TOLERANCE INTERVALS FOR ASSESSING INDIVIDUAL BIOEQUIVALENCE

Authors
BROWN EB IYER HK WANG CM
Citation
Eb. Brown et al., TOLERANCE INTERVALS FOR ASSESSING INDIVIDUAL BIOEQUIVALENCE, Statistics in medicine, 16(7), 1997, pp. 803-820
Citations number
28
Categorie Soggetti
Statistic & Probability","Medicine, Research & Experimental","Public, Environmental & Occupation Heath","Statistic & Probability","Medical Informatics
Journal title
Statistics in medicine → ACNP
ISSN journal
02776715
Volume
16
Issue
7
Year of publication
1997
Pages
803 - 820
Database
ISI
SICI code
0277-6715(1997)16:7<803:TIFAIB>2.0.ZU;2-U
Abstract
Evaluation of equivalence of two formulations of a drug typically enta ils the comparison of average bioavailabilities. Recently, however, au thors have become aware that this may be insufficient to assess indivi dual bioequivalence, that is, interchangeability of formulations on an individual basis. This paper outlines a tolerance interval procedure to assess individual bioequivalence based on a model that includes a s ubject by formulation interaction. We give methods for several higher- order cross-over designs along with examples. (C) 1997 by John Wiley & Sons, Ltd.