A Simulation Study to Evaluate Limited Sampling Strategies to Estimate Area under the Curve of Drug Concentration versus Time Following Repetitive Oral Dosing: Limited Sampling Model versus Naive Trapezoidal Method

2009 ◽  
Vol 32 (8) ◽  
pp. 1486-1490 ◽  
Author(s):  
Yuichiro Kayano ◽  
Isao Horiuchi ◽  
Yun-i Mori ◽  
Kazuya Ishida ◽  
Tomohisa Saito ◽  
...  
2009 ◽  
Vol 31 (5) ◽  
pp. 585-591 ◽  
Author(s):  
Brenda C M de Winter ◽  
Teun van Gelder ◽  
Ron A A Mathot ◽  
Petra Glander ◽  
Helio Tedesco-Silva ◽  
...  

2008 ◽  
Vol 27 (3) ◽  
pp. 325-328 ◽  
Author(s):  
Lillian S.L. Ting ◽  
Nilufar Partovi ◽  
Robert D. Levy ◽  
Andrew P. Ignaszewski ◽  
Mary H.H. Ensom

2015 ◽  
Vol 36 (7) ◽  
pp. 417-428 ◽  
Author(s):  
Sarem Sarem ◽  
Fahima Nekka ◽  
Iman Saad Ahmed ◽  
Catherine Litalien ◽  
Jun Li

2021 ◽  
Vol 14 (2) ◽  
pp. 162
Author(s):  
Félicien Le Louedec ◽  
Fanny Gallais ◽  
Fabienne Thomas ◽  
Mélanie White-Koning ◽  
Ben Allal ◽  
...  

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.


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