Sample size considerations for assessing individual bioequivalence based on the method of tolerance intervals.
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.
Esinhart
J D
JD
Medical Data Sciences Department, Glaxo Inc., Research Triangle Park, North Carolina 27709.
Chinchilli
V M
VM
D001682:Biological Availability; D008433:Mathematics; D010599:Pharmacokinetics; D011336:Probability; D013810:Therapeutic Equivalency