VETERINARY DRUG BIOEQUIVALENCE DETERMINATION

A bioequivalence trial is a statistically based comparison of two form ulations to demonstrate with a controlled consumer (patient) risk that two formulated drug products are interchangeable. The basic assumptio n underlying a bioequivalence trial is that essentially the same plasm a time-course leads to essentially the same effect allowing two formul ations to be interchanged, Bioequivalence is generally assessed using kinetic end points and in practice, two formulations in which bioavail ability parameters (rate and extent) differ by 20% or less, with a 90% degree of confidence, are considered to be bioequivalent, In this rev iew, the design and evaluation of bioequivalence studies are presented with special attention given to scientific issues.