posted by Helmut Homepage – Vienna, Austria, 2023-06-07 12:22 (373 d 04:17 ago) – Posting: # 23579
Views: 1,326

Hi Brus,

❝ But nothing is said about the option full-replicate 3-ways, 2-sequences: TRT / RTR,……

Stupid enough. We may run into trouble if we have to assess the study in a partial replicate design for ABE because \(\small{s_\text{wR} < 0.294}\). See this article. At a webinar in March 2023 I tried to ask Donald Schuirmann.
The 👨‍✈️ steering moderating the »Panel Dis­cus­sions« decided to ignore my question… Instead, the only question related to SABE was “How is a Highly Variable Drug defined?”, which Donald explained at great length. Oh dear, what a waste of time!

❝ … which does seem to be included in the guideline Statistical Approaches to Establishing Bio­equi­valence.

Pragmatic: This one is the newest one. ;-)

❝ Does this mean that this design can no longer be used?

I don’t see any reason for not doing so. Why should we use an inferior method in lieu of a better one? If in doubt, initiate a controlled correspondence with the [image].

Dif-tor heh smusma 🖖🏼 Довге життя Україна! [image]
Helmut Schütz

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

Complete thread:

UA Flag
 Admin contact
23,056 posts in 4,840 threads, 1,643 registered users;
133 visitors (0 registered, 133 guests [including 62 identified bots]).
Forum time: 16:39 CEST (Europe/Vienna)

Exploratory analysis: The art of finding a Rembrandt
in a Jackson Pollock.    Stephen Senn

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