scholarly journals Therapeutic Drug Monitoring of Micophenolate Mofetil in Cardiac Transplant Patients by Limited Sampling Strategy: An Update

2019 ◽  
Author(s):  
Massimo Baraldo ◽  
Sandro Sponga ◽  
Ugolino Livi
Keyword(s):  
Therapeutic Drug Monitoring ◽  
Drug Monitoring ◽  
Sampling Strategy ◽  
Limited Sampling Strategy ◽  
Therapeutic Drug ◽  
Cardiac Transplant ◽  
Transplant Patients ◽  
Limited Sampling

scholarly journals Limited Sampling Strategy for Determination of Ibrutinib Plasma Exposure: Joint Analyses with Metabolite Data

2021 ◽  
Vol 14 (2) ◽  
pp. 162
Author(s):  
Félicien Le Louedec ◽  
Fanny Gallais ◽  
Fabienne Thomas ◽  
Mélanie White-Koning ◽  
Ben Allal ◽  
...  
Keyword(s):  
Area Under The Curve ◽  
Sampling Strategy ◽  
Predictive Performance ◽  
Pharmacokinetic Profile ◽  
Limited Sampling Strategy ◽  
Joint Analysis ◽  
Therapeutic Drug ◽  
Post Dose ◽  
Limited Sampling ◽  
Three Samples

Therapeutic drug monitoring of ibrutinib is based on the area under the curve of concentration vs. time (AUCIBRU) instead of trough concentration (Cmin,ss) because of a limited accumulation in plasma. Our objective was to identify a limited sampling strategy (LSS) to estimate AUCIBRU associated with Bayesian estimation. The actual AUCIBRU of 85 patients was determined by the Bayesian analysis of the full pharmacokinetic profile of ibrutinib concentrations (pre-dose T0 and 0.5, 1, 2, 4 and 6 h post-dose) and experimental AUCIBRU were derived considering combinations of one to four sampling times. The T0–1–2–4 design was the most accurate LSS (root-mean-square error RMSE = 11.0%), and three-point strategies removing the 1 h or 2 h points (RMSE = 22.7% and 14.5%, respectively) also showed good accuracy. The correlation between the actual AUCIBRU and Cmin,ss was poor (r2 = 0.25). The joint analysis of dihydrodiol-ibrutinib metabolite concentrations did not improve the predictive performance of AUCIBRU. These results were confirmed in a prospective validation cohort (n = 27 patients). At least three samples, within the pre-dose and 4 h post-dose period, are necessary to estimate ibrutinib exposure accurately.

Therapeutic drug monitoring of tacrolimus in pediatric liver transplant patients

2001 ◽  
Vol 5 (2) ◽  
pp. 119-124 ◽  
Author(s):  
Gordon D. MacFarlane ◽  
Raman Venkataramanan ◽  
Sue V. McDiarmid ◽  
John D. Pirsch ◽  
Daniel G. Scheller ◽  
...  
Keyword(s):  
Therapeutic Drug Monitoring ◽  
Liver Transplant ◽  
Drug Monitoring ◽  
Therapeutic Drug ◽  
Transplant Patients ◽  
Pediatric Liver ◽  
Pediatric Liver Transplant

Evaluation of Existing Limited Sampling Models for Therapeutic Drug Monitoring of Busulphan in Children and Adults Undergoing SCT.

Blood ◽  
2004 ◽  
Vol 104 (11) ◽  
pp. 1150-1150
Author(s):  
Zuzana Hassan ◽  
Marie Sandström ◽  
Moustapha Hassan
Keyword(s):  
Therapeutic Drug Monitoring ◽  
Drug Monitoring ◽  
Conditioning Regimen ◽  
Trapezoidal Rule ◽  
Therapeutic Window ◽  
Therapeutic Drug ◽  
High Dose ◽  
Time Interval ◽  
Suitable Model ◽  
Limited Sampling

Abstract Busulphan (Bu) is used in high dose conditioning regimen prior to stem cell transplantation. Bu has a narrow therapeutic window and over- and under-dosing may have a fatal outcome. Bu pharmacokinetics and pharmacodynamics were extensively studied and wide inter- and intra-individual variation was found. Several limited sampling models (LSM) have been developed for Bu administered orally to simplify therapeutic drug monitoring and consequently dose adjustment. The aim of this study was to evaluate the existing LSM in adults and children undergoing conditioning regimen before SCT. Seventy-four patients (62 adults and 12 children) with malignant and non-malignant diseases were analysed. Plasma was sampled at 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5 and 6 hours after the first dose of Bu. Bu was determined using gas chromatography with electron capture detection. The area under the plasma concentration-time curve (AUC) for time interval 0 to 6 hours was determined using Winnonlin program and trapezoidal rule. Results were compared to the estimated AUCs using LSMs (Vassal 1992, Schuler 1994, Hassan 1996, Chatergoon 1997). The best correlation between the AUCs determined using trapezoidal rule and 3-points model by Schuler was found (R²=0.95 for all patients, R²=0.97 for children and R²=0.94 for adults). In children, a correlation between AUCs determined with trapezoidal rule and following LSMs was found: 2-points LSM by Schuler (R²=0.94), LSM by Hassan (R²=0.94), LSM by Vassal (R²=0.81) and 3 of 5 LSMs by Chatergoon (R²=0.85, 0.88 and 0.87, resp.). AUCs in children determined using Winnonlin showed good correlation with both Schuler’s models, model by Hassan and one of 4-points models by Chatergoon. However, the correlation between the AUCs determined using trapezoidal rule and Winnonlin was good in children (R²=0.98), but not in adults (R²=0.65). Thus, several limited sampling models are suitable for AUC estimation in children, while there is only one suitable model for adults. This conclusion is made with reservation that even the trapezoidal rule may underestimate the real AUC dependent on sampling density.

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