NTIDs [RSABE / ABEL]

posted by Helmut Homepage – Vienna, Austria, 2022-01-29 12:19 (118 d 04:38 ago) – Posting: # 22760
Views: 512

Hi Najib,

» […] one PSG asks you to refer to the second, …

The Draft Guidance on Warfarin Sodium of 2012 was the first describing the FDA’s method of reference-scaling for NTIDs. All later ones refer to the first and state

For details about the Method for Statistical Analysis Using the Reference-Scaled Average Bioequivalence Approach for narrow therapeutic index drugs, refer to the Guidance on Warfarin Sodium Tablets.


For the sample size estimation see there (including examples and references).

Dif-tor heh smusma 🖖 [image]
Helmut Schütz
[image]

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

Complete thread:

UA Flag
Activity
 Admin contact
22,108 posts in 4,630 threads, 1,567 registered users;
online 7 (0 registered, 7 guests [including 5 identified bots]).
Forum time: Friday 17:57 CEST (Europe/Vienna)

We absolutely must leave room for doubt
or there is no progress and no learning.
There is no learning without having to pose a question.
And a question requires doubt.
People search for certainty.
But there is no certainty.    Richard Feynman

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