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Assessing individual bioequivalence using the structural equation model
Author(s) -
Carrasco JosepLluís,
Jover Lluís
Publication year - 2003
Publication title -
statistics in medicine
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.996
H-Index - 183
eISSN - 1097-0258
pISSN - 0277-6715
DOI - 10.1002/sim.1452
Subject(s) - bioequivalence , equivalence (formal languages) , structural equation modeling , econometrics , intersection (aeronautics) , statistics , mathematics , maximum likelihood , statistical hypothesis testing , computer science , medicine , pharmacokinetics , engineering , aerospace engineering , discrete mathematics
Abstract The structural equation model (SEM) is introduced as a useful approach for assessing individual bio‐equivalence. SEM parameters are estimated using a partial likelihood analysis and the hypotheses of individual bioequivalence is evaluated in a disaggregate way, testing separately the hypothesis concerning SEM parameters, and assessing the overall hypothesis of individual bioequivalence using the intersection‐union principle. Limits of bioequivalence for SEM parameters are proposed and a power analysis is carried out. Copyright © 2003 John Wiley & Sons, Ltd.