Limited Sampling Strategy for Determination of Ibrutinib Plasma Exposure: Joint Analyses with Metabolite Data
Therapeutic drug monitoring of ibrutinib is based on the area under the curve of concentration vs. time (AUC<sub<IBRU</sub<) instead of trough concentration (C<sub<min,ss</sub<) because of a limited accumulation in plasma. Our objective was to identify a limited sampling strategy (LSS) to estimate AUC<sub<IBRU</sub< associated with Bayesian estimation. The actual AUC<sub<IBRU</sub< 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 AUC<sub<IBRU</sub< 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 AUC<sub<IBRU</sub< and C<sub<min,ss</sub< was poor (<i<r</i<<sup<2</sup< = 0.25). The joint analysis of dihydrodiol-ibrutinib metabolite concentrations did not improve the predictive performance of AUC<sub<IBRU</sub<. These results were confirmed in a prospective validation cohort (<i<n</i< = 27 patients). At least three samples, within the pre-dose and 4 h post-dose period, are necessary to estimate ibrutinib exposure accurately..
| Medienart: |
E-Artikel |
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| Erscheinungsjahr: |
2021 |
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| Erschienen: |
2021 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:14 |
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| Enthalten in: |
Pharmaceuticals - 14(2021), 2, p 162 |
| Sprache: |
Englisch |
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| Beteiligte Personen: |
Félicien Le Louedec [VerfasserIn] |
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| Links: |
doi.org [kostenfrei] |
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| Themen: |
Bayesian analysis |
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| doi: |
10.3390/ph14020162 |
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| funding: |
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| Förderinstitution / Projekttitel: |
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| PPN (Katalog-ID): |
DOAJ058721975 |
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| 520 | |a Therapeutic drug monitoring of ibrutinib is based on the area under the curve of concentration vs. time (AUC<sub<IBRU</sub<) instead of trough concentration (C<sub<min,ss</sub<) because of a limited accumulation in plasma. Our objective was to identify a limited sampling strategy (LSS) to estimate AUC<sub<IBRU</sub< associated with Bayesian estimation. The actual AUC<sub<IBRU</sub< 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 AUC<sub<IBRU</sub< 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 AUC<sub<IBRU</sub< and C<sub<min,ss</sub< was poor (<i<r</i<<sup<2</sup< = 0.25). The joint analysis of dihydrodiol-ibrutinib metabolite concentrations did not improve the predictive performance of AUC<sub<IBRU</sub<. These results were confirmed in a prospective validation cohort (<i<n</i< = 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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