Connections between average and individual bioequivalence

Authors
Munk, A
Citation
A. Munk, Connections between average and individual bioequivalence, STAT MED, 19(20), 2000, pp. 2843-2854
Citations number
34
Categorie Soggetti
Research/Laboratory Medicine & Medical Tecnology","Medical Research General Topics
Journal title
STATISTICS IN MEDICINE
ISSN journal
02776715 → ACNP
Volume
19
Issue
20
Year of publication
2000
Pages
2843 - 2854
Database
ISI
SICI code
0277-6715(20001030)19:20<2843:CBAAIB>2.0.ZU;2-X
Abstract
As pointed out by Anderson and Hauck and others, average bioequivalence doe s not guarantee that a patient, being on a drug, may switch to a different formulation. The consideration of individual bioequivalence was therefore s uggested. We investigate the relationship between these concepts and show h ow the standard test for average bioequivalence is related to the assessmen t of individual bioequivalence. This leads to a guide of when this test bec omes inappropriate. Copyright (C) 2000 John Wiley & Sons, Ltd.