Considering the weakness (non-specificity) of BE assessments it is suggested that in vitro drug dissolution/release testing would provide a better alternative to establish quality of pharmaceutical products such as tablet and capsule. It is argued that the use of in vitro dissolution test should be the method of choice for developing and monitoring improved or better quality generic products because BE assessment focuses only on equivalence and not on the improvement of the product quality. Other significant advantages of using an appropriate in vitro dissolution test in lieu of BE assessment are described..
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A bioequivalence study is conducted in humans to establish that two or more products are capable of providing same/similar blood/plasma drug levels. Underlying assumption is that if the products provide same plasma drug levels then their therapeutic effects would be the same as well, thus would allow interchangeability of the products such as the generics.

Therefore, for all practical purposes the bioequivalence assessment may be considered as a typical analytical chemistry test where the assessment is based on determining plasma levels. For conducting an appropriate and accurate analytical test, the test must follow some fundamental principles of analytical tests such as specificity and its validation (accuracy, precision and reproducibility). A test cannot be validated if it is not specific.

In this regard, a bioequivalence test is a non-specific test as plasma drug levels include (confounded) variabilities from stomach emptying/motility and liver metabolism of the drug – independent of the product characteristics. Therefore, caution is warranted in establishing quality of the test products based on the bio-equivalence test.

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Consideration should be given for simplicity and appropriate regulatory involvement as current practices and requirements certainly appear anti-innovation as well as making products less accessible and expensive to buy. For further discussion on the topic please follow the links (1, 2, 3).