title: Sample size considerations for assessing individual bioequivalence based on the method of tolerance intervals.
abstract: This is the consideration of sample sizes for assessing individual bioequivalence based on the use of tolerance intervals. The sample size procedures discussed include a direct distribution-free method, indirect parametric method and a direct parametric method. Design considerations are discussed based on the results of the direct parametric method. Tables are provided for easy access of results.
authors.affiliation: Medical Data Sciences Department, Glaxo Inc., Research Triangle Park, North Carolina 27709.
authors.forename: J D
authors.initials: JD
authors.lastname: Esinhart
authors.forename: V M
authors.initials: VM
authors.lastname: Chinchilli
mesh_terms: D001682:Biological Availability; D008433:Mathematics; D010599:Pharmacokinetics; D011336:Probability; D013810:Therapeutic Equivalency