BCS II waiver approach [Dissolution / BCS / IVIVC]
Dear All,
Drug compound is BCS-II [dosage form is solution filled in capsule], and objective is to formulate with Q1 & Q2 sameness to that of Reference. 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 ?
Drug compound is BCS-II [dosage form is solution filled in capsule], and objective is to formulate with Q1 & Q2 sameness to that of Reference. 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 ?
Complete thread:
- BCS II waiver approachyuvaneshwari 2019-01-23 06:09 [Dissolution / BCS / IVIVC]