Predictive performance of population pharmacokinetic parameters of tianeptine as applied to plasma concentrations from a post-marketing study |
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Authors: | T H Grasela J B Fiedler-Kelly C Salvadori C Marey R Jochemsen H Loo |
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Affiliation: | (1) Center for Pharmacoepidemiology Research, University at Buffalo, Buffalo, New York, USA;(2) I.R.I.S., Courbevoie, France;(3) Service Hospitalo-Universitaire de Sante Mentale et de Therapeutique, Hospital Sainte Anne, Paris, France;(4) Department of Pharmacy, SUNY at Buffalo, 319 Cooke Hall, 14260 Buffalo, NY, USA |
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Abstract: | Summary The predictive ability of population pharmacokinetic parameters of tianeptine, obtained from a mixed effect analysis of pre-marketing pharmacokinetic studies, was evaluated using tianeptine plasma concentrations obtained during a large multi-center post-marketing surveillance study.The mean prediction error was 7.8 ng·ml–1 and the root mean square prediction error was 52.1 ng/ml when initial estimates of population pharmacokinetic parameters were used to predict drug concentrations in one half of the post-marketing data. When the population parameters were revised to reflect the data collected in the first half of the post-marketing study, the mean prediction error was reduced to –3.2 ng·ml–1 and the root mean square prediction error was reduced to 29.5 ng·ml–1.These results suggest that population pharmacokinetic parameters obtained from pre-marketing data may not accurately predict drug concentrations in patients receiving the drug in the post-marketing setting. Once the population parameters are updated to reflect data from the post-marketing period, the predictive ability of the database increases, but substantial variability in the prediction error remains. |
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Keywords: | Tianeptine anti-depressant population pharmacokinetic prediction error |
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