Sample Size Efficiency of 4-Period, 2-Seq, 2-Formulation Design [RSABE / ABEL]

posted by Helmut Homepage – Vienna, Austria, 2022-01-28 22:06 (790 d 09:41 ago) – Posting: # 22758
Views: 1,459

Hi Sereng,

❝ […] The PSG also asks us to use the RSABE approach for properly adjusting the BE acceptance criteria based on "reference variability…


So far so good.

❝ … and comparing test and referenced product within-subject variability".


That’s rather unusual. Can you post a link to the guidance?

❝ Can we safely assume that conducting such a replicate study would (at least) reduce our sample size by 50% over a 2-Period, 2-Sequence, 2-Formulation BE study?


No, that’s wrong. See there.

❝ […] would there be any additional sample size efficiency arising from the use of the RSABE?


The idea behind RSABE is to maintain power independent from the CV.

Dif-tor heh smusma 🖖🏼 Довге життя Україна! [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
22,957 posts in 4,819 threads, 1,636 registered users;
97 visitors (0 registered, 97 guests [including 7 identified bots]).
Forum time: 07:48 CET (Europe/Vienna)

With four parameters I can fit an elephant,
and with five I can make him wiggle his trunk.    John von Neumann

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