Bioequivalence and Bioavailability Forum

Dear Sandeep,

in the recent past regulators generally became more and more strict. One the other hand see this thread.

❝ Say for e.g. if the 90% CI upper limit is 125.51.

You can try. If the metric was AUC and the acceptance range was fixed at 80.00–125 % in the protocol I’m afraid cards are stacked against you. If the PE was not too far away from 1 (=the study likely failed due to higher CV than anticipated) you may consider repeating it in a larger sample size. If you wait until getting a deficiency letter your timeframe will be rather close.
If the metric was C_max and the study is not intended for submission in the US, EU, Australia, or New Zealand, you have more headroom for starting an argument (some countries still accept a range wider than 80.00–125 %). Even if not stated in the protocol, try to get some references on safety (because upper CL > upper AL). Discuss the relevance.

Good luck.