart transplant patients receiving IR‐T and/or PR‐T. A tacrolimus population pharmacokinetic model, including identification of significant covariates, was developed using NONMEM.
Results
Overall, 23,176 tacrolimus concentration records were obtained from 408 patients. A 2‐compartment model with first‐order absorption and elimination described the concentration–time profiles. Tacrolimus absorption rate was 50% slower with PR‐T vs IR‐T. Tacrolimus apparent oral clearance was 44.3 L/h in Whites and 59% higher in Asians. Tacrolimus central volume of distribution was 108 L in males and 55% lower in females; trough concentrations were similar between formulations. Tacrolimus relative bioavailability was similar between formulations (geometric mean ratio PR‐T:IR‐T 95%, 90% confidence intervals: 89%, 101%). Asians had 83% and 51% higher relative bioavailability than Whites and Blacks, respectively, for IR‐T and PR‐T. Whites had 49% and 77% higher relative bioavailability than Blacks for PR‐T and IR‐T, respectively. Blacks had 52% lower relative bioavailability than Whites and Asians for IR‐T and PR‐T. Type of organ transplanted and patient population (adult/paediatric) did not have a significant effect on tacrolimus pharmacokinetics.
Conclusions
This population pharmacokinetic model described data from transplant recipients who received IR‐T and/or PR‐T. Tacrolimus trough concentrations and relative bioavailability were similar between formulations, supporting 1 mg:1 mg conversion from Prograf to Advagraf/Astagraf XL in clinical practice. |
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AbstractList | Aims
Develop a population pharmacokinetics model of tacrolimus in organ transplant recipients receiving twice‐daily, immediate‐release (IR‐T; Prograf) and/or once‐daily, prolonged‐release (PR‐T; Advagraf or Astagraf XL) tacrolimus.
Methods
Tacrolimus concentration–time profiles were analysed from 8 Phase II studies in adult and paediatric liver, kidney and heart transplant patients receiving IR‐T and/or PR‐T. A tacrolimus population pharmacokinetic model, including identification of significant covariates, was developed using NONMEM.
Results
Overall, 23,176 tacrolimus concentration records were obtained from 408 patients. A 2‐compartment model with first‐order absorption and elimination described the concentration–time profiles. Tacrolimus absorption rate was 50% slower with PR‐T vs IR‐T. Tacrolimus apparent oral clearance was 44.3 L/h in Whites and 59% higher in Asians. Tacrolimus central volume of distribution was 108 L in males and 55% lower in females; trough concentrations were similar between formulations. Tacrolimus relative bioavailability was similar between formulations (geometric mean ratio PR‐T:IR‐T 95%, 90% confidence intervals: 89%, 101%). Asians had 83% and 51% higher relative bioavailability than Whites and Blacks, respectively, for IR‐T and PR‐T. Whites had 49% and 77% higher relative bioavailability than Blacks for PR‐T and IR‐T, respectively. Blacks had 52% lower relative bioavailability than Whites and Asians for IR‐T and PR‐T. Type of organ transplanted and patient population (adult/paediatric) did not have a significant effect on tacrolimus pharmacokinetics.
Conclusions
This population pharmacokinetic model described data from transplant recipients who received IR‐T and/or PR‐T. Tacrolimus trough concentrations and relative bioavailability were similar between formulations, supporting 1 mg:1 mg conversion from Prograf to Advagraf/Astagraf XL in clinical practice. Aims Develop a population pharmacokinetics model of tacrolimus in organ transplant recipients receiving twice‐daily, immediate‐release (IR‐T; Prograf) and/or once‐daily, prolonged‐release (PR‐T; Advagraf or Astagraf XL) tacrolimus. Methods Tacrolimus concentration–time profiles were analysed from 8 Phase II studies in adult and paediatric liver, kidney and heart transplant patients receiving IR‐T and/or PR‐T. A tacrolimus population pharmacokinetic model, including identification of significant covariates, was developed using NONMEM. Results Overall, 23,176 tacrolimus concentration records were obtained from 408 patients. A 2‐compartment model with first‐order absorption and elimination described the concentration–time profiles. Tacrolimus absorption rate was 50% slower with PR‐T vs IR‐T. Tacrolimus apparent oral clearance was 44.3 L/h in Whites and 59% higher in Asians. Tacrolimus central volume of distribution was 108 L in males and 55% lower in females; trough concentrations were similar between formulations. Tacrolimus relative bioavailability was similar between formulations (geometric mean ratio PR‐T:IR‐T 95%, 90% confidence intervals: 89%, 101%). Asians had 83% and 51% higher relative bioavailability than Whites and Blacks, respectively, for IR‐T and PR‐T. Whites had 49% and 77% higher relative bioavailability than Blacks for PR‐T and IR‐T, respectively. Blacks had 52% lower relative bioavailability than Whites and Asians for IR‐T and PR‐T. Type of organ transplanted and patient population (adult/paediatric) did not have a significant effect on tacrolimus pharmacokinetics. Conclusions This population pharmacokinetic model described data from transplant recipients who received IR‐T and/or PR‐T. Tacrolimus trough concentrations and relative bioavailability were similar between formulations, supporting 1 mg:1 mg conversion from Prograf to Advagraf/Astagraf XL in clinical practice. Develop a population pharmacokinetics model of tacrolimus in organ transplant recipients receiving twice-daily, immediate-release (IR-T; Prograf) and/or once-daily, prolonged-release (PR-T; Advagraf or Astagraf XL) tacrolimus. Tacrolimus concentration-time profiles were analysed from 8 Phase II studies in adult and paediatric liver, kidney and heart transplant patients receiving IR-T and/or PR-T. A tacrolimus population pharmacokinetic model, including identification of significant covariates, was developed using NONMEM. Overall, 23,176 tacrolimus concentration records were obtained from 408 patients. A 2-compartment model with first-order absorption and elimination described the concentration-time profiles. Tacrolimus absorption rate was 50% slower with PR-T vs IR-T. Tacrolimus apparent oral clearance was 44.3 L/h in Whites and 59% higher in Asians. Tacrolimus central volume of distribution was 108 L in males and 55% lower in females; trough concentrations were similar between formulations. Tacrolimus relative bioavailability was similar between formulations (geometric mean ratio PR-T:IR-T 95%, 90% confidence intervals: 89%, 101%). Asians had 83% and 51% higher relative bioavailability than Whites and Blacks, respectively, for IR-T and PR-T. Whites had 49% and 77% higher relative bioavailability than Blacks for PR-T and IR-T, respectively. Blacks had 52% lower relative bioavailability than Whites and Asians for IR-T and PR-T. Type of organ transplanted and patient population (adult/paediatric) did not have a significant effect on tacrolimus pharmacokinetics. This population pharmacokinetic model described data from transplant recipients who received IR-T and/or PR-T. Tacrolimus trough concentrations and relative bioavailability were similar between formulations, supporting 1 mg:1 mg conversion from Prograf to Advagraf/Astagraf XL in clinical practice. |
Author | Bonate, Peter Lu, Zheng Keirns, James |
AuthorAffiliation | 2 Formerly Astellas Pharma Global Development, Inc. Northbrook Illinois USA 1 Astellas Pharma Global Development, Inc. Northbrook Illinois USA |
AuthorAffiliation_xml | – name: 1 Astellas Pharma Global Development, Inc. Northbrook Illinois USA – name: 2 Formerly Astellas Pharma Global Development, Inc. Northbrook Illinois USA |
Author_xml | – sequence: 1 givenname: Zheng surname: Lu fullname: Lu, Zheng email: zheng.lu@astellas.com organization: Astellas Pharma Global Development, Inc – sequence: 2 givenname: Peter surname: Bonate fullname: Bonate, Peter organization: Astellas Pharma Global Development, Inc – sequence: 3 givenname: James surname: Keirns fullname: Keirns, James organization: Formerly Astellas Pharma Global Development, Inc |
BackLink | https://www.ncbi.nlm.nih.gov/pubmed/30950096$$D View this record in MEDLINE/PubMed |
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Cites_doi | 10.1111/j.1600-6143.2010.03256.x 10.1097/FTD.0b013e3181bf8623 10.1111/j.1432-2277.2011.01254.x 10.1016/j.transproceed.2004.11.086 10.1097/FTD.0b013e3181ae44b9 10.1007/s002280100331 10.1002/lt.22211 10.1097/01.tp.0000264056.20105.b4 10.1097/00007691-200104000-00006 10.1097/01.tp.0000259248.60448.8a 10.2165/00003088-200645010-00004 10.1007/s10928-007-9081-1 10.1007/s40262-017-0567-8 10.1097/FPC.0b013e328364db84 10.1007/s00228-013-1584-7 10.1097/FTD.0b013e318198d092 10.1111/j.1365-2125.2008.03251.x 10.1016/j.cmpb.2003.11.003 10.3349/ymj.2014.55.5.1341 10.1111/j.1600-6143.2007.01803.x 10.1177/0091270003253624 10.1111/j.1600-6143.2011.03571.x 10.1038/86882 10.1038/aps.2014.110 10.1097/FTD.0b013e318244a7fd 10.1016/S0041-1345(98)00275-9 10.2165/00003088-200443100-00001 10.1111/j.1600-6143.2009.02794.x 10.1002/j.1552-4604.1997.tb04326.x 10.1016/j.healun.2011.02.008 10.1097/00007890-200212150-00014 10.1067/mcp.2001.113183 10.2147/PPA.S54922 10.1097/01.tp.0000265445.09987.f1 10.1097/TP.0b013e3182a203bd 10.1007/s00228-005-0933-6 10.1111/j.1365-2125.2010.03837.x |
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Keywords | pharmacokinetics immunosuppression transplantation NONMEM |
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License | Attribution-NonCommercial 2019 Astellas Pharma Inc. British Journal of Clinical Pharmacology published by John Wiley & Sons Ltd on behalf of British Pharmacological Society. This is an open access article under the terms of the http://creativecommons.org/licenses/by-nc/4.0/ License, which permits use, distribution and reproduction in any medium, provided the original work is properly cited and is not used for commercial purposes. |
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Notes | James Keirns confirms that the Principal Investigator for this paper is Zheng Lu. James Keirns is currently an independent consultant in clinical pharmacology. |
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References | 2004; 43 2010; 10 2015; 36 2014; 70 2002; 74 2013; 23 2011; 30 2011; 11 2008; 35 2001; 27 2005; 61 2011; 17 2001; 23 2012; 34 2001; 69 2004; 75 2009; 31 2006; 45 2011; 71 1997; 37 2013; 96 2009; 9 2007; 7 2011; 24 2015 2008; 66 2007; 83 2005; 37 1998; 30 2014; 8 2001; 57 2014; 55 2003; 43 2018; 57 e_1_2_9_30_1 e_1_2_9_31_1 e_1_2_9_11_1 e_1_2_9_34_1 e_1_2_9_10_1 e_1_2_9_35_1 e_1_2_9_13_1 e_1_2_9_32_1 e_1_2_9_12_1 e_1_2_9_33_1 e_1_2_9_15_1 e_1_2_9_38_1 e_1_2_9_14_1 e_1_2_9_39_1 e_1_2_9_17_1 e_1_2_9_36_1 e_1_2_9_16_1 e_1_2_9_37_1 e_1_2_9_19_1 e_1_2_9_18_1 e_1_2_9_41_1 e_1_2_9_42_1 e_1_2_9_20_1 e_1_2_9_40_1 e_1_2_9_22_1 e_1_2_9_21_1 e_1_2_9_24_1 e_1_2_9_23_1 e_1_2_9_8_1 e_1_2_9_7_1 e_1_2_9_6_1 e_1_2_9_5_1 e_1_2_9_4_1 e_1_2_9_3_1 e_1_2_9_2_1 e_1_2_9_9_1 e_1_2_9_26_1 e_1_2_9_25_1 e_1_2_9_28_1 e_1_2_9_27_1 e_1_2_9_29_1 |
References_xml | – volume: 36 start-page: 281 issue: 2 year: 2015 end-page: 288 article-title: A population pharmacokinetic study of tacrolimus in healthy Chinese volunteers and liver transplant patients publication-title: Acta Pharm Sin B – volume: 96 start-page: 897 issue: 10 year: 2013 end-page: 903 article-title: OSAKA trial: a randomized, controlled trial comparing tacrolimus QD and BD in kidney transplantation publication-title: Transplantation – volume: 83 start-page: 1639 issue: 12 year: 2007 end-page: 1642 article-title: Once‐daily tacrolimus extended release formulation: experience at 2 years postconversion from a Prograf‐based regimen in stable liver transplant recipients publication-title: Transplantation – volume: 11 start-page: 1965 issue: 9 year: 2011 end-page: 1971 article-title: Efficacy and safety of conversion from twice‐daily to once‐daily tacrolimus in a large cohort of stable kidney transplant recipients publication-title: Am J Transplant – volume: 8 start-page: 73 year: 2014 end-page: 81 article-title: Efficacy of a reduced pill burden on therapeutic adherence to calcineurin inhibitors in renal transplant recipients: an observational study publication-title: Patient Prefer Adherence – volume: 34 start-page: 46 issue: 1 year: 2012 end-page: 52 article-title: Pharmacokinetics in stable kidney transplant recipients after conversion from twice‐daily to once‐daily tacrolimus formulations publication-title: Ther Drug Monit – volume: 17 start-page: 167 issue: 2 year: 2011 end-page: 177 article-title: Pharmacokinetics for once‐daily versus twice‐daily tacrolimus formulations in de novo liver transplantation: a randomized, open‐label trial publication-title: Liver Transpl – volume: 10 start-page: 2632 issue: 12 year: 2010 end-page: 2643 article-title: Tacrolimus once daily (ADVAGRAF) versus twice daily (PROGRAF) in de novo renal transplantation: a randomized phase III study publication-title: Am J Transplant – volume: 69 start-page: 24 issue: 1 year: 2001 end-page: 31 article-title: The pharmacokinetics and metabolic dispostion of tacrolimus: a comparison across ethnic groups publication-title: Clin Pharmacol Ther – volume: 27 start-page: 383 issue: 4 year: 2001 end-page: 391 article-title: Sequence diversity in CYP3A promoters and characterization of the genetic basis of polymorphic CYP3A5 expression publication-title: Nat Genet – volume: 61 start-page: 409 issue: 5‐6 year: 2005 end-page: 416 article-title: Population pharmacokinetics of tacrolimus in full liver transplant patients: modelling of the post‐operative clearance publication-title: Eur J Clin Pharmacol – volume: 7 start-page: 1609 issue: 6 year: 2007 end-page: 1615 article-title: Once‐daily tacrolimus extended‐release formulation: 1‐year post‐conversion in stable pediatric liver transplant recipients publication-title: Am J Transplant – volume: 37 start-page: 1211 issue: 2 year: 2005 end-page: 1213 article-title: Conversion of stable liver transplant recipients from a twice‐daily Prograf‐based regimen to a once‐daily modified release tacrolimus‐based regimen publication-title: Transplant Proc – volume: 35 start-page: 185 issue: 2 year: 2008 end-page: 202 article-title: Extensions to the visual predictive check to facilitate model performance evaluation publication-title: J Pharmacokinet Pharmacodyn – volume: 83 start-page: 997 issue: 7 year: 2007 end-page: 999 article-title: Tacrolimus dose in black renal transplant recipients publication-title: Transplantation – volume: 23 start-page: 129 issue: 2 year: 2001 end-page: 133 article-title: Failure of traditional trough levels to predict tacrolimus concentrations publication-title: Ther Drug Monit – volume: 71 start-page: 391 issue: 3 year: 2011 end-page: 402 article-title: Population pharmacokinetic model and Bayesian estimator for two tacrolimus formulations—twice daily Prograf® and once daily Advagraf® publication-title: Br J Clin Pharmacol – volume: 43 start-page: 623 issue: 10 year: 2004 end-page: 653 article-title: Clinical pharmacokinetics and pharmacodynamics of tacrolimus in solid organ transplantation publication-title: Clin Pharmacokinet – volume: 24 start-page: 666 issue: 7 year: 2011 end-page: 675 article-title: Efficacy, safety, and immunosuppressant adherence in stable liver transplant patients converted from a twice‐daily tacrolimus‐based regimen to once‐daily tacrolimus extended‐release formulation publication-title: Transpl Int – volume: 43 start-page: 610 issue: 6 year: 2003 end-page: 623 article-title: Model appropriateness and population pharmacokinetic modeling publication-title: J Clin Pharmacol – volume: 66 start-page: 467 issue: 4 year: 2008 end-page: 472 article-title: A limited sampling strategy for tacrolimus in renal transplant patients publication-title: Br J Clin Pharmacol – volume: 57 start-page: 479 issue: 6‐7 year: 2001 end-page: 484 article-title: Population pharmacokinetics of tacrolimus in adult recipients receiving living‐donor liver transplantation publication-title: Eur J Clin Pharmacol – volume: 31 start-page: 467 issue: 4 year: 2009 end-page: 474 article-title: Early phase limited sampling strategy characterizing tacrolimus and mycophenolic acid pharmacokinetics adapted to the maintenance phase of renal transplant patients publication-title: Ther Drug Monit – volume: 83 start-page: 1648 issue: 12 year: 2007 end-page: 1651 article-title: Two years postconversion from a Prograf‐based regimen to a once‐daily tacrolimus extended‐release formulation in stable kidney transplant recipients publication-title: Transplantation – volume: 55 start-page: 1341 issue: 5 year: 2014 end-page: 1347 article-title: Safety and efficacy of conversion from twice‐daily tacrolimus to once‐daily tacrolimus one month after transplantation: randomized controlled trial in adult renal transplantation publication-title: Yonsei Med J – volume: 74 start-page: 1568 issue: 11 year: 2002 end-page: 1573 article-title: Ethnic disparity in clinical outcome after heart transplantation is abrogated using tacrolimus and mycophenolate mofetil‐based immunosuppression publication-title: Transplantation – volume: 31 start-page: 139 issue: 2 year: 2009 end-page: 152 article-title: Opportunities to optimize tacrolimus therapy in solid organ transplantation: report of the European consensus conference publication-title: Ther Drug Monit – volume: 37 start-page: 486 issue: 6 year: 1997 end-page: 495 article-title: Stability and performance of a population pharmacokinetic model publication-title: J Clin Pharmacol – volume: 57 start-page: 475 issue: 4 year: 2018 end-page: 489 article-title: A population pharmacokinetic model to predict the individual starting dose of tacrolimus following pediatric renal transplantation publication-title: Clin Pharmacokinet – volume: 31 start-page: 734 issue: 6 year: 2009 end-page: 742 article-title: Time of drug administration, CYP3A5 and ABCB1 genotypes, and analytical method influence tacrolimus pharmacokinetics: a population pharmacokinetic study publication-title: Ther Drug Monit – volume: 30 start-page: 1003 issue: 9 year: 2011 end-page: 1010 article-title: Pharmacokinetics in stable heart transplant recipients after conversion from twice‐daily to once‐daily tacrolimus formulations publication-title: J Heart Lung Transplant – volume: 45 start-page: 59 issue: 1 year: 2006 end-page: 75 article-title: Population pharmacokinetics of tacrolimus in whole blood and plasma in Asian liver transplant patients publication-title: Clin Pharmacokinet – volume: 70 start-page: 65 issue: 1 year: 2014 end-page: 77 article-title: Importance of hematocrit for a tacrolimus target concentration strategy publication-title: Eur J Clin Pharmacol – volume: 30 start-page: 1359 issue: 4 year: 1998 end-page: 1364 article-title: Demographic considerations in tacrolimus pharmacokinetics publication-title: Transplant Proc – volume: 75 start-page: 85 issue: 2 year: 2004 end-page: 94 article-title: Perl‐speaks‐NONMEM (PsN) – a Perl module for NONMEM related programming publication-title: Comput Methods Programs Biomed – volume: 9 start-page: 2505 issue: 11 year: 2009 end-page: 2513 article-title: Pharmacokinetics for once‐ versus twice‐daily tacrolimus formulations in de novo kidney transplantation: a randomized, open‐label trial publication-title: Am J Transplant – volume: 23 start-page: 563 issue: 10 year: 2013 end-page: 585 article-title: PharmGKB summary: cyclosporine and tacrolimus pathways publication-title: Pharmacogenet Genomics – year: 2015 – ident: e_1_2_9_10_1 doi: 10.1111/j.1600-6143.2010.03256.x – ident: e_1_2_9_13_1 doi: 10.1097/FTD.0b013e3181bf8623 – ident: e_1_2_9_7_1 doi: 10.1111/j.1432-2277.2011.01254.x – ident: e_1_2_9_3_1 – ident: e_1_2_9_17_1 doi: 10.1016/j.transproceed.2004.11.086 – ident: e_1_2_9_15_1 doi: 10.1097/FTD.0b013e3181ae44b9 – ident: e_1_2_9_20_1 doi: 10.1007/s002280100331 – ident: e_1_2_9_4_1 doi: 10.1002/lt.22211 – ident: e_1_2_9_24_1 doi: 10.1097/01.tp.0000264056.20105.b4 – ident: e_1_2_9_21_1 doi: 10.1097/00007691-200104000-00006 – ident: e_1_2_9_39_1 doi: 10.1097/01.tp.0000259248.60448.8a – ident: e_1_2_9_22_1 doi: 10.2165/00003088-200645010-00004 – ident: e_1_2_9_34_1 doi: 10.1007/s10928-007-9081-1 – ident: e_1_2_9_35_1 doi: 10.1007/s40262-017-0567-8 – ident: e_1_2_9_6_1 doi: 10.1097/FPC.0b013e328364db84 – ident: e_1_2_9_36_1 doi: 10.1007/s00228-013-1584-7 – ident: e_1_2_9_18_1 doi: 10.1097/FTD.0b013e318198d092 – ident: e_1_2_9_14_1 doi: 10.1111/j.1365-2125.2008.03251.x – ident: e_1_2_9_31_1 doi: 10.1016/j.cmpb.2003.11.003 – ident: e_1_2_9_25_1 doi: 10.3349/ymj.2014.55.5.1341 – ident: e_1_2_9_2_1 – ident: e_1_2_9_28_1 doi: 10.1111/j.1600-6143.2007.01803.x – ident: e_1_2_9_32_1 doi: 10.1177/0091270003253624 – ident: e_1_2_9_9_1 doi: 10.1111/j.1600-6143.2011.03571.x – ident: e_1_2_9_40_1 doi: 10.1038/86882 – ident: e_1_2_9_37_1 doi: 10.1038/aps.2014.110 – ident: e_1_2_9_16_1 doi: 10.1097/FTD.0b013e318244a7fd – ident: e_1_2_9_42_1 doi: 10.1016/S0041-1345(98)00275-9 – ident: e_1_2_9_5_1 doi: 10.2165/00003088-200443100-00001 – ident: e_1_2_9_12_1 doi: 10.1111/j.1600-6143.2009.02794.x – ident: e_1_2_9_33_1 doi: 10.1002/j.1552-4604.1997.tb04326.x – ident: e_1_2_9_27_1 doi: 10.1016/j.healun.2011.02.008 – ident: e_1_2_9_30_1 – ident: e_1_2_9_41_1 doi: 10.1097/00007890-200212150-00014 – ident: e_1_2_9_38_1 doi: 10.1067/mcp.2001.113183 – ident: e_1_2_9_8_1 doi: 10.2147/PPA.S54922 – ident: e_1_2_9_26_1 doi: 10.1097/01.tp.0000265445.09987.f1 – ident: e_1_2_9_11_1 doi: 10.1097/TP.0b013e3182a203bd – ident: e_1_2_9_29_1 doi: 10.1002/lt.22211 – ident: e_1_2_9_19_1 doi: 10.1007/s00228-005-0933-6 – ident: e_1_2_9_23_1 doi: 10.1111/j.1365-2125.2010.03837.x |
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Develop a population pharmacokinetics model of tacrolimus in organ transplant recipients receiving twice‐daily, immediate‐release (IR‐T; Prograf) and/or... Develop a population pharmacokinetics model of tacrolimus in organ transplant recipients receiving twice-daily, immediate-release (IR-T; Prograf) and/or... |
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SubjectTerms | Adult African Continental Ancestry Group - statistics & numerical data Asian Continental Ancestry Group - statistics & numerical data Biological Availability Biological Variation, Population - ethnology Clinical Trials, Phase II as Topic Delayed-Action Preparations - administration & dosage Delayed-Action Preparations - pharmacokinetics Drug Administration Schedule European Continental Ancestry Group - statistics & numerical data Female Graft Rejection - immunology Graft Rejection - prevention & control Heart Transplantation - adverse effects Humans immunosuppression Immunosuppressive Agents - administration & dosage Immunosuppressive Agents - pharmacokinetics Kidney Transplantation - adverse effects Liver Transplantation - adverse effects Male Middle Aged Models, Biological NONMEM Original pharmacokinetics Tacrolimus - administration & dosage Tacrolimus - pharmacokinetics Transplant Recipients - statistics & numerical data transplantation Young Adult |
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Title | Population pharmacokinetics of immediate‐ and prolonged‐release tacrolimus formulations in liver, kidney and heart transplant recipients |
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