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Population pharmacokinetic meta-analysis of vortioxetine in healthy individuals.

Areberg J, Petersen KB, Chen G, Naik H - Basic Clin. Pharmacol. Toxicol. (2014)

Bottom Line: CYP2D6 inferred metabolic status (ultra, extensive, intermediate or poor metabolisers) and age on oral clearance and height on central volume of distribution were identified as statistically significant covariate-parameter relationships.The final model was found to be reliable, stable and predictive.A reliable, stable and predictive pharmacokinetic model was developed to characterise pharmacokinetics of vortioxetine in the healthy population.

View Article: PubMed Central - PubMed

Affiliation: Division of Clinical and Quantitative Pharmacology, H. Lundbeck A/S, Valby, Denmark.

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Visual predictive check (VPC) plot for the final population pharmacokinetic model for vortioxetine in healthy individuals. Dose-normalised observed data (dots) and median, 2.5% and 97.5% percentiles for simulated data (solid lines) and dose-normalised observed data (dotted lines) are shown. The insert shows the first 20 hr after dosing.
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fig05: Visual predictive check (VPC) plot for the final population pharmacokinetic model for vortioxetine in healthy individuals. Dose-normalised observed data (dots) and median, 2.5% and 97.5% percentiles for simulated data (solid lines) and dose-normalised observed data (dotted lines) are shown. The insert shows the first 20 hr after dosing.

Mentions: The eta shrinkages for the final model were 22% (ka), 16% (V2/F) and 2% (CL/F). Epsilon shrinkage was 4%. According to the rule-of-thumb of 20–30% 12, a small degree of shrinkage was only found for ka. The VPC plot (fig. 5) showed that the observed values lay within the 95% confidence intervals. The estimated NPDE values followed an N(0,1) distribution.


Population pharmacokinetic meta-analysis of vortioxetine in healthy individuals.

Areberg J, Petersen KB, Chen G, Naik H - Basic Clin. Pharmacol. Toxicol. (2014)

Visual predictive check (VPC) plot for the final population pharmacokinetic model for vortioxetine in healthy individuals. Dose-normalised observed data (dots) and median, 2.5% and 97.5% percentiles for simulated data (solid lines) and dose-normalised observed data (dotted lines) are shown. The insert shows the first 20 hr after dosing.
© Copyright Policy - open-access
Related In: Results  -  Collection

License
Show All Figures
getmorefigures.php?uid=PMC4257570&req=5

fig05: Visual predictive check (VPC) plot for the final population pharmacokinetic model for vortioxetine in healthy individuals. Dose-normalised observed data (dots) and median, 2.5% and 97.5% percentiles for simulated data (solid lines) and dose-normalised observed data (dotted lines) are shown. The insert shows the first 20 hr after dosing.
Mentions: The eta shrinkages for the final model were 22% (ka), 16% (V2/F) and 2% (CL/F). Epsilon shrinkage was 4%. According to the rule-of-thumb of 20–30% 12, a small degree of shrinkage was only found for ka. The VPC plot (fig. 5) showed that the observed values lay within the 95% confidence intervals. The estimated NPDE values followed an N(0,1) distribution.

Bottom Line: CYP2D6 inferred metabolic status (ultra, extensive, intermediate or poor metabolisers) and age on oral clearance and height on central volume of distribution were identified as statistically significant covariate-parameter relationships.The final model was found to be reliable, stable and predictive.A reliable, stable and predictive pharmacokinetic model was developed to characterise pharmacokinetics of vortioxetine in the healthy population.

View Article: PubMed Central - PubMed

Affiliation: Division of Clinical and Quantitative Pharmacology, H. Lundbeck A/S, Valby, Denmark.

Show MeSH