title: Application of NONMEM method for evaluation of relative biological availability of ofloxacin.
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.
authors.affiliation: Department of Clinical Pharmacology, Changhai Hospital, China.
authors.forename: Z
authors.initials: Z
authors.lastname: Li
authors.forename: G
authors.initials: G
authors.lastname: Chen
authors.forename: H T
authors.initials: HT
authors.lastname: Zhuo
mesh_terms: D000328:Adult; D001682:Biological Availability; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D017711:Nonlinear Dynamics; D015242:Ofloxacin / Q000493:pharmacokinetics*; D012141:Respiratory Tract Infections / Q000378:metabolism; D014552:Urinary Tract Infections / Q000378:metabolism
chemical_list: D015242:Ofloxacin