Multicenter Study Of Amikacyn PK From Patients Under TDM.

A. Laffont(1), P. Girard(2), P. Maire(1), X. Barbaut(1), G. Chapelle, C. Pobel, T. Berod, C. Pivot, B. Lacarelle, J. Debord, R.W. Jelliffe, J.P. Boissel

(1)Hopital Antoine Charrial, Service Pharmacie, Lyon, (2)Unité de Pharmacologie Clinique, Hôpital Cardiologique, Lyon

Since 1988, the USC.PACK softwares have been used for TDM of Amikacyn, in various French Hospitals (Lyon, Marseille, Le Mans, Saintes, Papeete…). The data files from these hospitals have been gathered in order to be analysed using different population approach methods. This represents more than 630 patients, receiving I.V. Amikacyn repeatedly over a variable time period.

For each patient, the precise dosage history (time and amount of each I.V), a mean number of 4 levels per patient and the covariates age, sex, weight, eight, blood creatinin level, duration of the therapy and hospital have been recorded using the USC.PACK softwares. The data have been analysed using the single one compartment model with first order elimination ant the NONMEM software.

On a first step the FOCE method implemented in NONMEM has been used to estimate the statistical distribution of volume (V) and clearance (CL). The marginal distributions of volume and clearance appeared respectively multimodal.

On a second step the multivariate linear relationships between CL, V and the covariates have been investigated, using stepwise linear analysis.

On the third step, the full model has been fitted using the FO method. These NONMEM

Analysis and a preliminary non parametric analysis (NPEM) will be presented.

Reference: PAGE 2 (1993) Abstr 911 [www.page-meeting.org/?abstract=911]

Poster: oral presentation