No way [Dissolution / BCS / IVIVC]
Dear yuvaneshwari,
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.
❝ 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
Regards
Ohlbe
Complete thread:
- BCS II waiver approach yuvaneshwari 2019-01-23 06:09 [Dissolution / BCS / IVIVC]
- No wayOhlbe 2019-01-27 18:18
- No way yuvaneshwari 2019-01-28 05:16
- No wayOhlbe 2019-01-27 18:18