An Optimal Solution to Bioequivalence Problem

Abstract

n recent years, many generic drug products become •.•. available in the drug market, but are these generic products have the same quality, safety,

... and efficacy as their brand- name products?! Bioequivalence testing could provide an answer to the former question. • The problem of exhibiting the equivalence of two formulations has been examined using several approaches during the last decade. Different designs, criteria, models, and testing have been used. The proposed dissertation presents three different approaches for the assessment of bioequivalence between the generic and the brand-name drug products. The first is a test for bioequivalence using coefficient of variation. The second is a statistical algorithmic approach for bioequivalence assessment. And the third is a mathematical programming approach for average bioequivalence testing. Neither of them relies on any impractical assumption, and all of them give essential information about the analyzed data. Furthermore, the required computations for any of them are simple. However, the use of the first approach is recommended when the Inverse Gaussian distribution could be assumed to be the probability distribution of the data under consideration. And in the case of having a too