title: Predictive performance of population pharmacokinetic parameters of tianeptine as applied to plasma concentrations from a post-marketing study.
abstract: 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.
authors.affiliation: Center for Pharmacoepidemiology Research, University at Buffalo, New York.
authors.forename: T H
authors.initials: TH
authors.lastname: Grasela
authors.forename: J B
authors.initials: JB
authors.lastname: Fiedler-Kelly
authors.forename: C
authors.initials: C
authors.lastname: Salvadori
authors.forename: C
authors.initials: C
authors.lastname: Marey
authors.forename: R
authors.initials: R
authors.lastname: Jochemsen
authors.forename: H
authors.initials: H
authors.lastname: Loo
mesh_terms: D000293:Adolescent; D000328:Adult; D000929:Antidepressive Agents, Tricyclic / Q000097:blood* / Q000493:pharmacokinetics; D005260:Female; D006801:Humans; D008297:Male; D017891:Pharmacoepidemiology; D011237:Predictive Value of Tests; D011358:Product Surveillance, Postmarketing; D013841:Thiazepines / Q000097:blood* / Q000493:pharmacokinetics; D013997:Time Factors
chemical_list: D000929:Antidepressive Agents, Tricyclic; D013841:Thiazepines; C050504:tianeptine