Bioequivalence and Bioavailability Forum

Dear Marta,

❝ Do you have experience with biowaivers and ICH M9 guideline?

Many do have experience.

❝ 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?

When we are taking about biowaiver- mainly its for IR solid orals. and thus Q3 doesn't apply like for creams/gels/complex generic products.
Yes, indirectly reverse engineering is required and then CC/meeting with regulatory agency to confirm the similarity for Q1/Q2 could be one of the way.
Regards,
DShah