Eliane Fuseau(1), Sally Lettis(2) and Larry Lacey(1)
(1) Clinical pharmacokinetic department, (2)Medical statistics department, Glaxo Group Research Limited Greenford road, Greenford, Middlesex, UB6 OHE
Two simulated population pharmacokinetic data sets were generated in order to compare and evaluate the robustness of different population methods.
The first dataset comprises 100 subjects (half females). All subjects received the same single dose. Five blood samples were taken from each subject over a 16 hours collection interval. The pharmacokinetic model used for simulation was a one compartment model with first order rate of absorption.
The second dataset is more of the “population type”. It comprises 200 patients from two clinical trials whose data are appended. In one trial, patients received one of three oral doses whereas in the second trial patients received an intravenous dose followed by repeated oral administration for a period of time. One to three samples were taken from each subject. The simulations assumed a two compartment model. In both datasets, available covariates are sex, weight, height, age and serum creatinine.
The objective is to estimate population model parameters (fixed and random effects), and assess the influence of the covariates. Both datasets will be available on disquettes to those interested in participating in this exercise.
Reference: PAGE 2 () Abstr 905 [www.page-meeting.org/?abstract=905]
Poster: oral presentation