Bioequivalence and Bioavailability Forum

Dear BEBAC team,

Do you have experience with biowaivers and ICH M9 guideline?
When the M9 guidance mentions that we should have a formulation "qualitatively the same and quantitatively similar", especially for BCS class III drugs, how should be the quantitative formulation of the RLD justified? Is literature data enough, or do we need reverse engineering - and in this case, what is the level required (Q2 or Q3)? Only one method for each attribute or orthogonal analysis required?

This is not easy for some specific formulations, and the M9 is not clear in these requirements.

Thanks in advance for sharing your experience!

Kind regards,
Marta