NTI Criteria Waiver [Study As­sess­ment]

posted by sury – India, 2018-12-24 07:04 (1007 d 01:38 ago) – Posting: # 19711
Views: 1,633

(edited by mittyri on 2018-12-24 11:21)

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As per the Draft guidance we have conducted Full replicate design and now we got to know to know that study has lost his NTI Criteria i.e., 95% upper bound.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

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

Complete thread:

 Admin contact
21,700 posts in 4,538 threads, 1,542 registered users;
online 10 (0 registered, 10 guests [including 6 identified bots]).
Forum time: Sunday 09:43 CEST (Europe/Vienna)

A central lesson of science is that to understand complex issues
(or even simple ones), we must try to free our minds of dogma and
to guarantee the freedom to publish, to contradict, and to experiment.
Arguments from authority are unacceptable.    Carl Sagan

The Bioequivalence and Bioavailability Forum is hosted by
BEBAC Ing. Helmut Schütz