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

posted by Helmut Homepage – Vienna, Austria, 2018-01-19 13:21 (2312 d 01:37 ago) – Posting: # 18224
Views: 4,017

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).


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
23,029 posts in 4,834 threads, 1,644 registered users;
29 visitors (0 registered, 29 guests [including 4 identified bots]).
Forum time: 15:59 CEST (Europe/Vienna)

We must be careful not to confuse data with the abstractions
we use to analyze them.    William James

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