Bioequivalence and Bioavailability Forum

Hi arl_stat.

❝ The BE criteria for NTI drugs is 90-111%.

That's only true if you aim for Europe (EMA) or regulatory bodies which use similar recommendations.

For the FDA the story is different. They recommend RSABE for NTIDs. Search the forums category [RSABE / ABEL] or search the whole forum for "FDA NTID".

❝ It is expected to have a low variability for NTI drugs.

Not always. See f.i. this post with at least moderate variabilities for Cmax of NTIDs.

❝ What is the BE criteria for known NTI drugs who possess moderate to high variability?

The EMA doesn't make a distinction based on variability in their NTID criteria.

For the FDA the story is again different.
See the warfarin guidance for NTIDs with low variability.

See the dabigatran guidance for NTIDs with moderate to high variabilities. See also this thread wich discussed that topic.