Bioequivalence and Bioavailability Forum

Dear Samaya

❝ ANVISA accepts SABE design for highly variable drug products.

Not always. There have been cases where full study data along with the published information of higher variability >30% has been shared with ANVISA and they straight forward rejected it saying that they have sufficient information/study data with them which suggest that the product passed is not highly variable and asked us to do the same.

❝ We have recently submitted a protocol for a HVDP using full replicated design for ANVISA review. Along with a protocol, you can submit literature references showing >30% ISCV.

You just got lucky!!!! That's all I will say as per my interaction with ANVISA. They are tough nut to crack!!

❝ Widening criteria for confidence interval remained same as that of EU guidance.

Does this mean that widening given only for Cmax and max limit will be 69-143?
Any specific reason behind it?