Predictive performance of population pharmacokinetic parameters of tianeptine as applied to plasma concentrations from a post-marketing study

✍ Scribed by T. H. Grasela; J. B. Fiedler-Kelly; C. Salvadori; C. Marey; R. Jochemsen; H. Loo

• Book ID: 104719264
• Publisher: Springer
• Year: 1993
• Tongue: English
• Weight: 638 KB
• Volume: 45
• Category: Article
• ISSN: 0031-6970
• DOI: 10.1007/bf00315492

✦ Synopsis

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 data-base increases, but substantial variability in the prediction error remains.