Interval estimation for ratios in bioequivalence trials

Journal Article (Journal Article)

The problem for assessment of equivalence in variability of bioavailability between two drug products is considered. An exact confidence region for the ratio between intrasubject variabilities is derived when the intersubject variance is known. When the intersubject variance is unknown, a large sample approximation is considered. The proposed method for assessing equivalence in variability of bioavailability appears to be asymptotically uncorrelated with the sample mean ratio for average bioavailabilty. As a result, the proposed method in conjunction with the sample mean ratio method can be utilized for assessing population bioequivalence. An example concerning a bioequivalence trial with 24 healthy volunteers is presented to illustrate the proposed method.

Full Text

Duke Authors

Cited Authors

  • Chen, KW; Li, G; Sun, Y; Chow, SC

Published Date

  • January 1, 1997

Published In

Volume / Issue

  • 39 / 8

Start / End Page

  • 989 - 1002

International Standard Serial Number (ISSN)

  • 0323-3847

Digital Object Identifier (DOI)

  • 10.1002/bimj.4710390809

Citation Source

  • Scopus