TSD: BE in stage 1 [Power / Sample Size]

posted by Helmut Homepage – Vienna, Austria, 2018-01-19 13:21 (2583 d 21:19 ago) – Posting: # 18224
Views: 4,459

Hi Yura,

❝ If in carrying out a two-stage design in the first stage with N = 20 subjects bioequivalence is shown, what should be done with the second stage?


Open a bottle of champagne, since there is no need for a second stage (see the left branches of the flowcharts in this post). BTW, all of my TSDs passed in the 1st:-D
AFAIK, only the Indonesian agency requires a “second stage” in such a case for reasons I fail to comprehend. Think about a fixed-sample study which passed BE: would anybody ask for another one? IIRC, ElMaestro wrote a paper* about it (I’m traveling and can’t check).


Edit:

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
23,380 posts in 4,914 threads, 1,665 registered users;
83 visitors (0 registered, 83 guests [including 5 identified bots]).
Forum time: 10:41 CET (Europe/Vienna)

When people learn no tools of judgment
and merely follow their hopes,
the seeds of political manipulation are sown.    Stephen Jay Gould

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