Bioequivalence and Bioavailability Forum

Hi Forum Members,

Hope all are doing well...

As per USFDA NTI Criteria, the drug has to pass the full NTI Criteria i.e., Average Equivalence, 95% Upper bound criteria and Within test vs Reference 90% CI Upper limit should be less than 2.5

Coming to my drug here, it has been recently set to NTI criteria

As per the Draft guidance we have conducted Full replicate design and now we got to know to know that study has lost his NTI Criteria i.e., 95% upper bound.

But if i see the T/R Ratios were better than that of the marketed drug and we are confident about it

is there any way to justify that and get a waiver from NTI Criteria?


Thanks and Regards,
Sury

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Edit: Category changed; see also this post #1. [Mittyri]