Application of NONMEM method for evaluation of relative biological availability of ofloxacin

Zhongguo Yao Li Xue Bao. 1994 Jan;15(1):39-42.

Abstract

The nonlinear mixed effect model (NONMEM) method for analysis of population pharmacokinetics, was applied to evaluate the relative biological availability of 2 ofloxacin (Ofl) products. The data of randomized crossover study of 2 kinds of Ofl tablets in 12 healthy volunteers were analyzed by NONMEM, as well as standard approach. The relative biological availability evaluated by NONMEM (F = 97.3 +/- 5.0%) was close to that by standard approach (F = 98.2 +/- 3.6%). NONMEM was also valid in accurately evaluating the relative biological availability using sparse clinical data (F = 91.7 +/- 8.0%) which could not be analyzed by standard approach. Thus, the usefulness and advantages of NONMEM were ascertained for the evaluation of biological availability using observational or experimental data.

Publication types

  • Clinical Trial
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Biological Availability
  • Female
  • Humans
  • Male
  • Middle Aged
  • Nonlinear Dynamics
  • Ofloxacin / pharmacokinetics*
  • Respiratory Tract Infections / metabolism
  • Urinary Tract Infections / metabolism

Substances

  • Ofloxacin