Advances and Applications in Statistics
Volume 6, Issue 1, Pages 71 - 85
(April 2006)
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BAYESIAN METHODS FOR BIOEQUIVALENCE STUDIES
Janelle S. Erickson (U. S. A.), James D. Stamey (U. S. A.) and John W. Seaman (U. S. A.)
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Abstract: Bioequivalence studies focus on determining if drug formulations are therapeutically equivalent. This is important, for example, in the development of generic drugs. Once a brand-name drug goes off patent, other pharmaceutical companies can develop and market a generic drug provided they can demonstrate that the two drug formulations are bioequivalent. More recently, there has been concern about the interchangeability of brand name drugs and generic drugs for use in a given patient. We present a new Bayesian approach for assessing individual bioequivalence that can accommodate several models of bioequivalence. |
Keywords and phrases: bioequivalence, Bayesian, intrasubject correlation, subject-by-treatment interaction. |
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