Pharmacokinetic tools for the dose adjustment of ciclosporin in haematopoietic stem cell transplant patients.
cyclosporine modeling in stem cell transplants
Type de document :
Compte-rendu et recension critique d'ouvrage
DOI :
PMID :
Titre :
Pharmacokinetic tools for the dose adjustment of ciclosporin in haematopoietic stem cell transplant patients.
cyclosporine modeling in stem cell transplants
cyclosporine modeling in stem cell transplants
Auteur(s) :
Woillard, Jean-Baptiste [Auteur]
Pharmacologie des Immunosuppresseurs et de la Transplantation [PIST]
Lebreton, Vincent [Auteur]
Pharmacologie des Immunosuppresseurs et de la Transplantation [PIST]
Neely, Michael [Auteur]
Turlure, Pascal [Auteur]
Service d'Hématologie clinique et thérapie cellulaire [CHU Limoges]
Girault, Stéphane [Auteur]
Service d'Hématologie clinique et thérapie cellulaire [CHU Limoges]
Debord, Jean [Auteur]
Pharmacologie des Immunosuppresseurs et de la Transplantation [PIST]
Service de Pharmacologie, toxicologie et pharmacovigilance [CHU Limoges]
Marquet, Pierre [Auteur]
Dynamic Reconfigurable Massively Parallel Architectures and Languages [DREAMPAL]
Saint-Marcoux, Franck [Auteur]
Pharmacologie des Immunosuppresseurs et de la Transplantation [PIST]
Pharmacologie des Immunosuppresseurs et de la Transplantation [PIST]
Lebreton, Vincent [Auteur]
Pharmacologie des Immunosuppresseurs et de la Transplantation [PIST]
Neely, Michael [Auteur]
Turlure, Pascal [Auteur]
Service d'Hématologie clinique et thérapie cellulaire [CHU Limoges]
Girault, Stéphane [Auteur]
Service d'Hématologie clinique et thérapie cellulaire [CHU Limoges]
Debord, Jean [Auteur]
Pharmacologie des Immunosuppresseurs et de la Transplantation [PIST]
Service de Pharmacologie, toxicologie et pharmacovigilance [CHU Limoges]
Marquet, Pierre [Auteur]
Dynamic Reconfigurable Massively Parallel Architectures and Languages [DREAMPAL]
Saint-Marcoux, Franck [Auteur]
Pharmacologie des Immunosuppresseurs et de la Transplantation [PIST]
Titre de la revue :
British Journal of Clinical Pharmacology
Pagination :
836-46
Éditeur :
Wiley
Date de publication :
2014-09-30
ISSN :
0306-5251
Mot(s)-clé(s) en anglais :
non parametric
hematopoietic stem cell transplantation
parametric
pharmacokinetics
cyclosporine
hematopoietic stem cell transplantation
parametric
pharmacokinetics
cyclosporine
Discipline(s) HAL :
Sciences du Vivant [q-bio]/Sciences pharmaceutiques
Résumé en anglais : [en]
Ciclosporin A (CsA) is used in the prophylaxis and treatment of acute and chronic graft vs. host disease after haematopoietic stem cell (HSCT) transplantation. Our objective was to build and compare three independent ...
Lire la suite >Ciclosporin A (CsA) is used in the prophylaxis and treatment of acute and chronic graft vs. host disease after haematopoietic stem cell (HSCT) transplantation. Our objective was to build and compare three independent Bayesian estimators of CsA area under the curve (AUC) using a limited sampling strategy (LSS), to assist in dose adjustment. The Bayesian estimators were developed using in parallel: two independent parametric modelling approaches (nonmem® and iterative two stage (ITS) Bayesian modelling) and the non-parametric adaptive grid method (Pmetrics®). Seventy-two full pharmacokinetic profiles (at pre-dose and 0.33, 0.66, 1, 2, 3, 4, 6, 8 and 12h after dosing) collected from 40 HSCT patients given CsA were used to build the pharmacokinetic models, while 15 other profiles (n = 7) were kept for validation. For each Bayesian estimator, AUCs estimated using the full profiles were compared with AUCs estimated using three samples. The pharmacokinetic profiles were well fitted using a two compartment model with first order elimination, combined with a gamma function for the absorption phase with ITS and Pmetrics or an Erlang distribution with nonmem. The derived Bayesian estimators based on a C0-C1 h-C4 h sampling schedule (best LSS) accurately estimated CsA AUC(0,12 h) in the validation group (n = 15; nonmem: bias (mean ± SD)/RMSE 2.05% ± 13.31%/13.02%; ITS: 4.61% ± 10.56%/11.20%; Pmetrics: 0.30% ± 10.12%/10.47%). The dose chosen confronting the three results led to a pertinent dose proposal. The developed Bayesian estimators were all able to predict ciclosporin AUC(0,12 h) in HSCT patients using only three blood with minimal bias and may be combined to increase the reliability of CsA dose adjustment in routine.Lire moins >
Lire la suite >Ciclosporin A (CsA) is used in the prophylaxis and treatment of acute and chronic graft vs. host disease after haematopoietic stem cell (HSCT) transplantation. Our objective was to build and compare three independent Bayesian estimators of CsA area under the curve (AUC) using a limited sampling strategy (LSS), to assist in dose adjustment. The Bayesian estimators were developed using in parallel: two independent parametric modelling approaches (nonmem® and iterative two stage (ITS) Bayesian modelling) and the non-parametric adaptive grid method (Pmetrics®). Seventy-two full pharmacokinetic profiles (at pre-dose and 0.33, 0.66, 1, 2, 3, 4, 6, 8 and 12h after dosing) collected from 40 HSCT patients given CsA were used to build the pharmacokinetic models, while 15 other profiles (n = 7) were kept for validation. For each Bayesian estimator, AUCs estimated using the full profiles were compared with AUCs estimated using three samples. The pharmacokinetic profiles were well fitted using a two compartment model with first order elimination, combined with a gamma function for the absorption phase with ITS and Pmetrics or an Erlang distribution with nonmem. The derived Bayesian estimators based on a C0-C1 h-C4 h sampling schedule (best LSS) accurately estimated CsA AUC(0,12 h) in the validation group (n = 15; nonmem: bias (mean ± SD)/RMSE 2.05% ± 13.31%/13.02%; ITS: 4.61% ± 10.56%/11.20%; Pmetrics: 0.30% ± 10.12%/10.47%). The dose chosen confronting the three results led to a pertinent dose proposal. The developed Bayesian estimators were all able to predict ciclosporin AUC(0,12 h) in HSCT patients using only three blood with minimal bias and may be combined to increase the reliability of CsA dose adjustment in routine.Lire moins >
Langue :
Anglais
Vulgarisation :
Non
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