FDA: NTID and “HVNTID” [Design Issues]

posted by Helmut Homepage – Vienna, Austria, 2020-03-13 10:35 (357 d 19:09 ago) – Posting: # 21265
Views: 1,782

Hi Pharma_88,

» » » Further, what is the BE limit for such drugs?
» »
» » It depends on \(\small{s_{wR}}\) observed in the study, i.e., reference-scaling is applied. Furthermore – irrespective of passing the scaled limits – the study has to pass 80.00–125.00% as well and the upper confidence limit of \(\small{\sigma_{wT}/\sigma_{wR}}\) has to be ≤2.5.
»
» its common for all NTI or its varies from drug to drug?

The former. Check the guidances I linked above. Maybe there are more, do your homework.

There are exceptions: “Highly variable narrrow therapeutic index drugs”. AFAIK:2×2×4 design, conventional ABE with 80.00–125.00%, upper CL of \(\small{\sigma_{wT}/\sigma_{wR}}\) ≤2.5.
Certain inclusion criteria to decrease risk of bleeding (prothrombin time and activated partial thromboplastin time within their normal ranges, creatinine clearance ≤50 mL/min).

Dif-tor heh smusma 🖖
Helmut Schütz
[image]

The quality of responses received is directly proportional to the quality of the question asked. 🚮
Science Quotes

Complete thread:

Activity
 Admin contact
21,370 posts in 4,463 threads, 1,495 registered users;
online 7 (0 registered, 7 guests [including 3 identified bots]).
Forum time: Saturday 05:44 CET (Europe/Vienna)

If debugging is the process of removing bugs,
then programming must be the process of putting them in.    Edsger W. Dijkstra

The Bioequivalence and Bioavailability Forum is hosted by
BEBAC Ing. Helmut Schütz
HTML5