Bioequivalence and Bioavailability Forum

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

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Edit: Subject line shortened. [Helmut]