Statistical tests for multivariate bioequivalence

Although the U.S. Food and Drug Administration (FDA, 1992) recommends testing bioequivalence of individual pharmacokinetic parameters one at a time, it seems reasonable and interesting to conduct a test simultaneously for all the parameters. In this paper, we discuss several ways to construct such t...

Full description

Saved in:
Bibliographic Details
Published in:Biometrika 1999-06, Vol.86 (2), p.395-402
Main Authors: Wang, W, Gene Hwang, JT, Dasgupta, A
Format: Article
Language:English
Subjects:
Applications
Bioequivalence
Brand name drugs
Brand names
Confidence set
Coordinate systems
Crossovers
Cubes
Degrees of freedom
Exact sciences and technology
Gaussian distributions
Hypotheses
Intersection-union method
Likelihood-ratio test
Mathematics
Medical sciences
Multivariate analysis
Normal distribution
Null hypothesis
Numerical analysis
Power functions
Probability and statistics
Sciences and techniques of general use
Standard deviation
Statistics
Therapeutic equivalency
Citations: Items that cite this one
Online Access:Get full text
Tags: Add Tag
No Tags, Be the first to tag this record!
Description
Summary:Although the U.S. Food and Drug Administration (FDA, 1992) recommends testing bioequivalence of individual pharmacokinetic parameters one at a time, it seems reasonable and interesting to conduct a test simultaneously for all the parameters. In this paper, we discuss several ways to construct such tests. It is shown that the confidence set approach leads to a test which can be uniformly improved by the intersection of Schuirmann's two one-sided tests procedure. The latter test can further be improved upon noticeably by using the one-dimensional unbiased test of Brown, Hwang & Munk (1997). Numerical calculations of powers are given to support this claim.
ISSN:0006-3444
1464-3510
DOI:10.1093/biomet/86.2.395