Assessing individual bioequivalence using the structural equation model
- 21 February 2003
- journal article
- research article
- Published by Wiley in Statistics in Medicine
- Vol. 22 (6), 901-912
- https://doi.org/10.1002/sim.1452
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.Keywords
This publication has 32 references indexed in Scilit:
- A practical approach for evaluating population and individual bioequivalenceStatistics in Medicine, 2000
- Measurement-Methods Comparisons and Linear Statistical RelationshipTechnometrics, 1999
- Some thoughts on individual bioequivalenceJournal of Biopharmaceutical Statistics, 1997
- Individual bioequivalence—a regulatory updateJournal of Biopharmaceutical Statistics, 1997
- On population and individual bioequivalenceStatistics in Medicine, 1993
- Consideration of individual bioequivalenceJournal of Pharmacokinetics and Biopharmaceutics, 1990
- The Nonexistence of 100$(1 - \alpha)$% Confidence Sets of Finite Expected Diameter in Errors-in-Variables and Related ModelsThe Annals of Statistics, 1987
- A comparison of the Two One-Sided Tests Procedure and the Power Approach for assessing the equivalence of average bioavailabilityJournal of Pharmacokinetics and Biopharmaceutics, 1987
- A Note on the Maximum Likelihood Estimation of a Linear Structural RelationshipJournal of the American Statistical Association, 1964
- On a Heuristic Method of Test Construction and its use in Multivariate AnalysisThe Annals of Mathematical Statistics, 1953