Similarity Factor (f2) [Dissolution / BCS / IVIVC]

posted by joyjac – Philippines, 2006-10-06 02:26  – Posting: # 282
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There are instances when a better dissolution profile (on 12 units) is obtained for the test drug/generic than the reference-innovator drug, particularly, for BCS class II drugs (high permeability, low solubility) and BCS Class IV drugs (low permeability, low solubility). In some cases, the test drug achieved faster dissolution than the reference-innovator drug. Calculation of f2 value would also indicate that the 2 are not similar. Would you think it is alright to proceed with the BE testing even if the dissolution profile testing does not show similarity between the test and reference drug, f2 being lower than 50? Would there be a possibility that the test drug will show suprabioavailability? Potency assay showed uniformity among the tablets or capsules for both test and reference drug and within 90-110%. BTW, the drug in question is nifedipine, both test and reference are prepared as soft gel capsules.

Your thoughts on the above will be highly appreciated.

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