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The Total Least Squares Method in Individual Bioequivalence Evaluation
Author(s) -
Dragalin Vladimir,
Fedorov Valerii
Publication year - 2001
Publication title -
biometrical journal
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.108
H-Index - 63
eISSN - 1521-4036
pISSN - 0323-3847
DOI - 10.1002/1521-4036(200108)43:4<399::aid-bimj399>3.0.co;2-w
Subject(s) - bioequivalence , simple (philosophy) , statistics , mathematics , class (philosophy) , confidence interval , series (stratigraphy) , generalized least squares , least squares function approximation , statistical hypothesis testing , basis (linear algebra) , point (geometry) , computer science , algorithm , mathematical optimization , artificial intelligence , estimator , paleontology , bioinformatics , philosophy , geometry , epistemology , biology , bioavailability
We propose a simple method for comparison of series of matched observations. While in all our examples we address “individual bioequivalence” (IBE), which is the subject of much discussion in pharmaceutical statistics, the methodology can be applied to a wide class of cross‐over experiments, including cross‐over imaging. From the statistical point of view the considered models belong to the class of the “error‐in‐variables” models. In computational statistics the corresponding optimization method is referred to as the “least squares distance” and the “total least squares” method. The derived confidence regions for both intercept and slope provide the basis for formulation of the IBE criteria and methods for its assessing. Simple simulations show that the proposed approach is very intuitive and transparent, and, at the same time, has a solid statistical and computational background.