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RegisterBioequivalence Waiver for Lower Strengths of a BCS Class IV Drug [Regulatives / Guidelines]
Dear Praveen!
It will be good to evaluate it based on dissolution and not just PK linearity/dose proportionality for lower strength Biowaiver.
Divyen
❝ Would it be acceptable to waive in vivo bioequivalence studies for the 60 mg and 80 mg strengths? Or, given the BCS Class IV designation, are BE studies still required for each individual strength?
It will be good to evaluate it based on dissolution and not just PK linearity/dose proportionality for lower strength Biowaiver.
Divyen
Complete thread:
- Bioequivalence Waiver for Lower Strengths of a BCS Class IV Drug praveen_mvln 2025-07-03 14:10 [Regulatives / Guidelines]
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Bioequivalence Waiver for Lower Strengths of a BCS Class IV Drugdshah 2025-07-07 11:07
- Bioequivalence Waiver for Lower Strengths of a BCS Class IV Drug praveen_mvln 2025-07-11 11:26
- Bioequivalence Waiver for Lower Strengths of a BCS Class IV Drugdshah 2025-07-07 11:07
Ing. Helmut Schütz