This article discusses fluoxetine serum concentrations as displayed in a cl
inical setting. A racemic serum fluoxetine and norfluoxetine high-performan
ce liquid chromatography method, including ultraviolet light detection, was
used for routine therapeutic drug monitoring (TDM) purposes. In all, 508 s
amples were analyzed. For the scientific investigation, predefined inclusio
n and exclusion criteria were applied and 150 samples representative of tro
ugh values in steady-stale conditions with essential clinical information p
rovided on the assay request forms were evaluated, Fluoxetine plus norfluox
etine concentration-to-dose (C/D) ratio showed Gaussian distribution. Inter
individual coefficients of variation of fluoxetine and norfluoxetine serum
concentrations after different doses were found to be 40-63%. Intraindividu
al fluoxetine TDM variability was low. The Spearman rank correlation coeffi
cient for fluoxetine and norfluoxetine C/D ratios in first and second sampl
es was 0.68. Minor increases in norfluoxetine C/D and fluoxetine plus norfl
uoxetine C/D ratios were found in elderly patients compared with younger ad
ult patients. A higher body-mass index was associated with minor decreases
in fluoxetine and fluoxetine plus norfluoxetine C/D ratios. New fluoxetine
pharmacokinetic data are added to the results from earlier phases of drug d
evelopment. Moreover, the results of this study support the usefulness of a
fluoxetine TDM procedure for individual dose optimization, detection of dr
ug interactions, and assessments of patient compliance.