Bioequivalence and Bioavailability Forum

Hi Mikkabel,

❝ Furthermore, as I mentioned in a previous post the rationale to use two different batches of the reference product is to demonstrate that the reference product is variable from batch to batch and maybe not BE between them. The idea was to take two batches presenting two different profile in-vitro (opposite profiles but still within the specifications) resulting in two different PK profile. What do you think about this method?

Yes, this is a sneaky attempt, one that I have mainly seen with innovator companies going generic when pipelines dry up. "Let us show the regulators that two Ref batches exists which are hardly BE to each other, let's demonstrate how wrong the requirements are, then they will agree with us and relax their requirements for our product", that kind of thing.

Tested and tried, and not a generally healthy way forward. I am not saying it will never work, but I am saying it does not generally work. A famous publication not too long ago was one by Elise B Getz and colleagues from Oriel who went that way with DPI's containing Fp and Sx. This isn't for the fainthearted.

I would either give the regulators what they ask for, or fold my cards if that's not possible. At least some SA's are called for. Depending on your choices you risk getting stuck exactly where 20 other generic companies are currently stuck. Be very, very careful now.