Bioequivalence and Bioavailability Forum

Hi rocky,


Wow, 10.1 for the high strength and 10.3 for the others, that's creative thinking from your side

❝ My question is whether a three arm bio study (2.5mg x 4 vs 10mg (Test) vs 10mg (Ref) is acceptable on the above case and whether authorities allow to use two reference products (RMP & ERP) on the same DCP procedure?

That is likely your best try but you really are in a situation that is not covered in detail by EU guidelines. I imagine you are now in your clock-stop without time for a sc. advice? If authorities requested a biostudy then I guess you may have to do one unless you have very compelling reasons to believe they will back down. You could also just do 10 mg vs 10 mg initially, get approval for that and then do a line extension for the other strengths once you have thmbs up for the high strength. I think this would be a safer approach although I am sure your marketing folks will punch you in the face and tell you they want approval for everything here and now if you suggest that.
If you can then please give more details: API, reasons for other strengths, proposed 4.1 and 4.2 for the lower strengths, RMS, CMSs.
As regards the ERP/RMP issue I haven't understood it. Why is the ERP different from the RMP in your case?