Considering the weakness (non-specificity) of BE assessments, it is suggested that in vitro drug dissolution/release testing would provide a better alternative to establishing the quality of pharmaceutical products such as tablets and capsules. It is argued that using in vitro dissolution tests 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 improving the product quality. Other significant advantages of using an appropriate in vitro dissolution test in place of BE assessment are described.
For a further detailed explanation, please follow the link.