Follow the guidance (if possible) [Power / Sample Size]

posted by Helmut Homepage – Vienna, Austria, 2022-01-31 00:52 (788 d 05:54 ago) – Posting: # 22763
Views: 1,738

Hi Sereng,

❝ What are the sample size “benefits” or “efficiencies” of undertaking this study as a replicate CO design (e.g., Test 50 x 2; Ref 50 x 2) versus a 2-way CO (Test 100 x 2; Ref 100 x 2). Any help would be much appreciated.


None. In both cases you risk a Refuse-to-Receive because you deviate from the guidance (recommending the 20 µg strength administered as a 60 µg dose). Theoretically you could deviate from the guidance if you have good reasons for doing so and initiate a Controlled Correspondence. However, I think your chance is close to nil because the guidance offers the option of biowaivers for the strengths 13, 25, 50, 75, 88, 100, 112, 125, 137, 150, and 175 µg. Only if you can’t perform a study with the 20 µg strength – because you don’t have in your line of strengths – you can give it a try.

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;
89 visitors (0 registered, 89 guests [including 10 identified bots]).
Forum time: 06:46 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