No way [Dissolution / BCS / IVIVC]

posted by Ohlbe – France, 2019-01-27 17:18 (673 d 12:03 ago) – Posting: # 19813
Views: 1,591

Dear yuvaneshwari,

» Since API is in solution state filled in capsule, its solubility/bioavailability is improved tremendously.

» In the above scenario, can we consider for BCS based waiver approach ?

I think you have answered your own question. If solubility is the limiting factor, and your product has an improved solubility compared to the reference, how could you justify any kind of biowaiver ?

In any case: BCS-based biowaivers are only possible for class I and III products. Not the slightest chance if you're dealing with class II or IV.

Regards
Ohlbe

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