Bioequivalence and Bioavailability Forum

praveen_mvln
☆

India,
2025-07-03 16:10
(7 d 11:13 ago)

Posting: # 24405
Views: 222

Bioequivalence Waiver for Lower Strengths of a BCS Class IV Drug [Regulatives / Guidelines]

Hello Everyone,

I hope this message finds all well.

I have a query regarding the possibility of waiving in vivo bioequivalence studies for lower strengths of a drug classified as BCS Class IV.

The molecule in question is available in three strengths: 60 mg, 80 mg, and 100 mg. Assuming that:
– The 60 mg and 80 mg strengths are proportionally similar in formulation to the 100 mg strength, and
– The drug demonstrates linear pharmacokinetics over the relevant dose range,

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?

Your guidance on this matter would be greatly appreciated

Many Thanks
Praveen Kumar

Edit: Subject line shortened. [Helmut]

dshah ★★ India, 2025-07-07 13:07 (3 d 14:16 ago) @ praveen_mvln Posting: # 24407 Views: 122	Bioequivalence Waiver for Lower Strengths of a BCS Class IV Drug Post reply
	Dear Praveen! ❝ 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

Bio­equi­va­lence Waiver for Lower Strengths of a BCS Class IV Drug [Regulatives / Guidelines]

Bio­equi­va­lence Waiver for Lower Strengths of a BCS Class IV Drug

Bioequivalence Waiver for Lower Strengths of a BCS Class IV Drug [Regulatives / Guidelines]

Bioequivalence Waiver for Lower Strengths of a BCS Class IV Drug