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

posted by Helmut Homepage – Vienna, Austria, 2022-01-28 21:06 (159 d 20:56 ago) – Posting: # 22758
Views: 600

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 🖖 [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
22,193 posts in 4,651 threads, 1,574 registered users;
online 8 (2 registered, 6 guests [including 6 identified bots]).
Forum time: Thursday 19:02 CEST (Europe/Vienna)

Any sufficiently advanced technology
is indistinguishable from magic.    Arthur C. Clarke

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