Quality generic products without bioequivalence (BE) assessment – a simple and practical approach!

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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