Fallacies on bioequivalence

Many experts have stated certain opinions concerning bioavailability problems as if they were facts in order to promote entirely different 

Fallacy 3 In vitro rate of dissolution tests can disclose differences in bioavailabiiity and/or therapeutic effects without paraiiei data on the same drug products in human. It has been possible with some drug products to correlate results of in vitro rate of dissolution tests with results attained in human. However, in vitro rate of dissolution tests alone, without data in humans, will tell us nothing with respect to what may happen in humans. 

Fallacy 4 Bioavailabiiity must always be related to pharmacological effects or clinical response. The definition of bioavailabiiity, provided by the American Pharmaceutical Association says 

Toble7.7 Evidence of generic bioinequivalence for certain formulations approved by FDA  

Trade name Generic Class Problem Reference 

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